Phase III Clinical Program Expected to Begin in 2004
CAMBRIDGE, Mass., Oct. 1 /PRNewswire-FirstCall/ -- Biogen, Inc.
(Nasdaq: BGEN) today announced it has licensed from Fumapharm AG exclusive
rights to develop and market a new oral therapy for psoriasis entering Phase
III clinical trials in Europe. The product is a second-generation fumarate
derivative with an immunomodulatory mechanism of action. A first-generation
product is currently marketed as FUMADERM(R) in Germany, where it is the
leading prescription for oral systemic treatment of moderate-to-severe
psoriasis.
(Logo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Under the agreement, Biogen will receive worldwide development and
marketing rights, excluding Germany. Financial terms of the agreement were
not released.
Fumapharm has completed a Phase II clinical trial of the second-generation
product in psoriasis. Results of this double blind, multi-center study will be
announced at an upcoming dermatology conference. Biogen plans to collaborate
with Fumapharm to accelerate the Phase III clinical development and
registration program worldwide.
"This license agreement is one more step in continuing to strengthen and
expand our pipeline in our core biologic and therapeutic areas of focus," said
James C. Mullen, Chairman and CEO of Biogen. "Our understanding of autoimmune
diseases is a company strength and through the development and launch of the
first biologic treatment approved for psoriasis, we have gained a keen
scientific understanding of the disease and built a strong commercial
foundation for bringing dermatology products to market. The success of
FUMADERM in Germany as the leading oral systemic treatment for psoriasis is
very encouraging. Bringing this innovative therapy forward is one more step
Biogen can take toward improving the lives of people coping with this chronic
disease."
"Twenty years following the establishment of Fumapharm AG, and nine years
after approval of FUMADERM in Germany, Fumapharm has partnered with Biogen --
one of the most innovative and leading companies in the worldwide
pharmaceutical market -- on the further development of our improved fumarate
derivative," said Dr. Hans Peter Strebel, President and CEO of Fumapharm.
"Biogen and Fumapharm will work closely together to fully utilize the
potential of this promising product with the goal of providing a successful
therapy directed initially to treat psoriasis patients worldwide. This
license agreement provides not only the resources, but also combines the know-
how necessary to conduct all stages of research, development and marketing.
Fumapharm and Biogen are well under way to define the future together," Dr.
Strebel said.
About Biogen
Biogen is the world's oldest independent biotechnology company and 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, please
visit http://www.biogen.com.
About Fumapharm AG
Fumapharm is a privately held pharmaceutical company headquartered in
Lucerne, Switzerland.
FUMADERM(R) is the leading oral prescription drug for systemic treatment
of moderate-to-severe psoriasis in Germany. For more information, please visit
http://www.fumapharm.ch.
Safe Harbor
This press release contains forward-looking statements regarding the
clinical and therapeutic expectations for Fumapharm's product. 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'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:
Amy Ryan
Associate 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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http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
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CONTACT:
Media Contact: Amy Ryan, Associate 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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