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Preview Full Doc	2003	Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency (6K) Doc #298496: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}ex-991.txt {TEXT} EXHIBIT 99.1 03/CAT/13 Page 1 of 3 FOR IMMEDIATE RELEASE 15.00 BST, 10.00 EST, Friday 23 May 2003 For further information contact: Cambridge Antibody Technology Weber Shandwick Square Mile (Europe) -------------------------------- ------------------------------------ Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700 Peter Chambre, Chief Executive Officer Graham Herring John Aston, Chief Financial Officer Kevin Smith Rowena Gardner, Director of Corporate Communications BMC Communications/The Trout Group (USA) ---------------------------------------- Tel: 001 212 477 9007 Brad Miles, ext 17 (media) Brandon Lewis, ext.15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY REPORTS GRANTING OF POSITIVE OPINION FOR HUMIRATM BY EUROPEAN MEDICINES EVALUATION AGENCY Cambridge, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today acknowledges the announcement by Abbott Laboratories that the European Medicines Evaluation Agency (EMEA) has granted a positive opinion on HUMIRA(TM) (adalimumab, previously known as D2E7) for the treatment of rheumatoid arthritis (RA). HUMIRA was isolated and optimised by CAT and Abbott Laboratories as part of a broad scientific collaboration. Abbott Laboratories filed for European Union (EU) approval in April 2002. In an announcement dated 22 May 2003, Abbott Laboratories stated that the European Commission (EC) is expected to issue an authorization for marketing HUMIRA in EU countries in approximately 90 days. HUMIRA will be sent to pharmacies in Germany and the UK within two weeks of receipt of the marketing authorization. CAT will receive royalties on the sales of HUMIRA. In addition, approval in a country other than the US will trigger a milestone payment to CAT from Abbott Laboratories. {PAGE} Page 2 of 3 Abbott Laboratories reported that the positive opinion on HUMIRA, granted through the EMEA's Committee for Proprietary Medicinal Products (CPMP), was based on data obtained in four controlled clinical trials. In total, 23 trials have been conducted with HUMIRA, involving more than 2,400 RA patients worldwide. Abbott Laboratories also stated that HUMIRA will become the first human monoclonal antibody approved in Europe for RA, and the first tumour necrosis factor alpha (TNF-(alpha)) antagonist approved with an indication for use with methotrexate or as monotherapy. HUMIRA is indicated for the treatment of moderate to severe active RA when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. To ensure maximum efficacy, HUMIRA is given in combination with methotrexate. HUMIRA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. As set out in CAT's interim results for the six months ended 31 March 2003, CAT's entitlement to royalties in relation to sales of Humira is governed by an agreement dated 1 April 1995 between Cambridge Antibody Technology Limited and Knoll Aktiengesellschaft (now a subsidiary of Abbott Laboratories). The agreement allows for offset, in certain circumstances, of royalties due to third parties against royalties due to CAT, subject to a minimum royalty level. Abbott indicated to CAT in March 2003 its wish to initiate discussions regarding the applicability of these royalty offset provisions for Humira. CAT believes strongly that the offset provisions do not apply and will seek an outcome consistent with that position. - ENDS - Notes to Editors Cambridge Antibody Technology (CAT): o CAT is a UK-based biotechnology company using its proprietary technologies and capabilities in human monoclonal antibodies for drug discovery and drug development. Based near Cambridge, England, CAT currently employs around 290 people. o CAT is a leader in the discovery and development of human therapeutic antibodies and has an advanced proprietary platform technology for rapidly isolating human monoclonal antibodies using phage display systems. CAT has extensive phage antibody libraries, currently incorporating more than 100 billion distinct antibodies. These libraries form the basis for the Company's strategy to develop a portfolio of antibody-based drugs. o HumiraTM is the leading CAT-derived antibody. Six other CAT-derived human therapeutic antibodies are at various stages of clinical trials. {PAGE} Page 3 of 3 o CAT has alliances with a large number of pharmaceutical and biotechnology companies to discover, develop and commercialise human monoclonal antibody-based products. CAT has also licensed its proprietary human phage antibody libraries to several companies for target validation and drug discovery. CAT's collaborators include: Abbott, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome Sciences, Merck & Co, Pharmacia and Wyeth Research. o CAT is listed on the London Stock Exchange and on NASDAQ since June 2001. CAT raised(pound)41m in its IPO in March 1997 and(pound)93m in a secondary offering in March 2000. Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward looking statements are based on numerous assumptions regarding CAT's present and future business strategies and the environment in which CAT will operate in the future. Certain factors that could cause CAT's actual results, performance or achievements to differ materially from those in the forward looking statements include: market conditions, CAT's ability to enter into and maintain collaborative arrangements, success of product candidates in clinical trials, regulatory developments and competition. {/TEXT} {/DOCUMENT} 298496	Wyeth Wyeth As referenced in this Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency: Wyeth – for target validation and drug discovery. CAT's collaborators include: Abbott, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome Sciences, Merck & Co, Pharmacia and Wyeth Research. o CAT is listed on the London Stock Exchange and on NASDAQ since June 2001. CAT raised(pound)41m in its IPO _____________ dt 264741 ; Abbott Labs Abbott Laboratories ( Pharmaceutical Preparations ) As referenced in this Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency: Abbott Laboratories – POSITIVE OPINION FOR HUMIRATM BY EUROPEAN MEDICINES EVALUATION AGENCY Cambridge, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today acknowledges the announcement by Abbott Laboratories that the European Medicines Evaluation Agency (EMEA) has granted a positive opinion on HUMIRA(TM) (adalimumab, previously known as D2E7) for the treatment _____________ Abbott Laboratories – on HUMIRA(TM) (adalimumab, previously known as D2E7) for the treatment of rheumatoid arthritis (RA). HUMIRA was isolated and optimised by CAT and Abbott Laboratories as part of a broad scientific collaboration. Abbott Laboratories filed for European Union (EU) approval in April 2002. In an announcement dated 22 _____________ Abbott Laboratories – the treatment of rheumatoid arthritis (RA). HUMIRA was isolated and optimised by CAT and Abbott Laboratories as part of a broad scientific collaboration. Abbott Laboratories filed for European Union (EU) approval in April 2002. In an announcement dated 22 May 2003, Abbott Laboratories stated that the European _____________ Abbott Laboratories – of a broad scientific collaboration. Abbott Laboratories filed for European Union (EU) approval in April 2002. In an announcement dated 22 May 2003, Abbott Laboratories stated that the European Commission (EC) is expected to issue an authorization for marketing HUMIRA in EU countries in approximately 90 days. HUMIRA _____________ Abbott Laboratories. – on the sales of HUMIRA. In addition, approval in a country other than the US will trigger a milestone payment to CAT from Abbott Laboratories. {PAGE} Page 2 of 3 Abbott Laboratories reported that the positive opinion on HUMIRA, granted through the EMEA's Committee for Proprietary _____________ dt 264532 ; CATG Cambridge Antibody Technology Group plc ( Commercial Physical & Biological Research ) As referenced in this Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency: Cambridge Antibody Technology Group – in March 2000. Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward _____________ dt 264925 ;	Human Genome Human Genome Sciences Inc. ( In Vitro & In Vivo Diagnostic Substances ) As referenced in this Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency: Human Genome Sciences, – human phage antibody libraries to several companies for target validation and drug discovery. CAT's collaborators include: Abbott, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome Sciences, Merck & Co, Pharmacia and Wyeth Research. o CAT is listed on the London Stock Exchange and on NASDAQ since June 2001. CAT _____________ dt 262223 ; Merck Merck & Co., Inc. ( Pharmaceutical Preparations ) As referenced in this Cambridge Antibody Technology Reports Granting of Positive Opinion for Humiratm by European Medicines Evaluation Agency: Merck – libraries to several companies for target validation and drug discovery. CAT's collaborators include: Abbott, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome Sciences, Merck & Co, Pharmacia and Wyeth Research. o CAT is listed on the London Stock Exchange and on NASDAQ since June 2001. CAT raised( _____________ dt 261913
Full Doc	2003	Proposed Merger of CAT and OGS Proposed Merger of CAT and OGS (105K) Doc #298519: This document is immediately available for purchase, but does not have a preview available for viewing. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}exh991.txt {TEXT} EXHIBIT 99.1 23 January 2003 Not for release, publication or distribution in, into or from Australia, Canada or Japan CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC ("CAT") AND OXFORD GLYCOSCIENCES PLC ("OGS") --------------------------------------------------------- PROPOSED MERGER OF CAT AND OGS The Boards of CAT and OGS announce that they have agreed the terms of a recommended merger to create a leading European biotechnology company combining the key strengths of the two organisations. Rationale for the Merger The Merger will create an enlarged entity with greater scientific, organisational and financial resources. In particular: o the Enlarged Group will have a stronger and broader portfolio, with two approved products, seven additional products in clinical trials and seven pre-clinical products; o the Merger will significantly strengthen the Enlarged Group's core capabilities in research and development by combining CAT's leading human monoclonal antibody product development expertise with OGS' oncology drug discovery capabilities and target pool and by increasing the breadth of the discovery and pre-clinical portfolios; o the Enlarged Group will have substantially greater financial strength. This will increase the ability to fund product development to later stages, thereby retaining greater value, and reduce the need for additional capital. Pro-forma net cash was (pound)260.1 million as at 31 December 2002; and o cost savings based on the removal of duplicated activities have been identified in the areas of corporate overhead, R&D and real estate. These savings are expected to have a cash effect of approximately (pound)10 million in the first full financial year following completion of the Merger. In addition, further savings are expected from a portfolio review to focus R&D expenditure on the highest quality projects. The results of this review will be announced in November 2003. Terms of the Merger The Merger of CAT and OGS will be effected by way of a scheme of arrangement under section 425 of the Companies Act. Upon completion of the Merger, OGS Shareholders will receive: for each OGS Share 0.3620 New CAT Shares Holders of OGS ADSs will receive: 1 {PAGE} for each OGS ADS 0.3620 New CAT ADSs o Based upon CAT's share price of 540.0 pence, being the Closing Price of a CAT Share on 22 January 2003, the last Business Day prior to this announcement, the Merger values each OGS Share at 195.5 pence, and the entire issued and to be issued share capital of OGS at approximately (pound)109.6 million. This represents a premium of 28.2 per cent. over the Closing Price of 152.5 pence per OGS Share. o Based on the volume weighted average trading price of CAT Shares in the last ten Business Days prior to this announcement of 581.7 pence, the Merger values each OGS Share at 210.6 pence and the entire issued and to be issued share capital of OGS at approximately (pound)118.2 million. This represents a premium of 43.3 per cent. over the volume weighted average trading price of OGS Shares in the last ten Business Days prior to this announcement of 147.0 pence per OGS Share. o Following completion of the Merger, which is expected to occur in March 2003, and based on the current issued share capital of each company, CAT Shareholders will hold approximately 64.3 per cent. and OGS Shareholders will hold approximately 35.7 per cent. of the issued share capital of CAT. o CAT has received irrevocable undertakings from those OGS Directors who hold OGS Shares (other than Dr Drakeman*) representing in aggregate 273,843 OGS Shares, or approximately 0.5 per cent. of the issued share capital of OGS, under which they have agreed to vote in favour of the resolutions to implement the Merger. o CAT has also received non-binding letters of intent to vote in favour of the resolutions to implement the Merger from Invesco Asset Management Limited and Fidelity Investments International Limited in respect of a total of 16,021,763 OGS Shares, representing approximately 28.7 per cent. of the issued share capital of OGS. o The Merger is subject to the conditions set out in Appendix I, including, amongst other things, the approval of the Merger by shareholders of both CAT and OGS, the obtaining of relevant regulatory consents and the sanction of the Scheme by the Court. Proposed Board and management team o Following completion of the Merger, CAT will continue to be chaired by Professor Peter Garland. Peter Chambre and John Aston will remain Chief Executive Officer and Chief Financial Officer respectively. o Dr David Ebsworth, currently Chief Executive Officer of OGS, will be invited to join the CAT Board as an executive director to assist in the integration process. It is the intention of both CAT and Dr Ebsworth that, after completion of that process, he will remain on the CAT Board as a non-executive director. o Dr David Glover, who will remain as Chief Medical Officer of CAT, will co-chair the portfolio review of the Enlarged Group with Professor Raj Parekh, currently Chief Scientific Officer of OGS. Professor Parekh will be invited to join the CAT Board as an executive director upon completion of the Merger and it is the intention of both CAT and Professor Parekh that, following the completion of the portfolio review, he will remain on the CAT Board as a non-executive director. 2 {PAGE} o Dr James Hill, currently a non-executive director of OGS, will be invited to join the CAT Board as a non-executive director. o Dr Chris Moyses, currently Chief Medical Officer of OGS, and Denis Mulhall, currently Chief Financial Officer of OGS, will be invited to join the CAT Executive Committee. 298519	Wyeth Wyeth As referenced in this Proposed Merger of CAT and OGS: /Wyeth – 152 - Scarring post glaucoma Phase III surgery CAT-192 Genzyme Scleroderma Phase I/II CAT-213 - Allergic disorders Phase I/II J695 Abbott/Wyeth Rheumatoid arthritis Phase II Crohn's disease Phase II LymphoStat-BTM HGSI Systemic lupus Phase I erythematosus TRAIL-R1 mAb HGSI Cancer _____________ Wyeth – diseases Pre-clinical OGT 2378 - Cancer Pre-clinical TRAIL-R2 mAb HGSI Cancer Pre-clinical MDX-OGS 001 Medarex Cancer Pre-clinical Undisclosed Wyeth Undisclosed Pre-clinical Undisclosed HGSI Undisclosed Pre-clinical Undisclosed Undisclosed Undisclosed Pre-clinical --------------------------------------------------------------------------------------------------- {/TABLE} (1) Also in development for psoriasis, psoriatic arthropathy _____________ Wyeth – alliances in place with established pharmaceutical and biotechnology companies. Present partners include Abbott Laboratories, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck, Pharmacia and Wyeth Research. CAT completed its initial public offering and listing on the London Stock Exchange in March 1997, raising (pound)41 million. In April _____________ Wyeth. – clinical trials. OGS has a leading proteomics business which has several collaborations with partners including Bayer, GSK, Pfizer, Pioneer Hi-Bred/DuPont and Wyeth. In addition it has a joint venture, Confirmant Limited, to develop the protein atlas of the human genome. OGS receives royalties for _____________ "Wyeth – member of the OGS Group is interested or any undertaking in which OGS and such undertakings (aggregating their interests) have a Substantial Interest. "Wyeth Research" or "Wyeth" Wyeth Ayerst Research, a division of Wyeth Pharmaceuticals, Inc. "Xoma" Xoma Technology Limited and Xoma Ireland Limited. For the purposes _____________ dt 264748 ; Abbott Labs Abbott Laboratories ( Pharmaceutical Preparations ) As referenced in this Proposed Merger of CAT and OGS: Abbott Laboratories, – from research collaborations and licensing of its technologies. HumiraTM, the most advanced CAT-derived human monoclonal antibody, isolated and optimised in collaboration with Abbott Laboratories, has been approved by the FDA for marketing in the US as a treatment for rheumatoid arthritis and was filed by Abbott _____________ Abbott Laboratories, – at various stages of clinical trials. CAT has a number of alliances in place with established pharmaceutical and biotechnology companies. Present partners include Abbott Laboratories, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck, Pharmacia and Wyeth Research. CAT completed its initial public offering and listing on the London _____________ Abbott Laboratories – and licensees in the 2003 financial year are expected to be at least comparable to the 2002 financial year. On 31 December 2002, Abbott Laboratories announced that it had received FDA approval to market Humira for the treatment of rheumatoid arthritis in the US. This approval was received _____________ "Abbott Laboratories" – and OGS Shares in the last ten Business Days prior to this announcement have been sourced from Bloomberg. 25 {PAGE} APPENDIX III Definitions "Abbott Laboratories" or "Abbott" Abbott GmbH & Co. KG. "Actelion" Actelion Pharmaceuticals Ltd. "Admission" the admission of the New CAT Shares to the Official List _____________ dt 264536 ; Amgen Amgen, Inc. As referenced in this Proposed Merger of CAT and OGS: Amgen, – stages of clinical trials. CAT has a number of alliances in place with established pharmaceutical and biotechnology companies. Present partners include Abbott Laboratories, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck, Pharmacia and Wyeth Research. CAT completed its initial public offering and listing on the London Stock _____________ "Amgen" – shares to the London Stock Exchange's market for listed securities becoming effective. "ADR" an American depositary receipt. "ADS" an American depositary share. "Amgen" Amgen Inc. "Australia" the Commonwealth of Australia, its states, territories and possessions and all areas subject to its jurisdiction or any political _____________ Amgen – to the London Stock Exchange's market for listed securities becoming effective. "ADR" an American depositary receipt. "ADS" an American depositary share. "Amgen" Amgen Inc. "Australia" the Commonwealth of Australia, its states, territories and possessions and all areas subject to its jurisdiction or any political sub-division _____________ dt 264842 ;	Bayer Bayer AG ( Biotechnology & Drugs ) As referenced in this Proposed Merger of CAT and OGS: Bayer AG. – the Commonwealth of Australia, its states, territories and possessions and all areas subject to its jurisdiction or any political sub-division thereof. "Bayer" Bayer AG. "Board" the board of directors of CAT or OGS, as the context requires. "Business Day" a day (not being a Saturday or _____________ dt 264587 ; CATG Cambridge Antibody Technology Group plc ( Commercial Physical & Biological Research ) As referenced in this Proposed Merger of CAT and OGS: CAMBRIDGE ANTIBODY TECHNOLOGY GROUP – exh991.txt {TEXT} EXHIBIT 99.1 23 January 2003 Not for release, publication or distribution in, into or from Australia, Canada or Japan CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC ("CAT") AND OXFORD GLYCOSCIENCES PLC ("OGS") --------------------------------------------------------- PROPOSED MERGER OF CAT AND OGS The Boards of CAT and OGS announce that they have _____________ CAMBRIDGE ANTIBODY TECHNOLOGY GROUP – 44 20 7638 1554). 5 {PAGE} 23 January 2003 Not for release, publication or distribution in, into or from Australia, Canada or Japan CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC ("CAT") AND OXFORD GLYCOSCIENCES PLC ("OGS") -------------------------------------------------------- PROPOSED MERGER OF CAT AND OGS 1. Introduction The Boards of CAT and OGS announce that _____________ Cambridge Antibody Technology Group – of the Euro. "Canada" Canada, its provinces, territories and possessions and all areas subject to its jurisdiction or any political subdivision thereof. "CAT" Cambridge Antibody Technology Group plc. "CAT ADSs" ADSs of CAT, each of which represents one Existing CAT Share. "CAT Board" the board of directors of CAT. "CAT _____________ dt 264939 ; Dyax Dyax Corp. ( Commercial Physical & Biological Research )
Preview Full Doc	2003	Elan Seeks Binding Arbitration Regarding Agreement with Pfizer Elan Seeks Binding Arbitration Regarding Agreement with Pfizer (4K) Doc #302588: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}elan6k121203ex99-1.txt {DESCRIPTION}PRESS RELEASE {TEXT} Exhibit 99.1 FOR IMMEDIATE RELEASE Investors: Media: Emer Reynolds Anita Kawatra Ph: 353-1-709-4000 Ph: 212-407-5755 800-252-3526 800-252-3526 ELAN SEEKS BINDING ARBITRATION REGARDING AGREEMENT WITH PFIZER Elan reaffirms commitment to groundbreaking Alzheimer's research DUBLIN, IRELAND, Dec. 11, 2003 - Elan Corporation, plc announced today that it is seeking binding arbitration in connection with a dispute regarding its Exclusive and Mutual Beta Secretase Inhibitors Research, Development and Marketing Agreement (the "Agreement") with Pfizer Inc. The Agreement, originally entered into with Pharmacia Corporation in August 2000, concerns the discovery of small molecule inhibitors of beta secretase at the research stage for the treatment of Alzheimer's disease. The binding arbitration is based on Elan's termination of the Agreement for cause due to certain breaches by Pfizer. As a result of the termination, Elan believes that it holds the exclusive worldwide license to the intellectual property developed in connection with the beta secretase research program. "Prior to taking this step we made every effort to come to a mutually acceptable resolution that would enable us to move forward either with Pfizer or independently," said Kelly Martin, Elan President and Chief Executive Officer. "Given the potential medical importance of the beta secretase program and our leadership position in Alzheimer's research and development, we will take the appropriate course of action to protect and enforce our rights under the Agreement. As one of the world's leading companies dedicated to the treatment of Alzheimer's disease, Elan remains focused on changing the course of the disease in an effort to ultimately help millions of patients and their loved ones." In addition to its beta secretase research, Elan's Alzheimer's program includes a beta amyloid immunotherapy strategy, in collaboration with Wyeth, and research work on the development of {PAGE} inhibitors to gamma secretase, which, like beta secretase, is also associated with the development of the beta amyloid peptide. Neither its immunotherapy projects nor its gamma secretase research is affected by Elan's termination of the Pfizer collaboration. About Elan Elan is focused on the discovery, development, manufacturing, sale and marketing of novel therapeutic products in neurology, severe pain and autoimmune diseases. Elan (NYSE: ELN) shares trade on the New York, London and Dublin Stock Exchanges. This document contains forward-looking statements about Elan's financial condition, results of operations and business prospects that involve substantial risks and uncertainties. You can identify these statements by the fact that they use words such as "anticipate", "estimate", "project", "envisage", "intend", "plan", "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance or events. Among the factors that could cause actual results to differ materially from those described herein are the following: the timing and outcome of Elan's binding arbitration with Pfizer Inc. regarding the beta secretase program; the success of Elan's research and development activities, including Elan's immunotherapy projects and its gamma secretase research, and the speed with which regulatory authorizations and product launches may be achieved; competitive developments affecting Elan's current products and products under development; the trend towards managed care and health care cost containment; possible legislation affecting pharmaceutical pricing; exposure to product liability and other types of lawsuits; and Elan's ability to protect its intellectual property. A further list and description of these risks, uncertainties and other matters can be found in Elan's Annual Report on Form 20-F for the fiscal year ended December 31, 2002, and in its Reports of Foreign Issuer on Form 6-K. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. {/TEXT} {/DOCUMENT} 302588	Wyeth Wyeth As referenced in this Elan Seeks Binding Arbitration Regarding Agreement with Pfizer: Wyeth, – loved ones." In addition to its beta secretase research, Elan's Alzheimer's program includes a beta amyloid immunotherapy strategy, in collaboration with Wyeth, and research work on the development of {PAGE} inhibitors to gamma secretase, which, like beta secretase, is also associated with the development _____________ dt 270129 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this Elan Seeks Binding Arbitration Regarding Agreement with Pfizer: Elan Corp – 252-3526 ELAN SEEKS BINDING ARBITRATION REGARDING AGREEMENT WITH PFIZER Elan reaffirms commitment to groundbreaking Alzheimer's research DUBLIN, IRELAND, Dec. 11, 2003 - Elan Corp oration, plc announced today that it is seeking binding arbitration in connection with a dispute regarding its Exclusive and Mutual Beta Secretase Inhibitors _____________ dt 271395 ;	Pfizer Pfizer, Inc. ( Pharmaceutical Preparations ) As referenced in this Elan Seeks Binding Arbitration Regarding Agreement with Pfizer: Pfizer Inc – binding arbitration in connection with a dispute regarding its Exclusive and Mutual Beta Secretase Inhibitors Research, Development and Marketing Agreement (the "Agreement") with Pfizer Inc . The Agreement, originally entered into with Pharmacia Corporation in August 2000, concerns the discovery of small molecule inhibitors of beta secretase at _____________ Pfizer Inc – cause actual results to differ materially from those described herein are the following: the timing and outcome of Elan's binding arbitration with Pfizer Inc . regarding the beta secretase program; the success of Elan's research and development activities, including Elan's immunotherapy projects and its gamma _____________ dt 272537 ; Pharmacia Pharmacia Corp. ( Pharmaceutical Preparations ) As referenced in this Elan Seeks Binding Arbitration Regarding Agreement with Pfizer: Pharmacia Corp – its Exclusive and Mutual Beta Secretase Inhibitors Research, Development and Marketing Agreement (the "Agreement") with Pfizer Inc. The Agreement, originally entered into with Pharmacia Corp oration in August 2000, concerns the discovery of small molecule inhibitors of beta secretase at the research stage for the treatment of Alzheimer' _____________ dt 274675
Preview Full Doc	2003	Elan Reports Second Quarter 2003 Financial Results Elan Reports Second Quarter 2003 Financial Results (68K) Doc #302623: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}elan6k091703ex.txt {DESCRIPTION}PRESS RELEASE {TEXT} EXHIBIT 99.1 FOR IMMEDIATE RELEASE Contacts: Investors: (U.S.) Investors: (Europe) Media: Jack Howarth Emer Reynolds Anita Kawatra Ph: 212-407-5740 Ph: 353-1-709-4000 Ph: 212-331-8800 800-252-3526 00800 28352600 800-252-3526 ELAN REPORTS SECOND QUARTER 2003 FINANCIAL RESULTS Dublin, Ireland, september 17, 2003-- Elan Corporation, plc (NYSE: ELN) ("Elan") today announced its second quarter 2003 financial results and provided an update on the progress of its product development activities and on its recovery plan. As previously announced on September 4, 2003, Elan filed with the Securities and Exchange Commission ("SEC") its 2002 Annual Report on Form 20-F which included a restatement of its 2001 U.S. GAAP financial results to consolidate Elan Pharmaceutical Investments III, Ltd. ("EPIL III"), and an adjustment to its previously reported unaudited U.S. GAAP financial information to consolidate Shelly Bay Holdings Ltd. and to reflect certain other adjustments. The analysis provided below reflects this restatement and the adjustments, which are detailed in Appendix 3. Commenting on the results and recovery plan Kelly Martin, Elan's President and Chief Executive Officer, said "Elan's second quarter results are characterized by solid progress with our operating plan, including asset divestitures, cost reductions, and debt reduction. We remain focused on executing our plans of improving and simplifying Elan's financial position, reducing historical legal and regulatory issues, investing in our exciting pipeline of products, and building world class operations aligned with our therapeutic focus areas of neurology, severe pain and autoimmune diseases. Our science continues to be the driver for our discovery and development programs providing the inspiration for the employees of Elan who have worked tirelessly to bring important products to patients". {PAGE} Elan Second Quarter 2003 Financial Results And Recovery Plan Update Page 2 Second Quarter 2003 Financial Highlights o Total revenue of $245.5 million compared to $451.6 million in the second quarter of 2002, a decrease of 46%. o Revenue from retained products (excluding Zanaflex(TM) revenue of $0.2 million in the second quarter of 2003 and $64.1 million in the second quarter of 2002) of $148.4 million compared to $138.4 million in the second quarter of 2002, an increase of 7%. o Negative EBITDA of $23.9 million (before including net gains on disposal of businesses and recovery plan related charges of $40.8 million) for the second quarter of 2003 compared to positive EBITDA of $54.5 million in the second quarter of 2002 (before charging recovery plan related charges of $235.4 million). (See "Non-GAAP Financial Information" on Appendix 2). o Net gain of $244.0 million recorded on disposal of non-core businesses (mainly primary care franchise) before charging $196.4 million related to purchase of related royalty rights from Pharma Operating Ltd. ("Pharma Operating"), a wholly owned subsidiary of Pharma Marketing Ltd. ("Pharma Marketing"). o Net income of $17.3 million ($0.05 earnings per diluted share) compared to net loss of $719.7 million ($2.06 loss per diluted share) in the second quarter of 2002. o Cash and cash equivalents at June 30, 2003 of $973.0 million (including $7.1 million in restricted cash held by EPIL III) compared to $1,013.9 million (including $8.9 million in restricted cash held by EPIL III) at December 31, 2002. R&D Update o An Investigational New Drug ("IND") application was filed with the U.S. Food and Drug Administration ("FDA") in August for the study of a monoclonal antibody as part of the Alzheimer's immunotherapy program. The antibody is being developed in close collaboration with Wyeth and is directed against A-beta amyloid and is intended for the treatment of mild to moderate Alzheimer's disease. The FDA has 30 days to comment on the submission after which, if the agency does not raise any major concerns, a phase I clinical trial can be initiated in the fourth quarter of this year. o In July, Elan together with Biogen, Inc. ("Biogen") announced that the Crohn's disease (induction) trial of Antegren(TM) (natalizumab) did not meet the primary outcome measure at {PAGE} Elan Second Quarter 2003 Financial Results And Recovery Plan Update Page 3 week 10. However, a statistically significant difference was observed at week 12. The data clearly showed biological activity similar to that seen in the Phase II study published in the New England Journal of Medicine earlier this year. o The Antegren data from the Crohn's disease (induction) trial will be presented in October at the American College of Gastroenterology 2003 Congress in Baltimore, Maryland and in November at the United European Gastroenterology Week 2003 Congress in Madrid, Spain. o Elan received approval from the FDA in August 2003 to market two new lower dosage strengths, 25 mg and 50 mg, of Zonegran(TM)(zonisamide) in addition to the original 100 mg capsule already available as adjunctive therapy for the treatment of partial seizures in adults with epilepsy. With the availability of the 25 mg and 50 mg strengths expected in the fourth quarter of this year, physicians now have the benefit of more flexible dosing options to better manage patients and achieve effective seizure control. The new lower dosage strengths will be manufactured by Elan at its facility in Athlone, Ireland. A European Marketing Authorization Application ("MAA") filing for Zonegran for use as adjunctive therapy in partial seizures is anticipated prior to the end of 2003. o Elan filed an MAA for Prialt(TM) for treatment of severe chronic pain in May 2003. The EMEA has accepted the file for review. Elan expects to file with the FDA a New Drug Application ("NDA") for Prialt in the first quarter of 2004. July 2002 Recovery Plan - Implementation Update o Consideration received to date from asset divestitures is in excess of $1.7 billion. The principal elements are as follows: $ million Primary Care Franchise 750.0 Abelcet(TM) 360.0 Investments 310.0 302623	Wyeth Wyeth As referenced in this Elan Reports Second Quarter 2003 Financial Results: Wyeth – the study of a monoclonal antibody as part of the Alzheimer's immunotherapy program. The antibody is being developed in close collaboration with Wyeth and is directed against A-beta amyloid and is intended for the treatment of mild to moderate Alzheimer's disease. The FDA has _____________ dt 270132 ; Biogen Biogen, Inc. As referenced in this Elan Reports Second Quarter 2003 Financial Results: Biogen, Inc – major concerns, a phase I clinical trial can be initiated in the fourth quarter of this year. o In July, Elan together with Biogen, Inc . ("Biogen") announced that the Crohn's disease (induction) trial of Antegren(TM) (natalizumab) did not meet the primary outcome measure at {PAGE} _____________ dt 276471 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this Elan Reports Second Quarter 2003 Financial Results: Elan Corp – 212-331-8800 800-252-3526 00800 28352600 800-252-3526 ELAN REPORTS SECOND QUARTER 2003 FINANCIAL RESULTS Dublin, Ireland, september 17, 2003-- Elan Corp oration, plc (NYSE: ELN) ("Elan") today announced its second quarter 2003 financial results and provided an update on the progress of its product _____________ dt 271416 ;	King Pharma King Pharmaceuticals Inc. As referenced in this Elan Reports Second Quarter 2003 Financial Results: King Pharmaceuticals, – franchise (principally its rights to Sonata(TM)(zaleplon) and Skelaxin(TM)(metaxalone), related inventory and rights to enhanced formulations of these products) to King Pharmaceuticals, Inc. The transaction resulted in a net pre-tax gain of approximately $243.6 million, before taking account of a $196.4 _____________ dt 273584 ; Ligand Pharma Ligand Pharmaceuticals, Inc. ( Pharmaceutical Preparations ) As referenced in this Elan Reports Second Quarter 2003 Financial Results: Ligand Pharmaceuticals, – to the partnering of rights to Elan's generic form of Adalat CC and the restructuring of Elan's Avinza license agreement with Ligand Pharmaceuticals, Inc. ("Ligand"), which occurred in 2002. The remaining unamortized revenue on these products of $120.2 million will be recognised as revenue _____________ dt 267912 ; Elan Pharmaceutical Investments III, Ltd.
Preview Full Doc	2003	Elan Completes Sale of Its Primary Care Franchise After Receiving Shareholder Approval Elan Completes Sale of Its Primary Care Franchise After Receiving Shareholder Approval (2K) Doc #302653: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.2 {SEQUENCE}4 {FILENAME}elan6k061303ex992.txt {DESCRIPTION}PRESS RELEASE - ELAN COMPLETES SALE {TEXT} Exhibit 99.2 FOR IMMEDIATE RELEASE Contacts: Investors: (U.S.) Investors: (Europe) Media: Jack Howarth Emer Reynolds Sunny Uberoi Ph: 212-407-5740 Ph: 353-1-709-4000 Ph: 212-994-8206 800-252-3526 00800 28352600 800-252-3526 ELAN COMPLETES SALE OF ITS PRIMARY CARE FRANCHISE AFTER RECEIVING SHAREHOLDER APPROVAL DUBLIN, Ireland, June 13, 2003 - Elan Corporation, plc (NYSE: ELN) ("Elan") today announced the completion of the sale of its primary care franchise (principally its rights to Sonata(TM)(zaleplon) and Skelaxin(TM)(metaxalone), related inventory and rights to enhanced formulations of these products) to King Pharmaceuticals, Inc. (NYSE: KG) ("King"). Elan has realized net cash proceeds of $314.5 million from the transaction, which was previously announced on May 20, 2003, after giving effect to the elimination of contractual and potential future payments relating to Sonata and Pharma Operating Ltd., a wholly owned subsidiary of Pharma Marketing Ltd., and a final payment by Elan to Wyeth in respect of Sonata. Elan's primary care sales team, consisting of approximately 350 personnel, will transfer their employment to King. All claims under the pending lawsuit between Elan and King, which had been suspended pending the closing of the transaction, will be dismissed by the parties with prejudice. At a special shareholders meeting held yesterday (the "Extraordinary General Meeting"), Elan's shareholders approved an ordinary resolution for the sale of the primary care franchise. Elan is focused on the discovery, development, manufacturing, selling and marketing of novel therapeutic products in neurology, pain management and autoimmune diseases. Elan shares trade on the New York, London and Dublin Stock Exchanges. {/TEXT} {/DOCUMENT} 302653	Wyeth Wyeth As referenced in this Elan Completes Sale of Its Primary Care Franchise After Receiving Shareholder Approval: Wyeth – payments relating to Sonata and Pharma Operating Ltd., a wholly owned subsidiary of Pharma Marketing Ltd., and a final payment by Elan to Wyeth in respect of Sonata. Elan's primary care sales team, consisting of approximately 350 personnel, will transfer their employment to King. All claims _____________ dt 270137 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this Elan Completes Sale of Its Primary Care Franchise After Receiving Shareholder Approval: Elan Corp – 3526 00800 28352600 800-252-3526 ELAN COMPLETES SALE OF ITS PRIMARY CARE FRANCHISE AFTER RECEIVING SHAREHOLDER APPROVAL DUBLIN, Ireland, June 13, 2003 - Elan Corp oration, plc (NYSE: ELN) ("Elan") today announced the completion of the sale of its primary care franchise (principally its rights to Sonata(TM)( _____________ dt 271434 ;	King Pharma King Pharmaceuticals Inc. As referenced in this Elan Completes Sale of Its Primary Care Franchise After Receiving Shareholder Approval: King Pharmaceuticals, – franchise (principally its rights to Sonata(TM)(zaleplon) and Skelaxin(TM)(metaxalone), related inventory and rights to enhanced formulations of these products) to King Pharmaceuticals, Inc. (NYSE: KG) ("King"). Elan has realized net cash proceeds of $314.5 million from the transaction, which was previously announced on _____________ dt 273586
Preview Full Doc	2003	Elan Announces Agreement with King to Settle Lawsuit Elan Announces Agreement with King to Settle Lawsuit (9K) Doc #302660: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}elan6k052003ex.txt {DESCRIPTION}PRESS RELEASE {TEXT} EXHIBIT 99.1 FOR IMMEDIATE RELEASE Contacts: Investors: (U.S.) Investors: (Europe) Media: Jack Howarth Emer Reynolds Sunny Uberoi Ph: 212-407-5740 Ph: 353-1-709-4000 Ph: 212-994-8206 800-252-3526 00800 28352600 800-252-3526 ELAN ANNOUNCES AGREEMENT WITH KING TO SETTLE LAWSUIT Agreement Clears Way for Completion of Sale of Primary Care Franchise DUBLIN, IRELAND, MAY 20, 2003 -- Elan Corporation, plc (NYSE: ELN) today announced that it has reached an agreement with King Pharmaceuticals, Inc. (NYSE: KG) ("King") to settle the pending lawsuit relating to the previously announced sale of Elan's primary care franchise (principally its rights to Sonata(TM)(zaleplon) and Skelaxin(TM)(metaxalone), related inventory and rights to enhanced formulations of these products) to King. Pursuant to the settlement, Elan and King have agreed to proceed with the primary care transaction on the terms outlined in this news release and suspend their lawsuit pending the closing of the transaction. Effective on the closing, all claims under the lawsuit will be released and the parties will dismiss the lawsuit with prejudice. Terms of Amended Transaction o Gross consideration to be paid by King on closing of approximately $750 million, which sum includes the transfer of Sonata and Skelaxin inventory with a value of $40 million and includes product related liabilities for Sonata of approximately $218 million to be assumed by King at closing (assuming a closing date of June 30, 2003). o Elan will receive an additional $25 million milestone payment on January 2, 2004, contingent on the ongoing patent exclusivity of Skelaxin. {PAGE} Elan Announces Agreement with King to Settle Lawsuit o Elan to receive payments of 5% of net sales of the current formulation of Skelaxin through December 31, 2005 and, thereafter, beginning in 2006 and continuing through December 3, 2021, Elan will receive payments of 10% of net sales of the current formulation of Skelaxin in excess of $50 million annually. o King to deposit $400 million in escrow to be released on the earlier of the closing of the transaction, termination of the revised agreement, subject to certain conditions, and October 24, 2003. o Elan to receive up to an additional $61 million in milestone payments (comprising up to $86 million in clinical, regulatory and sales milestones less up to $25 million in milestones that Elan is obligated to pay a third party) relating to the development of enhanced formulations of Sonata, contingent on the achievement of certain clinical and regulatory events. o King to offer employment to Elan's primary care employees (approximately 375 employees). After giving effect to the amended terms of the transaction, the closing of the primary care transaction will result in the following: o Cumulative consideration received by Elan from asset divestitures of approximately $1.6 billion. o Total contractual and potential future payments reported at March 31, 2003 have been reduced from approximately $3.1 billion to approximately $2.6 billion, reflecting the elimination of approximately $443 million of contractual and potential future payments related to Sonata and Pharma Operating Ltd. ("Pharma Operating"), a wholly-owned subsidiary of Pharma Marketing Ltd. ("Pharma Marketing"). o Total cash balances at March 31, 2003 increased by approximately $312 million to approximately $1.3 billion, reflecting net cash proceeds from the primary care transaction after giving effect to the elimination of contractual and potential future payments related to Sonata and Pharma Operating and a final payment of $20 million in respect of Sonata payable by Elan to Wyeth. o Transaction expected to result in a pre-tax gain of approximately $35 million, after taking account of a $200 million charge related to the purchase of royalty rights attaching to Sonata from Pharma Operating, the transfer of related inventory to King and transaction costs. {PAGE} Elan Announces Agreement with King to Settle Lawsuit Kelly Martin, President and Chief Executive Officer said, "The agreement to settle this lawsuit clears the way for us to close the sale of our primary care franchise to King. Moreover, the new, amended agreements enable us to participate in future revenue streams on sales of Skelaxin. The successful resolution of this matter will represent an excellent outcome for Elan and our shareholders." Martin concluded, "Upon closing, Elan will have exceeded its target of raising $1.5 billion from asset divestitures. We continue to move forward on multiple aspects of our recovery plan, including the advancement or our science and product development, the simplification of our balance sheet and the further adjustment of our operating construct in terms of costs, locations, personnel and strategic focus." Pharma Marketing As previously announced on January 30, 2003, Elan and Pharma Operating have agreed that, contingent on closing of the sale of Sonata, Elan expects, on the closing date, to pay Pharma Operating an estimated $200 million ($225 million less royalty payments on all related products paid or due to Pharma Operating from January 1, 2003 to the closing of the sale estimated at $25 million based on a closing date of June 30, 2003) to acquire the Pharma Operating royalty rights with respect to Sonata and the Prialt(TM) product. In addition, Elan will have an option to purchase Pharma Operating's royalty rights on the Zonegran(TM), Frova(TM) and Zanaflex(TM) products until January 3, 2005, an extension from the earlier option termination date of June 30, 2003. The current purchase option price has been reduced to $110 million plus 15% per annum from the earlier date of the Sonata sale closing or July 1, 2003, less royalty payments made for periods after the Sonata sale closing. {PAGE} Elan Announces Agreement with King to Settle Lawsuit Shareholder Approval and Closing Contingencies Elan has decided to seek shareholder approval for the amended primary care transaction at a special meeting to be held as soon as practicable. The transaction, which is expected to be completed prior to June 30, 2003, is subject to certain contingencies and other customary closing conditions, 302660	Wyeth Wyeth As referenced in this Elan Announces Agreement with King to Settle Lawsuit: Wyeth. – future payments related to Sonata and Pharma Operating and a final payment of $20 million in respect of Sonata payable by Elan to Wyeth. o Transaction expected to result in a pre-tax gain of approximately $35 million, after taking account of a $200 million charge _____________ dt 270138 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this Elan Announces Agreement with King to Settle Lawsuit: Elan Corp – ANNOUNCES AGREEMENT WITH KING TO SETTLE LAWSUIT Agreement Clears Way for Completion of Sale of Primary Care Franchise DUBLIN, IRELAND, MAY 20, 2003 -- Elan Corp oration, plc (NYSE: ELN) today announced that it has reached an agreement with King Pharmaceuticals, Inc. (NYSE: KG) ("King") to settle the pending _____________ dt 271437 ;	King Pharma King Pharmaceuticals Inc. As referenced in this Elan Announces Agreement with King to Settle Lawsuit: King Pharmaceuticals, – of Primary Care Franchise DUBLIN, IRELAND, MAY 20, 2003 -- Elan Corporation, plc (NYSE: ELN) today announced that it has reached an agreement with King Pharmaceuticals, Inc. (NYSE: KG) ("King") to settle the pending lawsuit relating to the previously announced sale of Elan's primary care franchise (principally _____________ dt 273588
Preview Full Doc	2003	Elan First Quarter 2003 Financial Results and Recovery Plan Update Elan First Quarter 2003 Financial Results and Recovery Plan Update (56K) Doc #302662: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}elan6k043003ex.txt {DESCRIPTION}PRESS RELEASE {TEXT} EXHIBIT 99.1 elan Corporate Bulletin FOR IMMEDIATE RELEASE Contacts: Investors: (U.S.) Investors: (Europe) Media: Jack Howarth Emer Reynolds Sunny Uberoi Ph: 212-407-5740 Ph: 353-1-709-4000 Ph: 212-994-8206 800-252-3526 00800 28352600 800-252-3526 ELAN FIRST QUARTER 2003 FINANCIAL RESULTS AND RECOVERY PLAN UPDATE Dublin, Ireland, April 30, 2003-- Elan Corporation, plc (NYSE: ELN) ("Elan") today announced its first quarter 2003 results and provided an update on its recovery plan. Commenting on the results and recovery plan Kelly Martin, Elan's president and chief executive officer, said, "Elan remains on course with its 18-month recovery plan. We further reduced costs during the quarter, which has put us closer toward our goal of operating Elan on a break-even basis prior to the launch of our new products." Martin continued, "Since announcing our recovery plan in July 2002, we continue to make progress in simplifying our balance sheet and increasing transparency. We enter the second quarter of 2003 with sales growth in our retained product portfolio and continued focus on executing our pipeline of products in the areas of neurology, autoimmune diseases and pain." Martin concluded, "While there is much to be done, we remain focused on executing our goals of simplifying Elan's balance sheet, streamlining our operational model and advancing our science and product development." {PAGE} Elan First Quarter 2003 Financial Results And Recovery Plan Update Page 2 First Quarter 2003 Financial Highlights o Total revenue of $260.0 million compared to $446.6 million in the first quarter of 2002, a decrease of 42%. o Revenue from retained products (excluding Zanaflex(TM) revenue of $0.8 million in the first quarter of 2003 and $53.7 million in the first quarter of 2002) of $148.8 million compared to $104.1 million in the first quarter of 2002, an increase of 43%. o Net loss of $130.2 million ($0.37 loss per diluted share) compared to net income of $50.0 million ($0.14 earnings per diluted share) in the first quarter of 2002. o Cash balances at March 31, 2003 of $983.6 million compared to $1,005.0 million at December 31, 2002. o Negative EBITDA of $67.1 million for the first quarter of 2003 compared to positive EBITDA of $47.2 million in the first quarter of 2002 (See "Non-GAAP Financial Information" on Appendix 2) Recovery Plan - Implementation Update o As at March 31, 2003, cash received from asset divestitures was in excess of $825.0 million. The principal elements are as follows: $ million Abelcet(TM) 360.0 Avinza(TM) 100.0 Athena Diagnostics 82.0 Actiq(TM) 50.0 Adalat(TM)CC 45.0 Investments 146.0 o Agreement to sell primary care franchise to King Pharmaceuticals, Inc. ("King") for gross consideration of approximately $850 million subject to previously announced litigation. o Additional asset divestitures and balance sheet simplification proceeding according to plan. o Headcount reduced to less than 3,150 employees from approximately 4,700 employees in July 2002, a decrease of approximately 1,550 (approximately 450] of which were related to asset divestitures). {PAGE} Elan First Quarter 2003 Financial Results And Recovery Plan Update Page 3 o Significant reduction of 29% in selling, general and administrative expenses in the first quarter of 2003 to $127.7 million from $178.7 million in the first quarter of 2002 (approximately $15.0 million of this reduction relates to asset divestitures). Recovery Plan - R&D Update o Antegren(TM) (natalizumab) Phase III trials for Crohn's disease and multiple sclerosis ("MS") progressing on target. o Expect to announce Phase III results for Antegren in Crohn's disease during the summer. o New Drug Application ("NDA") for Antegren in Crohn's disease expected to be filed around year-end. o Expect to file an NDA for Prialt(TM) around year-end. o Alzheimer's immunotherapeutic pre-clinical studies on track for two Investigational New Drug ("IND") filings this year. o With respect to Frova(TM), Dr Stephen Silberstein, Professor of Neurology at the Thomas Jefferson Hospital in Philadelphia, presented data from a double-blind, placebo-controlled, clinical trial of 545 women that showed Frova prevented menstrually-associated migraines in up to 50% of women in the trial. o One new trial with Zonegran(TM), which was undertaken by scientists at Duke University and published in the Journal of the American Medical Association on April 9, 2003, reported on the use of Zonegran in potentially inducing weight loss in obese adults. o Announced strategic research alliance with Ingenium Pharmaceuticals AG ("Ingenium") for the identification and development of novel therapeutics for pain management. 302662	Wyeth Wyeth As referenced in this Elan First Quarter 2003 Financial Results and Recovery Plan Update: Wyeth – with the implementation of the recovery plan of $13.0 million, and $16.5 million in connection with the restructuring of arrangements with Wyeth in relation to Sonata prior to Elan's agreement to sell the primary care franchise to King and the purchase of the Canadian _____________ Wyeth – loss in obese adults. {PAGE} Elan First Quarter 2003 Financial Results And Recovery Plan Update Page 16 Alzheimer's Immunotherapy Program Elan and Wyeth are making significant progress in the Alzheimer's immunotherapy program and have targeted two IND submissions from this program during 2003. These INDs _____________ Wyeth – program during 2003. These INDs include the previously announced monoclonal antibody program, as well as a novel immunotherapeutic Abeta peptide conjugate. Elan and Wyeth are leveraging the innovative conjugate technology that Wyeth uses in some of its other products. This conjugate is engineered to provide a strongly _____________ Wyeth – announced monoclonal antibody program, as well as a novel immunotherapeutic Abeta peptide conjugate. Elan and Wyeth are leveraging the innovative conjugate technology that Wyeth uses in some of its other products. This conjugate is engineered to provide a strongly immunogenic non-self T-cell epitope in concert _____________ dt 270140 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this Elan First Quarter 2003 Financial Results and Recovery Plan Update: elan Corp – {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}elan6k043003ex.txt {DESCRIPTION}PRESS RELEASE {TEXT} EXHIBIT 99.1 elan Corp orate Bulletin FOR IMMEDIATE RELEASE Contacts: Investors: (U.S.) Investors: (Europe) Media: Jack Howarth Emer Reynolds Sunny Uberoi Ph: 212-407-5740 Ph: _____________ Elan Corp – 800-252-3526 00800 28352600 800-252-3526 ELAN FIRST QUARTER 2003 FINANCIAL RESULTS AND RECOVERY PLAN UPDATE Dublin, Ireland, April 30, 2003-- Elan Corp oration, plc (NYSE: ELN) ("Elan") today announced its first quarter 2003 results and provided an update on its recovery plan. Commenting on the _____________ dt 271439 ; King Pharma King Pharmaceuticals Inc. As referenced in this Elan First Quarter 2003 Financial Results and Recovery Plan Update: King Pharmaceuticals, – Diagnostics 82.0 Actiq(TM) 50.0 Adalat(TM)CC 45.0 Investments 146.0 o Agreement to sell primary care franchise to King Pharmaceuticals, Inc. ("King") for gross consideration of approximately $850 million subject to previously announced litigation. o Additional asset divestitures and balance sheet simplification _____________ King Pharmaceuticals, – cash, liquid resources, and investments and other assets capable of being monetized to meet its liquidity requirements; the outcome of the litigation with King Pharmaceuticals, Inc. relating to the sale to King of Elan's primary care franchise, the timely completion of which is an important component _____________ dt 273590 ;	Ligand Pharma Ligand Pharmaceuticals, Inc. ( Pharmaceutical Preparations ) As referenced in this Elan First Quarter 2003 Financial Results and Recovery Plan Update: Ligand Pharmaceuticals, – to the partnering of rights to Elan's generic form of Adalat CC and the restructuring of Elan's Avinza license agreement with Ligand Pharmaceuticals, Inc., which occurred in 2002. The remaining unamortised revenue on these products of $128.7 million will be recognised as revenue over _____________ dt 267914 ; Duke Duke University ( Universities ) As referenced in this Elan First Quarter 2003 Financial Results and Recovery Plan Update: Duke University – migraines in up to 50% of women in the trial. o One new trial with Zonegran(TM), which was undertaken by scientists at Duke University and published in the Journal of the American Medical Association on April 9, 2003, reported on the use of Zonegran in potentially inducing _____________ Duke University – therapy in partial seizures is anticipated prior to the end of 2003. One new trial with Zonegran, which was undertaken by scientists at Duke University and published in the Journal of the American Medical Association on April 9, 2003, reported on the use of Zonegran in potentially inducing _____________ dt 270106
Full Doc	2004	Medimmune Incorporates Reacquisition of Flumist Franchise from Wyeth into Financial Guidance Medimmune Incorporates Reacquisition of Flumist Franchise from Wyeth into Financial Guidance (6K) Doc #272371: This document is immediately available for purchase, but does not have a preview available for viewing. MedImmune Inc EX-99 2 ex99_1guidupdtpr.htm UPDATED GUIDANCE PRESS RELEASE Exhibit 99.1 MEDIMMUNE INCORPORATES REACQUISITION OF FLUMIST FRANCHISE FROM WYETH INTO FINANCIAL GUIDANCE GAITHERSBURG, MD, April 27, 2004 MedImmune, Inc. (Nasdaq: MEDI) today announced that it is incorporating the reacquisition of the FluMist (Influenza Virus Vaccine Live, Intranasal) franchise from Wyeth into its financial guidance. In a press release issued yesterday, MedImmune and Wyeth announced the dissolution of their collaboration for FluMist and all related technologies, including the next generation of the vaccine, CAIV-T. We are very pleased to have completed our discussions with Wyeth on these matters, stated David M. Mott, MedImmunes president and chief executive officer. Wyeths exit from the collaboration for FluMist returns all rights to the vaccines franchise to MedImmune. As soon as we receive antitrust clearance, we look forward to transitioning activities from Wyeth and implementing the development and commercialization plan weve been working on for the last several months. Our expectation is that the foundation we are building now with FluMist and CAIV-T, in addition to other promising programs, will help us achieve our long-term goals of reaching $2 billion in revenues by 2009. Subject to obtaining necessary government approval, MedImmune will assume full responsibility for all sales, marketing, manufacturing and development activities for FluMist and CAIV-T. Wyeths early exit from the collaboration will result in MedImmune taking a one-time charge of approximately $73 million in the second quarter to write-off unamortized intangibles associated with the termination of the collaboration agreements. During 2004, MedImmune will also record non-recurring charges of approximately $30 million for newly acquired in-process research and development (IPR&D) costs, based upon a preliminary valuation of the transaction. As a convenience to investors, MedImmune is providing an update to its guidance. All guidance and objectives provided are projections and are based upon numerous assumptions, many of which MedImmune cannot control and that may not develop as MedImmune expects. Consequently, actual results may differ materially from the guidance and objectives described in this release. Please refer to the Disclosure Notice below. Guidance for the Year Ending December 31, 2004 o Revenues: projected to range from $1.11 billion to $1.15 billion o Product sales: approximately low double-digit increase over 2003 - Synagis: approximately 10 percent increase over 2003 - Ethyol: approximately 10 percent increase over 2003 o Total revenues associated with FluMist: $35 million to $45 million o Gross margins: approximately 67 percent o R&D: approximately 26 percent of product sales (or 21 percent, excluding about $40 million in non-recurring expenses and milestones associated with the Wyeth transition activities) o SG&A: approximately 36 percent of product sales o Tax rate: approximately 42 percent to 43 percent (or 37 percent, excluding approximately $5 million to $7 million of non-deductible IPR&D costs) o Diluted EPS: $0.06 to $0.12 (or diluted EPS of $0.42 to $0.49, excluding the estimated $30 million in non-recurring IPR&D costs; $40 million in non-recurring transition expenses; and $73 million for the one-time charge associated with the termination of the Wyeth collaboration) Guidance for the Quarter Ending June 30, 2004 o Revenues: projected to range from $90 million to $95 million o Loss per share: $0.48 to $0.52 (or loss per share of $0.17 to $0.21, excluding about $27 million in non-recurring IPR&D costs; $18 million in non-recurring transition expenses; and $73 million for the one-time charge associated with the termination of the Wyeth collaboration) Long-Term Financial Objectives o Reach approximately $2 billion in revenues in 2009 o Achieve five-year compound annual growth in EPS (before non-recurring IPR&D costs, non-recurring transition expenses and one-time charge) of approximately 35 percent from the 2004 guidance range of $0.42 to $0.49 Conference Call & Webcast MedImmunes management will discuss the dissolution of the companys collaborative agreements with Wyeth and the related financial impact on Tuesday, April 27, 2004 at 9:00 a.m. eastern time. A live webcast of this discussion may be accessed in the Investor Relations section of MedImmunes website, www.medimmune.com. A replay of the webcast will also be available via our website until May 4, 2004. An audio replay of the webcast will be available, beginning at 11:00 a.m. eastern time on April 27, 2004 and ending at midnight on May 4, 2004 by calling (888) 286-8010. The passcode for the audio replay is 71209217. About MedImmune MedImmune is a leading biotechnology company focused on researching, developing and commercializing products to prevent or treat infectious disease, autoimmune disease and cancer. MedImmune actively markets four products, Synagis (palivizumab), Ethyol (amifostine), FluMist (Influenza Virus Vaccine Live, Intranasal), and CytoGam (cytomegalovirus immune globulin intravenous (human)), and has additional products in clinical testing. MedImmune employs approximately 1,800 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom and the Netherlands. For more information on MedImmune and its products, visit the companys website at www.medimmune.com. DISCLOSURE NOTICE: This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect managements current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in the companys filings with the U.S. Securities and Exchange Commission. The company is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. _________________ 272371	Wyeth Wyeth As referenced in this Medimmune Incorporates Reacquisition of Flumist Franchise from Wyeth into Financial Guidance: WYETH – EX-99 2 ex99_1guidupdtpr.htm UPDATED GUIDANCE PRESS RELEASE Exhibit 99.1 MEDIMMUNE INCORPORATES REACQUISITION OF FLUMIST FRANCHISE FROM WYETH INTO FINANCIAL GUIDANCE GAITHERSBURG, MD, April 27, 2004 MedImmune, Inc. (Nasdaq: MEDI) today announced that it is incorporating the reacquisition of the FluMist ( _____________ Wyeth – 2004 MedImmune, Inc. (Nasdaq: MEDI) today announced that it is incorporating the reacquisition of the FluMist (Influenza Virus Vaccine Live, Intranasal) franchise from Wyeth into its financial guidance. In a press release issued yesterday, MedImmune and Wyeth announced the dissolution of their collaboration for FluMist and all _____________ Wyeth – of the FluMist (Influenza Virus Vaccine Live, Intranasal) franchise from Wyeth into its financial guidance. In a press release issued yesterday, MedImmune and Wyeth announced the dissolution of their collaboration for FluMist and all related technologies, including the next generation of the vaccine, CAIV-T. We are _____________ Wyeth – and all related technologies, including the next generation of the vaccine, CAIV-T. We are very pleased to have completed our discussions with Wyeth on these matters, stated David M. Mott, MedImmunes president and chief executive officer. Wyeths exit from the collaboration for FluMist returns all rights _____________ Wyeth – returns all rights to the vaccines franchise to MedImmune. As soon as we receive antitrust clearance, we look forward to transitioning activities from Wyeth and implementing the development and commercialization plan weve been working on for the last several months. Our expectation is that the foundation we _____________ dt 166977 ;	MedImmune MedImmune, Inc. ( Biological Products ) As referenced in this Medimmune Incorporates Reacquisition of Flumist Franchise from Wyeth into Financial Guidance: MEDIMMUNE INC – EX-99 2 ex99_1guidupdtpr.htm UPDATED GUIDANCE PRESS RELEASE Exhibit 99.1 MEDIMMUNE INC ORPORATES REACQUISITION OF FLUMIST FRANCHISE FROM WYETH INTO FINANCIAL GUIDANCE GAITHERSBURG, MD, April 27, 2004 MedImmune, Inc. (Nasdaq: MEDI) today announced that it _____________ MedImmune, Inc – UPDATED GUIDANCE PRESS RELEASE Exhibit 99.1 MEDIMMUNE INCORPORATES REACQUISITION OF FLUMIST FRANCHISE FROM WYETH INTO FINANCIAL GUIDANCE GAITHERSBURG, MD, April 27, 2004 MedImmune, Inc . (Nasdaq: MEDI) today announced that it is incorporating the reacquisition of the FluMist (Influenza Virus Vaccine Live, Intranasal) franchise from Wyeth into _____________ dt 180973
Preview Full Doc	2004	Neurocrine and Wyeth Satisfy Hart-Scott-Rodino Requirements for the Acquisition of Indiplon Royalty Stream Neurocrine and Wyeth Satisfy Hart-Scott-Rodino Requirements for the Acquisition of Indiplon Royalty Stream (3K) Doc #273577: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}7 {FILENAME}a97375exv99w1.txt {DESCRIPTION}EXHIBIT 99.1 {TEXT} {PAGE} EXHIBIT 99.1 FOR IMMEDIATE RELEASE: Claudia Jones or Elizabeth Foster 858-658-7600 NEUROCRINE AND WYETH SATISFY HART-SCOTT-RODINO REQUIREMENTS FOR THE ACQUISITION OF INDIPLON ROYALTY STREAM SAN DIEGO, CA, March 16, 2004 - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced the expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act in connection with the purchase from Wyeth (NYSE:WYE) all of Wyeth's financial interest in indiplon, Neurocrine's late stage Phase III compound for the treatment of insomnia. In addition to the requirements of the Hart-Scott-Rodino Act being met, Wyeth's Board of Directors has also approved this transaction. Neurocrine will now retain all milestone, royalty and other payments on indiplon commercialization that would have otherwise been payable to Wyeth. This also provides Neurocrine ownership and control over the indiplon composition of matter patent which expires in 2020. The transaction is valued at approximately $95 million, with $50 million payable in cash and $45 million payable in Neurocrine stock at the closing price of $56.04 per share, which was determined by a 15 day average price preceding the signing of the agreement. The stock has certain registration rights and otherwise will be salable under Rule 144 upon the termination of the applicable holding periods. With the requirements of the Hart-Scott-Rodino Act satisfied, Wyeth has assigned to Neurocrine its license agreement with DOV and all Wyeth's right, title and interest in and to the indiplon composition patent filed by Neurocrine in Wyeth's name. The financial interest in indiplon arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. in exchange for milestone payments and royalties on future sales of indiplon. Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com. -MORE- {PAGE} In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with Neurocrine's indiplon development program and business and finances including, but not limited to, risk that indiplon will not successfully proceed through Phase III clinical trials or that Phase III clinical trials will not show that it is safe and effective in treating humans; determinations by regulatory and governmental authorities; our reliance on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the Company's Form 10K for December 31, 2003. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof. # # # {/TEXT} {/DOCUMENT} 273577	Wyeth Wyeth As referenced in this Neurocrine and Wyeth Satisfy Hart-Scott-Rodino Requirements for the Acquisition of Indiplon Royalty Stream: WYETH – txt {DESCRIPTION}EXHIBIT 99.1 {TEXT} {PAGE} EXHIBIT 99.1 FOR IMMEDIATE RELEASE: Claudia Jones or Elizabeth Foster 858-658-7600 NEUROCRINE AND WYETH SATISFY HART-SCOTT-RODINO REQUIREMENTS FOR THE ACQUISITION OF INDIPLON ROYALTY STREAM SAN DIEGO, CA, March 16, 2004 - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) _____________ Wyeth – today announced the expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act in connection with the purchase from Wyeth (NYSE:WYE) all of Wyeth's financial interest in indiplon, Neurocrine's late stage Phase III compound for the treatment of insomnia. _____________ Wyeth' – the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act in connection with the purchase from Wyeth (NYSE:WYE) all of Wyeth' s financial interest in indiplon, Neurocrine's late stage Phase III compound for the treatment of insomnia. In addition to the requirements of _____________ Wyeth' – late stage Phase III compound for the treatment of insomnia. In addition to the requirements of the Hart-Scott-Rodino Act being met, Wyeth' s Board of Directors has also approved this transaction. Neurocrine will now retain all milestone, royalty and other payments on indiplon commercialization that _____________ Wyeth. – approved this transaction. Neurocrine will now retain all milestone, royalty and other payments on indiplon commercialization that would have otherwise been payable to Wyeth. This also provides Neurocrine ownership and control over the indiplon composition of matter patent which expires in 2020. The transaction is valued _____________ dt 183053 ; DOV Pharma DOV Pharmaceutical, Inc. ( Pharmaceutical Preparations ) As referenced in this Neurocrine and Wyeth Satisfy Hart-Scott-Rodino Requirements for the Acquisition of Indiplon Royalty Stream: DOV Pharmaceutical, – patent filed by Neurocrine in Wyeth's name. The financial interest in indiplon arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. in exchange for milestone payments and royalties on future sales of indiplon. Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company _____________ dt 206652 ;	Neurocrine Neurocrine Biosciences, Inc. ( Biological Products ) As referenced in this Neurocrine and Wyeth Satisfy Hart-Scott-Rodino Requirements for the Acquisition of Indiplon Royalty Stream: Neurocrine Biosciences, – 658-7600 NEUROCRINE AND WYETH SATISFY HART-SCOTT-RODINO REQUIREMENTS FOR THE ACQUISITION OF INDIPLON ROYALTY STREAM SAN DIEGO, CA, March 16, 2004 - Neurocrine Biosciences, Inc. (NASDAQ: NBIX) today announced the expiration of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act in connection _____________ Neurocrine Biosciences, – of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. in exchange for milestone payments and royalties on future sales of indiplon. Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the _____________ Neurocrine Biosciences, – markets in the world including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, stroke, and certain female health disorders. Neurocrine Biosciences, Inc. news releases are available through the Company's website via the Internet at http://www.neurocrine.com. -MORE- {PAGE} In addition _____________ dt 191295
Preview Full Doc	2004	Neurocrine Biosciences Acquires Wyeths Indiplon Royalty Stream Neurocrine Biosciences Acquires Wyeths Indiplon Royalty Stream (8K) Doc #273586: Click preview link for longer preview. Neurocrine Biosciences Inc pressrelease012904 EX-99 3 pressreleasewyeth.htm Exhibit 99.1 For Immediate Release Claudia Jones or Elizabeth Foster of Neurocrine Biosciences (858) 658-7600 NEUROCRINE BIOSCIENCES ACQUIRES WYETHS INDIPLON ROYALTY STREAM COMPANY TO HOST CONFERENCE CALL AND WEBCAST FRIDAY, FEBRUARY 27, 2004 San Diego, CA, February 26, 2004, - Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced it has purchased from Wyeth (NYSE:WYE) all of Wyeths financial interest in indiplon, Neurocrines late stage clinical development compound for the treatment of insomnia. Neurocrine will now retain all milestone, royalty and other payments on indiplon commercialization that would have otherwise been payable to Wyeth. The transaction also provides Neurocrine ownership and control over the indiplon composition of matter patent which expires in 2020. The transaction is valued at approximately $95 million, with $50 million payable in cash and $45 million payable in Neurocrine common stock at a 15 day average price preceding the signing of the agreement. The stock will have certain registration rights and otherwise be salable under Rule 144 upon the termination of applicable holding periods. The acquisition of the indiplon royalty stream from Wyeth has important strategic value for Neurocrine and its shareholders. This transaction leverages our strong cash and equity currency to bolster future earnings. Our indiplon royalty obligations of six percent are now reduced to three and one-half percent and will be accretive to earnings in our first year of commercialization, said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences. Upon approval of the transaction Wyeth will assign to Neurocrine its license agreement with DOV and all of Wyeths right, title and interest in and to the indiplon composition patent filed by Neurocrine in Wyeths name. Wyeths financial interest in indiplon arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. (NASDAQ:DOVP) in which Wyeth licensed the indiplon technology to DOV Pharmaceutical in exchange for milestone payments and royalties on future sales of indiplon. Neurocrine signed an exclusive license and development agreement with DOV in 1998 for indiplon and all therapeutic indications of this compound. In 2002, Neurocrine entered a worldwide agreement with Pfizer (NYSE:PFE) for the development and commercialization of indiplon for the treatment of insomnia. -more- Indiplon is a unique non-benzodiazapine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. There are two formulations of indiplon, immediate release and modified release. Both formulations are being studied in clinical trials to address different types of sleep problems. Neurocrine is conducting one of the most comprehensive clinical programs in insomnia to address the multiple needs of younger and older adult patients with insomnia such as sleep initiation, sleep maintenance, and the need for chronic usage. Neurocrine has initiated and is completing all of its Phase III safety and efficacy trials to support a New Drug Application (NDA) for the two formulations, expected in the first half of 2004 for indiplon for multiple insomnia indications. The Phase III program alone will have data from approximately 5,000 patients with different types of insomnia. Indiplon was licensed from DOV Pharmaceutical in 1998. Insomnia is a prevalent condition in the United States, with nearly one-half of the adult population reporting trouble sleeping a few nights per week or more, according to the National Sleep Foundations (NSF) Sleep in America Poll 2002. Approximately 35 percent of the adult population reports that they have experienced insomnia every night or almost every night within the past year. Insomnia remains a disorder with high unmet medical needs, including prolonged awakenings during the night with difficulty falling back to sleep. This transaction is contingent upon the approval of Wyeths Board of Directors and the requirements of the Hart-Scott-Rodino Antitrust Improvements Act. Neurocrine will host a live Conference Call and Webcast to further discuss its purchase of Wyeths financial interest in indiplon on Friday, February 27, 2004 at 11:00 AM EST / 8:00 AM PST. Participants may access the live Conference Call by dialing 1-800-245-3043 (US) or 785-832-1508 (International) and using the access code of NBIX. The call can also be accessed via the webcast through the Companys website at www.neurocrine.com. A replay of the call will be available approximately 2 hours after the call concludes and can be accessed by dialing 1-888-566-0831 (US) or 402-220-0121 (International). The call will be archived until March 12, 2004. Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the largest pharmaceutical markets in the world including insomnia, certain female and male disorders, anxiety, depression, diabetes, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Companys website via the Internet at http://www.neurocrine.com -more- Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of womens health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the worlds largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Companys major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. DOV Pharmaceutical, Inc. is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system and other disorders, including cardiovascular and urological, that involve alterations in neuronal processing. The company has six product candidates in clinical trials addressing therapeutic indications with significant unmet needs. In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with the Companys indiplon clinical development program and planned regulatory activities. Specifically, the risks and uncertainties the Company faces with respect to its indiplon program include, but are not limited to, risk that indiplon may not successfully proceed through Phase III clinical trials or Phase III clinical trials may fail to demonstrate that indiplon is safe and effective in treating humans; risk that the Company may not complete indiplon Phase III clinical trials on the Companys projected timelines for various reasons, including the possibility that patient recruitment may be slower than expected; risk that the clinical investigators and contract research organizations upon which the Company relies to conduct its clinical programs may not be diligent, careful or timely, and may make mistakes, in the conduct of the programs; risk relating to the Companys dependence on contract manufacturers for clinical drug supply and compliance with regulatory requirements for marketing approval; risk that the Company may not successfully co-ordinate the completion and submission of planned regulatory filings on the Companys projected timelines; risk that the Company may not receive regulatory approval for indiplon or approval may be delayed; risks associated with the Companys dependence on corporate collaborators for commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Companys products; risk that the Company will be unable to raise additional funding required to complete development of all of its product candidates; and the other risks described in the Companys Form 10-K for the year ended December 31, 2002, the Companys most recent report on Form 10-Q and the Companys final prospectus supplement and accompanying prospectus relating to its recent offering. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof. # # # 273586	Wyeth Wyeth As referenced in this Neurocrine Biosciences Acquires Wyeths Indiplon Royalty Stream: Wyeth – AND WEBCAST FRIDAY, FEBRUARY 27, 2004 San Diego, CA, February 26, 2004, - Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced it has purchased from Wyeth (NYSE:WYE) all of Wyeths financial interest in indiplon, Neurocrines late stage clinical development compound for the treatment of insomnia. Neurocrine will _____________ Wyeth. – treatment of insomnia. Neurocrine will now retain all milestone, royalty and other payments on indiplon commercialization that would have otherwise been payable to Wyeth. The transaction also provides Neurocrine ownership and control over the indiplon composition of matter patent which expires in 2020. The transaction is _____________ Wyeth – rights and otherwise be salable under Rule 144 upon the termination of applicable holding periods. The acquisition of the indiplon royalty stream from Wyeth has important strategic value for Neurocrine and its shareholders. This transaction leverages our strong cash and equity currency to bolster future earnings. Our _____________ Wyeth – earnings in our first year of commercialization, said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences. Upon approval of the transaction Wyeth will assign to Neurocrine its license agreement with DOV and all of Wyeths right, title and interest in and to the indiplon composition _____________ Wyeth – the indiplon composition patent filed by Neurocrine in Wyeths name. Wyeths financial interest in indiplon arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. (NASDAQ:DOVP) in which Wyeth licensed the indiplon technology to DOV Pharmaceutical in exchange for milestone payments and royalties _____________ dt 183054 ; DOV Pharma DOV Pharmaceutical, Inc. ( Pharmaceutical Preparations ) As referenced in this Neurocrine Biosciences Acquires Wyeths Indiplon Royalty Stream: DOV Pharmaceutical, – composition patent filed by Neurocrine in Wyeths name. Wyeths financial interest in indiplon arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. (NASDAQ:DOVP) in which Wyeth licensed the indiplon technology to DOV Pharmaceutical in exchange for milestone payments and royalties on future _____________ DOV Pharmaceutical – arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. (NASDAQ:DOVP) in which Wyeth licensed the indiplon technology to DOV Pharmaceutical in exchange for milestone payments and royalties on future sales of indiplon. Neurocrine signed an exclusive license and development agreement with DOV in _____________ DOV Pharmaceutical – indications. The Phase III program alone will have data from approximately 5,000 patients with different types of insomnia. Indiplon was licensed from DOV Pharmaceutical in 1998. Insomnia is a prevalent condition in the United States, with nearly one-half of the adult population reporting trouble sleeping a _____________ DOV Pharmaceutical, – improve the quality of life for people worldwide. The Companys major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health. DOV Pharmaceutical, Inc. is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system _____________ dt 206653 ;	Neurocrine Neurocrine Biosciences, Inc. ( Biological Products ) As referenced in this Neurocrine Biosciences Acquires Wyeths Indiplon Royalty Stream: Neurocrine Biosciences – pressrelease012904 EX-99 3 pressreleasewyeth.htm Exhibit 99.1 For Immediate Release Claudia Jones or Elizabeth Foster of Neurocrine Biosciences (858) 658-7600 NEUROCRINE BIOSCIENCES ACQUIRES WYETHS INDIPLON ROYALTY STREAM COMPANY TO HOST CONFERENCE CALL AND WEBCAST FRIDAY, FEBRUARY 27, 2004 San _____________ NEUROCRINE BIOSCIENCES – pressrelease012904 EX-99 3 pressreleasewyeth.htm Exhibit 99.1 For Immediate Release Claudia Jones or Elizabeth Foster of Neurocrine Biosciences (858) 658-7600 NEUROCRINE BIOSCIENCES ACQUIRES WYETHS INDIPLON ROYALTY STREAM COMPANY TO HOST CONFERENCE CALL AND WEBCAST FRIDAY, FEBRUARY 27, 2004 San Diego, CA, February 26, 2004, - Neurocrine _____________ Neurocrine Biosciences, – BIOSCIENCES ACQUIRES WYETHS INDIPLON ROYALTY STREAM COMPANY TO HOST CONFERENCE CALL AND WEBCAST FRIDAY, FEBRUARY 27, 2004 San Diego, CA, February 26, 2004, - Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced it has purchased from Wyeth (NYSE:WYE) all of Wyeths financial interest in indiplon, Neurocrines late stage _____________ Neurocrine Biosciences. – half percent and will be accretive to earnings in our first year of commercialization, said Gary Lyons, President and Chief Executive Officer of Neurocrine Biosciences. Upon approval of the transaction Wyeth will assign to Neurocrine its license agreement with DOV and all of Wyeths right, title and _____________ Neurocrine Biosciences, – be accessed by dialing 1-888-566-0831 (US) or 402-220-0121 (International). The call will be archived until March 12, 2004. Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological and endocrine diseases and disorders. Our product candidates address some of the _____________ dt 191304
Full Doc	2004	Neose Technologies Reports Fourth Quarter and 2003 Year End Financial Results Neose Technologies Reports Fourth Quarter and 2003 Year End Financial Results (10K) Doc #273796: This document is immediately available for purchase, but does not have a preview available for viewing. NEOSE TECHNOLOGIES, INC. 102 Witmer Road, Horsham, PA 19044 215.315.9000 fax:215.315.9100 email: info@neose.com www.neose.com NEOSE TECHNOLOGIES REPORTS FOURTH QUARTER AND 2003 YEAR END FINANCIAL RESULTS HORSHAM, PA, February 12, 2004?Neose Technologies, Inc. (NasdaqNM: NTEC) today announced financial results for the fourth quarter and year ended December 31, 2003. For the quarter ended December 31, 2003, the Company reported a net loss of $9,696,000, or $0.49 per basic and diluted share, compared to a net loss of $6,377,000, or $0.45 . . . 273796	Wyeth Wyeth As referenced in this Neose Technologies Reports Fourth Quarter and 2003 Year End Financial Results: Wyeth – The decrease in revenues for the 2003 period was primarily due to the completion of activities in 2002 under the Companys agreement with Wyeth Pharmaceuticals. NEOSE TECHNOLOGIES, INC. Page 2 Operating expenses for the twelve months ended December 31, 2003 were $37,969,000, compared to $33, _____________ dt 183064 ; Neose Neose Technologies, Inc. ( Medicinal Chemicals & Botanical Products ) As referenced in this Neose Technologies Reports Fourth Quarter and 2003 Year End Financial Results: NEOSE TECHNOLOGIES, – Press Release EX-99.1 3 dex991.htm PRESS RELEASE Exhibit 99.1 NEOSE TECHNOLOGIES, INC. 102 Witmer Road, Horsham, PA 19044 215.315.9000 fax:215.315.9100 email: info@neose.com www.neose.com NEOSE _____________ NEOSE TECHNOLOGIES – NEOSE TECHNOLOGIES, INC. 102 Witmer Road, Horsham, PA 19044 215.315.9000 fax:215.315.9100 email: info@neose.com www.neose.com NEOSE TECHNOLOGIES REPORTS FOURTH QUARTER AND 2003 YEAR END FINANCIAL RESULTS HORSHAM, PA, February 12, 2004Neose Technologies, Inc. (NasdaqNM: NTEC) today announced financial results for _____________ NEOSE TECHNOLOGIES, – in revenues for the 2003 period was primarily due to the completion of activities in 2002 under the Companys agreement with Wyeth Pharmaceuticals. NEOSE TECHNOLOGIES, INC. Page 2 Operating expenses for the twelve months ended December 31, 2003 were $37,969,000, compared to $33,991,000 _____________ NEOSE TECHNOLOGIES, – broadcast over the Internet through First Call Events, which can be accessed via the following link: http://www.firstcallevents.com/service/ajwz398863486gf12.html NEOSE TECHNOLOGIES, INC. Page 3 To listen to the live call, please go to the web site at least fifteen minutes early to register, _____________ NEOSE TECHNOLOGIES, – Neose expects to enter into strategic partnerships for the inclusion of its technologies into products being developed by other biotechnology and pharmaceutical companies. NEOSE TECHNOLOGIES, INC. Page 4 Statements of Operations (in thousands, except per share data) (unaudited) Three months ended December 31, Twelve months ended December _____________ dt 191140 ;	Novo Nordisk Novo Nordisk AS ( Pharmaceutical Preparations )
Preview Full Doc	2004	Inhibitex Initiates Enrollment in Pivotal Phase III Trial for Veronate Inhibitex Initiates Enrollment in Pivotal Phase III Trial for Veronate (4K) Doc #274054: Click preview link for longer preview. PRESS RELEASE www.inhibitex.com CONTACTS: Inhibitex, Inc. Russell H. Plumb Lilian Stern (investors) Kathryn Morris (media) Chief Financial Officer Stern Investor Relations, Inc. KMorrisPR (678) 746-1136 212.362.1200 845.635.9828 Rplumb@inhibitex.com Lilian@sternir.com Kathryn@kmorrispr.com FOR IMMEDIATE RELEASE INHIBITEX INITIATES ENROLLMENT IN PIVOTAL PHASE III TRIAL FOR VERONATE ATLANTA, Georgia June 30, 2004 Inhibitex, Inc. announced today that it has initiated enrollment in its pivotal Phase III clinical trial for Veronate, a novel antibody-based investigational drug being developed to prevent hospital-associated infections in very low birth weight infants. The primary endpoint of the trial is to demonstrate efficacy in the prevention of hospital-associated infections due to Staphylococcus aureus (S. aureus) in very low birth weight infants that weigh between 500 and 1,250 grams at birth. Secondary end points of the trial include a reduction in the frequency of hospital-associated infections due to Candida species (fungus) and Coagulase-negative staphylococci, and a reduction in the mortality rate among these high-risk infants. 274054	Wyeth Wyeth As referenced in this Inhibitex Initiates Enrollment in Pivotal Phase III Trial for Veronate: Wyeth – The Company has retained all world-wide rights to both of these product candidates. The Companys three preclinical programs include a partnership with Wyeth to develop staphylococcal vaccines. This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of _____________ dt 183074 ; Inhibitex Inhibitex, Inc. ( Biological Products ) As referenced in this Inhibitex Initiates Enrollment in Pivotal Phase III Trial for Veronate: .inhibitex. – 1 PRESS RELEASE JUNE 30, 2004 EX-99.1 2 g89867exv99w1.htm EX-99.1 PRESS RELEASE JUNE 30, 2004 PRESS RELEASE www.inhibitex. com CONTACTS: Inhibitex, Inc. Russell H. Plumb Lilian Stern (investors) Kathryn Morris (media) Chief Financial Officer Stern Investor Relations, Inc. KMorrisPR (678) 746- _____________ Inhibitex, – JUNE 30, 2004 EX-99.1 2 g89867exv99w1.htm EX-99.1 PRESS RELEASE JUNE 30, 2004 PRESS RELEASE www.inhibitex.com CONTACTS: Inhibitex, Inc. Russell H. Plumb Lilian Stern (investors) Kathryn Morris (media) Chief Financial Officer Stern Investor Relations, Inc. KMorrisPR (678) 746-1136 212. _____________ @inhibitex. – Stern (investors) Kathryn Morris (media) Chief Financial Officer Stern Investor Relations, Inc. KMorrisPR (678) 746-1136 212.362.1200 845.635.9828 Rplumb@inhibitex. com Lilian@sternir.com Kathryn@kmorrispr.com FOR IMMEDIATE RELEASE INHIBITEX INITIATES ENROLLMENT IN PIVOTAL PHASE III TRIAL FOR VERONATE ATLANTA, Georgia June _____________ INHIBITEX – Inc. KMorrisPR (678) 746-1136 212.362.1200 845.635.9828 Rplumb@inhibitex.com Lilian@sternir.com Kathryn@kmorrispr.com FOR IMMEDIATE RELEASE INHIBITEX INITIATES ENROLLMENT IN PIVOTAL PHASE III TRIAL FOR VERONATE ATLANTA, Georgia June 30, 2004 Inhibitex, Inc. announced today that it has initiated enrollment _____________ Inhibitex, – sternir.com Kathryn@kmorrispr.com FOR IMMEDIATE RELEASE INHIBITEX INITIATES ENROLLMENT IN PIVOTAL PHASE III TRIAL FOR VERONATE ATLANTA, Georgia June 30, 2004 Inhibitex, Inc. announced today that it has initiated enrollment in its pivotal Phase III clinical trial for Veronate, a novel antibody-based investigational _____________ dt 182585 ; Russell H. Plumb;	Lilian Stern; Kathryn Morris
Full Doc	2004	Ligand Reports Financial Results for 2003 and Provides 2004 Guidance Ligand Reports Financial Results for 2003 and Provides 2004 Guidance (26K) Doc #278859: This document is immediately available for purchase, but does not have a preview available for viewing. {DOCUMENT} {TYPE}EX-99 {SEQUENCE}3 {FILENAME}ex99-1.txt {DESCRIPTION}03/03/04 PRESS RELEASE {TEXT} Exhibit 99.1 Contact: Paul V. Maier Senior VP and CFO (858) 550-7573 LIGAND REPORTS FINANCIAL RESULTS FOR 2003 AND PROVIDES 2004 GUIDANCE -- RECORD REVENUES FOR FOURTH QUARTER PRODUCE FIRST QUARTER OF PROFITS IN COMPANY HISTORY-- -- NET PRODUCT SALES FOR YEAR INCREASE 110%; TOTAL REVENUES UP 46% -- SAN DIEGO, CA - MARCH 3, 2004 - Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported total revenues for the year ended December 31, 2003, of $141.1 million, compared to $96.6 million in 2002, an increase of 46%. Loss before the non-cash cumulative effect of a change in accounting principle for the year was $35.5 million ($0.50 per share), compared to $32.6 million ($0.47 per share) in 2002, representing an increase of 9% (6% per share). Including the $2.0 million non-cash cumulative effect of the change in accounting principle (FIN 46-R), net loss for the year ended December 31, 2003, was $37.5 million ($0.53 per share). For the fourth quarter ended December 31, 2003, total revenues were $57.6 million, compared to $27.3 million for the same period in 2002, an increase of 111%. Income before the non-cash cumulative effect of a change in accounting principle for the fourth quarter of 2003 was $7.9 million ($0.11 per share or $0.10 per fully diluted share) compared to a net loss of $6.7 million ($0.09 per share) for the same period in 2002. Including the $2.0 million non-cash cumulative effect of the change in accounting principle recorded in the fourth quarter of 2003, net income was $5.9 million ($0.08 per share). "Ligand's strong financial results for 2003 reflect the impact of key growth drivers AVINZA(R) and ONTAK(R), and the exercise of Royalty Pharma SERM option, which contributed to the company achieving the first quarter of profits in its history," said Paul V. Maier, Ligand's senior vice president and chief financial officer. "The commercial organization's accelerating product sales growth in 2003, more than double the 2002 results, reflects the success of AVINZA after nine months of co-promotion with Organon and strong prescription demand growth of in-line oncology products ONTAK and Targretin(R) capsules. The accelerating {PAGE} prescription growth of AVINZA, which achieved 3.8% market share in the last full week of December 2003, coupled with significant progress in new pharmacy distribution, managed care acceptance and positive physician acceptance, met or exceeded key 2003 goals. In addition, continued solid other revenues underscore the strength and evolution of Ligand's corporate partner portfolio of product assets." Ligand's total net product sales for the year were $114.6 million, compared to $54.5 million in 2002, an increase of 110%. For the fourth quarter of 2003, total net product sales were $42.4 million, compared to $13.9 million for the same period in 2002, an increase of 205%. Sales of individual products were: {TABLE} {CAPTION} --------------------------------- -------------- -------------- --------------- --------------- 2003 NET SALES 2002 NET SALES 4Q2003 NET 4Q2002 NET (MILLION) (MILLION) SALES (MILLION) SALES (MILLION) {S} {C} {C} {C} {C} --------------------------------- -------------- -------------- --------------- --------------- AVINZA(R) $66.2 $12.2 $32.0 $ 2.0 --------------------------------- -------------- -------------- --------------- --------------- ONTAK(R)(denileukin diftitox) $34.3 $26.6 $ 7.1 $ 7.4 --------------------------------- -------------- -------------- --------------- --------------- Targretin(R)(bexarotene) capsules $10.1 $12.2 $ 2.6 $ 3.6 --------------------------------- -------------- -------------- --------------- --------------- Targretin gel and $ 4.0 $ 3.4 $ .7 $ .8 Panretin(R)(alitretinoin) gel --------------------------------- -------------- -------------- --------------- --------------- TOTAL NET PRODUCT SALES $114.6 $54.5 $42.4 $13.8 --------------------------------- -------------- -------------- --------------- --------------- {/TABLE} Research and development expenses were $67.7 million for 2003, compared to $58.8 million in 2002, an increase of 15% that resulted primarily from clinical expenses associated with the acceleration of the SPIRIT I and II Phase III studies of Targretin capsules in non-small cell lung cancer. To date, Ligand has fully enrolled more than 1,200 patients required for the two studies, and expects survival data by the end of this year. In the fourth quarter, R&D expenses were $16.5 million, comparable to $16.4 million in the same period of 2002. Selling, general, and administrative expenses were $51.7 million for 2003, compared to $41.7 million for 2002, an increase of 24%, due primarily to increased AVINZA sales and marketing expenses. In the fourth quarter, SG&A expenses were $12.4 million, compared to $11.0 million in the same period of 2002, an increase of 13%. Additionally, co-promote expenses for 2003 and the fourth quarter were $9.4 million. "Our R&D and SG&A expenses in the fourth quarter and full year were in line with our expectations and the lower end of our annual guidance given at the beginning of 2003," Maier said. 2 {PAGE} Loss from operations was $19.2 million for 2003, compared to $24.2 million in 2002, a decrease of 21%. In the fourth quarter, operating profit was $10.6 million, compared to an operating loss of $5.5 million in the same period of 2002, due to strong product sales growth and the exercise of Royalty Pharma SERM option. Effective December 31, 2003, Ligand implemented Financial Accounting Standards Board Interpretation No. 46 (R) "Consolidation of Variable Interest Entities." As a result of this accounting change, Ligand consolidated Nexus Equity VI LLC, the entity from which the company leases one of its corporate office buildings, and recorded a $2.0 million one-time non-cash cumulative effect of a change in accounting principle. Net cash generated from operations for the fourth quarter of 2003 was $9.2 million. As of December 31, 2003, Ligand had cash, cash equivalents, short-term investments and restricted cash of $100.7 million, compared to $74.9 million at the end of 2002, an increase of 34%, that resulted primarily from the completion of a private placement during the third quarter with net proceeds of $45 million and positive operating cash flow of $9.2 million generated during the fourth quarter of 2003. AVINZA UPDATE "AVINZA had a very strong fourth quarter," Maier said. "Total prescriptions increased 91% (based on IMS NPA monthly data, which does not include institutional use in hospitals, Federal facilities and other non-retail outlets) compared to the prior quarter, reflecting continued accelerating growth. In addition, our weekly prescription market share of 3.8% for the last full week of December 2003 was at the high end of our goal to achieve 3-4% `run rate' as we exited 2003, and achieving our goal of becoming the third largest proprietary brand in the sustained-release opioid market. Since co-promotion began, our uptake in prescriptions has increased ten-fold and been comparable to that of the two market leaders at similar stages of their launches, and we believe that results will continue to improve as formulary access, retail pharmacy, distribution, and Organon's primary care sales force productivity also improve." 278859	Wyeth Wyeth As referenced in this Ligand Reports Financial Results for 2003 and Provides 2004 Guidance: Wyeth. – exchange for .7% of potential future sales of three SERMs (selective estrogen receptor modulators) nearing completion of Phase III development at Pfizer and Wyeth. The SERMs are lasofoxifene, in Phase III studies for osteoporosis at Pfizer, and bazedoxifene and bazedoxifene/Premarin(R), which are in Phase _____________ Wyeth – are lasofoxifene, in Phase III studies for osteoporosis at Pfizer, and bazedoxifene and bazedoxifene/Premarin(R), which are in Phase III trials at Wyeth for osteoporosis and hormone replacement therapy. 5 {PAGE} o LIGAND EARNS MILESTONES AS WYETH ADVANCES NSP989 INTO PHASE II STUDIES FOR CONTRACEPTION. NSP989 _____________ WYETH – Premarin(R), which are in Phase III trials at Wyeth for osteoporosis and hormone replacement therapy. 5 {PAGE} o LIGAND EARNS MILESTONES AS WYETH ADVANCES NSP989 INTO PHASE II STUDIES FOR CONTRACEPTION. NSP989 is a non-steroidal progestin resulting from Ligand's research collaboration with Wyeth. o _____________ Wyeth. – AS WYETH ADVANCES NSP989 INTO PHASE II STUDIES FOR CONTRACEPTION. NSP989 is a non-steroidal progestin resulting from Ligand's research collaboration with Wyeth. o LIGAND, TAP AGREE TO EXTEND R&D COLLABORATION TO DISCOVER AND DEVELOP NOVEL SARM DRUGS. The TAP/Ligand collaboration, which began _____________ dt 202819 ;	Ligand Pharma Ligand Pharmaceuticals, Inc. ( Pharmaceutical Preparations ) As referenced in this Ligand Reports Financial Results for 2003 and Provides 2004 Guidance: Ligand Pharmaceuticals – QUARTER OF PROFITS IN COMPANY HISTORY-- -- NET PRODUCT SALES FOR YEAR INCREASE 110%; TOTAL REVENUES UP 46% -- SAN DIEGO, CA - MARCH 3, 2004 - Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported total revenues for the year ended December 31, 2003, of $141.1 million, compared to $96.6 million _____________ LIGAND PHARMACEUTICALS – of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. # # # 7 {PAGE} LIGAND PHARMACEUTICALS INCORPORATED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in thousands, except per share data) {TABLE} {CAPTION} THREE MONTHS ENDED YEAR ENDED DECEMBER 31, DECEMBER 31, ---------------------------------------------------------------------- _____________ LIGAND PHARMACEUTICALS – common shares that would be issued upon the conversion of convertible notes and the exercise of outstanding warrants and stock options. 8 {PAGE} LIGAND PHARMACEUTICALS INCORPORATED CONSOLDIATED BALANCE SHEETS (in thousands) {TABLE} {CAPTION} DECEMBER 31, 2003 DECEMBER 31, 2002 ----------------------- -------------------------- {S} {C} {C} ASSETS Current assets: Cash, cash equivalents _____________ dt 213187
Preview Full Doc	2004	King Pharmaceuticals Announces Appointment of Brian A. Markison as President and CEO and as a Member of the Company's Board of Directors King Pharmaceuticals Announces Appointment of Brian A. Markison as President and CEO and as a Member of the Company's Board of Directors (9K) Doc #281642: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}2 {FILENAME}g90005exv99w1.txt {DESCRIPTION}EX-99.1 PRESS RELEASE 07/16/04 {TEXT} {PAGE} EXHIBIT 99.1 N E W S R E L E A S E (KING PHARMACEUTICALS LOGO) -------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE KING PHARMACEUTICALS ANNOUNCES APPOINTMENT OF BRIAN A. MARKISON AS PRESIDENT AND CEO AND AS A MEMBER OF THE COMPANY'S BOARD OF DIRECTORS BRISTOL, TENNESSEE, July 16, 2004 - King Pharmaceuticals, Inc. (NYSE:KG) reported today that the Company's Board of Directors has concluded its search to select the Company's new top executive officer and has appointed Brian A. Markison as King's President and Chief Executive Officer. King also announced the election of Mr. Markison to the Company's Board of Directors. Mr. Markison stated, "I am very pleased to accept this excellent opportunity. Since joining King earlier this year, I have grown even more confident in the ability of our Company and its employees to successfully enhance shareholder value as we more fully leverage the superb foundation and capabilities that our Company has worked hard to establish since King's inception ten years ago." Ted G. Wood, Chairman of King, stated, "I am extremely pleased to announce our selection of Brian Markison as our Company's President and Chief Executive Officer and his appointment as a member of our Board of Directors. Brian has a tremendous level of experience in our industry, having worked in a wide variety of key executive management positions with one of the world's top pharmaceutical companies, strong business acumen, and superb leadership skills. Accordingly, we have great confidence in Brian's ability to successfully lead King Pharmaceuticals." Mr. Markison has distinguished himself for over 22 years in a variety of strategic, sales, marketing, international, and domestic general management positions within Bristol-Myers Squibb Company. Prior to joining King as its Chief Operating Officer on March 8, 2004, he served as President of Bristol-Myers Squibb's Oncology, Virology and Oncology Therapeutics Network businesses. ABOUT KING PHARMACEUTICALS King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management. FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, which reflect management's current views of future events and operations, including, but not limited to, statements pertaining to the enhancement of shareholder value. Some important factors which may cause results to differ materially from such forward-looking statements include dependence on King's and Wyeth (more) {PAGE} Pharmaceuticals' ability to successfully market Altace(R) (ramipril) under the co-promotion agreement between King and Wyeth; dependence on the development and implementation of successful marketing strategies for Altace(R) by King and Wyeth; dependence on growth of net sales of King's branded pharmaceutical products, particularly Altace(R), Skelaxin(R) (metaxalone), Sonata(R) (zaleplon), and Thrombin-JMI(R) (thrombin, topical, bovine, USP); dependence on the successful marketing and sales of King's products, including, but not limited to, Altace(R), Skelaxin(R), Levoxyl(R) (levothyroxine sodium tablets, USP), and Sonata(R); dependence on royalty revenues from Adenoscan(R) (adenosine); dependence on King's ability to reposition Sonata(R) in the insomnia marketplace and expand upon its opportunities in that market with an extended release formulation of Sonata(R); dependence on management of King's growth and integration of its acquisitions; dependence on the extent to which the U.S. Securities and Exchange Commission ("SEC") and the Office of the Inspector General ("OIG") and other governmental agencies concur with King's best estimate of the extent to which it underpaid amounts due under Medicaid and other governmental pricing programs and King's determination of the reasons for such underpayments; dependence on any determination or final outcome arising out of the previously announced investigations of the Company by the SEC and OIG; dependence on whether King is able to prevail in pending shareholder securities litigation; dependence on the extent to which any governmental sanctions are imposed due to King's underpayment of amounts due under Medicaid and other governmental pricing programs; dependence on the possibility that regulatory authorities may initiate proceedings against King and/or its officers and directors; dependence on King's ability to continue to acquire branded products, including products in development; dependence on the high cost and uncertainty of research, clinical trials, and other development activities involving pharmaceutical products, including, but not limited to, King Pharmaceuticals Research and Development's pre-clinical and clinical pharmaceutical product development projects, including binodenoson, T-62, and MRE0094; dependence on the U.S. Food and Drug Administration's ("FDA") approval of King's supplemental New Drug Application ("sNDA") for Intal(R) HFA (cromolyn sodium); dependence on King's and Elan's ability to successfully develop new formulations of Sonata(R); dependence on the unpredictability of the duration and results of the FDA's review of Investigational New Drug Applications ("IND"), New Drug Applications ("NDA"), sNDAs, and Abbreviated New Drug Applications ("ANDA") and/or the review of other regulatory agencies worldwide; dependence on King's ability to maintain effective patent protection for Altace(R) through October 2008, and successfully defend against any attempt to challenge the enforceability of patents relating to the product; dependence on King's ability to maintain effective patent protection for Sonata(R) and Skelaxin(R), including new formulations of such products, and successfully defend against any attempt to challenge the enforceability of patents relating to the products; dependence on the ability of the Company's dedicated field sales force representatives to successfully market King's branded pharmaceutical products; dependence on whether our customers order pharmaceutical products in excess of normal quantities during any quarter which could cause our sales of branded pharmaceutical products to be lower in a subsequent quarter than they would otherwise have been; dependence on the extent to which Inventory Management Agreements facilitate enhanced management of wholesale channel inventories of our products going forward; dependence on King's ability to continue to successfully execute the Company's proven growth strategies and to continue to capitalize on strategic opportunities in the future for sustained long- (more) {PAGE} term growth; dependence on the availability and cost of raw materials; dependence on no material interruptions in supply by contract manufacturers of King's products; dependence on the potential effect on sales of our existing branded pharmaceutical products as a result of the potential development and approval of a generic substitute for any such product or other new competitive products; dependence on the extent to which therapeutic substitution for Levoxyl(R) occurs; dependence on the potential effect of future acquisitions and other transactions pursuant to our growth strategies on King's financial results; dependence on our compliance with FDA and other government regulations that relate to our business; and dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; and manufacturing capacity constraints. Other important factors that may cause actual results to differ materially from the 281642	Wyeth Wyeth As referenced in this King Pharmaceuticals Announces Appointment of Brian A. Markison as President and CEO and as a Member of the Company's Board of Directors: Wyeth – shareholder value. Some important factors which may cause results to differ materially from such forward-looking statements include dependence on King's and Wyeth (more) {PAGE} Pharmaceuticals' ability to successfully market Altace(R) (ramipril) under the co-promotion agreement between King and Wyeth; dependence on the _____________ Wyeth; – on King's and Wyeth (more) {PAGE} Pharmaceuticals' ability to successfully market Altace(R) (ramipril) under the co-promotion agreement between King and Wyeth; dependence on the development and implementation of successful marketing strategies for Altace(R) by King and Wyeth; dependence on growth of net _____________ Wyeth; – co-promotion agreement between King and Wyeth; dependence on the development and implementation of successful marketing strategies for Altace(R) by King and Wyeth; dependence on growth of net sales of King's branded pharmaceutical products, particularly Altace(R), Skelaxin(R) (metaxalone), Sonata(R) (zaleplon), and _____________ dt 226997 ; Bristol-Myers Bristol-Myers Squibb Co. ( Pharmaceutical Preparations ) As referenced in this King Pharmaceuticals Announces Appointment of Brian A. Markison as President and CEO and as a Member of the Company's Board of Directors: Bristol-Myers Squibb – Mr. Markison has distinguished himself for over 22 years in a variety of strategic, sales, marketing, international, and domestic general management positions within Bristol-Myers Squibb Company. Prior to joining King as its Chief Operating Officer on March 8, 2004, he served as President of Bristol-Myers Squibb's _____________ Bristol-Myers Squibb' – within Bristol-Myers Squibb Company. Prior to joining King as its Chief Operating Officer on March 8, 2004, he served as President of Bristol-Myers Squibb' s Oncology, Virology and Oncology Therapeutics Network businesses. ABOUT KING PHARMACEUTICALS King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. _____________ dt 225663 ;	King Pharma King Pharmaceuticals Inc. As referenced in this King Pharmaceuticals Announces Appointment of Brian A. Markison as President and CEO and as a Member of the Company's Board of Directors: (KING PHARMACEUTICALS – 99.1 PRESS RELEASE 07/16/04 {TEXT} {PAGE} EXHIBIT 99.1 N E W S R E L E A S E (KING PHARMACEUTICALS LOGO) -------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE KING PHARMACEUTICALS ANNOUNCES APPOINTMENT OF BRIAN A. MARKISON AS PRESIDENT AND CEO AND AS A MEMBER OF THE COMPANY' _____________ KING PHARMACEUTICALS – 04 {TEXT} {PAGE} EXHIBIT 99.1 N E W S R E L E A S E (KING PHARMACEUTICALS LOGO) -------------------------------------------------------------------------------- FOR IMMEDIATE RELEASE KING PHARMACEUTICALS ANNOUNCES APPOINTMENT OF BRIAN A. MARKISON AS PRESIDENT AND CEO AND AS A MEMBER OF THE COMPANY'S BOARD OF DIRECTORS BRISTOL, TENNESSEE, _____________ King Pharmaceuticals, – BRIAN A. MARKISON AS PRESIDENT AND CEO AND AS A MEMBER OF THE COMPANY'S BOARD OF DIRECTORS BRISTOL, TENNESSEE, July 16, 2004 - King Pharmaceuticals, Inc. (NYSE:KG) reported today that the Company's Board of Directors has concluded its search to select the Company's new _____________ King Pharmaceuticals. – s top pharmaceutical companies, strong business acumen, and superb leadership skills. Accordingly, we have great confidence in Brian's ability to successfully lead King Pharmaceuticals. " Mr. Markison has distinguished himself for over 22 years in a variety of strategic, sales, marketing, international, and domestic general management positions _____________ KING PHARMACEUTICALS – Operating Officer on March 8, 2004, he served as President of Bristol-Myers Squibb's Oncology, Virology and Oncology Therapeutics Network businesses. ABOUT KING PHARMACEUTICALS King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize _____________ dt 221453 ; Brian A. Markison
Preview Full Doc	2004	King Pharmaceuticals Reports Fourth-Quarter and Year-End 2003 Financial Results King Pharmaceuticals Reports Fourth-Quarter and Year-End 2003 Financial Results (60K) Doc #281649: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}3 {FILENAME}g87312exv99w1.txt {DESCRIPTION}EX-99.1 PRESS RELEASE 02/19/04 {TEXT} {PAGE} [KING PHARMACEUTICAL LOGO] EXHIBIT 99.1 NEWS RELEASE FOR IMMEDIATE RELEASE KING PHARMACEUTICALS REPORTS FOURTH-QUARTER AND YEAR-END 2003 FINANCIAL RESULTS JEFFERSON J. GREGORY ANNOUNCES PLANS TO RETIRE AS CEO AND HIS INTENT TO CONTINUE AS CHAIRMAN BRISTOL, TENNESSEE, February 19, 2004 - King Pharmaceuticals, Inc. (NYSE:KG) announced today that total revenues increased 41% to $382.6 million during the fourth quarter ending December 31, 2003, compared to $272.0 million in the fourth quarter of 2002. Including special items, net earnings increased to $42.0 million and diluted earnings per share increased to $0.17 during the fourth quarter of 2003, compared to a net loss of $31.4 million and a diluted loss per share of $0.13 in the same period the prior year. Net earnings, excluding special items, increased 14% to $76.7 million and diluted earnings per share increased 14% to $0.32 during the fourth quarter ending December 31, 2003, compared to net earnings of $67.2 million and diluted earnings per share of $0.28 in the fourth quarter of 2002. For the year ending December 31, 2003, total revenues increased 35% to $1.521 billion compared to $1.128 billion for 2002. Net earnings, including special items, decreased 42% to $105.9 million and diluted earnings per share decreased 41% to $0.44 for the twelve months ending December 31, 2003, compared to net earnings of $182.5 million and diluted earnings per share of $0.74 during the prior year. Excluding special items, net earnings increased 13% to $339.3 million and diluted earnings per share increased 14% to $1.40 for the twelve months ending December 31, 2003, compared to net earnings of $301.0 million and diluted earnings per share of $1.23 in 2002. Total revenues for the fourth quarter and year ending December 31, 2003 would have been $18.9 million higher and diluted earnings per share, excluding special items, would have equaled $0.33 and $1.41, respectively, but for an increase in the accrual for estimated amounts due under Medicaid and other governmental pricing programs for the years 1998 through 2002 and the related accrual for amounts due under the Medicaid pricing program for the period from 1994 through 1997, each of which is based on a recently completed comprehensive audit, as discussed in greater detail below. The accrual for amounts due under Medicaid for the period 1998 through 2002 was substantially offset by reductions in the co-promotion fee due with respect to Altace(R), as also described below. King recorded special items during the fourth quarter ending December 31, 2003, the net of which resulted in a charge totaling $56.4 million, or $34.7 million net of tax. More specifically, special items during the fourth quarter of 2003 include the following: i) a charge in the amount of $32.9 million primarily related to an increase in the accrual for Lorabid(R) (loracarbef) purchase commitments in excess of expected demand; ii) a charge in the amount of $14.6 million which (more) {PAGE} primarily relates to the write-off of certain unutilized intangible assets; iii) a charge in the amount of $6.8 million due to an increase in the valuation allowance for Novavax, Inc. convertible notes held by the Company resulting from a decrease in the share price of Novavax common stock during the fourth quarter of 2003; iv) a charge in the amount of $3.8 million due to professional fees associated with the previously announced ongoing investigations of the Company by the Securities and Exchange Commission ("SEC") and the Office of Inspector General of the Department of Health and Human Services ("OIG"); and v) income in the amount of $1.7 million resulting from a gain on the sale of certain non-income producing intangible assets. During the twelve months ending December 31, 2003, King recorded special items totaling $353.8 million, or $233.4 million net of tax, primarily due to charges for acquired in-process research and development associated with King's acquisition of the primary care business in the United States and Puerto Rico of Elan Corporation, plc on June 12, 2003 and Meridian Medical Technologies, Inc. on January 8, 2003, and an intangible asset impairment charge for Florinef(R) (fludrocortisone acetate). The increase in King's revenues during the fourth quarter and the twelve months ending December 31, 2003 in comparison to the same periods of the prior year is attributable primarily to the acquisition of Sonata(R) (zaleplon) and Skelaxin(R) (metaxalone) from Elan on June 12, 2003, and the acquisition of Meridian on January 8, 2003. Additionally, the growth in total revenues for the year ending December 31, 2003 was due to increased net sales of certain branded pharmaceutical products, particularly Altace(R) (ramipril) and Thrombin-JMI(R) (thrombin, topical, bovine, USP). Net revenue from branded pharmaceuticals, including royalty income, totaled $348.5 million for the fourth quarter of 2003, a 33% increase over the fourth quarter of 2002, and equaled $1.369 billion for the year ending December 31, 2003, a 25% increase over the prior year. Meridian, King's wholly-owned subsidiary, contributed $25.8 million to the Company's net revenue in the fourth quarter of 2003, and $124.2 million during the year ending December 31, 2003. During the fourth quarter and year ending December 31, 2003, net revenue from contract manufacturing and other equaled $8.3 million and $27.9 million, respectively. Altace(R) net sales equaled $108.1 million in the fourth quarter of 2003, compared to $109.5 million during the fourth quarter of 2002. Net sales of Altace(R) grew 17% to $527.1 million during the twelve months ending December 31, 2003 compared to $450.0 million in the prior year, while total prescriptions grew 19% during the same period of 2003. Net sales of Altace(R) would have been $11.2 million higher during the fourth quarter and year ending December 31, 2003 but for an increase in the accrual for estimated amounts due under Medicaid and other governmental pricing programs for the years 1998 through 2002 and the related accrual for amounts due under the Medicaid pricing program for the period from 1994 through 1997, each of which is based on the recently completed comprehensive audit, as discussed in greater detail below. Prescriptions for Altace(R) continued their record of growth, as total prescriptions for the product recently achieved a new all-time high based on the four-week moving average as reported by IMS for the week ending February 6, 2004. Channel inventories of Altace(R) decreased by approximately one month in the fourth quarter of 2003 according to IMS America Pipeline Data. King is actively engaged in negotiations with its wholesale customers to establish (more) {PAGE} inventory management agreements that should facilitate improved management of inventory levels. In the meantime, King anticipates that Altace(R) sales during the first quarter of 2004 will be adversely affected as channel inventory levels continue to decline and in anticipation of entering into such agreements. Net sales of Skelaxin(R) totaled $61.4 million and Sonata(R) net sales equaled $35.8 million during the fourth quarter ending December 31, 2003. For the twelve months ending December 31, 2003, King and Elan's combined net sales of Skelaxin(R) and Sonata(R) totaled $239.3 million and $120.7 million, respectively. King acquired these products from Elan on June 12, 2003. Levoxyl(R) (levothyroxine sodium tablets, USP) net sales recovered during the fourth quarter of 2003, totaling $48.6 million, a 15% increase from $42.1 million during the fourth quarter of 2002. Net sales of Levoxyl(R) decreased 21% to $134.1 million for the twelve months ending December 2003, compared to $169.5 281649	Wyeth Wyeth As referenced in this King Pharmaceuticals Reports Fourth-Quarter and Year-End 2003 Financial Results: Wyeth – may differ materially from the forward-looking statements. Some important factors which may cause results to differ include: dependence on King's and Wyeth Pharmaceuticals' ability to successfully market Altace(R) under the co-promotion agreement between King and Wyeth; dependence on the development and implementation of _____________ Wyeth; – differ include: dependence on King's and Wyeth Pharmaceuticals' ability to successfully market Altace(R) under the co-promotion agreement between King and Wyeth; dependence on the development and implementation of successful marketing strategies for Altace(R) by King and Wyeth; dependence on growth of net _____________ Wyeth; – co-promotion agreement between King and Wyeth; dependence on the development and implementation of successful marketing strategies for Altace(R) by King and Wyeth; dependence on growth of net sales of King's branded pharmaceutical products, particularly Altace(R), Skelaxin(R), Levoxyl(R), Sonata(R), and _____________ dt 226998 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this King Pharmaceuticals Reports Fourth-Quarter and Year-End 2003 Financial Results: Elan Corp – in-process research and development associated with King's acquisition of the primary care business in the United States and Puerto Rico of Elan Corp oration, plc on June 12, 2003 and Meridian Medical Technologies, Inc. on January 8, 2003, and an intangible asset impairment charge for Florinef( _____________ Elan Corp – program, designed to select the most effective extended release formulation of Sonata(R) utilizing the commercially proven drug (more) {PAGE} delivery technology of Elan Corp oration plc, is anticipated to begin before the end of April 2004." Mr. Macione emphasized, "This is an important step forward for King _____________ dt 206869 ;	King Pharma King Pharmaceuticals Inc. As referenced in this King Pharmaceuticals Reports Fourth-Quarter and Year-End 2003 Financial Results: KING PHARMACEUTICALS – txt {DESCRIPTION}EX-99.1 PRESS RELEASE 02/19/04 {TEXT} {PAGE} [KING PHARMACEUTICAL LOGO] EXHIBIT 99.1 NEWS RELEASE FOR IMMEDIATE RELEASE KING PHARMACEUTICALS REPORTS FOURTH-QUARTER AND YEAR-END 2003 FINANCIAL RESULTS JEFFERSON J. GREGORY ANNOUNCES PLANS TO RETIRE AS CEO AND HIS INTENT TO CONTINUE _____________ King Pharmaceuticals, – FINANCIAL RESULTS JEFFERSON J. GREGORY ANNOUNCES PLANS TO RETIRE AS CEO AND HIS INTENT TO CONTINUE AS CHAIRMAN BRISTOL, TENNESSEE, February 19, 2004 - King Pharmaceuticals, Inc. (NYSE:KG) announced today that total revenues increased 41% to $382.6 million during the fourth quarter ending December 31, 2003, _____________ King Pharmaceuticals. – Elan Corporation plc, is anticipated to begin before the end of April 2004." Mr. Macione emphasized, "This is an important step forward for King Pharmaceuticals. The successful development of an extended release formulation of Sonata(R), along with the new promotional campaign planned for our immediate release _____________ KING PHARMACEUTICALS – for not less than 30 days following the call by dialing 1-888-274-8335 (US only) or 402-220-2327 (international). ABOUT KING PHARMACEUTICALS King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize _____________ King Pharmaceuticals – dependence on the high cost and uncertainty of research, clinical trials, and other development activities involving pharmaceutical products, including, but not limited to, King Pharmaceuticals Research and Development's pre-clinical and clinical pharmaceutical product development projects, including binodenoson, T-62, and MRE0094; dependence on FDA approval of _____________ dt 221460 ; Novavax Novavax, Inc. ( Biological Products ) As referenced in this King Pharmaceuticals Reports Fourth-Quarter and Year-End 2003 Financial Results: Novavax, – certain unutilized intangible assets; iii) a charge in the amount of $6.8 million due to an increase in the valuation allowance for Novavax, Inc. convertible notes held by the Company resulting from a decrease in the share price of Novavax common stock during the fourth _____________ Novavax – increase in the valuation allowance for Novavax, Inc. convertible notes held by the Company resulting from a decrease in the share price of Novavax common stock during the fourth quarter of 2003; iv) a charge in the amount of $3.8 million due to professional fees associated _____________ Novavax' – New Drug Application ("ANDA") now pending on the Company's diazepam-filled auto-injector and the sNDA for Intal(R) HFA; dependence on Novavax' s ability to successfully manufacture Estrasorb(TM); dependence on King's and Novavax's ability to successfully launch and market Estrasorb(TM) as _____________ Novavax' – injector and the sNDA for Intal(R) HFA; dependence on Novavax's ability to successfully manufacture Estrasorb(TM); dependence on King's and Novavax' s ability to successfully launch and market Estrasorb(TM) as planned; dependence on King's and Elan's ability to successfully develop new _____________ Novavax – pharmaceutical products to be lower in a subsequent quarter than they would otherwise have been; dependence on changes in the share price of Novavax common stock which is the underlying collateral for the Novavax convertible notes held by the Company; dependence on King's ability to continue _____________ dt 215940
Preview Full Doc	2004	Curis Reports First Quarter 2004 Results Curis Reports First Quarter 2004 Results (8K) Doc #288311: Click preview link for longer preview. FOR IMMEDIATE RELEASE Curis Reports First Quarter 2004 Results CAMBRIDGE, MA, April 28, 2004 - Curis, Inc. (NASDAQ:CRIS), a therapeutic drug development company, today reported its financial results for the first quarter ended March 31, 2004. For the first quarter of 2004, the Company reported a net loss applicable to common stockholders of $4,038,000 or ($0.10) per share, as compared to a net loss of $4,470,000 or ($0.14) per share for the prior year period. Revenues for the first quarter of 2004 were $856,000 as compared to $435,000 . . . 288311	Wyeth Wyeth As referenced in this Curis Reports First Quarter 2004 Results: Wyeth – of $421,000 or 97%. The increase was primarily due to revenues recognized by the Company under its ongoing collaborations with Genentech and Wyeth Pharmaceuticals. In the prior year period, revenues were principally generated under the Companys collaboration with ES Cell International that has since concluded. Operating _____________ Wyeth – 37,538,000 as of December 31, 2003. The $637,000 increase was primarily due to cash received under the Companys collaboration with Wyeth Pharmaceuticals. Our cash position, including marketable securities and long-term investments, continues to remain strong. We expect that our existing cash, together with _____________ Wyeth – including marketable securities and long-term investments, continues to remain strong. We expect that our existing cash, together with expected future payments from Wyeth Pharmaceuticals and Genentech under our collaboration agreements, will enable us to continue to execute on our business strategy, said Michael Gray, Curis Chief _____________ Wyeth – 2004 has been another successful period for Curis. The quarter was highlighted by two key events. First, we established a broad collaboration with Wyeth Pharmaceuticals to use Curis Hedgehog agonist technology to develop therapeutics for the treatment of neurological disorders. Wyeth is one of the worlds largest _____________ Wyeth – we established a broad collaboration with Wyeth Pharmaceuticals to use Curis Hedgehog agonist technology to develop therapeutics for the treatment of neurological disorders. Wyeth is one of the worlds largest research-driven pharmaceutical companies, and we are pleased to have them as a collaborator. If the Hedgehog _____________ dt 227090 ;	Curis Curis, Inc. ( Biological Products ) As referenced in this Curis Reports First Quarter 2004 Results: Curis, Inc – 1 2 dex991.htm PRESS RELEASE Exhibit 99.1 FOR IMMEDIATE RELEASE Curis Reports First Quarter 2004 Results CAMBRIDGE, MA, April 28, 2004 - Curis, Inc . (NASDAQ:CRIS), a therapeutic drug development company, today reported its financial results for the first quarter ended March 31, 2004. For the _____________ CURIS, INC – this year or early in 2005. We are very pleased that our Hedgehog antagonist technology is making meaningful strides toward human clinical testing. CURIS, INC . CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three-months ended March 31, 2004 2003 Revenues $ 855,805 $ 435,358 Operating expenses: Research and _____________ CURIS, INC – common share $ (0.10 ) $ (0.14 ) Weighted average common shares for basic and diluted net loss computation 41,105,756 31,731,009 ### CURIS, INC . CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) March 31, 2004 December 31, 2003 ASSETS Cash, cash equivalents, marketable securities and long-term investments $ 38, _____________ Curis, Inc – 871,277 Total stockholders equity 37,651,425 38,865,213 Total liabilities and stockholders equity $ 56,098,738 $ 55,736,490 ### About Curis, Inc . Curis, Inc. is a therapeutic drug development company. Curis technology focus is on regulatory pathways that control repair and regeneration. Curis product _____________ Curis, Inc – Total stockholders equity 37,651,425 38,865,213 Total liabilities and stockholders equity $ 56,098,738 $ 55,736,490 ### About Curis, Inc. Curis, Inc . is a therapeutic drug development company. Curis technology focus is on regulatory pathways that control repair and regeneration. Curis product development program _____________ dt 239080
Full Doc	2004	Cima Labs Announces First-Quarter Financial Results; Patient Enrollment Begins in Oravescent Fentanyl Phase III Clinical Trials Cima Labs Announces First-Quarter Financial Results; Patient Enrollment Begins in Oravescent Fentanyl Phase III Clinical Trials (17K) Doc #296664: This document is immediately available for purchase, but does not have a preview available for viewing. {DOCUMENT} {TYPE}EX-99 {SEQUENCE}2 {FILENAME}a4634858ex99.txt {DESCRIPTION}EXHIBIT 99 PRESS RELEASE {TEXT} Exhibit 99 CIMA LABS Announces First-Quarter Financial Results; Patient Enrollment Begins in OraVescent Fentanyl Phase III Clinical Trials EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--May 6, 2004--CIMA LABS INC. (NASDAQ: CIMA) today reported financial results for the first quarter ended March 31, 2004. For the first quarter of 2004: -- Revenues were $15.7 million, compared with $16.7 million in the first quarter of 2003 and $20.8 million in the sequential fourth quarter of 2003. -- The Company's operating income was $198,000, compared with operating income of $3.9 million in the first quarter last year. CIMA reported an operating loss of $10.6 million for the sequential fourth quarter of 2003. -- The Company's net income was $53,000, or $0.00 per diluted share, compared with net income of $3.2 million, or $0.22 per diluted share, for the first quarter of 2003. CIMA reported a net loss of $9.8 million, or $(0.67) per share, for the sequential fourth quarter of 2003. Operating income for the first quarter of 2004 includes $1.2 million in expenses related to the Company's proposed merger with Cephalon, Inc. (NASDAQ: CEPH). Under generally accepted accounting principles (GAAP), CIMA is required, as the accounting acquiree, to expense costs related to the merger as they are incurred. Certain of these costs are not considered tax deductible for financial reporting purposes. Excluding these merger-related expenses, pro forma operating income for the first quarter of 2004 was $1.4 million (9.0 percent of revenues), compared with $3.1 million (15.0 percent of revenues), for the sequential fourth quarter of 2003. Excluding merger-related expenses and assuming a normalized tax rate of 37.5 percent, pro forma net income for the first quarter of 2004 was $1.3 million, or $0.08 per diluted share, compared with $2.3 million, or $0.16 per diluted share, for the sequential fourth quarter of 2003. CIMA's pro forma operating income, pro forma net income, and pro forma net income per diluted share are not based on GAAP. The Company believes such non-GAAP information provides investors with an additional means of measuring corporate performance and a consistent basis for comparing CIMA's results for the first quarter of 2004 with results for prior quarters. Within this news release, the Company has included tables that provide a reconciliation of these pro forma measures to comparable measures reported under GAAP. Operations Review "CIMA's partner-driven and proprietary businesses continued to perform well in the first quarter," said Steven B. Ratoff, chairman and interim CEO. "Revenue generated by two of our top three products -- Organon's Remeron SolTabs and AstraZeneca's Zomig ZMT -- increased by a combined $2.0 million from the first quarter of 2003. Remeron SolTabs remained strong despite generic competition in the United States, suggesting that Organon is having success with its European initiatives. Revenues from Wyeth declined from a year ago, as we were shipping launch quantities of Alavert during the first quarter of 2003." "Meanwhile, we made good progress in our OraVescent Fentanyl development activity, initiating patient enrollment slightly ahead of our second-quarter target. As we previously disclosed, we are on track toward an OraVescent Fentanyl regulatory submission in 2005 and a potential commercial launch in 2006," said Ratoff. Stated Chief Operating Officer John Hontz, Ph.D., "Our capacity expansion remained on schedule and on budget during the first quarter, and we expect our third blister-packaged production line to be operational by the middle of 2004. As a result, we will be able to return to normal operations and cut back to a five-day workweek while still meeting our partners' current production needs. Looking ahead, due to the long lead times involved, we have placed an initial order totaling $5 million in equipment for additional production capacity, including requirements for CIMA's OraVescent Fentanyl." Financial Review Stated Chief Financial Officer James Hawley, "CIMA's first-quarter revenue was on target. We reported better than expected bottom-line results due to lower than anticipated R&D spending, stronger gross profit on product sales based on a favorable product mix, and tight operating expense controls. As a consequence, CIMA reported operating income of $198,000 during the first quarter, versus the $3 million to $4 million operating loss we had expected." "First-quarter revenues from Wyeth's Alavert were down from the sequential fourth quarter because a significant portion of our shipments to Wyeth in Q4 were for packaging for future sale," said Hawley. "Although revenues from Organon's Remeron SolTabs held up quite well in the first quarter, we are seeing the effect of generic competition in the U.S. Revenues from AstraZeneca's Zomig increased sequentially and from the comparable quarter a year ago." "While we expected patient enrollment in our Phase III OraVescent Fentanyl clinical trials to begin in the second quarter, we built a sizable cushion into our R&D forecast in the event we were able to commence enrollment ahead of schedule. Although we were able to begin enrollment late in the first quarter, our guidance proved too aggressive and actual spending came in approximately $2.5 million below our estimate," said Hawley. "CIMA's cash and available-for-sale securities totaled $115.3 million at March 31, 2004, compared with $110.2 million at December 31, 2003," said Hawley. "Our cash position remains stable and strong, and we concluded the quarter with no debt on our balance sheet." Because CIMA recognized the remaining federal tax benefits from prior net operating losses in the fourth quarter of 2003, the Company's effective tax rate for the first quarter of 2004 was the normalized 37.5 percent rate expected to be applied going forward to pretax income before merger-related expenses. Business Outlook In light of CIMA's impending merger with Cephalon, the Company will not be providing financial guidance for the second quarter of 2004. Looking at the full year, however, CIMA expects revenue derived from its partner-based collaborative business to decline in 2004, based on three factors: 1) Shipments of Alavert to Wyeth are expected to be lower in 2004, reflecting unfavorable comparisons with the product's launch year in 2003; 2) The introduction of a generic version of Remeron SolTabs in the United States will have an adverse effect on revenues from Organon; 3) AstraZeneca's decision to move Zomig to an independent distributor will cause royalty revenue from this partner to decline, as the selling price on which CIMA derives royalties will be lower. Revenue from products the Company currently expects its partners to launch in 2004 will partially offset the anticipated decline in partner-based revenue. Furthermore, had CIMA not entered into merger negotiations, the Company believes it would have signed an agreement with a licensing partner for OraVescent Fentanyl in 2004, which would have more than offset these factors. Concluded Ratoff, "Our collaborative pipeline is strong, and OraVescent Fentanyl is moving toward launch as planned. CIMA's collaborative drug pipeline now includes a total of 16 partner-driven products, 11 of which have been announced. We continue to expect Alamo and Schwarz product launches in 2004, with an additional four to six partner launches possible in 2005. We anticipate seeing the majority of the products currently in our pipeline commercially launched by the end of 2006. CIMA continues to be encouraged by the prospects for its 296664	Wyeth Wyeth As referenced in this Cima Labs Announces First-Quarter Financial Results; Patient Enrollment Begins in Oravescent Fentanyl Phase III Clinical Trials: Wyeth – Remeron SolTabs remained strong despite generic competition in the United States, suggesting that Organon is having success with its European initiatives. Revenues from Wyeth declined from a year ago, as we were shipping launch quantities of Alavert during the first quarter of 2003." "Meanwhile, we made good _____________ Wyeth' – of $198,000 during the first quarter, versus the $3 million to $4 million operating loss we had expected." "First-quarter revenues from Wyeth' s Alavert were down from the sequential fourth quarter because a significant portion of our shipments to Wyeth in Q4 were for packaging _____________ Wyeth – expected." "First-quarter revenues from Wyeth's Alavert were down from the sequential fourth quarter because a significant portion of our shipments to Wyeth in Q4 were for packaging for future sale," said Hawley. "Although revenues from Organon's Remeron SolTabs held up quite well in the _____________ Wyeth – CIMA expects revenue derived from its partner-based collaborative business to decline in 2004, based on three factors: 1) Shipments of Alavert to Wyeth are expected to be lower in 2004, reflecting unfavorable comparisons with the product's launch year in 2003; 2) The introduction of a _____________ dt 255568 ; Cephalon Cephalon, Inc. As referenced in this Cima Labs Announces First-Quarter Financial Results; Patient Enrollment Begins in Oravescent Fentanyl Phase III Clinical Trials: Cephalon, Inc – 2003. Operating income for the first quarter of 2004 includes $1.2 million in expenses related to the Company's proposed merger with Cephalon, Inc . (NASDAQ: CEPH). Under generally accepted accounting principles (GAAP), CIMA is required, as the accounting acquiree, to expense costs related to the merger _____________ Cephalon, Inc – of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the Company's proposed merger with Cephalon, Inc ., the timing of the introduction of new products incorporating CIMA's technologies, the future success of products marketed by CIMA's partners _____________ dt 255940 ;	Cima Labs Cima Labs Inc. As referenced in this Cima Labs Announces First-Quarter Financial Results; Patient Enrollment Begins in Oravescent Fentanyl Phase III Clinical Trials: CIMA LABS – {DOCUMENT} {TYPE}EX-99 {SEQUENCE}2 {FILENAME}a4634858ex99.txt {DESCRIPTION}EXHIBIT 99 PRESS RELEASE {TEXT} Exhibit 99 CIMA LABS Announces First-Quarter Financial Results; Patient Enrollment Begins in OraVescent Fentanyl Phase III Clinical Trials EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--May 6, 2004-- _____________ -CIMA LABS – Announces First-Quarter Financial Results; Patient Enrollment Begins in OraVescent Fentanyl Phase III Clinical Trials EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--May 6, 2004--CIMA LABS INC. (NASDAQ: CIMA) today reported financial results for the first quarter ended March 31, 2004. For the first quarter of 2004: -- Revenues were $ _____________ CIMA LABS – listen to the conference call by visiting the Company's website, www.cimalabs.com. The call will be archived on this site. About CIMA LABS CIMA develops and manufactures prescription and over-the-counter products based upon its proprietary, orally disintegrating drug delivery technologies, OraSolv(R) and _____________ CIMA LABS – 14,331 14,008 Total assets 231,991 230,268 Current liabilities 15,053 15,689 Stockholders' equity 216,938 214,579 CONTACT: CIMA LABS INC. James Hawley, 952-947-8700 investorrelations@cimalabs.com or Sharon Merrill Associates, Inc. Ehren Lister, 617-542-5300 elister@investorrelations.com {/TEXT} {/ _____________ dt 256206
Preview Full Doc	2004	Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004 Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004 (50K) Doc #298447: Click preview link for longer preview. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}2 {FILENAME}ex-991.txt {TEXT} EXHIBIT 99.1 04/CAT/08 Page 1 of 14 FOR IMMEDIATE RELEASE 07.00 BST, 02.00 EST Monday 17 May 2004 For further information contact: Cambridge Antibody Technology Weber Shandwick Square Mile (Europe) ----------------------------- ------------------------------------ Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700 Peter Chambre, Chief Executive Officer Kevin Smith John Aston, Chief Financial Officer Louise Robson Rowena Gardner, Director of Corporate Communications BMC Communications/The Trout Group (USA) ---------------------------------------- Tel: +1 212 477 9007 Brad Miles, ext 17 (media) Brandon Lewis, ext 15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY INTERIM RESULTS FOR THE SIX MONTHS ENDED 31 MARCH 2004 Cambridge, UK...Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today announces financial results for the six months ended 31 March 2004 and a business update. Summary Developments since the First Quarter results: o Trial for litigation with Abbott set by London High Court for November 2004 o Library licences granted to Genzyme and Wyeth o Enrolment in US trial of Trabio(R) to be completed in the third quarter of 2004 o Wyeth progressing an anti-GDF-8 antibody, licensed from CAT o Further pre-clinical studies of GC-1008 underway o Plans for anti-TGF(beta) collaboration with Genzyme in development Previously announced: o Preliminary results from CAT-192 Phase I/II clinical trial o Enrolment complete in Phase III pivotal International clinical trial of Trabio o Co-development agreement with Amgen restructured on attractive terms o Co-development agreement with Elan terminated by CAT o Extension of manufacturing agreement with Lonza o Second tranche of equity investment by Genzyme {PAGE} Page 2 of 14 Financial: o Net cash and liquid resources of(pound)107.6 million at 31 March 2004 ((pound)107.8 million at 30 September 2003) o Net cash outflow before management of liquid resources and financing: (pound)14.2 million for the six months ended 31 March 2004 compared with(pound)13.2 million for the six months ended 31 March 2003 o Revised financial guidance: net cash outflow before management of liquid resources and financing for the year to 30 September 2004 expected to be less than (pound)35 million (after Genzyme investment, net cash outflow after financing less than (pound)21 million) Paul Nicholson, CAT's Chairman, said "We are pleased to report that CAT has continued to make progress in the first half of the financial year. We are also pleased that the High Court has fixed a trial date in November 2004 to hear our dispute with Abbott in accordance with our wish that the courts resolve the dispute at the earliest opportunity. We look forward to putting our case before the High Court in November." CAT Product Candidates In April 2004, three-year follow up results of a Phase II clinical trial of Trabio (lerdelimumab), a human anti-TGF(beta)2 monoclonal antibody, in patients undergoing first time phacotrabeculectomy (combined surgery to simultaneously treat glaucoma and a cataract) were presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO). The results show that patients treated with Trabio at the time of surgery have lower intraocular pressure (IOP) levels compared to placebo-treated patients. Additionally, the proportion of patients returning to IOP-lowering medication remains lower for Trabio than placebo groups. In the US clinical trial of Trabio compared to 5-fluorouracil (5FU) in patients undergoing surgery for glaucoma (trabeculectomy) enrolment is ongoing and is now expected to be complete in the third quarter of 2004. In the Phase II/III European clinical trial of Trabio in 344 patients undergoing first time trabeculectomy, it is expected that preliminary data at one year follow up will be available in the fourth quarter of 2004. Enrolment is complete in the Phase III pivotal International clinical trial of Trabio in patients undergoing first time trabeculectomy. A total of 393 patients in six European countries and South Africa were randomised in the double-blind trial which compares Trabio with placebo. Data from this trial are expected in early 2005 when all patients will have completed at least one year of follow-up post surgery. In February, preliminary results from a Phase I/II clinical trial of CAT-192 (metelimumab), a human anti-TGF(beta)1 monoclonal antibody, were announced. The double-blind, placebo-controlled trial enrolled 45 patients at 12 medical centres in the US and Europe. Patients were randomised to receive one of three dose levels of CAT-192 (0.5 mg/kg, 5 mg/kg or 10 mg/kg) or matching placebo, given as an intravenous infusion every six weeks for four doses. {PAGE} Page 3 of 14 The primary objective of the trial was to assess the safety, tolerability and pharmacokinetics of CAT-192 in patients suffering from diffuse systemic sclerosis. Preliminary results show that the primary objective of the trial was met; CAT-192 was generally safe and well-tolerated at each dose level. Elimination half-life was consistently around three weeks. There were no treatment-related serious adverse events observed. The secondary objective was to evaluate the potential clinical outcomes for any future trial in systemic sclerosis, however, no definitive conclusions regarding the efficacy of CAT-192 are able to be drawn at this time. An Investigational New Drug (IND) application for a Phase I trial in the US in idiopathic pulmonary fibrosis (IPF) of GC-1008, a pan-specific human anti-TGF(beta) monoclonal antibody being developed by CAT and Genzyme, has been filed with the US Food and Drug Administration (FDA). Following 298447	Wyeth Wyeth As referenced in this Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004: Wyeth – Quarter results: o Trial for litigation with Abbott set by London High Court for November 2004 o Library licences granted to Genzyme and Wyeth o Enrolment in US trial of Trabio(R) to be completed in the third quarter of 2004 o Wyeth progressing an anti- _____________ Wyeth – granted to Genzyme and Wyeth o Enrolment in US trial of Trabio(R) to be completed in the third quarter of 2004 o Wyeth progressing an anti-GDF-8 antibody, licensed from CAT o Further pre-clinical studies of GC-1008 underway o Plans for anti-TGF( _____________ Wyeth – HGSI has stated that further development of ABthrax will depend on the US Government's willingness to commit to the purchase of ABthrax. Wyeth is moving forward with MYO-029, a human monoclonal antibody discovered by CAT in collaboration with Wyeth and licensed to Wyeth, that neutralises _____________ Wyeth – commit to the purchase of ABthrax. Wyeth is moving forward with MYO-029, a human monoclonal antibody discovered by CAT in collaboration with Wyeth and licensed to Wyeth, that neutralises the effects of a protein called GDF-8, which is associated with reduced skeletal muscle mass. MYO- _____________ Wyeth, – of ABthrax. Wyeth is moving forward with MYO-029, a human monoclonal antibody discovered by CAT in collaboration with Wyeth and licensed to Wyeth, that neutralises the effects of a protein called GDF-8, which is associated with reduced skeletal muscle mass. MYO-029 is being _____________ dt 264719 ; Abbott Labs Abbott Laboratories ( Pharmaceutical Preparations ) As referenced in this Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004: Abbott Laboratories. – HUMIRA(TM) HUMIRA(TM) (adalimumab) is a human anti-TNF(alpha) monoclonal antibody which was isolated and optimised by CAT in collaboration with Abbott Laboratories. It is the first CAT-derived antibody to receive approval for marketing and is now approved for sale in 41 countries. Abbott _____________ dt 264523 ; Amgen Amgen, Inc. ;	CATG Cambridge Antibody Technology Group plc ( Commercial Physical & Biological Research ) As referenced in this Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004: CAMBRIDGE ANTIBODY TECHNOLOGY GROUP – year this would result in net cash outflow after financing of less than (pound)21 million. {PAGE} Page 8 of 14 {TABLE} {CAPTION} CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC INTERIM Statement of Results for the SIX MONTHS ended 31 MARCH 2004 CONSOLIDATED PROFIT AND LOSS ACCOUNT (unaudited) Six months Six months _____________ CAMBRIDGE ANTIBODY TECHNOLOGY GROUP – prepared in accordance with UK GAAP. The dollar translations are solely for the convenience of the reader. {PAGE} Page 9 of 14 {CAPTION} CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC INTERIM Statement of Results for the SIX MONTHS ended 31 MARCH 2004 Consolidated Balance Sheet (unaudited) As at As at As at _____________ CAMBRIDGE ANTIBODY TECHNOLOGY GROUP – prepared in accordance with UK GAAP. The dollar translations are solely for the convenience of the reader. {PAGE} Page 10 of 14 {CAPTION} CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC INTERIM Statement of Results for the SIX MONTHS ended 31 March 2004 Consolidated Cash Flow Statement (unaudited) Six months Six months Six _____________ Cambridge Antibody Technology Group – and financial statements for the year ended 30 September 2003 are available from the Corporate Communications Department at the Company's registered office: Cambridge Antibody Technology Group plc Milstein Building Granta Park Cambridge CB1 6GH UK Tel: +44 (0) 1223 471 471 E-mail: investor.relations@cambridgeantibody.com {PAGE} Page _____________ Cambridge Antibody Technology Group – in March 2000. Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward _____________ dt 264894 ; Human Genome Human Genome Sciences Inc. ( In Vitro & In Vivo Diagnostic Substances ) As referenced in this Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004: Human Genome Sciences, – clinical trial of ABT-874 in patients with active Crohn's disease will also be presented at Digestive Disease Week. In January 2004, Human Genome Sciences, Inc (HGSI) announced that it has begun enrolling and dosing patients in a Phase II clinical trial of LymphoStat-B(TM), a _____________ Human Genome Sciences, – pre-clinical development stage. o CAT has also licensed its proprietary technologies to several companies. CAT's licensees include: Abbott, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck & Co, Pfizer and Wyeth Research. o CAT is listed on the London Stock Exchange and on NASDAQ. CAT raised (pound)41m _____________ dt 262188 ; Merck Merck & Co., Inc. ( Pharmaceutical Preparations ) As referenced in this Cambridge Antibody Technology Interim Results for the Six Months Ended 31 March 2004: Merck – the two royalty payments made by Abbott. Revenues of (pound)1.1 million were generated from contract research fees under collaborations with Amgen, Merck & Co., Pfizer and Wyeth Research. Other revenues of (pound)0.4 million were recognised in the period. Direct costs for the six _____________ Merck – stage. o CAT has also licensed its proprietary technologies to several companies. CAT's licensees include: Abbott, Amgen, Chugai, Genzyme, Human Genome Sciences, Merck & Co, Pfizer and Wyeth Research. o CAT is listed on the London Stock Exchange and on NASDAQ. CAT raised (pound)41m in _____________ dt 261891
Full Doc	2004	Cambridge Antibody Technology Grants Licence to Wyeth Cambridge Antibody Technology Grants Licence to Wyeth (5K) Doc #298451: This document is immediately available for purchase, but does not have a preview available for viewing. Cambridge Antibody Technology Group plc 04/CAT/07 EXHIBIT 99.1 04/CAT/07 Page 1 of 2 FOR IMMEDIATE RELEASE 13.00 GMT, 08:00 EST Wednesday 11 February 2004 For further information contact: Cambridge Antibody Technology Tel: +44 (0) 1223 471 471 Peter Chambr?, Chief Executive Officer John Aston, Chief Financial Officer Rowena Gardner, Director of Corporate Communications Weber Shandwick Square Mile (Europe) Tel: +44 (0) 20 7067 0700 Kevin Smith Rachel Lankester BMC Communications/The Trout Group (USA) Tel: +1 212 477 . . . 298451	Wyeth Wyeth As referenced in this Cambridge Antibody Technology Grants Licence to Wyeth: WYETH – Group (USA) Tel: +1 212 477 9007 Brad Miles, ext 17 (media) Brandon Lewis, ext 15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY GRANTS LICENCE TO WYETH Cambridge, UK Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today announces that Wyeth (NYSE:WYE) has exercised an option to license CATs _____________ Wyeth – Lewis, ext 15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY GRANTS LICENCE TO WYETH Cambridge, UK Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today announces that Wyeth (NYSE:WYE) has exercised an option to license CATs proprietary antibody phage display libraries for in-house use. The libraries will support _____________ Wyeth – in therapeutic antibody drug discovery and development across a broad range of therapeutic areas. This option to license CATs libraries was granted to Wyeth as part of the collaboration agreement entered into in March 1999. In return for Wyeths exercise of the option, CAT will receive an _____________ Wyeth – the collaboration agreement entered into in March 1999. In return for Wyeths exercise of the option, CAT will receive an upfront licence fee. Wyeth has a number of exclusive therapeutic and diagnostic antibody product options related to its use of the library which, if exercised, will result _____________ Wyeth – milestone and royalty payments. Page 2 of 2 Peter Chambr, Chief Executive Officer of CAT, commented We have developed an excellent relationship with Wyeth over the past four years that has already resulted in Wyeth taking two exclusive product licences to human antibodies identified through work carried _____________ dt 264720 ; CATG Cambridge Antibody Technology Group plc ( Commercial Physical & Biological Research ) As referenced in this Cambridge Antibody Technology Grants Licence to Wyeth: Cambridge Antibody Technology Group – in March 2000. Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward _____________ dt 264895 ;	Human Genome Human Genome Sciences Inc. ( In Vitro & In Vivo Diagnostic Substances ) As referenced in this Cambridge Antibody Technology Grants Licence to Wyeth: Human Genome Sciences, – and one at pre-clinical development stage. CAT has also licensed its proprietary technologies to several companies. CATs licensees include: Abbott, Amgen, Chugai, Human Genome Sciences, Merck & Co, Pfizer and Wyeth Research. CAT is listed on the London Stock Exchange and on NASDAQ. CAT raised 41m in its _____________ dt 262190 ; Merck Merck & Co., Inc. ( Pharmaceutical Preparations )
Full Doc	2004	Elan and Wyeth Announce Results from Phase IIA Clinical Trial of AN-1792 Elan and Wyeth Announce Results from Phase IIA Clinical Trial of AN-1792 (9K) Doc #302522: This document is immediately available for purchase, but does not have a preview available for viewing. {DOCUMENT} {TYPE}EX-99.1 {SEQUENCE}2 {FILENAME}elan6k072104ex99-1.txt {DESCRIPTION}PRESS RELEASE {TEXT} Exhibit 99.1 Investors: Media: Elan: Emer Reynolds Elan: Anita Kawatra Ph: 353-1-709-4000 Ph: 212-407-5755 800-252-3526 800-252-3526 Wyeth: Justin Victoria Wyeth: Gerald V. Burr Ph: 973-660-5340 Ph: 484-865-5138 ELAN AND WYETH ANNOUNCE RESULTS FROM PHASE IIa CLINICAL TRIAL OF AN-1792 Philadelphia, PA - July 21, 2004 - Elan Corporation, plc and Wyeth Pharmaceuticals announced today several key findings from their Phase IIa clinical trial of an investigational Alzheimer's disease (AD) treatment, AN-1792, which were presented in Philadelphia at the 9th International Conference on Alzheimer's Disease and Related Disorders. AN-1792 is a synthetic form of the beta amyloid peptide that pathologically builds up in the brains of persons with AD. Although dosing with AN-1792 was halted in January 2002 after reports of encephalitis in a subset of patients, the trial remained blinded and the patients were followed in the study until December 2002. While clinical development of AN-1792 has been terminated, the results presented today support the beta amyloid immunotherapy approach, which is thought to treat Alzheimer's disease using an immunologic approach to clear beta amyloid from the brain. The results include less worsening on a neuropsychological test battery, including the memory component at 12 months in patients who developed an antibody response to AN-1792 compared to the placebo group. In addition, in three autopsy examinations of patients treated with AN-1792, reduction of beta amyloid plaque was observed. {PAGE} "These results are significant because they suggest that it may be possible to reduce plaque buildup in the brain and alter the pathologic findings of patients with Alzheimer's disease," said Dale Schenk, PhD, Senior Vice President and Chief Scientific Officer, Elan. "These data offer hope that beta amyloid immunotherapy may be able to make a meaningful difference for these patients." Sid Gilman, MD, FRCP, William J. Herdman Professor and Director, Michigan Alzheimer's Disease Research Center, University of Michigan, and Nick Fox, MD, FRCP, MRC Senior Clinical Fellow; Reader in Neurology, Institute of Neurology; Neurologist, National Hospital for Neurology and Neurosurgery, were principal investigators in the trial and presented the data today at the 9th International Conference on Alzheimer's Disease & Related Disorders. AN-1792 Phase IIa Study Findings o A number of clinical endpoints were examined in this interrupted trial. Though primary cognitive endpoints did not demonstrate improvement in those treated with AN-1792, a composite neuropsychological performance measure, including the memory component, improved at 12 months in anti beta amyloid antibody responders compared to placebo-treated patients. o Evidence of beta amyloid plaque reduction was observed in three autopsy cases that have been examined from the Phase I and IIa AN-1792 trials. The observed plaque clearance is consistent with those findings of numerous laboratories investigating beta amyloid immunotherapy in animal models of Alzheimer's disease. An analysis is in progress of a fourth autopsy case showing evidence of active plaque removal. o Levels of tau protein in cerebral spinal fluid (CSF), a marker known to be elevated in AD, were lower in anti beta amyloid antibody responders. o Brain volume was lower in anti beta amyloid antibody responders as measured by magnetic resonance imaging (MRI).(1) "The significance of any of these data individually is not clear; however, collectively the study results from AN-1792 underscore the importance of our novel immunotherapeutic approach to the treatment of this devastating disease and indicate that further study of this approach is ---------- 1 Fox, Nick C. et. al., abstract for International Conference on Alzheimer's Disease and Related Disorders, Philadelphia, July, 2004. "Effects of A-beta Immunotherapy (AN-1792) on MRI Measures on Brain, Ventricle and Hippocampal Volumes in Alzheimer's Disease." {PAGE} warranted," said Gary L. Stiles, MD, FACC, Chief Medical Officer, Executive Vice President, Wyeth Pharmaceuticals. "That is why Wyeth and Elan are now in the clinic evaluating a new compound, AAB-001, a humanized monoclonal antibody." About the Phase IIa AN-1792 Clinical Trial The AN-1792 Phase IIa study was an international, double-blind placebo-controlled trial that assessed 372 patients with mild to moderate Alzheimer's disease. Because of an expected 25 percent antibody response rate in those treated with AN-1792, patients were randomized 4:1 to receive either active immunization with AN-1792 or placebo. The study was designed to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the beta amyloid peptide. The evaluation included standard clinical assessments of cognition as well as the assessment of surrogate markers of Alzheimer's disease. Dosing was halted in January 2002 after reports of encephalitis in a subset of patients; however, the trial remained blinded and patients were followed in the study until December 2002. Because Alzheimer's disease is a terminal diagnosis, autopsies were performed on the patients in the clinical study who have since died to confirm previous diagnosis of the disease. Other Immunotherapeutic Approaches Elan and Wyeth are currently pursuing beta amyloid immunotherapy for mild to moderate Alzheimer's disease in a Phase I safety study of a new compound, AAB-001. AAB-001 is a humanized monoclonal antibody that binds to and clears beta amyloid peptide in experimental animal models. It is designed to provide the anti beta amyloid antibodies directly to the patient, rather than requiring the patient to mount an immune response. Elan and Wyeth are also developing ACC-001, a novel beta amyloid-related active immunization approach, which is currently being evaluated in preclinical studies. This approach is intended to induce a highly specific antibody response to beta amyloid. About Alzheimer's Disease 302522	Wyeth Wyeth As referenced in this Elan and Wyeth Announce Results from Phase IIA Clinical Trial of AN-1792: Wyeth: – Investors: Media: Elan: Emer Reynolds Elan: Anita Kawatra Ph: 353-1-709-4000 Ph: 212-407-5755 800-252-3526 800-252-3526 Wyeth: Justin Victoria Wyeth: Gerald V. Burr Ph: 973-660-5340 Ph: 484-865-5138 ELAN AND WYETH ANNOUNCE RESULTS FROM PHASE IIa _____________ Wyeth: – Emer Reynolds Elan: Anita Kawatra Ph: 353-1-709-4000 Ph: 212-407-5755 800-252-3526 800-252-3526 Wyeth: Justin Victoria Wyeth: Gerald V. Burr Ph: 973-660-5340 Ph: 484-865-5138 ELAN AND WYETH ANNOUNCE RESULTS FROM PHASE IIa CLINICAL TRIAL OF _____________ WYETH – 800-252-3526 800-252-3526 Wyeth: Justin Victoria Wyeth: Gerald V. Burr Ph: 973-660-5340 Ph: 484-865-5138 ELAN AND WYETH ANNOUNCE RESULTS FROM PHASE IIa CLINICAL TRIAL OF AN-1792 Philadelphia, PA - July 21, 2004 - Elan Corporation, plc and Wyeth Pharmaceuticals announced today _____________ Wyeth – 5138 ELAN AND WYETH ANNOUNCE RESULTS FROM PHASE IIa CLINICAL TRIAL OF AN-1792 Philadelphia, PA - July 21, 2004 - Elan Corporation, plc and Wyeth Pharmaceuticals announced today several key findings from their Phase IIa clinical trial of an investigational Alzheimer's disease (AD) treatment, AN-1792, _____________ Wyeth – Brain, Ventricle and Hippocampal Volumes in Alzheimer's Disease." {PAGE} warranted," said Gary L. Stiles, MD, FACC, Chief Medical Officer, Executive Vice President, Wyeth Pharmaceuticals. "That is why Wyeth and Elan are now in the clinic evaluating a new compound, AAB-001, a humanized monoclonal antibody." About _____________ dt 270125 ; Elan Elan Corp., plc ( Pharmaceutical Preparations ) As referenced in this Elan and Wyeth Announce Results from Phase IIA Clinical Trial of AN-1792: Elan Corp – 5340 Ph: 484-865-5138 ELAN AND WYETH ANNOUNCE RESULTS FROM PHASE IIa CLINICAL TRIAL OF AN-1792 Philadelphia, PA - July 21, 2004 - Elan Corp oration, plc and Wyeth Pharmaceuticals announced today several key findings from their Phase IIa clinical trial of an investigational Alzheimer's disease (AD) _____________ Elan Corp – and other countries, it is expected that more than 37 million people worldwide will be afflicted by the disease by 2025. About Elan Elan Corp oration, plc is a neuroscience-based biotechnology company that is focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, _____________ dt 271358 ;	Michigan University of Michigan, Ann Arbor ( Universities ) As referenced in this Elan and Wyeth Announce Results from Phase IIA Clinical Trial of AN-1792: University of Michigan, – make a meaningful difference for these patients." Sid Gilman, MD, FRCP, William J. Herdman Professor and Director, Michigan Alzheimer's Disease Research Center, University of Michigan, and Nick Fox, MD, FRCP, MRC Senior Clinical Fellow; Reader in Neurology, Institute of Neurology; Neurologist, National Hospital for Neurology and Neurosurgery, _____________ dt 270611