CAMBRIDGE, Mass., SAN DIEGO, Calif. and LUCERNE, Switzerland, April 29
/PRNewswire-FirstCall/ -- Biogen Idec (Nasdaq: BIIB) and Fumapharm AG today
announced results from a Phase II study of BG-12, an oral fumarate, in
patients with severe psoriasis. Patients who received BG-12 in the trial
showed greater improvement in their psoriasis than patients receiving placebo.
The results were presented today at the spring symposium of the European
Academy of Dermatology and Venereology (EADV) in Budapest, Hungary.
(Logo: http://www.newscom.com/cgi-bin/prnh/20031112/LAW121LOGO )
Burt A. Adelman, M.D., Biogen Idec's Executive Vice President, Development
said, "It is encouraging that 42% of patients receiving the highest dose of
BG-12 achieved at least a 75% improvement in their Psoriasis Area and Severity
Index (PASI) after 12 weeks, as compared to 11% of patients receiving placebo.
We look forward to reviewing the results of the ongoing Phase III trial in
Europe and enhancing Biogen Idec's dermatology franchise."
The trial, conducted by Fumapharm, was a multicenter, double-blind,
placebo-controlled, dose-ranging Phase II study of 144 patients with severe
forms of psoriasis. Patients were equally randomized within four treatment
groups and received either placebo or BG-12 at one of three different doses
(120 mg, 360 mg, or 720 mg per day) for 12 weeks. Patients were evaluated
using the PASI score, a common measure of overall psoriasis severity.
Some patients began improving as early as two weeks after the drug was
administered. The key analysis was the PASI score at 12 weeks.
Hans Peter Strebel, Ph.D., President and CEO of Fumapharm said, "Our
partnership with Biogen Idec positions us well to jointly develop this
promising approach to treating psoriasis."
Other Phase II study details include:
* At week 12, median percentage reductions from baseline PASI were 71% for
patients receiving 720 mg, 52% for patients receiving 360 mg, 31% for
patients receiving 120 mg and 6% for patients receiving placebo.
* At week 12, 42% of patients in the 720 mg dose group achieved PASI 75,
as compared to 11% of placebo patients. PASI 75 represents a reduction
of the PASI score of at least 75% from baseline measurement.
The most commonly reported adverse events were flushing, elevations in
liver function tests and common colds, which were generally transient and mild
to moderate in severity.
In September 2003, Biogen Idec licensed certain exclusive rights to
develop and market BG-12 from Fumapharm. Biogen Idec development plans for
BG-12 include a range of autoimmune and inflammatory diseases, such as
psoriasis and multiple sclerosis.
About Biogen Idec
Biogen Idec (Nasdaq: BIIB) creates new standards of care in oncology and
immunology. As a global leader in the development, manufacturing, and
commercialization of novel therapies, Biogen Idec transforms scientific
discoveries into advances in human healthcare. For press releases and
additional information about the company, please visit
http://www.biogenidec.com .
About Fumapharm AG
Fumapharm is a privately held pharmaceutical company headquartered in
Lucerne, Switzerland. For more information, please visit
http://www.fumapharm.ch.
Safe Harbor
This press release contains forward-looking statements regarding the
development of BG-12 for psoriasis. These statements are based on our current
beliefs and expectations. They are subject to the risks inherent in drug
development, including the risks that the effects of the product in larger
clinical trials may not be as expected or that there may be safety issues or
other problems or delays that arise during clinical trials, unexpected
technical or manufacturing hurdles, or intellectual property disputes. 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. For more
detailed information on the risks and uncertainties associated with these
forward looking statements and Biogen Idec's other activities see Biogen
Idec's Annual Report on Form 10-K filed with the SEC. Biogen Idec does not
undertake any obligation to publicly update any forward-looking statements.
Media Contact:
Jose Juves
Associate Director, Public Affairs
Biogen Idec
(617) 914-6524
Investment Community Contact:
Christina Dillon
Manager, Investor Relations
Biogen Idec
(617) 679-2812
SOURCE Biogen Idec
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http://www.biogen.com
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CONTACT:
Jose Juves, Associate Director, Public
Affairs, +1-617-914- 6524, or Christina Dillon, Manager, Investor
Relations, +1-617-679-2812 both of Biogen Idec
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