Berlex suit is dismissed! Story below:
CAMBRIDGE, Mass., Oct. 8 /PRNewswire -- Biogen, Inc. (Nasdaq: BGEN) today
announced that Judge James Robertson of the U.S. District Court of the
District of Columbia has dismissed a suit filed by Berlex Laboratories, Inc.,
claiming the Food and Drug Administration's approval of AVONEX(TM)
(Interferon beta-1a) was improper.
Judge Robertson held that the FDA acted lawfully when it determined that
AVONEX was "clinically superior" to Betaseron under the Orphan Drug law and
that "FDA's determination that AVONEX is safe, pure and potent is amply
supported by the record."
Jim Vincent, Biogen's Chairman and Chief Executive Officer said, "This is
a major victory for the multiple sclerosis community and Biogen. The Berlex
action was frivolous and inappropriate and against the best interests of
people with MS and their physicians.
"Since its introduction to the U.S. market in May, AVONEX has been
enthusiastically received by patients and physicians. It is the only drug
shown to slow accumulation of physical disability and to reduce the number and
frequency of exacerbations in patients with relapsing forms of MS. In
addition, it has a convenient, once-a-week dosing regimen and a moderate side-
effect profile."
Biogen, Inc., headquartered in Cambridge, MA, is a biopharmaceutical
company principally engaged in discovering and developing drugs for human
healthcare through genetic engineering. The Company's revenues are generated
from U.S. sales of AVONEX (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 is focused primarily on developing and testing
novel products for multiple sclerosis, inflammatory and respiratory diseases
and certain viruses and cancers. |
