CAMBRIDGE, Mass., Nov. 10 /PRNewswire-FirstCall/ -- 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: 617-914-6524
Investment Community Contact:
Elizabeth Woo
Senior, Director Investor Relations
Biogen, Inc.
Tel: 617-679-2812
SOURCE Biogen, Inc.
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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.
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