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BIOGEN’S
AVONEXÒ
(Interferon beta-1a) SHOWS A BENEFICIAL EFFECT |
Data
Monitoring Committee Recommends Stopping CHAMPS Trial Early;
Biogen
to Apply for Broadened Label with Regulatory Authorities
Cambridge, MA
(February 1, 2000) – Biogen, Inc. (BGEN/NASDAQ) announced today that its
CHAMPS study has shown a highly statistically significant beneficial effect of
AVONEXÒ
(Interferon beta-1a) on delaying the development of clinically definite
multiple sclerosis (MS). The study will stop early following positive results
(p=0.0023) as assessed by the independent Data Monitoring Committee.
The Data Monitoring Committee determined that a beneficial effect of
AVONEXÒ
on the primary endpoint had been established at the interim analysis,
exceeding the pre-established criteria (p<0.029) required for early
termination of the trial.
The secondary
endpoints of MRI analysis were also positive, supporting the primary endpoint.
Biogen plans to file an application for a broadened prescribing label
for AVONEXÒ
with regulatory agencies worldwide.
CHAMPS, which stands for Controlled
High
Risk Subjects AVONEXÒ Multiple Sclerosis Prevention Study,
was a randomized, double-blind, placebo-controlled trial. The primary objective of the CHAMPS study was to determine
whether AVONEXÒ is beneficial in delaying the onset of clinically definite
MS in people who have experienced the recent onset of a first demyelinating
event. Clinically definite MS is
identified by the presence of at least two demyelinating events, separated by
time and location in the central nervous system (CNS).
The CHAMPS study, which began in 1996,
involved 383 patients at 50 sites in the U.S. and Canada.
Inclusion criteria included the first occurrence of an isolated,
well-defined neurologic event consistent with MS, i.e., either optic neuritis or
a spinal cord syndrome or brainstem/cerebellar syndrome.
Study participants received either 30 micrograms of AVONEXÒ
or placebo injected intramuscularly once a week for up to three years.
Jim Vincent, Biogen’s Chairman and CEO, said, “This is a clear demonstration that a therapeutic intervention can be effective in delaying the onset of clinically definite MS in high-risk individuals and confirms the benefit of early treatment in MS. Everything we continue to learn about AVONEXÒ supports the "treat early" guidelines issued by the U.S. National Multiple Sclerosis Society and other MS societies worldwide and confirms use along a broad spectrum of this progressively disabling disease.”
AVONEXÒ was launched in the U.S. in 1996 for the treatment of relapsing forms of MS and currently is marketed internationally in more than 60 countries. With approximately 83,000 patients now on AVONEXÒ therapy, it is the leading treatment for multiple sclerosis worldwide.
MS
is a chronic, inflammatory disease of the CNS in which most patients incur
disability over time. MS affects
approximately 400,000 people in the United States, two‑thirds of whom are
women. Disease onset typically occurs in young adults between the
ages of 20 and 40.
The
disease is believed to be caused by the destruction of myelin by the immune
system. Myelin is the fatty tissue
that surrounds and protects CNS nerve fibers and facilitates the flow of nerve
impulses to and from the brain. The
loss of myelin disrupts the conduction of nerve impulses, producing the symptoms
of MS.
Disease symptoms vary substantially from patient to patient. However, common symptoms include weakness, numbness, fatigue, vision problems, slurred speech, poor coordination, short‑term memory loss, depression, and bowel or bladder dysfunction. Severe cases of MS can be characterized by partial or complete paralysis.
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 worldwide 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’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.
This material is provided as general medical information and is not intended as advice for individual patients; please contact your physician for specific recommendations.
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