Biogen Idec (NASDAQ: BIIB) today announced the U.S. Food and Drug
Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017)
Fast Track designation for relapsing multiple sclerosis (RMS). Biogen
Idec is currently enrolling patients in a global Phase III study
evaluating the efficacy and safety of either bi-weekly or once-monthly
injections of PEGylated interferon beta-1a in this patient
population.
“Early-stage clinical trials suggest that PEGylated interferon beta-1a
has the potential to offer less frequent dosing without compromising
efficacy, which would be a significant development for people living
with multiple sclerosis,” said Michael Panzara, M.D., M.P.H., vice
president and chief medical officer of neurology at Biogen Idec. “We
look forward to working closely with the FDA to expedite the compound’s
development and review process.”
The FDA's Fast Track program is designed to expedite the review of new
drugs that are intended to treat serious or life-threatening conditions
and demonstrate the potential to address unmet medical needs.
Biogen Idec plans to enroll more than 1,200 patients in the Phase III,
randomized, double-blind, placebo-controlled trial designed to evaluate
the efficacy and safety of PEGylated interferon beta-1a in patients with
RMS. The global trial, called ADVANCE, will determine the efficacy of
PEGylated interferon beta-1a in reducing relapse rates in patients with
RMS at one year. The study will also examine if, over time, treatment
with PEGylated interferon beta-1a can slow disease progression and lead
to a decrease in the number of T2 hyperintense brain lesions commonly
seen in MS patients.
Patients interested in learning more about the ADVANCE trial may speak
with their physician or e-mail ADVANCEstudy@biogenidec.com.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high
unmet medical needs. Founded in 1978, Biogen Idec is a global leader in
the discovery, development, manufacturing, and commercialization of
innovative therapies. Patients in more than 90 countries benefit from
Biogen Idec's significant products that address diseases such as
lymphoma, multiple sclerosis, and rheumatoid arthritis. For product
labeling, press releases and additional information about the company,
please visit www.biogenidec.com.
Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the
development of PEGylated interferon beta-1a as a potential treatment for
various indications. These statements are based on the company’s current
beliefs and expectation. Drug development involves a high degree of
risk. Factors which could cause actual results to differ materially from
the company's current expectations include the risk that we may not
fully enroll our planned clinical trials, unexpected concerns may arise
from additional data or analysis, that regulatory authorities may
require additional information, further studies, or may fail to approve
the drug, or that the company may encounter other unexpected hurdles.
For more detailed information on the risks and uncertainties associated
with Biogen Idec's drug development and other activities, see the
periodic reports of Biogen Idec filed with the Securities and Exchange
Commission. Biogen Idec assumes no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Biogen Idec Media Contact:
Jennifer Neiman, 617-914-6524
Senior
Manager, Public Affairs
or
Biogen Idec Investor Relations
Contact:
Eric Hoffman, 617-679-2812
Director, Investor
Relations
