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 | 2001 |
King Pharmaceuticals Reports Solid Revenue Growth for Third Quarter 2001 of 39% to $230.1 Million and Diluted Earnings per Share Growth of 33% to $0.28 Excluding Special Charges
King Pharmaceuticals Reports Solid Revenue Growth for Third Quarter 2001 of 39% to $230.1 Million and Diluted Earnings per Share Growth of 33% to $0.28 Excluding Special Charges (31K)
Doc #281684: Click preview link for longer preview.
{DOCUMENT}
{TYPE}EX-99.1
{SEQUENCE}3
{FILENAME}g72455aex99-1.txt
{DESCRIPTION}PRESS RELEASE
{TEXT}
{PAGE}
Exhibit 99.1
N E W S R E L E A S E
(KING PHARMACEUTICALS LOGO)
--------------------------------------------------------------------------------
FOR IMMEDIATE RELEASE
KING PHARMACEUTICALS REPORTS SOLID REVENUE GROWTH FOR
THIRD QUARTER 2001 OF 39% TO $230.1 MILLION AND
DILUTED EARNINGS PER SHARE GROWTH OF 33% TO $0.28,
EXCLUDING SPECIAL CHARGES
BRISTOL, TENNESSEE, October 29, 2001 - King Pharmaceuticals, Inc. (NYSE:KG)
announced today that net earnings equaled $64.8 million for the third quarter
ending September 30, 2001, an increase of 38% over the third quarter of last
year, excluding special charges. For the nine months ending September 30, 2001,
net earnings equaled $166.4 million, an increase of 52% over the same period of
2000, excluding special charges.
Diluted earnings per share was $0.28 for the third quarter of 2001, up 33% from
$0.21 for the third quarter of 2000, excluding special charges. Diluted earnings
per share increased 44% to $0.72 for the nine months ending September 30, 2001,
compared to $0.50 for the same period of 2000, excluding special charges. All
earnings per share data reflects the Company's four for three stock split
distributed on July 19, 2001.
King recorded special charges totaling $5.3 million during the third quarter
ending September 30, 2001. Specifically, King recorded merger and restructuring
costs of $3.3 million related to the further integration of Jones Pharma
Incorporated ("Jones"). King merged with Jones in August 2000 in a tax-free
pooling of interests transaction. Other special charges incurred during the
third quarter 2001 relate to the write-off of obsolete Levoxyl(R) (levothyroxine
sodium tablets, USP) inventory. The U.S. Food and Drug Administration ("FDA")
approved the new drug application ("NDA") for a new formulation of Levoxyl on
May 25, 2001. Pursuant to FDA guidance, King may distribute only the FDA
approved new formulation of Levoxyl(R) after August 14, 2001.
During the third quarter of 2000, King recorded special charges totaling $96.2
million. Specifically, King recorded merger and restructuring costs related to
King's merger with Jones, restructuring and nonrecurring charges related to the
Company's decision to discontinue Fluogen(R) (Influenza Virus Vaccine,
Trivalent, Types A and B) and the Company's decision to discontinue development
of Pallacor(TM), and an extraordinary charge related to the write-off of
financing costs resulting from the repayment of debt. Additionally, during the
six months ending June 30, 2000, King recorded extraordinary charges related to
the write-off of financing costs resulting from the repayment of debt under
King's senior credit facility, and merger and restructuring costs related to
King's merger with Medco Research, Inc., since renamed King Pharmaceuticals
Research and Development, Inc., in a tax-free pooling of interests transaction.
Including special charges, net earnings and diluted earnings per share during
the third quarter of 2001 totaled $61.5 million and $0.27, respectively.
Likewise, including special charges, net earnings totaled $162.5 million and
diluted earnings per share equaled $0.70 during the first nine months of 2001.
Revenues totaled $230.1 million for the third quarter ending September 30, 2001,
a 39% increase over the third quarter of 2000, and $617.9 million for the nine
months ending September 30, 2001, a 39% increase over the same period of the
prior year.
(more)
{PAGE}
The increase in third quarter revenues and net earnings is attributable
primarily to the sales growth of a variety of the Company's branded
pharmaceutical products, including, in particular, Altace(R) (ramipril) and
Levoxyl(R). King's branded pharmaceutical products are marketed primarily by its
wholly owned subsidiary, Monarch Pharmaceuticals, Inc.
Net revenue from branded pharmaceuticals, including royalty income, totaled
$223.1 million for the third quarter of 2001, a 46% increase over the third
quarter of 2000. For the third quarter ending September 30, 2001, revenue from
contract manufacturing equaled $6.3 million, while remaining revenue, comprised
primarily of generic sales, totaled $702 thousand.
Altace(R) net sales grew to $76.2 million in the third quarter of 2001,
exceeding our projected range, a 51% increase over the third quarter of 2000.
Altace(R) new prescriptions totaled approximately 628,000 and total
prescriptions equaled approximately 1,849,000 during the third quarter of 2001,
increases of 65.3% and 65.1% respectively, over the third quarter of 2000,
according to IMS America monthly prescription data.
Levoxyl(R) net sales grew to $27.1 million in the third quarter of 2001, a 65%
increase over the third quarter of 2000.
Net sales of Thrombin-JMI(R) totaled $16.6 million in the third quarter of 2001,
a 39% increase from $11.9 million in the third quarter of the prior year.
Lorabid(R) (loracarbef) net sales totaled $6.1 million in the third quarter of
2001.
Royalty revenues from Adenoscan(R) (adenosine) and Adenocard(R) (adenosine)
totaled $11.6 million in the third quarter of 2001, a 26% increase from $9.2
million in the third quarter of the prior year.
Net cash provided by operating activities equaled $76.4 million for the third
quarter ending September 30, 2001. As of September 30, 2001, cash and cash
equivalents totaled approximately $20 million. James R. Lattanzi, Chief
Financial Officer of King, explained, "Cash on hand was reduced during the third
quarter 2001 to finance King's acquisition of three branded pharmaceutical
products, along with another fully paid license for a fourth product, from
Bristol-Myers Squibb Company on August 8, 2001. Total consideration paid by King
to Bristol-Myers Squibb for the four branded pharmaceutical products equaled
$285 million."
King has revised upward projected ranges for estimated net sales of Altace(R),
estimated total revenue, and estimated diluted earnings per share, for year-end
2001 to reflect actual results for the third quarter of 2001 as follows (dollars
in millions, except EPS):
{TABLE}
{CAPTION}
--------------------------------------------------
YEAR-END 2001
-------------
--------------------------------------------------
{S} {C}
Altace(R) net sales $279 - 284
--------------------------------------------------
Revenue $865 - 875
--------------------------------------------------
Diluted EPS $1.01 - 1.02
(excluding special charges)
--------------------------------------------------
{/TABLE}
281684
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Wyeth
As referenced in this King Pharmaceuticals Reports Solid Revenue Growth for Third Quarter 2001 of 39% to $230.1 Million and Diluted Earnings per Share Growth of 33% to $0.28 Excluding Special Charges:
Wyeth- – Joseph R.
Gregory, Vice Chairman of King stated, "During the course of King's conference
call scheduled for later today, King, together with Wyeth- Ayerst Laboratories,
will in my opinion announce a very positive recent development in relation to
the forthcoming planned direct to consumer campaign for
_____________
dt 227007
;
Bristol-Myers
As referenced in this King Pharmaceuticals Reports Solid Revenue Growth for Third Quarter 2001 of 39% to $230.1 Million and Diluted Earnings per Share Growth of 33% to $0.28 Excluding Special Charges:
Bristol-Myers Squibb – quarter 2001 to finance King's acquisition of three branded pharmaceutical
products, along with another fully paid license for a fourth product, from
Bristol-Myers Squibb Company on August 8, 2001. Total consideration paid by King
to Bristol-Myers Squibb for the four branded pharmaceutical products equaled
$285 million."
_____________
Bristol-Myers Squibb – another fully paid license for a fourth product, from
Bristol-Myers Squibb Company on August 8, 2001. Total consideration paid by King
to Bristol-Myers Squibb for the four branded pharmaceutical products equaled
$285 million."
King has revised upward projected ranges for estimated net sales of Altace(R),
estimated
_____________
dt 225665
;
|
King Pharma
As referenced in this King Pharmaceuticals Reports Solid Revenue Growth for Third Quarter 2001 of 39% to $230.1 Million and Diluted Earnings per Share Growth of 33% to $0.28 Excluding Special Charges:
(KING PHARMACEUTICALS – FILENAME}g72455aex99-1.txt
{DESCRIPTION}PRESS RELEASE
{TEXT}
{PAGE}
Exhibit 99.1
N E W S R E L E A S E
(KING PHARMACEUTICALS LOGO)
--------------------------------------------------------------------------------
FOR IMMEDIATE RELEASE
KING PHARMACEUTICALS REPORTS SOLID REVENUE GROWTH FOR
THIRD QUARTER 2001 OF 39% TO $230.1 MILLION AND
DILUTED EARNINGS
_____________
KING PHARMACEUTICALS – RELEASE
{TEXT}
{PAGE}
Exhibit 99.1
N E W S R E L E A S E
(KING PHARMACEUTICALS LOGO)
--------------------------------------------------------------------------------
FOR IMMEDIATE RELEASE
KING PHARMACEUTICALS REPORTS SOLID REVENUE GROWTH FOR
THIRD QUARTER 2001 OF 39% TO $230.1 MILLION AND
DILUTED EARNINGS PER SHARE GROWTH OF 33% TO $
_____________
King Pharmaceuticals, – TO $230.1 MILLION AND
DILUTED EARNINGS PER SHARE GROWTH OF 33% TO $0.28,
EXCLUDING SPECIAL CHARGES
BRISTOL, TENNESSEE, October 29, 2001 - King Pharmaceuticals, Inc. (NYSE:KG)
announced today that net earnings equaled $64.8 million for the third quarter
ending September 30, 2001, an increase
_____________
King Pharmaceuticals
– debt under
King's senior credit facility, and merger and restructuring costs related to
King's merger with Medco Research, Inc., since renamed King Pharmaceuticals
Research and Development, Inc., in a tax-free pooling of interests transaction.
Including special charges, net earnings and diluted earnings per share
_____________
King
Pharmaceuticals – including but not limited to, King's merger with Jones Pharma
Incorporated and King's merger with Medco Research, Inc., now known as King
Pharmaceuticals Research and Development, Inc., dependence on King's ability to
continue to acquire branded products, the high cost and uncertainty of research,
clinical
_____________
dt 221492
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| Full Doc
| 2003 |
MedImmune Reports 2002 Fourth Quarter and Year-End Results
MedImmune Reports 2002 Fourth Quarter and Year-End Results (34K)
Doc #272436: This document is immediately available for purchase, but does not have a preview available for viewing.
Exhibit 99.1
MEDIMMUNE REPORTS 2002 FOURTH QUARTER AND YEAR-END RESULTS
-2002 Total Revenue Increased 37 Percent to a Record $848 Million-
2002 Highlights
o Worldwide Synagis (palivizumab) sales up 29 percent to $668 million
o Ethyol (amifostine) sales exceeded $80 million
o FluMist receives favorable recommendation from FDA Advisory Panel
o Positive Phase 3 data for Synagis in congenital heart disease infants submitted to FDA
o MedImmune Vaccines, Inc. created through $1.6 billion acquisition of Aviron
o Three new preclinical programs in-licensed
o Synagis approved and launched in Japan and Canada
o Construction of new headquarters and FluMist manufacturing facilities initiated
o MedImmune Ventures, Inc. established
GAITHERSBURG, MD, January 30, 2003 - MedImmune, Inc. (Nasdaq: MEDI) today announced that total revenue for the fourth
quarter of 2002 increased 30 percent to $382 million, driving revenue to $848 million for the full year ended December 31,
2002. Revenue growth was due primarily to the continued success of Synagis, the company's flagship product used to prevent
respiratory syncytial virus (RSV) in high-risk infants. Worldwide sales of Synagis in 2002 were $668 million, a 29-percent
increase over 2001 sales of $516 million. For the 2002 fourth quarter, worldwide sales of Synagis increased 25 percent to
$312 million from $250 million in the 2001 period. Sales of Ethyol, the company's first oncology product, exceeded $80
million during 2002 and $25 million in the 2002 fourth quarter. In 2001, MedImmune recorded Ethyol revenues of $20 million
and $14 million for the year and fourth quarter, respectively. Other revenue in the fourth quarter of 2002 included $25
million related to compensation for 2002 FluMist manufacturing costs from Wyeth, the company's co-promotion partner for the
product.
"We made substantial progress in 2002 toward our long-term goals," stated David M. Mott, chief executive officer. "Product
sales increased 36 percent; we completed the acquisition and integration of a vaccine company that provides us with our
next potential blockbuster product, FluMist; we completed a successful Phase 3 trial with Synagis in children with
congenital heart disease; we added three new programs to our preclinical pipeline; and we broke ground on a number of
construction projects, including our new headquarters and research and development facility, as well as a new production
facility for FluMist."
Mr. Mott added, "In 2003, we look forward to launching FluMist, moving into Phase 3 with our human papillomavirus vaccine
for the prevention of cervical cancer, and taking two programs from our preclinical pipeline forward into clinical trials.
We expect to achieve a major financial milestone for MedImmune in 2003 with revenues exceeding $1 billion for the first
time, reflecting revenue growth of 24 percent to 30 percent. We also expect our earnings to more than double in 2003."
For the fourth quarter 2002, MedImmune reported net earnings of $85 million, or $0.33 per diluted share. For the year
ended December 31, 2002, MedImmune reported a loss of $1.1 billion or $4.40 per share. This loss reflects the impact of a
$1.2 billion in-process research and development charge associated with the purchase of MedImmune Vaccines (formerly known
as Aviron), as well as the inclusion of MedImmune Vaccines' operations in MedImmune's results as of January 10, 2002. In
2001, MedImmune reported net earnings of $99 million, or $0.45 per diluted share, for the fourth quarter, and $149 million,
or $0.68 per diluted share for the year.
Adjusted Results
MedImmune also announced "adjusted" results for 2002, which exclude certain amounts associated with the acquisition of
MedImmune Vaccines. MedImmune computes "adjusted" earnings by adding back amounts that are related to the acquisition of
MedImmune Vaccines, including: the in-process research and development charge; amortization of intangible assets;
compensation expense associated with the assumption and vesting of unvested stock options, retention and severance
payments; and amortization of premium on convertible subordinated notes. MedImmune believes the "adjusted" results are
more indicative of the underlying trends in the operations of the business, and will continue to provide "adjusted" results
in addition to reporting earnings computed in accordance with generally accepted accounting principles (GAAP). The
accompanying schedules present the reconciliation from GAAP results to "adjusted" results, with additional details included
in the notes to those schedules.
Fourth Quarter Adjusted Earnings
For the 2002 fourth quarter, MedImmune's adjusted net earnings were $92 million, or $0.36 per diluted share.
Gross margins on product sales for the 2002 fourth quarter were 76 percent versus 77 percent in the 2001 fourth quarter,
reflecting the cost of additional royalty payments related to domestic Synagis sales in 2002, partially offset by
manufacturing cost reductions for Synagis.
Research and development expenses rose to $30 million in the 2002 fourth quarter from $21 million last year. The increases
were due largely to the inclusion of MedImmune Vaccines' activities and gaining access to various technologies and
intellectual property to advance our pipeline.
Selling, general and administrative costs in the fourth quarter of 2002 increased to $102 million from $67 million in the
2001 period, due primarily to increased co-promotion expenses for Synagis, the acquisition of MedImmune Vaccines, and
higher marketing expenses for Synagis and Ethyol.
Other operating expenses in the fourth quarter of 2002 were $26 million compared to $2 million in the fourth quarter last
year. In addition to pre-production expenses for FluMist, other operating expenses included a $13 million charge for the
write-off of plasma manufacturing assets due to the outsourcing of CytoGam manufacturing activities.
The number of shares used in computing basic and diluted earnings per share increased by approximately 34 million primarily
due to shares issued for the acquisition of MedImmune Vaccines.
Adjusted Earnings for the Year 2002
MedImmune's adjusted earnings for 2002 were $107 million, or $0.42 per diluted share.
Gross margins on product sales for 2002 were 74 percent, down two percentage points from the comparable period last year,
largely due to the additional royalty payments in 2002 related to domestic Synagis sales.
Research and development expenses rose to $135 million in 2002 from $83 million in the 2001 year, largely due to the
inclusion of MedImmune Vaccines' activities, gaining access to various technologies and intellectual property to advance
our pipeline, and the progress of the research pipeline over the course of 2002.
Selling, general and administrative costs in 2002 increased to $287 million from $195 million in the 2001 period due
primarily to: the acquisition of MedImmune Vaccines; increased co-promotion expenses for Synagis; higher sales and
marketing expenses for Synagis and Ethyol; increases in infrastructure costs to support the growth of the business; and
costs associated with the settlement of a contractual dispute.
Other operating expenses in 2002 were $79 million compared to $10 million in the 2001 period, primarily due to costs
associated with the manufacture of FluMist and the fixed asset write-off associated with the outsourcing of CytoGam
manufacturing activities during the fourth quarter.
Results for the year also reflect approximately $14 million in impairment losses on certain equity investments that were
affected by the downward movement in the capital markets during 2002.
The number of shares used in computing basic and diluted earnings per share increased by approximately 33 million primarily
due to shares issued for the acquisition of MedImmune Vaccines.
Cash and marketable securities at December 31, 2002 were $1.4 billion compared to $778 million at December 31, 2001,
primarily reflecting cash and securities received as a part of the acquisition of MedImmune Vaccines and positive cash flow
from operations.
Looking Ahead in 2003
The following forward-looking information is being provided as a convenience to investors. The guidance and objectives
provided below are projections and assume the continued growth and success of MedImmune's existing business, including
sales of Synagis and Ethyol, as well as the approval of FluMist by the FDA in the second quarter of 2003 and the subsequent
initiation of sales of FluMist in the U.S. in the second half of 2003 and progress on MedImmune's pipeline. Investors
should note that sales of Synagis occur primarily during the fourth and first calendar quarters when RSV is most prevalent
in the Northern Hemisphere, and that sales of FluMist are expected to primarily occur in the second half of the year, which
is the most common time for yearly influenza vaccinations. The company's quarterly results are expected to reflect this
seasonality for its marketed products. The projections provided here are provided on an "adjusted" basis, except where
specifically identified as GAAP. Further, the projections are based upon numerous assumptions, many of which MedImmune
cannot control and which may not develop as MedImmune expects. Consequently, actual results may differ materially from the
guidance and objectives described herein. Please refer to the Disclosure Notice below.
Guidance for the year ending December 31, 2003
o Adjusted earnings per diluted share: $0.88 to $0.93 (110% to 121% growth over 2002)
o GAAP earnings per diluted share: $0.84 to $0.89
o Total revenue of $1.05 to $1.1 billion (24% to 30% growth over 2002)
- Projected product sales growth: 21% to 25% over 2002
- Projected growth of Synagis: 16% to 20% over 2002
- Projected growth of Ethyol: 20% to 25% over 2002
- Total FluMist revenue (product sales and other revenue from milestones and royalties): $120 million to $140 million
o Gross margins: approximately 71% of product sales
o Research and development expense: projected to range from $140 million to $145 million
o Selling, general and administrative: projected to be 32% to 33% of product sales
o Other expenses: projected to range from $17 million to $20 million
o Tax rate: approximately 37%
Guidance for the quarter ending March 31, 2003
o Adjusted earnings per diluted share: $0.40 to $0.43 (38% to 48% growth over 2002)
272436
|
Wyeth
As referenced in this MedImmune Reports 2002 Fourth Quarter and Year-End Results:
Wyeth, – fourth quarter, respectively. Other revenue in the fourth quarter of 2002 included $25
million related to compensation for 2002 FluMist manufacturing costs from Wyeth, the company's co-promotion partner for the
product.
"We made substantial progress in 2002 toward our long-term goals," stated David
_____________
dt 166988
;
|
MedImmune
As referenced in this MedImmune Reports 2002 Fourth Quarter and Year-End Results:
MedImmune, Inc – Japan and Canada
o Construction of new headquarters and FluMist manufacturing facilities initiated
o MedImmune Ventures, Inc. established
GAITHERSBURG, MD, January 30, 2003 - MedImmune, Inc . (Nasdaq: MEDI) today announced that total revenue for the fourth
quarter of 2002 increased 30 percent to $382 million, driving revenue to $
_____________
MedImmune, Inc – will receive required regulatory clearance or that, even if such regulatory clearance were received, such products
would ultimately achieve commercial success.
- Tables Follow -
MedImmune, Inc .
Condensed Consolidated Statements of Operations (1)
(in thousands, except per share data)
Three Months Ended December 31 Year Ended December 31,
---------- --------- ------------ ----------
2002
_____________
MedImmune, Inc – of operations for MedImmune Vaccines, Inc., formerly Aviron,
which was acquired through an exchange offer and merger transaction valued at $1.6 billion.
MedImmune, Inc .
Adjusted Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
Three Months Ended December 31, 2002 Three Months Ended
Acquisition-
_____________
MedImmune, Inc – connection with a retention plan.
(6) Consists of $0.5 million, relating to the amortization of premium on MedImmune Vaccines' Convertible Subordinated Notes.
MedImmune, Inc .
Adjusted Consolidated Statements of Operations (Unaudited)
(in thousands, except per share data)
Year Ended December 31, 2002 Year Ended
Acquisition-related December
_____________
MedImmune, Inc – process technology of $1.2 billion, primarily related to MedImmune Vaccines'
lead product candidate, FluMist, which has not been approved by the FDA.
MedImmune, Inc .
Condensed Consolidated Balance Sheets (1)
(in thousands)
December 31, December 31,
2002 2001
----------- -----------
Assets:
Cash and marketable securities $ 1,423,056 $ 777,
_____________
dt 181031
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Preview
Full Doc
| 2002 |
Immunex Secures Additional Manufacturing Capacity for Enbrel(R)(Etanercept) at Genentech, Inc.
Immunex Secures Additional Manufacturing Capacity for Enbrel(R)(Etanercept) at Genentech, Inc. (7K)
Doc #284794: Click preview link for longer preview.
{DOCUMENT}
{TYPE}EX-99.1
{SEQUENCE}4
{FILENAME}dex991.txt
{DESCRIPTION}PRESS RELEASE DATED APRIL 15, 2002
{TEXT}
{PAGE}
EXHIBIT 99.1
For Immediate Release, April 15, 2002
CONTACT :
Robin Shapiro (media), 206.389.4040
Mark Leahy (investors), 206.389.4363
Immunex Secures Additional Manufacturing Capacity for ENBREL(R)(etanercept) at
Genentech, Inc.
Immunex Takes Additional Steps to Expand Supply To Help Keep Up with Growing
Demand for Sales of ENBREL
--------------------------------------------------------------------------------
SEATTLE, WA - Immunex Corporation [Nasdaq: IMNX] today announced a manufacturing
agreement with Genentech, Inc. to produce ENBREL(R) (etanercept) at Genentech's
manufacturing facility in South San Francisco. Subject to the approval of the
U.S. Food and Drug Administration, the facility is expected to add supply
capacity for ENBREL, beginning in 2004. Currently, ENBREL is manufactured at a
plant operated by Immunex's manufacturing partner, and at Immunex's Rhode Island
facility, expected to be approved later this year.
"We're working hard to help assure that the growing demand for ENBREL is met,"
said Peggy Phillips, Immunex's executive vice president and chief operating
officer.
ENBREL was launched in 1998 and is now marketed for reducing signs and symptoms
and inhibiting the progression of structural damage in patients with moderately
to severely active rheumatoid arthritis (RA). ENBREL is also the first and only
therapy approved to reduce the signs and symptoms of active arthritis in
patients with psoriatic arthritis. Additionally, Immunex is studying ENBREL in a
Phase 2/3 clinical study for psoriasis, and Phase 3 clinical studies for
ankylosing spondylitis and Wegener's granulomatosis.
"This Genentech agreement adds flexibility and depth to our plans to expand the
production capacity of ENBREL to the multi-billion dollar level," said Phillips.
The agreement will be for a fixed time frame. Upon approval of the FDA, which
the parties hope to obtain in early 2004, the Genentech facility will become a
licensed manufacturing site for commercial supply of ENBREL. Under the terms of
the agreement, Genentech will produce ENBREL through 2005, and the parties can
by mutual agreement extend production through 2006.
The collaboration with Genentech represents another in a series of strategic
steps Immunex is taking to increase both short-term and long-term supply of
ENBREL. In November 2001, Immunex broke ground on the BioNext Project(TM),
second manufacturing plant in West Greenwich, Rhode Island, which will be
dedicated to the production of ENBREL and other products. Once completed, it
will be one of the largest and most advanced cell culture manufacturing centers
in the world.
ABOUT ENBREL
ENBREL is the only TNF receptor on the market. It acts by binding TNF, one of
the dominant inflammatory cytokines or regulatory proteins that play an
important role in both normal immune function and the cascade of reactions that
cause the inflammatory process of RA and psoriatic arthritis. The binding of
ENBREL to TNF renders the bound TNF biologically inactive, resulting in
significant reduction in inflammatory activity.
{PAGE}
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING
DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE INFECTIONS
OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED
OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN
REPORTED. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS. DO
NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN ALLERGY
TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN PATIENTS
PRONE TO INFECTION. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT
ENBREL OR INFECTIONS.
There have been reports of serious nervous system disorders such as multiple
sclerosis, seizures, or inflammation of the nerves of the eyes. Tell your doctor
if you have ever had any of these disorders or if you develop them after
starting ENBREL(R) (etanercept). There have also been rare reports of serious
blood disorders, some involving death. Contact your doctor immediately if you
develop symptoms such as persistent fever, bruising, bleeding, or paleness. It
is unclear if ENBREL has caused these nervous system or blood disorders. If your
doctor confirms serious blood problems, you may need to stop using ENBREL.
The most frequent adverse events in placebo-controlled RA clinical trials
involving 349 adults were injection site reactions (ISR) (37%), infections
(35%), and headache (17%). Only the rate of ISR was higher than that of placebo.
The most frequent adverse events in a methotrexate-controlled clinical trial of
415 adults with early-stage RA were infections (64%), ISR (34%), and headache
(24%). Of these, only the rate of ISR was higher than that of methotrexate. In
all 1,197 RA patients studied, malignancies were rare (1%).
Adverse events in the psoriatic arthritis trial were similar to those reported
in RA clinical trials.
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE),
market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of
North America. Immunex manufactures ENBREL. Additional information about ENBREL,
including full prescribing information, can be found on the company-sponsored
Web site at (www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735).
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of
women's health care, cardiovascular disease, central nervous system,
inflammation, hemophilia, oncology and vaccines.
Wyeth (NYSE: WYE) is one of the world's 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. Wyeth's major divisions include Wyeth
Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
NOTE: Except for the historical information contained herein, this news release
contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines to
differ materially are risks associated with research and clinical development,
regulatory approvals, our supply capabilities and reliance on third-party
manufacturers, product commercialization, competition, litigation and other risk
factors listed from time to time in reports filed by Immunex with the SEC,
including but not limited to risks described under the caption "Important
Factors That May Affect Our Business, Our Results of Operations and Our Stock
Price" within our most recently filed Form 10-K. The forward-looking statements
contained in this news release represent our judgment as of the date of this
release. Immunex undertakes no obligation to publicly update any forward-looking
statements. An electronic version of this news release -- as well as additional
information about Immunex of interest to investors, customers, future employees
and patients -- is available on the Immunex home page at www.immunex.com.
# # #
284794
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Wyeth
As referenced in this Immunex Secures Additional Manufacturing Capacity for Enbrel(R)(Etanercept) at Genentech, Inc.:
Wyeth – malignancies were rare (1%).
Adverse events in the psoriatic arthritis trial were similar to those reported
in RA clinical trials.
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE),
market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of
North America. Immunex manufactures
_____________
Wyeth – events in the psoriatic arthritis trial were similar to those reported
in RA clinical trials.
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE),
market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of
North America. Immunex manufactures ENBREL. Additional information about
_____________
Wyeth – those reported
in RA clinical trials.
Immunex Corporation and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE),
market ENBREL in North America. Other Wyeth affiliates market ENBREL outside of
North America. Immunex manufactures ENBREL. Additional information about ENBREL,
including full prescribing information, can be found on the
_____________
Wyeth – toll-free 888-4ENBREL (888-436-2735).
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of
women's health care, cardiovascular disease, central nervous system,
inflammation, hemophilia,
_____________
Wyeth, – 436-2735).
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of
women's health care, cardiovascular disease, central nervous system,
inflammation, hemophilia, oncology and vaccines.
Wyeth (
_____________
dt 227038
;
Genentech
As referenced in this Immunex Secures Additional Manufacturing Capacity for Enbrel(R)(Etanercept) at Genentech, Inc.:
Genentech, Inc – CONTACT :
Robin Shapiro (media), 206.389.4040
Mark Leahy (investors), 206.389.4363
Immunex Secures Additional Manufacturing Capacity for ENBREL(R)(etanercept) at
Genentech, Inc .
Immunex Takes Additional Steps to Expand Supply To Help Keep Up with Growing
Demand for Sales of ENBREL
--------------------------------------------------------------------------------
SEATTLE, WA - Immunex Corporation [
_____________
Genentech, Inc – To Help Keep Up with Growing
Demand for Sales of ENBREL
--------------------------------------------------------------------------------
SEATTLE, WA - Immunex Corporation [Nasdaq: IMNX] today announced a manufacturing
agreement with Genentech, Inc . to produce ENBREL(R) (etanercept) at Genentech's
manufacturing facility in South San Francisco. Subject to the approval of the
U.S.
_____________
dt 233810
;
| |
Preview
Full Doc
| 2002 |
Immunex Announces Settlement of Certain Litigations Relating to Merger with Amgen Inc.
Immunex Announces Settlement of Certain Litigations Relating to Merger with Amgen Inc. (6K)
Doc #284796: Click preview link for longer preview.
{DOCUMENT}
{TYPE}EX-99
{SEQUENCE}4
{FILENAME}s625998.txt
{DESCRIPTION}EXHIBIT 99.2 - PRESS RELEASE
{TEXT}
FOR IMMEDIATE RELEASE CONTACT: Josh Schroeter (media)
Monday, April 29, 2002 206.389.4335
John Calhoun (investors)
206.389.4361
Immunex Announces Settlement Of Certain
Litigations Relating To Merger With Amgen Inc.
SEATTLE, WA - Immunex Corporation (Nasdaq: IMNX) announced today the
settlement, which is subject to court approval among other things, of three
lawsuits against Immunex and certain of its directors and officers relating
to the proposed acquisition of Immunex by Amgen Inc.: (i) a suit filed by
David Osher, on behalf of a class of Immunex shareholders, against Immunex,
all members of the Immunex board of directors, Wyeth and Amgen; (ii) a suit
filed by Adele Brody, on behalf of a class of Immunex shareholders, against
Immunex, Wyeth, all members of the Immunex board of directors and the
marital community of each named individual; and (iii) a suit filed by Edwin
Weiner, on behalf of a class of Immunex shareholders, against Immunex,
against Immunex, Wyeth, all members of the Immunex board of directors and
the marital community of each named individual.
In connection with the settlement, (i) Immunex and Amgen agreed to reduce
the termination fee payable by Immunex or Amgen under certain circumstances
set forth in the Amended and Restated Agreement and Plan of Merger among
Immunex, Amgen and a wholly-owned subsidiary of Amgen by $20 million, (ii)
Immunex obtained an updated opinion from Merrill Lynch, Pierce, Fenner &
Smith Incorporated regarding the fairness of the merger consideration from
a financial point of view to be received by Immunex shareholders, and (iii)
Immunex agreed to provide certain additional disclosures regarding the
merger in a Current Report on Form 8-K, which is being filed with the
Securities and Exchange Commission today.
On December 17, 2001, Immunex agreed to be acquired by Amgen. The
acquisition will merge Immunex, one of the fastest growing biotechnology
companies in the industry, with Amgen, the largest biotechnology company.
Pending required shareholder approval for both companies, and approval by
regulatory authorities, the transaction is expected to be completed as
early as June 2002. Shareholder meetings for both companies are scheduled
to occur on May 16, 2002.
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Note: Except for the historical information contained herein, this news
release contains forward-looking statements that involve substantial risks
and uncertainties. Among the factors that could cause actual results or
timelines to differ materially are risks associated with research and
clinical development, regulatory approvals, our supply capabilities and
reliance on third-party manufacturers, product commercialization,
competition, litigation and other risk factors listed from time to time in
reports filed by Immunex with the Securities and Exchange Commission,
including but not limited to risks described under the caption "Important
Factors That May Affect Our Business, Our Results of Operation and Our
Stock Price" within our most recently filed Form 10-K. The forward-looking
statements contained in this news release represent our judgment as of the
date of this release. Immunex undertakes no obligation to publicly update
any forward-looking statements. An electronic version of this news
release-as well as additional information about Immunex of interest to
investors, customer, future employees and patients-is available on the
Immunex home page at www.immunex.com.
Where you can find Additional Information about the Acquisition:
In connection with the proposed acquisition, Immunex and Amgen filed with
the Securities and Exchange Commission on March 22, 2002, their joint proxy
statement/prospectus that contains important information about the merger.
Investors and security holders of Immunex and Amgen are urged to read the
joint proxy statement/prospectus filed with the Securities and Exchange
Commission on March 22, 2002, and any other relevant materials filed by
Immunex or Amgen because they contain, or will contain, important
information about Immunex, Amgen and the acquisition. The joint proxy
statement/prospectus filed with the Securities and Exchange Commission on
March 22, 2002, other relevant materials and any other documents filed, or
to be filed, by Immunex or Amgen with the Securities and Exchange
Commission, may be obtained free of charge at the Securities and Exchange
Commission's web site at www.sec.gov. In addition, investors and security
holders may obtain free copies of the documents filed with the Securities
and Exchange Commission by Immunex by contacting Immunex Corporation, 51
University Street, Seattle, WA 98101, Attn: Investor Relations. Investors
and security holders may obtain free copies of the documents filed with the
Securities and Exchange Commission by Amgen by directing a request to:
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, Attn: Investor
Relations. Investors and security holders are urged to read the joint proxy
statement/prospectus filed with the Securities and Exchange Commission on
March 22, 2002 and any other relevant materials filed by Immunex or Amgen
before making any voting or investment decision with respect to the
acquisition. Immunex, Amgen and their respective executive officers and
directors may be deemed to be participants in the solicitation of proxies
from the shareholders of Immunex and Amgen in favor of the merger.
Information about the executive officers and directors of Immunex and their
ownership of Immunex common stock, and information about the executive
officers and directors of Amgen and their ownership of Amgen common stock
is set forth in the joint proxy statement/prospectus for Immunex's annual
meeting of shareholders and Amgen's annual meeting of stockholders, which
has been filed with the Securities and Exchange Commission. Investors and
security holders may obtain more detailed information regarding the direct
and indirect interests of Immunex, Amgen and their respective executive
officers and directors in the merger by reading the joint proxy
statement/prospectus regarding the acquisition.
###
{/TEXT}
{/DOCUMENT}
284796
|
Wyeth
As referenced in this Immunex Announces Settlement of Certain Litigations Relating to Merger with Amgen Inc.:
Wyeth – suit filed by
David Osher, on behalf of a class of Immunex shareholders, against Immunex,
all members of the Immunex board of directors, Wyeth and Amgen; (ii) a suit
filed by Adele Brody, on behalf of a class of Immunex shareholders, against
Immunex, Wyeth, all members of
_____________
Wyeth, – board of directors, Wyeth and Amgen; (ii) a suit
filed by Adele Brody, on behalf of a class of Immunex shareholders, against
Immunex, Wyeth, all members of the Immunex board of directors and the
marital community of each named individual; and (iii) a suit filed by
_____________
Wyeth, – each named individual; and (iii) a suit filed by Edwin
Weiner, on behalf of a class of Immunex shareholders, against Immunex,
against Immunex, Wyeth, all members of the Immunex board of directors and
the marital community of each named individual.
In connection with the settlement, (i)
_____________
dt 227039
;
Amgen
As referenced in this Immunex Announces Settlement of Certain Litigations Relating to Merger with Amgen Inc.:
Amgen – Monday, April 29, 2002 206.389.4335
John Calhoun (investors)
206.389.4361
Immunex Announces Settlement Of Certain
Litigations Relating To Merger With Amgen Inc.
SEATTLE, WA - Immunex Corporation (Nasdaq: IMNX) announced today the
settlement, which is subject to court approval among other things, of three
lawsuits
_____________
Amgen – among other things, of three
lawsuits against Immunex and certain of its directors and officers relating
to the proposed acquisition of Immunex by Amgen Inc.: (i) a suit filed by
David Osher, on behalf of a class of Immunex shareholders, against Immunex,
all members of the Immunex
_____________
Amgen; – by
David Osher, on behalf of a class of Immunex shareholders, against Immunex,
all members of the Immunex board of directors, Wyeth and Amgen; (ii) a suit
filed by Adele Brody, on behalf of a class of Immunex shareholders, against
Immunex, Wyeth, all members of the
_____________
Amgen – members of the Immunex board of directors and
the marital community of each named individual.
In connection with the settlement, (i) Immunex and Amgen agreed to reduce
the termination fee payable by Immunex or Amgen under certain circumstances
set forth in the Amended and Restated Agreement and
_____________
Amgen – of each named individual.
In connection with the settlement, (i) Immunex and Amgen agreed to reduce
the termination fee payable by Immunex or Amgen under certain circumstances
set forth in the Amended and Restated Agreement and Plan of Merger among
Immunex, Amgen and a wholly-owned subsidiary
_____________
dt 227271
;
| |
Preview
Full Doc
| 2002 |
Immunex Announces First Quarter 2002 Results
Immunex Announces First Quarter 2002 Results (16K)
Doc #284797: Click preview link for longer preview.
{DOCUMENT}
{TYPE}EX-99.1
{SEQUENCE}3
{FILENAME}dex991.txt
{DESCRIPTION}IMMUNEX PRESS RELEASE DATED APRIL 22, 2002
{TEXT}
{PAGE}
Exhibit 99.1
For Immediate Release, April 22, 2002
CONTACT:
Robin Shapiro (media), Immunex Corporation, 206.389.4040
Mark Leahy (investors), Immunex Corporation, 206.389.4363
Immunex Announces First Quarter 2002 Results
Product Sales Growth Drives Financial Performance:
Revenue and Product Sales Up 25%, Operating Income Up 61%
================================================================================
SEATTLE -- Immunex Corporation (Nasdaq: IMNX) today reported financial results
for the first quarter of 2002. Total revenues were up 25 percent to $272.0
million for the first three months of 2002 compared to $217.8 million in the
first quarter of 2001. Total product sales in the first quarter of 2002 were
$265.4 million, up 25 percent over the prior-year quarter. As a result,
operating income increased 61 percent to $27.1 million in the first quarter of
2002, compared to $16.9 million in the first quarter of 2001. Net income was
$34.9 million, or 6 cents per share in the first quarter of 2002, compared to
net income of $39.8 million, or 7 cents per share in the first quarter of 2001.
Net income was down comparably quarter over quarter as the company's tax rate
changed from 15 percent in the first quarter of 2001 to 31 percent in the first
quarter of 2002.
"Strong sales growth continues to fuel our business momentum," said Ed Fritzky,
Chairman and CEO of Immunex. "A new indication, manufacturing progress and an
expanded sale force for ENBREL are expected to help us achieve more growth in
2002."
Sales of ENBREL(R) (etanercept), the company's flagship drug to treat rheumatoid
arthritis and psoriatic arthritis, grew 31 percent to $216.5 million for the
first quarter of 2002, compared with $164.9 million in the first quarter of
2001. Sales of ENBREL for the first quarter were comparable to the fourth
quarter of 2001 as the company managed demand with available supply.
"Demand for ENBREL has grown substantially because it has been a breakthrough
therapy in rheumatoid arthritis and psoriatic arthritis," said Peggy Phillips,
executive vice president and chief operating officer. "We anticipate that demand
will continue to grow from current and potential future indications, including
ankylosing spondylitis and psoriasis. To keep pace with future anticipated
demand, we are investing in technology and facilities to substantially increase
supply."
ENBREL is currently manufactured by Boehringer Ingelheim Pharma KG in Germany.
Immunex's goal is to gain Food and Drug Administration (FDA) approval of its
manufacturing plant in Rhode Island by year end. Last week the company announced
progress toward increased mid-term supply of ENBREL, which is anticipated to be
significantly boosted in 2004 and 2005 by additional contract manufacturing with
Genentech, Inc. Two additional plants are under
-1-
{PAGE}
construction; a second facility in Rhode Island owned by Immunex and a facility
in Ireland owned by Wyeth, the company's co-promotion partner for ENBREL.
Net sales of LEUKINE(R) (sargramostim) and NOVANTRONE(R) (mitoxantrone for
injection concentrate) grew 22 percent to $47.9 million for the first quarter,
compared to $39.3 million in the first quarter of 2001. Sales of NOVANTRONE grew
46 percent quarter-over-quarter to $19.3 million, supported by strong demand in
worsening multiple sclerosis.
Research and development investments totaled $53.7 million for the first quarter
of 2002, compared to $49.2 million for the first quarter of 2001. Increase in
these investments primarily supported initiation for new clinical trials for
ENBREL in psoriasis, ankylosing spondylitis and Wegener's disease; clinical
trials for IL-R type 2 in rheumatoid arthritis; and for ABX-EGF in cancer.
Expenses related to selling, general and administrative (SG&A) activities
totaled $120.9 million for the first quarter of 2002, up 30 percent when
compared to the same period in 2001, primarily due to the higher profit sharing
payments to Wyeth from higher sales of ENBREL. In addition, a new sales force
for ENBREL launched a new indication for reducing the signs and symptoms of
active arthritis in patients with psoriatic arthritis in January 2002.
Cash and cash equivalents, including restricted investments were $1.3 billion as
of March 31, 2002.
On December 17, 2001, Immunex agreed to be acquired by Amgen Inc. The
acquisition will merge Immunex, one of the fastest growing biotechnology
companies in the industry with Amgen, the largest biotechnology company. Pending
required shareholder approval for both companies, and approval by regulatory
authorities, the transaction is expected to be completed as early as June 2002.
Shareholder meetings for both companies are scheduled to occur on May 16, 2002.
Immunex Corporation is a leading biopharmaceutical company dedicated to
improving lives through immune system science innovations.
Note: Except for the historical information contained herein, this news release
contains forward-looking statements that involve substantial risks and
uncertainties. Among the factors that could cause actual results or timelines to
differ materially are risks associated with research and clinical development,
regulatory approvals, our supply capabilities and reliance on third-party
manufacturers, product commercialization, competition, litigation and other risk
factors listed from time to time in reports filed by Immunex with the SEC,
including but not limited to risks described under the caption "Important
Factors That May Affect Our Business, Our Results of Operation and Our Stock
Price" within our most recently filed Form 10-K. The forward-looking statements
contained in this news release represent our judgment as of the date of this
release. Immunex undertakes no obligation to publicly update any forward-looking
statements. An electronic version of this news release-as well as additional
information about Immunex of interest to investors, customer, future employees
and patients-is available on the Immunex home page at www.immunex.com.
---------------
-2-
{PAGE}
Where you can find Additional Information about the Acquisition
In connection with the proposed acquisition, Immunex and Amgen filed with the
SEC on March 22, 2002, Amendment No. 1 to their joint proxy statement/prospectus
that contains important information about the merger. Investors and security
holders of Immunex and Amgen are urged to read the Amendment No. 1 to the joint
proxy statement/prospectus filed with the SEC on March 22, 2002, and any other
relevant materials filed by Immunex or Amgen because they contain, or will
contain, important information about Immunex, Amgen and the acquisition. The
Amendment No. 1 to the joint proxy statement/prospectus filed with the SEC on
March 22, 2002, other relevant materials and any other documents filed, or to be
filed, by Immunex or Amgen with the SEC, may be obtained free of charge at the
SEC's web site at www.sec.gov. In addition, investors and security holders may
obtain free copies of the documents filed with the SEC by Immunex by contacting
Immunex Corporation, 51 University Street, Seattle, WA 98101, Attn: Investor
Relations. Investors and Security holders may obtain free copies of the
documents filed with the SEC by Amgen by directing a request to: Amgen Inc., One
284797
|
Wyeth
As referenced in this Immunex Announces First Quarter 2002 Results:
Wyeth, – additional plants are under
-1-
{PAGE}
construction; a second facility in Rhode Island owned by Immunex and a facility
in Ireland owned by Wyeth, the company's co-promotion partner for ENBREL.
Net sales of LEUKINE(R) (sargramostim) and NOVANTRONE(R) (mitoxantrone for
injection concentrate) grew
_____________
Wyeth – quarter of 2002, up 30 percent when
compared to the same period in 2001, primarily due to the higher profit sharing
payments to Wyeth from higher sales of ENBREL. In addition, a new sales force
for ENBREL launched a new indication for reducing the signs and symptoms
_____________
dt 227040
;
Amgen
As referenced in this Immunex Announces First Quarter 2002 Results:
Amgen – equivalents, including restricted investments were $1.3 billion as
of March 31, 2002.
On December 17, 2001, Immunex agreed to be acquired by Amgen Inc. The
acquisition will merge Immunex, one of the fastest growing biotechnology
companies in the industry with Amgen, the largest biotechnology company. Pending
_____________
Amgen, – agreed to be acquired by Amgen Inc. The
acquisition will merge Immunex, one of the fastest growing biotechnology
companies in the industry with Amgen, the largest biotechnology company. Pending
required shareholder approval for both companies, and approval by regulatory
authorities, the transaction is expected to be
_____________
Amgen – at www.immunex.com.
---------------
-2-
{PAGE}
Where you can find Additional Information about the Acquisition
In connection with the proposed acquisition, Immunex and Amgen filed with the
SEC on March 22, 2002, Amendment No. 1 to their joint proxy statement/prospectus
that contains important information about the
_____________
Amgen – Amendment No. 1 to their joint proxy statement/prospectus
that contains important information about the merger. Investors and security
holders of Immunex and Amgen are urged to read the Amendment No. 1 to the joint
proxy statement/prospectus filed with the SEC on March 22, 2002, and
_____________
Amgen – to the joint
proxy statement/prospectus filed with the SEC on March 22, 2002, and any other
relevant materials filed by Immunex or Amgen because they contain, or will
contain, important information about Immunex, Amgen and the acquisition. The
Amendment No. 1 to the joint proxy statement/
_____________
dt 227272
;
|
Genentech
As referenced in this Immunex Announces First Quarter 2002 Results:
Genentech, Inc – toward increased mid-term supply of ENBREL, which is anticipated to be
significantly boosted in 2004 and 2005 by additional contract manufacturing with
Genentech, Inc . Two additional plants are under
-1-
{PAGE}
construction; a second facility in Rhode Island owned by Immunex and a facility
in Ireland
_____________
dt 233811
;
|
Preview
Full Doc
| 2002 |
Cambridge Antibody Technology Broadens Relationship with Merck & Co., Inc.
Cambridge Antibody Technology Broadens Relationship with Merck & Co., Inc. (6K)
Doc #298536: Click preview link for longer preview.
{DOCUMENT}
{TYPE}EX-99.1
{SEQUENCE}3
{FILENAME}ex-991.txt
{TEXT}
EXHIBIT 99.1
02/CAT/25
Page 1 of 3
FOR IMMEDIATE RELEASE
07.00 GMT 02.00 EST 30 OCTOBER 2002
For further information contact:
Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)
Tel: +44 (0) 1763 263 233 Tel: +44 (0) 20 7950 2800
Peter Chambre, Chief Executive Officer Kevin Smith
John Aston, Chief Financial Officer Graham Herring
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 BROADENS RELATIONSHIP WITH MERCK & CO., INC.
Licence granted to human antibody libraries
Melbourn, UK...Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG)
announces today that it has entered into a second agreement with Merck &
Co., Inc. (NYSE: MRK) in respect of its proprietary human antibody
technologies. Under the terms of this second agreement, CAT has granted
Merck a licence to its human phage antibody libraries. The libraries will
be used by Merck to support and promote discovery research and development
across a broad range of therapeutic areas.
CAT will receive an upfront licence fee including a technology access fee
upon transfer of the libraries to the designated Merck sites. In addition
CAT may receive future option, milestone and royalty payments from Merck.
Merck receives option rights to develop therapeutic and diagnostic products
on an exclusive basis.
{PAGE}
Page 2 of 3
CAT and Merck entered into a separate collaboration and licence agreement a
year ago for the research and development of products specific for a
protein involved in disease mediated by HIV.
Peter Chambre, Chief Executive Officer of CAT, commented "We have been
greatly encouraged by the progress of our product collaboration with Merck
to date, so the announcement of this second broad agreement just one year
later is immensely exciting. While our first agreement had represented
CAT's first product alliance in infectious disease, the prospect of our
world-leading antibody technologies now being applied more widely within
the Merck organisation is greatly welcomed by CAT. We are delighted with
the enthusiasm being shown by well-established pharmaceutical companies
such as Merck for the potential of CAT's technology".
-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 280 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 D2E7, the leading CAT-derived antibody, has been submitted for
regulatory review by Abbott (responsible for development and
marketing) following the completion of Phase III trials. Six other
CAT-derived human therapeutic antibodies are at various stages of
clinical trials.
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.
{PAGE}
Page 3 of 3
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.
Merck & Co., Inc.
o Merck & Co., Inc. is a leading research-driven pharmaceutical products
and services company. Merck discovers, develops, manufactures and
markets a broad range of innovative products to improve human and
animal health, directly and through its joint ventures. Merck-Medco
manages pharmacy benefits for employers, insurers and other plan
sponsors, encouraging the appropriate use of medicines and providing
disease management programs. Through these complementary capabilities,
Merck works to improve quality of life and contain overall health-care
costs.
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}
298536
|
Wyeth
As referenced in this Cambridge Antibody Technology Broadens Relationship with Merck & Co., Inc.:
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.
{PAGE}
Page 3 of 3
o CAT is listed on the London Stock Exchange and on NASDAQ since June
2001. CAT raised (
_____________
dt 264756
;
CATG
As referenced in this Cambridge Antibody Technology Broadens Relationship with Merck & Co., Inc.:
Cambridge
Antibody Technology Group – health-care
costs.
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 264949
;
|
Human Genome
As referenced in this Cambridge Antibody Technology Broadens Relationship with Merck & Co., Inc.:
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.
{PAGE}
Page 3 of 3
o CAT is listed on the London Stock Exchange and on
_____________
dt 262243
;
Merck
As referenced in this Cambridge Antibody Technology Broadens Relationship with Merck & Co., Inc.:
MERCK – Group
(USA)
Tel: 001 212 477 9007
Brad Miles, ext.17 (media)
Brandon Lewis, ext.15 (investors)
CAMBRIDGE ANTIBODY TECHNOLOGY BROADENS RELATIONSHIP WITH MERCK & CO., INC.
Licence granted to human antibody libraries
Melbourn, UK...Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG)
announces today that it has
_____________
Merck – human antibody libraries
Melbourn, UK...Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG)
announces today that it has entered into a second agreement with Merck &
Co., Inc. (NYSE: MRK) in respect of its proprietary human antibody
technologies. Under the terms of this second agreement, CAT has granted
_____________
Merck – Merck &
Co., Inc. (NYSE: MRK) in respect of its proprietary human antibody
technologies. Under the terms of this second agreement, CAT has granted
Merck a licence to its human phage antibody libraries. The libraries will
be used by Merck to support and promote discovery research and development
_____________
Merck – terms of this second agreement, CAT has granted
Merck a licence to its human phage antibody libraries. The libraries will
be used by Merck to support and promote discovery research and development
across a broad range of therapeutic areas.
CAT will receive an upfront licence fee including
_____________
Merck – of therapeutic areas.
CAT will receive an upfront licence fee including a technology access fee
upon transfer of the libraries to the designated Merck sites. In addition
CAT may receive future option, milestone and royalty payments from Merck.
Merck receives option rights to develop therapeutic and diagnostic
_____________
dt 261929
|
| Full Doc
| 2003 |
MedImmune Provides Update on Flumist Launch and Revises Guidance for 2003 Fourth Quarter and Full Year
MedImmune Provides Update on Flumist Launch and Revises Guidance for 2003 Fourth Quarter and Full Year (10K)
Doc #272395: This document is immediately available for purchase, but does not have a preview available for viewing.
MedImmune Inc
Exhibit 99.1
EX-99 3 ex99_1pr111703.htm EX99_1 NOVEMBER 17 PRESS RELEASE
Exhibit 99.1
MEDIMMUNE PROVIDES UPDATE ON FLUMIST LAUNCH AND REVISES GUIDANCE FOR 2003 FOURTH QUARTER AND FULL YEAR
GAITHERSBURG, MD, November 17, 2003 MedImmune, Inc. (Nasdaq: MEDI) announced today that due to lower than expected product demand for FluMist (Influenza Virus Vaccine Live, Intranasal) in the products inaugural season, the company has reduced its 2003 fourth quarter and full-year revenue and earnings expectations. Other than FluMist, the components of MedImmunes business remain strong and on track.
I am disappointed to say that at this point, roughly half-way through the approximately twelve-week peak immunization season for FluMist, we have not seen the anticipated ramp up in demand, said David M. Mott, MedImmunes chief executive officer. We are working with our partners at Wyeth to evaluate the reasons for the shortcomings and to develop our plan for the future.
We remain confident that FluMist is a great product and an important medical advance in the prevention of influenza disease, continued Mott. As we go forward, we will seek to build upon the successes we have achieved with FluMist this season, which include having gained FDA approval of the product in June and meeting our 2003 manufacturing objectives of shipping 4.1 million doses to Wyeth ahead of schedule.
Revised Guidance for 2003
MedImmune is reducing its revenue and earnings guidance for the 2003 fourth quarter and full year as outlined below. Driving these changes is a reduction in expected FluMist revenues for the full year of 2003 to $55 million to $85 million from the previously stated guidance of $120 million to $140 million. As a result, total revenues for 2003 have been reduced to a range of $1.04 billion to $1.1 billion from the previously stated guidance of $1.1 billion to $1.15 billion. Adjusted earnings per diluted share for 2003 are now expected to range from $0.72 to $0.80 versus prior guidance of $0.88 to $0.93. GAAP earnings per diluted share for 2003 are now expected to be $0.68 to $0.76 versus prior guidance of $0.84 to $0.89.
Through the third quarter 2003, MedImmune recorded $38 million in FluMist revenues, largely comprised of milestones and manufacturing supply goal payments, as well as contractual reimbursements for clinical and marketing expenditures. In the fourth quarter, the Company expects to record approximately $10 million in manufacturing supply goal payments and contractual reimbursements. In addition, the Company has estimated that manufacturing transfer payments and royalties will range from $7 million to $37 million in the fourth quarter. MedImmunes total FluMist revenues are highly sensitive to small changes in the number of doses sold by Wyeth and in the percentage of product that is ultimately returned by customers. Fluctuations in these and other variables could cause actual FluMist revenues and our diluted earnings per share for the fourth quarter and the full year to fall outside the revised ranges.
Looking Ahead in 2003
As a result of the issues described above, MedImmune is providing revised guidance computed in accordance with generally accepted accounting principles (GAAP) and computed on an as adjusted basis, as well as a reconciliation between the two, as a convenience to its investors. The adjusted guidance excludes certain amounts associated with the acquisition in 2002 of MedImmune Vaccines. To reconcile MedImmunes adjusted guidance to its GAAP guidance for 2003, the following acquisition-related expenses should be excluded from the GAAP guidance: approximately $6 million in cost of sales; approximately $3 million in research and development; approximately $8 million in selling, general and administrative expense; and approximately $3 million in other operating expenses. In addition, approximately $3 million of net interest income should be excluded from the GAAP guidance to reconcile to the adjusted guidance. The guidance and objectives provided below 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.
Revised 2003 Full Year Guidance
Revenue Guidance for 2003
o Total revenues: $1.04 billion to $1.1 billion (23% to 29% growth over 2002)
- Product sales: 21% to 29% over 2002
- *Synagis (palivizumab) revenues: 23% to 27% over 2002
- *Ethyol(amifostine) revenues: 20% to 25% over 2002
- Total FluMist revenues (product sales and other revenues): $55 million to $85 million
GAAP Guidance for 2003
o Earnings per diluted share: $0.68 to $0.76 (compared to a 2002 loss of $4.40 per share)
o *Gross margins: approximately 71%
o *R&D: $157 million to $162 million
o SG&A: 35% to 36% of product sales
o *Other operating expenses: $25 million to $27 million
o *Tax rate: approximately 37%
Adjusted Guidance for 2003
o Earnings per diluted share: $0.72 to $0.80 (71% to 90% growth over 2002)
o *Gross margins: approximately 71%
o *R&D: $155 million to $160 million
o SG&A: 34% to 35% of product sales
o *Other operating expenses: $22 million to $24 million
o *Tax rate: approximately 37%
*Denotes items that have not changed since MedImmunes previous guidance on October 23, 2003.
Revised Guidance for the Quarter Ending December 31, 2003
The changes in FluMist expectations have reduced the companys fourth quarter revenue expectations to $385 million to $445 million versus the previous fourth-quarter revenue guidance of $450 million to $500 million. Adjusted earnings per diluted share for the 2003 fourth quarter are now expected to range from $0.28 to $0.36 per share versus the previous guidance of $0.44 to $0.49. GAAP earnings per diluted share for the fourth quarter are now expected to be $0.26 to $0.34 versus prior guidance of $0.42 to $0.47. The difference between the GAAP and adjusted guidance is approximately $7 million of net pretax expenses associated with the acquisition of MedImmune Vaccines.
Conference Call & Webcast
MedImmune is holding a live webcast of a discussion by MedImmune management on Tuesday, November 18, 2003 at 8:00 a.m. Eastern Time. The live webcast may be accessed in the investor section of MedImmunes website, www.medimmune.com. A replay of the webcast will also be available via the MedImmune website until November 25, 2003. An audio replay of the webcast will be available, beginning at 11:00 a.m. Eastern Time on November 18, 2003 and ending at midnight November 25, 2003 by calling (888) 286-8010. The passcode for the audio replay is 36379947.
About MedImmune, Inc.
MedImmune, Inc., 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), FluMist (Influenza Virus Vaccine Live, Intranasal), Ethyol (amifostine), and CytoGam (cytomegalovirus immune globulin intravenous (human)), and has additional products in clinical testing. MedImmune employs about 1,700 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom, and the Netherlands. FluMist is manufactured by MedImmune Vaccines, Inc., and co-promoted with a division of Wyeth (NYSE: WYE). For more information on MedImmune and its products, visit the companys website at www.medimmune.com.
DISCLOSURE NOTICE: The information contained in this document is as of November 17, 2003 and will not be updated as a result of new information or future events. This document contains forward-looking statements regarding MedImmunes future financial performance and business prospects. Those statements involve substantial risks and uncertainties. You can identify those statements by the fact that they contain words such as anticipate, believe, estimate, expect, intend, project or other terms of similar meaning. Those statements reflect managements current beliefs and are based on numerous assumptions, which MedImmune cannot control and which may not develop as MedImmune expects. Consequently, actual results may differ materially from those projected in the forward-looking statements. Among the factors that could cause actual results to differ materially are: seasonal demand for and supply of Synagis and FluMist; whether FluMist demand will achieve current launch year expectations; availability of competitive products in the market; availability of third-party reimbursement for the cost of our products; effectiveness and safety of our products; exposure to product liability, intellectual property or other types of litigation; foreign currency exchange rate and interest rate fluctuations; changes in generally accepted accounting principles; growth in costs and expenses; the impact of acquisitions, divestitures and other unusual items; and the risks, uncertainties and other matters discussed in MedImmunes Annual Report on Form 10-K for the year ended December 31, 2002, its quarterly reports on Form 10-Q, its current reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission. MedImmune cautions that RSV disease and influenza occur primarily during the winter months; MedImmune believes its operating results will reflect that seasonality for the foreseeable future. MedImmune is also 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. This press release contains certain financial measures that are adjusted to exclude amounts required by GAAP, and includes the most directly comparable GAAP measure for each adjusted measure, as well as a reconciliation between the GAAP results and the adjusted results. This press release can be found on MedImmunes website at http://www.medimmune.com in the box marked News or with the archived press releases on the Investor Summary page.
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Wyeth
As referenced in this MedImmune Provides Update on Flumist Launch and Revises Guidance for 2003 Fourth Quarter and Full Year:
Wyeth – not seen the anticipated ramp up in demand, said David M. Mott, MedImmunes chief executive officer. We are working with our partners at Wyeth to evaluate the reasons for the shortcomings and to develop our plan for the future.
We remain confident that FluMist is a great
_____________
Wyeth – include having gained FDA approval of the product in June and meeting our 2003 manufacturing objectives of shipping 4.1 million doses to Wyeth ahead of schedule.
Revised Guidance for 2003
MedImmune is reducing its revenue and earnings guidance for the 2003 fourth quarter and full year
_____________
Wyeth – 37 million in the fourth quarter. MedImmunes total FluMist revenues are highly sensitive to small changes in the number of doses sold by Wyeth and in the percentage of product that is ultimately returned by customers. Fluctuations in these and other variables could cause actual FluMist revenues
_____________
Wyeth – as Pennsylvania, California, the United Kingdom, and the Netherlands. FluMist is manufactured by MedImmune Vaccines, Inc., and co-promoted with a division of Wyeth (NYSE: WYE). For more information on MedImmune and its products, visit the companys website at www.medimmune.com.
DISCLOSURE NOTICE: The information
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MedImmune
As referenced in this MedImmune Provides Update on Flumist Launch and Revises Guidance for 2003 Fourth Quarter and Full Year:
MedImmune, Inc – 99.1
MEDIMMUNE PROVIDES UPDATE ON FLUMIST LAUNCH AND REVISES GUIDANCE FOR 2003 FOURTH QUARTER AND FULL YEAR
GAITHERSBURG, MD, November 17, 2003 MedImmune, Inc . (Nasdaq: MEDI) announced today that due to lower than expected product demand for FluMist (Influenza Virus Vaccine Live, Intranasal) in the products
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MedImmune, Inc – 18, 2003 and ending at midnight November 25, 2003 by calling (888) 286-8010. The passcode for the audio replay is 36379947.
About MedImmune, Inc .
MedImmune, Inc., is a leading biotechnology company focused on researching, developing, and commercializing products to prevent or treat infectious disease, autoimmune disease,
_____________
MedImmune, Inc – and ending at midnight November 25, 2003 by calling (888) 286-8010. The passcode for the audio replay is 36379947.
About MedImmune, Inc.
MedImmune, Inc ., is a leading biotechnology company focused on researching, developing, and commercializing products to prevent or treat infectious disease, autoimmune disease, and cancer.
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Medimmune Reports Record Revenues for 2003 Third Quarter and Nine-Month Period
Medimmune Reports Record Revenues for 2003 Third Quarter and Nine-Month Period (30K)
Doc #272398: This document is immediately available for purchase, but does not have a preview available for viewing.
MEDIMMUNE REPORTS RECORD REVENUES
FOR 2003 THIRD QUARTER AND NINE-MONTH PERIOD
Highlights for First Nine Months of 2003
o Total revenues increased 38 percent
o Synagis? and Ethyol? sales increased 37 percent and 29 percent, respectively
o Adjusted net earnings in 2003 grew to $113 million ($0.44 per diluted share) versus adjusted net earnings of $14 million ($0.06 per diluted share) in 2002
o GAAP net earnings in 2003 grew to $107 million ($0.42 per diluted share) versus a GAAP net loss of $1.2 billion ($4.75 per share) in 2002
o . . .
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Wyeth
As referenced in this Medimmune Reports Record Revenues for 2003 Third Quarter and Nine-Month Period:
Wyeth, – in the American Academy of Pediatrics Influenza Vaccine Implementation Information for 2003/2004.
As of September 30, 2003, MedImmune billed $30 million to Wyeth, the company's co-promotion partner for FluMist, for 2.4 million doses shipped in the quarter. As a result of a
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Wyeth – co-promotion partner for FluMist, for 2.4 million doses shipped in the quarter. As a result of a supplemental agreement signed with Wyeth on September 30, 2003, and in accordance with generally accepted accounting principles (GAAP), these transfer-related billings are expected to be recorded as
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Wyeth – price for the first season is determinable. Therefore, as of September 30, 2003, the cost of the 2.4 million doses shipped to Wyeth is reflected on MedImmune's balance sheet in inventory, and the $13 million collected as the end of the quarter from Wyeth is
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Wyeth – to Wyeth is reflected on MedImmune's balance sheet in inventory, and the $13 million collected as the end of the quarter from Wyeth is reflected as an advance.
Total revenues for the 2003 nine-month period increased 38 percent to $647 million from $469 million in
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Wyeth, – biologic products targeting a novel pro-inflammatory cytokine to treat severe inflammatory diseases. In connection with the September 30, 2003 supplemental agreement with Wyeth, MedImmune agreed to pay $10 million for its part in co-funding certain international Phase 3 studies conducted by Wyeth with the
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CTI
As referenced in this Medimmune Reports Record Revenues for 2003 Third Quarter and Nine-Month Period:
Critical Therapeutics. – Our business development efforts have resulted in the in-licensing of exciting new targets, such as MT103 from Micromet and HMGB-1 from Critical Therapeutics. And finally, we completed one of the most attractive biotech convertible debt financings, and initiated a stock buy-back program.
For the
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Critical Therapeutics, – to accessing rights to data and developmental opportunities for two technologies. In July 2003, MedImmune agreed to make a $10 million payment to Critical Therapeutics, Inc. as a part of their newly established collaboration to co-develop biologic products targeting a novel pro-inflammatory cytokine to treat
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MedImmune
As referenced in this Medimmune Reports Record Revenues for 2003 Third Quarter and Nine-Month Period:
MedImmune, Inc – Application filed for Numax(TM)
o In-licensed rights to technologies targeting B-cell lymphoma and inflammatory diseases
GAITHERSBURG, MD, October 23, 2003 MedImmune, Inc . (Nasdaq: MEDI) today announced that total revenues for the third quarter of 2003 increased 34 percent to $99 million from $74 million
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MedImmune, Inc – at http://www.medimmune.com in the box marked News or with the archived press releases on the Investor Summary page.
Tables Follow
MedImmune, Inc .
Condensed Consolidated Statements of Operations (Unaudited) (1)
(in thousands, except per share data)
Three Months Ended
September 30,
Nine Months Ended
September
_____________
MedImmune, Inc – share
249,371
250,830
254,684
249,080
(1) Certain prior year amounts have been reclassified to conform to the current presentation.
MedImmune, Inc .
Selected Financial Information Reconciliation of GAAP to Adjusted Results (Unaudited) (1)
(in thousands, except per share data)
Three Months Ended September 30,
_____________
MedImmune, Inc – conjunction with the merger transaction.
(10)
Consists of $0.5 million relating to the amortization of premium on MedImmune Vaccines Convertible Subordinated Notes.
MedImmune, Inc .
Selected Financial Information Reconciliation of GAAP to Adjusted Results (Unaudited) (1)
(in thousands, except per share data)
Nine Months Ended September 30,
_____________
MedImmune, Inc – FDA on June 17, 2003.
(12)
Consists of $1.4 million relating to the amortization of premium on MedImmune Vaccines Convertible Subordinated Notes.
MedImmune, Inc .
Condensed Consolidated Balance Sheets (1)
(in thousands)
September 30,
December 31,
2003
2002
(unaudited)
Assets:
Cash and marketable securities
$
1,712,827
$
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Nasal Mist Influenza Vaccine Licensed in the U.S. [No. 1]
Nasal Mist Influenza Vaccine Licensed in the U.S. [No. 1] (7K)
Doc #272414: This document is immediately available for purchase, but does not have a preview available for viewing.
Exhibit 99.1
FDA APPROVES FluMist
FIRST NASAL MIST INFLUENZA VACCINE LICENSED IN THE U.S.
First Innovation in Flu Vaccine Delivery in Over 50 Years
Gaithersburg, MD, and Madison, NJ (June 17, 2003) - The U.S. Food and Drug Administration (FDA) today approved FluMist
(Influenza Virus Vaccine Live, Intranasal), the first influenza vaccine delivered as a nasal mist available in the United States for
healthy people. FluMist will be available in physicians' offices and some pharmacies beginning in late summer to early fall,
in time for this flu season.
FluMist, indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy
children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age, is manufactured and marketed by MedImmune
Vaccines, Inc., a wholly owned subsidiary of MedImmune, Inc. (Nasdaq: MEDI), and is co-marketed by Wyeth Vaccines, a business unit
of Wyeth Pharmaceuticals, a division of Wyeth (NYSE:WYE).
"The innovative delivery of FluMist is changing the way we think about flu prevention and could increase the number of
healthy people who receive a yearly influenza vaccination," said Robert B. Belshe, MD, professor of Internal Medicine, Pediatrics,
Molecular Microbiology and Immunology at Saint Louis University, and the lead investigator of key FluMist clinical trials.
"There is a strong need for healthy people to get vaccinated against influenza. For example, healthy school-aged children are often
the first to be infected by influenza and can infect others in the community."
Each year in the U.S., influenza infects an estimated 17 million to 50 million people, many of whom are otherwise healthy
children and adults. Influenza also results in approximately $3 billion to $15 billion annually in direct and indirect costs,
including approximately 70 million missed workdays and approximately 38 million missed school days.
"MedImmune is proud to bring FluMist to market as a new, needle-free option to help reduce the occurrence and impact of
the flu," said David Mott, Chief Executive Officer of MedImmune, Inc.
"The FDA approval of FluMist brings the public an innovative vaccine delivery system aimed at protecting the health of
school-aged children and adults," said Geno Germano, Executive Vice President and General Manager of Wyeth Global Vaccines.
"FluMist is cutting-edge technology in influenza vaccine delivery in the U.S."
Clinical Data
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In a clinical trial with adults aged 18 years to 41 years (N=60), the ability of FluMist to protect adults from influenza
illness was 85 percent (95 percent confidence interval [CI]: 28, 100) in those who were intentionally exposed to wild-type virus. In
a two-year pediatric field trial, the efficacy of FluMist in preventing influenza was 87 percent (P is less than or equal to
0.05) among healthy children aged 60 months to 84 months (N=544). In placebo-controlled clinical trials, the most common solicited
adverse events in healthy children (n=214) included runny nose/nasal congestion, cough, irritability, headache, decreased activity,
sore throat, fever (oral temperature >100F), muscle aches, chills, and vomiting. In placebo-controlled clinical trials, the
most common adverse events in healthy adults (n=2,548) included runny nose, headache, sore throat, tiredness/weakness, muscle aches,
cough, and chills. In clinical trials, in the indicated population, these events were transient.
FluMist is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy
children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age.
There are risks associated with all vaccines, including FluMist. FluMist does not protect 100% of individuals
vaccinated, or protect against viral strains not represented in the vaccine. FluMist is not indicated for children less than 5
years or for adults 50 years and older. FluMist is contraindicated in persons with hypersensitivity to any component of the
vaccine, including eggs; in children and adolescents receiving aspirin therapy or aspirin-containing therapy; in individuals with a
history of Guillain-Barr syndrome; and in individuals with known or suspected immune deficiency. The safety and efficacy of
FluMist have not been established in pregnant women or for patients with chronic underlying medical conditions, including
asthma or reactive airway disease; the vaccine should not be administered to these patients. See Prescribing Information for
indications and usage, dosage and administration, and safety information.
About MedImmune, Inc., and Wyeth
---------------------------------
MedImmune, Inc., is a leading biotechnology company focused on researching, developing, and commercializing products to prevent
or treat infectious disease, autoimmune disease, and cancer. MedImmune currently markets four products, Synagis (palivizumab),
Ethyol (amifostine), CytoGam (cytomegalovirus immune globulin intravenous [human]), and FluMist (influenza virus
vaccine live, intranasal), and has several products in clinical testing. MedImmune employs over 1,700 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, visit the company's Web site at http://www.medimmune.com.
Wyeth Vaccines is a business unit of Wyeth Pharmaceuticals, a division of Wyeth. Wyeth Pharmaceuticals has leading products in
the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines.
Wyeth is one of the world's 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 Company's major divisions include Wyeth Pharmaceuticals, Wyeth
Consumer Healthcare and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations
of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty
of pharmaceutical research, product development, manufacturing and commercialization, economic conditions, including interest and
currency exchange rate fluctuations, the impact of competitive or generic products, product liability and other types of lawsuits,
the impact of legislative and regulatory compliance and obtaining approvals, and patent, and other risks and uncertainties,
including those detailed from time to time in Wyeth's and MedImmune's periodic reports, including quarterly reports on Form 10-Q and
annual reports on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the
forward-looking statements. The Companies assume no obligation to publicly update any forward-looking statements, whether as a
result of new information, future events or otherwise.
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