SEATTLE, March 22 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX) and
American Home Products Corporation (NYSE: AHP) announced today that guidance
from an independent data monitoring board indicates that ongoing studies of
ENBREL(R) (etanercept) in chronic heart failure (CHF) would not be able to
meet efficacy endpoints. Based on this guidance, the companies have decided
not to proceed with the large Phase 2/3 clinical studies in CHF.
"Future development decisions for ENBREL in CHF will be made after we have
complete analysis of all data from these studies," said Leslie Garrison, MD,
MPH, Immunex senior vice president of clinical development.
The data monitoring board was prospectively established to periodically
evaluate the efficacy and safety from the studies. The board is comprised of
independent physicians, statisticians and epidemiologists not associated with
the study or the sponsors.
The Phase 2/3 program of ENBREL in CHF consists of two studies: The
Randomized Etanercept North American Strategy to Study Antagonism of Cytokines
(RENAISSANCE) was conducted by Immunex in North America; The Research into
Etanercept Antagonism in Ventricular Dysfunction (RECOVER) was conducted in
Europe by Wyeth-Ayerst, a division of AHP. The primary endpoint of the studies
was: 1) improvement in clinical composite score of each study (defined by
New York Heart Association Class, patient's global assessment, hospitalization
for heart failure and death) and 2) a combined morbidity/mortality evaluation
of both studies.
The companies are contacting investigators regarding this development. If
doctors or patients would like additional information, they can call
800-Immunex (800-466-8639).
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 website at (http://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.
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 new 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-K. 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.
Immunex will host a conference call and live webcast at 2:30 p.m. PST
today to discuss Immunex information disclosed today.
The live webcast can be accessed by going to the Immunex website at:
http://www.immunex.com/investor_fs3.html. Following the webcast, an archived
version of the call will be available at the same address until
March 29, 2001.
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 of Immunex Corporation,
206-389-4040; Doug Petkus of Wyeth-Ayerst, 610-902-7336; or
Lowell Weiner of American Home Products, 973-660-5013; or
investors, Mark Leahy of Immunex Corporation, 206-389-4363; or
Justin Victoria of American Home Products, 973-660-5340
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