Biogen Idec Receives Notification from FDA of PDUFA Date Extension for ALPROLIX™

  Biogen Idec Receives Notification from FDA of PDUFA Date Extension for

Business Wire

CAMBRIDGE, Mass. -- December 2, 2013

Biogen Idec (NASDAQ:BIIB) announced today that the U.S. Food and Drug
Administration (FDA) has extended the initial Prescription Drug User Fee Act
(PDUFA) date for its review of the Biologics License Application (BLA) for
ALPROLIX™, the company’s investigational long-lasting recombinant factor IX Fc
fusion protein candidate for hemophilia B. The PDUFA date has been extended by
three months, which is the standard extension period.

In response to a request from FDA, Biogen Idec submitted additional
information related to the validation of a manufacturing step for ALPROLIX.
Due to the timing of this submission, the FDA extended the PDUFA date to allow
additional time for review of the marketing application.


ALPROLIX is an investigational fully recombinant, long-lasting clotting factor
therapy in late-stage clinical development for the treatment of hemophilia B.
ALPROLIX uses Fc fusion technology, which takes advantage of a naturally
occurring pathway that delays the breakdown of IgG1 (protein commonly found in
the body) and cycles it back into the bloodstream. The Fc portion of IgG1 is
fused to factor IX in ALPROLIX and is thought to be responsible for the
prolonged time ALPROLIX circulates in the body. While Fc fusion is an
established technology that has been used for more than 15 years, Biogen Idec
is the only company to apply it in hemophilia.

ALPROLIX is also under review by regulatory authorities in several countries,
including Canada, Australia and Japan.

About Hemophilia B

Hemophilia B is a rare, chronic, inherited disorder in which the ability of a
person’s blood to clot is impaired. Hemophilia B occurs in about one in 25,000
male births annually, and more rarely in females, affecting about 3,000 people
in the United States. It is caused by having substantially reduced or no
factor IX activity, which is needed for normal blood clotting. People with
hemophilia B experience bleeding episodes that can cause pain, irreversible
joint damage and life-threatening hemorrhage. Prophylactic infusions of factor
IX can temporarily replace clotting factors necessary to control bleeding and
prevent new bleeding episodes. The Medical and Scientific Advisory Council of
the National Hemophilia Foundation recommends prophylaxis as the optimal
therapy for people with severe hemophilia B.

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


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Investor Relations:
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