Canadian Neurologist Heads International Team of Researchers
CAMBRIDGE, Mass., April 16 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced that the company is launching an
international multi-center study to determine the long-term safety,
tolerability and efficacy of its multiple sclerosis drug AVONEX(R) (Interferon
beta-1a) compared to Serono S.A.'s REBIF(R) (Interferon beta-1a). Heading the
research initiative as the principal investigator is Thomas J. (Jock) Murray,
M.D., of Dalhousie University, Halifax, Canada. Dr. Murray is Director of the
Dalhousie MS Research Unit and Professor of Medical Humanities.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Commenting on the clinical initiative, Dr. Murray said, "This study will
be the first to evaluate the effect of these two interferon therapies over a
sustained and long period of time in patients with relapsing multiple
sclerosis. We will approach the clinical initiative in two ways. One phase of
the study will be a retrospective analysis of patients who have been on either
AVONEX or Rebif therapy for a period of time. The second phase of the study
will follow these patients and others for and additional three years, thus
following them for a total of up to five years to evaluate the long term
effect of therapy on the disease."
The two-phase study will first evaluate patients who have been on therapy
for a minimum of 15 and a maximum of 21 months prior to enrollment into the
trial and have an Expanded Disability Status Scale (EDSS) score between 0.0
and 5.5. EDSS is an established neurological scale that measures physical
disability. The patients will be divided into two groups, one which includes
patients who were treated with a 30 mcg dose of AVONEX administered
intramuscularly once a week and another which includes patients treated with
44 mcg of Rebif administered subcutaneously three times a week. These
patients will also be followed for an additional three years to evaluate the
long-term efficacy of Interferon beta-1a therapy on a number of clinical and
MRI measures.
Murray added, "I am excited to begin work on this much needed comparative
study that will provide reliable and valuable information on AVONEX and REBIF
over a broad spectrum of clinical disease measurements. With five years of
data, from a comprehensive, controlled study, this research will help
clinicians and patients make the most appropriate treatment choices for MS.
"Although there has been a lot of talk in the MS community lately about
comparative clinical studies, those studies were conducted for short periods
of time and looked only at narrow measures of efficacy. We don't know the
impact on safety or efficacy from long-term frequent dosing with Interferons.
I believe that only long-term studies can determine how these MS therapies
truly work in this life-long chronic disease."
The study's clinical research team will include neurologists and other MS
researchers. Dr. Cary Pfeffer, Biogen's Vice President of Global Medical
Affairs said, "As the leader in MS treatment and research, Biogen is committed
to supporting this important new research. We look forward to bringing both
physicians and patients a real life analysis of these MS treatments."
About AVONEX(R)
AVONEX is the leading treatment for multiple sclerosis worldwide, with
more than 118,000 patients on therapy. It was launched in the U.S. in 1996
and later in Europe for the treatment of relapsing forms of MS to slow the
progression of disability and reduce relapses. AVONEX is marketed
internationally in more than 65 countries.
The most common side effects associated with AVONEX treatment are flu-like
symptoms, muscle ache, fever, and chills. Other common side effects seen, but
not statistically different between AVONEX and control groups, were headache,
pain and asthenia (weakness). These side effects usually go away within a day
after the injection and occur less often as the treatment continues. AVONEX
should be used with caution in people with depression and people with seizure
disorders. AVONEX should not be used by pregnant women. People with cardiac
disease should be closely monitored. Routine periodic blood chemistry and
hematology tests are recommended during treatment with AVONEX. Please see
complete prescribing information available at http://www.avonex.com.
About Biogen
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biotechnology 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 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.
AVONEX(R) is a registered trademark of Biogen, Inc.
REBIF(R) is a registered trademark of Serono, S.A.
Media Contact:
Kathleen O'Donnell
Associate Director, Public Affairs
Biogen, Inc.
617-679-2837
Investor Contact:
Elizabeth Woo
Director, Investor Relations
Biogen, Inc.
617-679-2822
SOURCE Biogen, Inc.
 back to top
Related links:
http://www.biogen.com.
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
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/101550.html
CONTACT:
Media Contact: Kathleen O'Donnell, Associate
Director, Public Affairs, +1-617-679-2837, or Investor Contact:
Elizabeth Woo, Director, Investor Relations, +1-617-679-2822,
both Biogen, Inc.
|
