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Biogen Announces Results of Phase II Trials With ADENTRI(TM) at American Heart
Association Meeting
CAMBRIDGE, Mass., Nov. 10 /PRNewswire-FirstCall/ -- Biogen 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: 617-914-6524
Investment Community Contact:
Elizabeth Woo
Senior, Director Investor Relations
Biogen, Inc.
Tel: 617-679-2812
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
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DATASOURCE: Biogen, Inc.
CONTACT: 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.
Web site: http://www.biogen.com/
Company News On-Call: http://www.prnewswire.com/comp/101550.html