Biogen to Apply for Broadened Label with Regulatory Authorities
CAMBRIDGE, Mass., Feb. 1 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN) announced today that its CHAMPS study has shown a highly statistically significant beneficial effect of AVONEX(R) (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 AVONEX(R) 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 AVONEX(R) with regulatory agencies worldwide.
CHAMPS, which stands for Controlled High Risk Subjects AVONEX(R) Multiple Sclerosis Prevention Study, was a randomized, double-blind, placebo-controlled trial. The primary objective of the CHAMPS study was to determine whether AVONEX(R) 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 AVONEX(R) 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 AVONEX(R) 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."
AVONEX(R) 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 AVONEX(R) 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(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.
SOURCE Biogen, Inc.
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