Ralph
22.03.2001, 22:53
Grund ist diese meldung !
CHF Studies of ENBREL(R) (etanercept) Will Conclude Early, Monitoring Board Advises Study Not Likely to Meet Efficacy Endpoints
SEATTLE, March 22 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX - news) and American Home Products Corporation (NYSE: AHP - news) announced today that guidance from an independent data monitoring board indicates that ongoing studies of ENBREL® (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 (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 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.
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Das kann passieren, wenn man nur von einem Produkt richtige Einnahmen erwarten kann.
Ralph
CHF Studies of ENBREL(R) (etanercept) Will Conclude Early, Monitoring Board Advises Study Not Likely to Meet Efficacy Endpoints
SEATTLE, March 22 /PRNewswire/ -- Immunex Corporation (Nasdaq: IMNX - news) and American Home Products Corporation (NYSE: AHP - news) announced today that guidance from an independent data monitoring board indicates that ongoing studies of ENBREL® (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 (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 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.
====================================================
Das kann passieren, wenn man nur von einem Produkt richtige Einnahmen erwarten kann.
Ralph