Committee Requests Additional Clinical Information
CAMBRIDGE, Mass., Feb. 20 /PRNewswire-FirstCall/--
Biogen, Inc. (Nasdaq: BGEN) announced today that the Committee for Proprietary
Medicinal Products (CPMP), the scientific advisory body of the European
Medicines Evaluation Agency (EMEA), requested more information relating to its
application for AMEVIVE(R) (alefacept) for psoriasis. In the final assessment
received this week, the CPMP determined that more clinical information is
needed to approve the product. Biogen has withdrawn its application and plans
to develop the additional clinical information necessary to obtain approval of
AMEVIVE for psoriasis patients in Europe. Developing the data and re-filing
the application to gain approval could take several years.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
This action should have no impact on the company's 2003 financial
guidance. Biogen will be evaluating the impact on guidance for 2004 and
beyond, considering the delay of European revenue as well as sales and
marketing expense, and updating this outlook in its quarterly earnings call.
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 about
the company, please visit http://www.biogen.com.
Safe Harbor
In addition to historical information, this press release contains
forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995. Reference is made in
particular to plans for the development of additional clinical data in
response to the determination of the Committee for Proprietary
Medicinal Products (CPMP) and the Company's expectations regarding the impact
of the decision on financial results. These statements are based on the
Company's current beliefs and expectations as to such future outcomes. There
is no assurance that the Company will be able to generate data satisfactory to
the CPMP. There are also a number of risks and uncertainties that could cause
actual financial results to differ materially from our expectations. For
example, financial results may be affected by the impact of competitive
products on AVONEX(R) (interferon beta-1a) sales, any slowing of growth of the
multiple sclerosis market, any change in market acceptance of AVONEX in key
markets worldwide, the level of success in launching AMEVIVE in the United
States and the impact on expenses of development, sales and marketing
activities and in-licensing and product opportunities as well as the other
risks and uncertainties described from time to time in the Company's
periodic reports filed with the Securities and Exchange Commission.
Conference Call And Webcast
The company will host a call for investors at 9:00 a.m. EST on February
20, 2003, and will be accessible through the investor relations section of
Biogen's homepage, http://www.biogen.com.
Media Contact:
Amy McKnight
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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Related links:
http://www.biogen.com
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
CONTACT:
Media Contact, Amy McKnight, 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
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