CHMP Issues Positive Opinion for TECFIDERA™ (Dimethyl Fumarate) as a First-Line Treatment for Multiple Sclerosis in the

  CHMP Issues Positive Opinion for TECFIDERA™ (Dimethyl Fumarate) as a
  First-Line Treatment for Multiple Sclerosis in the European Union

     -European Commission Decision Anticipated In Second Quarter of 2013-

Business Wire

WESTON, Mass. -- March 22, 2013

Today Biogen Idec (NASDAQ: BIIB) announced that it has received a positive
opinion from the Committee for Medicinal Products for Human Use (CHMP) in the
European Union (EU) recommending a marketing authorization be granted for
TECFIDERA^™ (dimethyl fumarate) as a first-line oral treatment for adults with
relapsing-remitting multiple sclerosis (RRMS). The CHMP, on the basis of
quality, safety and efficacy data submitted by Biogen Idec, considers there to
be a favorable benefit-to-risk balance for TECFIDERA.

The CHMP's recommendation is now referred to the European Commission (EC),
which grants marketing authorization for medicines in the European Union. The
U.S. Food and Drug Administration is expected to make a decision on the
marketing application for TECFIDERA in the United States in the coming days.

“With the CHMP’s positive opinion for TECFIDERA, we are one step closer to
offering the European MS community a treatment with compelling efficacy and a
favorable safety profile in the convenience of a pill – a combination we
believe will have a significant positive impact on the way people live with
this chronic disease,” said George A. Scangos, Ph.D., chief executive officer
of Biogen Idec. “Biogen Idec is committed to delivering innovative treatments
and setting new standards for the next generation of medicines. We believe
TECFIDERA will raise expectations for what people living with MS can achieve
with their therapy.”

The CHMP opinion for TECFIDERA is based on data from a large clinical
development program that included two global Phase 3 studies, DEFINE and
CONFIRM, involving more than 2,600 RRMS patients, as well as an ongoing
extension study in which some patients have been followed for more than four
years. In DEFINE, TECFIDERA, administered twice-daily, significantly reduced
the proportion of patients who relapsed by 49 percent (p<0.0001), the
annualized relapse rate (ARR) by 53 percent (p<0.0001), and 12-week confirmed
disability progression, as measured by the Expanded Disability Status Scale
(EDSS), by 38 percent (p=0.0050) compared to placebo at two years. In CONFIRM,
twice-daily TECFIDERA significantly reduced ARR by 44 percent (p<0.0001) and
the proportion of patients who relapsed by 34 percent (p<0.0001) compared to
placebo at two years. While not statistically significant, TECFIDERA showed a
21 percent reduction in 12-week confirmed disability progression in CONFIRM.
In addition, both studies showed TECFIDERA significantly reduced lesions in
the brain compared to placebo, as measured by magnetic resonance imaging
(MRI).

“Clinical studies demonstrated TECFIDERA was an effective therapy with a
favorable safety profile for people with relapsing-remitting MS,” said
Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and
The London School of Medicine and Dentistry. “This, combined with its
interesting suggested mechanism of action, should position TECFIDERA as a
first-line therapy choice.”

The most common side effects associated with TECFIDERA seen in clinical trials
are flushing and gastrointestinal (GI) events (i.e., diarrhea, nausea, and
abdominal pain). Other side effects include a decrease in mean lymphocyte
counts during the first year of treatment, which then plateaued. There was no
increased risk of malignancy or serious infections associated with TECFIDERA
treatment, and no opportunistic infections were observed.

The European Commission decision on TECFIDERA is expected in approximately two
months. TECFIDERA will mark the fourth therapy Biogen Idec offers people
living with MS.

About TECFIDERA™

TECFIDERA™ (dimethyl fumarate) is an oral therapeutic candidate for the
treatment of multiple sclerosis (MS). TECFIDERA is the only currently known
investigational compound for the treatment of relapsing-remitting MS that has
experimentally demonstrated activation of the Nrf-2 pathway. This pathway
provides a way for cells in the body to defend themselves against inflammation
and oxidative stress caused by conditions like MS.

In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM,
two global, placebo-controlled Phase 3 clinical trials that evaluated 240 mg
of TECFIDERA, administered either twice a day (BID) or three times a day
(TID), for two years. TECFIDERA is also currently under review by regulatory
authorities in the United States, Australia, Canada and Switzerland.

About Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, often disabling disease that attacks the
central nervous system (CNS), which is made up of the brain, spinal cord and
optic nerves. Symptoms may be mild or severe, ranging from numbness in the
limbs to paralysis or loss of vision. The progression, severity, and specific
symptoms of MS are unpredictable and vary from one person to another. MS
affects an estimated 2.5 million people worldwide,^1 with approximately
400,000 sufferers in the European Union.^2 Relapsing-remitting MS is the most
common form of the disease, accounting for 85 percent of cases, and is
characterized by clearly defined acute attacks with full recovery or with
residual deficit upon recovery.^3

AboutBiogen Idec

Through cutting-edge science and medicine,Biogen Idecdiscovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in
1978,Biogen Idecis the world’s oldest independent biotechnology company.
Patients worldwide benefit from its leading multiple sclerosis therapies, and
the company generates more than$5 billionin annual revenues. For product
labeling, press releases and additional information about the company, please
visit www.biogenidec.com.

Safe Harbor

This press release contains forward-looking statements, including statements
about anticipated regulatory approvals and the potential therapeutic impact of
TECFIDERA. These statements may be identified by words such as "believe,"
"expect," "may," "plan," "potential," "will" and similar expressions, and are
based on our current beliefs and expectations. You should not place undue
reliance on these statements. These statements involve risks and uncertainties
that could cause actual results to differ materially from those reflected in
such statements, including risks associated with obtaining regulatory
approval, uncertainty of success in commercialization of TECFIDERA and the
other risks and uncertainties that are described in the Risk Factors section
of our most recent annual or quarterly report and in other reports we have
filed with the SEC. Any forward-looking statements speak only as of the date
of this press release and we assume no obligation to update any
forward-looking statements, whether as a result of new information, future
events or otherwise.

^1 Multiple Sclerosis International Federation. About MS – What is MS. Date
Accessed: 21 March 2013. http://www.msif.org/en/about_ms/what_is_ms.html

^2 European Multiple Sclerosis Platform. MS Fact Sheet. Date accessed: 21
March 2013. http://www.emsp.org/multiple-sclerosis/ms-fact-sheet

^3 Multiple Sclerosis International Federation. About MS – Types and Course.
Date Accessed: 21 March 2013. http://www.msif.org/en/about_ms/types_of_ms.html

Contact:

US MEDIA CONTACT:
Biogen Idec
Kate Niazi-Sai, +1-781-464-3260
public.affairs@biogenidec.com
or
EX-US MEDIA CONTACT:
Biogen Idec International
Shannon Altimari, +41 41 392 16 77
or
INVESTOR CONTACT:
Biogen Idec
Kia Khaleghpour, +1-781-464-2442
IR@biogenidec.com
 
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