Bob, full of questions - see prior post on Interferon = FYI
Biogen Commends FDA Ruling Upholding Orphan Drug Act With Regard to AVONEX(R)
Interferon Beta-1a)
CAMBRIDGE, Mass., March 1 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN) said
that today's U.S. Food and Drug Administration (FDA) ruling upholding orphan
drug exclusivity for the Company's AVONEX(R) (Interferon beta-1a), as well
Berlex Laboratories' Betaseron(R) (Interferon beta-1b), is in the best
interests of the entire multiple sclerosis community and a safeguard for
future drug development. As a result of the decision, Serono Laboratories
will be unable to market Rebif(R)(Interferon beta-1a) in the United States
until the AVONEX(R) period of exclusivity expires in 2003.
Jim Vincent, Biogen's Chairman and Chief Executive Officer, said, "The
Agency's decision reinforces our confidence that the FDA makes its decisions
on the merits of good science and clinical results. People with MS and their
physicians in the U.S. currently have three safe and effective therapies
available to treat multiple sclerosis. These include AVONEX(R), which is
approved for all relapsing forms of MS, and is the drug of choice among people
with MS and their physicians. As today's FDA ruling makes clear, Rebif(R)
does not offer greater efficacy or safety and does not provide a significant
addition to patient care. AVONEX(R) has proven to be a safe and effective
once-a-week treatment with a moderate side-effect profile, without the
injection-site reactions, skin necrosis, and neutralizing antibody levels
associated with Rebif(R).
"Today's FDA ruling is in the best interests of the entire MS community --
patients, physicians, advocates and researchers -- and a long-term benefit to
America's public health. Safeguarding the Orphan Drug Act preserves the
incentives for continued private sector research in multiple sclerosis and
other rare diseases. At Biogen, we have been reinvesting more than 30 percent
of revenues into research and development of novel compounds, a level of
investment substantially greater than the average for the pharmaceutical
industry. This includes research on additional drugs that could benefit
people with MS."
Under the federal Orphan Drug Act, companies receiving FDA marketing clearance
for products for rare diseases in the U.S. receive a seven-year period of
market exclusivity. This provides an incentive for pharmaceutical companies
to invest in research and development activities in these areas.
In addition to historical information, this press release contains forward-
looking statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Reference is made in particular to forward- looking
statements regarding Biogen's current expectation that AVONEX(R) will remain
the preferred therapy among multiple sclerosis patients and their physicians.
These statements are based on the Company's current beliefs and expectations
as to such future outcomes. Factors which could cause actual results to
differ materially from the Company's current expectations include, without
limitation: unanticipated changes in the level of patient satisfaction with
AVONEX(R); the nature of regulatory, pricing, and reimbursement decisions
worldwide with respect to the Company's product and competitors' products; the
impact of competition; the impact of litigation; the nature of results of
clinical trials involving the Company's product; the other risks commonly
associated with commercialization of drugs; and the other risks and
uncertainties detailed from time to time in the Company's periodic reports
filed with the Securities and Exchange Commission.
Biogen, Inc., winner of the 1998 U.S. National Medal of Technology, is a
biopharmaceutical company principally engaged in discovering and developing
drugs for human healthcare through genetic engineering. Headquartered in
Cambridge, MA, the Company's revenues are generated from U.S. and European
sales of AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of
multiple sclerosis, and from the worldwide sales by licensees of a number of
products, including alpha interferon and hepatitis B vaccines and diagnostic
products. Biogen's research and development activities are focused on novel
products for multiple sclerosis, inflammatory, respiratory, kidney and
cardiovascular diseases and in developmental biology and gene therapy. For
copies of press releases and additional information about the Company, please
consult Biogen's Homepage on the World Wide Web at http://www.biogen.com.
Rebif is a trademark of Serono Laboratories. Betaseron is a trademark of
Berlex Laboratories Inc.
SOURCE Biogen, Inc.
CO: Biogen, Inc.
ST: Massachusetts
IN: MTC
SU: