CHMP Determines Dimethyl Fumarate in TECFIDERA® to be a New Active Substance in the European Union

  CHMP Determines Dimethyl Fumarate in TECFIDERA® to be a New Active Substance
  in the European Union

- Assessment Follows March 2013 Positive Opinion for TECFIDERA as a First-line
                      Treatment for Multiple Sclerosis -

                 - European Commission Decision Anticipated -

Business Wire

CAMBRIDGE, Mass. -- November 22, 2013

Today Biogen Idec (NASDAQ: BIIB) reported that the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) has
determined that dimethyl fumarate in TECFIDERA qualifies as a new active
substance (NAS). This designation will provide 10 years of regulatory
exclusivity for TECFIDERA in the European Union (EU).

The NAS determination follows a positive opinion by the CHMP in March 2013
recommending marketing authorization in the EU for TECFIDERA as a first-line
oral treatment for adults with relapsing-remitting multiple sclerosis (RRMS).
The CHMP’s determination will now be referred to the European Commission (EC),
which grants marketing authorization for medicines in the EU.

“We are heartened by the CHMP’s NAS determination, which brings us closer to
our goal of providing this important new treatment to multiple sclerosis (MS)
patients in Europe. We are ready to introduce TECFIDERA in EU countries
shortly after anticipated approval,” said Douglas Williams, Ph.D., executive
vice president of Research and Development at Biogen Idec. “This designation
validates the tremendous investment we have made in TECFIDERA and enables us
to invest in future research focused on reversing the course of MS and
hopefully one day finding a cure for patients.”

If approved, TECFIDERA will mark the fourth therapy that Biogen Idec offers to
people living with MS in the European Union.


TECFIDERA is an oral therapy for relapsing forms of MS, including RRMS, the
most common form of MS. TECFIDERA is currently approved in the United States,
Canada and Australia, and is under review by regulatory authorities in the
European Union.

TECFIDERA has been proven to reduce MS relapses, progression of disability and
MS brain lesions, while demonstrating a favorable safety and tolerability
profile. In clinical trials, the most common adverse events associated with
TECFIDERA were flushing and GI events. Other side effects included a decrease
in mean lymphocyte counts during the first year of treatment, which then
remained stable. The efficacy and safety of TECFIDERA has been studied in a
large, global clinical program, which includes an ongoing long-term extension

It is believed that TECFIDERA provides a new approach to treating MS by
activating the Nrf2 pathway, although its exact mechanism of action is
unknown. This pathway provides a way for cells in the body to defend
themselves against inflammation and oxidative stress caused by conditions like

AboutBiogen Idec

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

Safe Harbor

This press release contains forward-looking statements, including statements
about the anticipated approval of TECFIDERA by the EC. These statements may be
identified by words such as "believe," "expect," “anticipate,” "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 the risk that the EC may fail to approve or may delay approval of
TECFIDERA or may not follow the recommendation of the CHMP, the risk that we
encounter other unexpected hurdles or difficulties in launching in EU
countries, 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.


Biogen Idec
Kate Niazi-Sai, +1-781-464-3260
Biogen Idec International
Katja Buller, +41 41 392 17 92
Biogen Idec
Claudine Prowse, Ph.D., +1-781-464-2442
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