Current Patients Respond Overwhelmingly; System Established for Future
Patients
SEATTLE, Jan. 3 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) and
Wyeth-Ayerst Laboratories, a division of American Home Products Corporation
(NYSE: AHP) announced today successful completion of the first phase of the
ENBREL(R) (etanercept) Enrollment Program in the United States. In an
extraordinary response to the program, over 70,000 people have already
registered.
The proactive program was begun in November 2000 to identify and enroll
current users of the highly prescribed TNF (tumor necrosis factor) inhibitor
ENBREL because demand could temporarily exceed supply. Immunex and
Wyeth-Ayerst initiated the program to help ensure uninterrupted therapy for
the patients already using ENBREL.
"We believe the extraordinary response to this program demonstrates the
value of ENBREL. Because we understand the difference this breakthrough
therapy can make in the lives of patients, our number one goal is to meet the
needs of current users," said Peggy Phillips, Immunex chief operating officer.
"ENBREL is the only product of its kind -- a TNF inhibitor that can be used as
a single agent -- and may be of benefit to many of the one million Americans
with moderately to severely active RA. Our ultimate goal is to provide ENBREL
to every patient who is prescribed this valuable treatment."
Use of ENBREL continues to grow, reaching record levels in December, and a
wait list has now been established to serve the needs of future patients. As
of January 1, 2001 patients considering therapy with ENBREL but not yet
receiving the treatment are wait listed on a first-come, first-served basis
for additional supply as it becomes available. People who believe they are
candidates for ENBREL are encouraged to talk to their doctor first, and then
to call 1-888-4ENBREL to enroll in the program. Patients with prescriptions
filled before January 1, 2001, who have not yet enrolled, still need to do so
by calling 1-888-4ENBREL and use an Enrollment number to order refills.
To satisfy the growing demand for ENBREL, Immunex and Wyeth-Ayerst
initiated a program over two years ago to substantially increase supply of
ENBREL. The companies are investing over $400 million to update an existing
facility in Rhode Island to create a state-of-the-art manufacturing plant that
is expected to potentially double the North American supply. The first test
manufacturing runs of ENBREL from this facility are planned for 2001.
Additional product should be available, pending approval by the U.S. Food and
Drug Administration of this facility. For the longer term, additional
expansion is planned in Rhode Island, and at a facility being constructed by
Wyeth-Ayerst in Ireland.
About ENBREL
Based on the data from a study recently published in the New England
Journal of Medicine, the U.S. Food and Drug Administration approved ENBREL on
June 6, 2000 for an additional indication: reducing signs and symptoms and
delaying structural damage in patients with moderately to severely active
rheumatoid arthritis (RA). The FDA originally approved ENBREL on
November 2, 1998 to reduce signs and symptoms of moderately to severely active
rheumatoid arthritis for patients who have an inadequate response to one or
more disease modifying anti-rheumatic drugs (DMARDs). ENBREL is the only TNF
inhibitor that can be used with or without methotrexate.
ENBREL acts by binding TNF. TNF is one of the dominant cytokines or
proteins that play an important role in normal immune function and the cascade
of reactions that cause the inflammatory process of RA. ENBREL competitively
inhibits binding of TNF molecules to the TNF receptor (TNFR) sites. The
binding of ENBREL to TNF renders the bound TNF biologically inactive,
resulting in significant reduction in inflammatory activity.
SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING
DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE EVENTS
OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED
OR POORLY CONTROLLED DIABETES. 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.
There have been rare reports of serious nervous system disorders such as
multiple sclerosis and/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. 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 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%). Only the rate of ISR was higher than that of
methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%).
Immunex Corporation and Wyeth-Ayerst Laboratories, a division of
American Home Products Corporation, market ENBREL in North America. Other AHP
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
(http://www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735).
Immunex Corporation is a biopharmaceutical company dedicated to improving
lives through immune system science innovations.
American Home Products Corporation's Wyeth-Ayerst division is a major
research-oriented pharmaceutical company with leading products in the areas of
women's health care, cardiovascular disease therapies, central nervous system
drugs, anti-inflammatory agents, vaccines, oncology and hemophilia products
and generic pharmaceuticals.
American Home Products Corporation is one of the world's largest
research-based pharmaceutical and health care products companies. It is a
leader in the discovery, development, manufacturing, and marketing of
prescription drugs and over-the-counter medications. It also is a global
leader in vaccines, biotechnology and animal health care.
NOTE: This news release contains forward-looking statements that involve
risks and uncertainties, including risks associated with clinical development,
regulatory approvals, our reliance on third-party manufacturers, product
commercialization and other risks described from time to time in the SEC
reports filed by Immunex, including the most recently filed Form 10-Q. 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 http://www.immunex.com.
SOURCE Immunex Corporation
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Related links:
http://www.immunex.com
Company News On-Call:
http://www.prnewswire.com/comp/434644.html or fax,
800-758-5804, ext. 434644
CONTACT:
Media, Robin Shapiro, 206-389-4040, or
Investors, Mark Leahy, 206-389-4363, both of Immunex Corporation;
or Media, Doug Petkus of Wyeth-Ayerst Laboratories, 610-902-7336
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