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Biogen Announces Results of Phase II Trials With ADENTRI at American Heart
Association Meeting
CAMBRIDGE, Mass., November 10 /PRNewswire/ -- Biogen (Nasdaq: BGEN) today
announced positive results of a Phase II
study of oral ADENTRI(TM), an adenosine receptor antagonist, in patients
with stable heart failure. The results were announced at the annual meeting
of the American Heart Association, which is being held this week in
Orlando, Florida.
(Logo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
"We are very pleased with the results of our Phase II trial of oral
ADENTRI and plan to meet with the FDA to review these data in preparation
for moving forward with the development of this promising compound," said
Burt Adelman, M.D., Biogen's Executive Vice President of Research &
Development.
The trial was a randomized, double blind, placebo-controlled study that
evaluated the safety, pharmacology and clinical effects of oral ADENTRI
among stable heart failure patients. Patients were maintained on their
usual medications, including ACE inhibitors and diuretics, and were dosed
with either placebo or one of four doses of ADENTRI, administered once
daily for 10 days. The evaluation of safety, which was the primary endpoint
of the study, did not reveal any significant safety concerns during the 10
days of dosing or during an additional 30 days of follow up. In addition,
the study showed increases in sodium excretion above baseline and above
placebo beginning on Day 1, and continuing over the 10-day dosing period.
These effects were not accompanied by reductions in kidney function or
substantial increases in potassium excretion.
ADENTRI is a novel adenosine receptor antagonist that has the potential
to maintain renal function during standard heart failure therapy, while
causing natriuresis (or sodium excretion).
About Biogen
Biogen is a leader in biologics research, development and
manufacturing. A pioneer in leading edge research in immunology,
neurobiology and oncology, Biogen brings novel therapies to improve
patients' lives around the world through its global marketing capabilities.
For press releases and additional information about the company, please
visit http://www.biogen.com.
This press release contains forward-looking statements regarding the
expectations for development of ADENTRI. These statements are based on our
current beliefs and expectations. Actual results could differ materially.
Drug development involves a high degree of risk. Only a small number of
research and development programs result in the commercialization of a
product. Success in animal models or early stage clinical trials does not
ensure that later stage or larger scale clinical trials will be successful.
The results of studies of the product in larger clinical trials may not be
as expected or safety issues or other problems or delays may arise during
clinical trials. For more detailed information on the risks and
uncertainties associated with these forward looking statements and Biogen's
other activities see the Outlook section in MD&A of Biogen's Annual Report
on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. Biogen
does not undertake any obligation to publicly update any forward-looking
statements.
Media Contact:
Kathryn Bloom
Senior Director, Public Affairs
Biogen, Inc.
Tel: +1-617-914-6524
Investment Community Contact:
Elizabeth Woo
Senior, Director Investor Relations
Biogen, Inc.
Tel: +1-617-679-2812
Web site: http://www.biogen.com
Media Contact: Kathryn Bloom, Senior Director, Public Affairs,
+1-617-914-6524, or Investment Community Contact: Elizabeth Woo, Senior,
Director Investor Relations, +1-617-679-2812, both of Biogen, Inc./
Company News On-Call: http://www.prnewswire.com/comp/101550.html/
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO AP
Archive: http://photoarchive.ap.org PRN Photo Desk, +1-888-776-6555 or
+1-212-782-2840/
FCMN Contact: kara_pagliaro@biogen.com /