Sobi's partner Biogen Idec receives notification from FDA of PDUFA date
extension for ALPROLIX(TM)
Stockholm, Sweden, Dec. 2, 2013 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum
AB's (publ) (Sobi) partner Biogen Idec 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.
The updated timeline for FDA approval will not impact Sobi's planned European
About ALPROLIX and the Fc Fusion Technology Platform
ALPROLIX is an investigational fully recombinant, long-lasting clotting factor
therapy in late-stage clinical development for the treatment of haemophilia B.
ALPROLIX uses Fc fusion technology, which makes use 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, which may extend the time between
prophylactic infusions. 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
ALPROLIX is also under review by regulatory authorities in several countries,
including Canada, Australia and Japan.
About Haemophilia B
Haemophilia B is a rare, chronic, inherited disorder in which the ability of a
person's blood to clot is impaired. Haemophilia B occurs in about one in
25,000 male births annually, and more rarely in females. It is caused by
having substantially reduced or no factor IX activity, which is needed for
normal blood clotting. People with haemophilia B experience bleeding episodes
that can cause pain, irreversible joint damage and life-threatening
haemorrhage. 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
Haemophilia Foundation recommends prophylaxis as the optimal therapy for
people with severe haemophilia B.
About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the
development and commercialization of ALPROLIX in haemophilia B. Biogen Idec
leads development, has manufacturing rights, and has commercialization rights
in North America and all other regions excluding the Sobi territory. Sobi has
the right to opt in to assume final development and commercialization in
Europe (including Russia), the Middle East and Northern Africa.
Sobi is an international specialty healthcare company dedicated to rare
diseases. Our mission is to develop and deliver innovative therapies and
services to improve the lives of patients. The product portfolio is primarily
focused on inflammation and genetic diseases, with three late stage biological
development projects within haemophilia and neonatology. We also market a
portfolio of specialty and rare disease products for partner companies. Sobi
is a pioneer in biotechnology with world-class capabilities in protein
biochemistry and biologics manufacturing. In 2012, Sobi had total revenues of
SEK 1.9 billion (€ 215 M) and about 500 employees. The share (STO: SOBI) is
listed on NASDAQ OMX Stockholm. More information is available at www.sobi.com.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers, develops and
delivers to patients worldwide innovative therapies for the treatment of
neurodegenerative diseases, haemophilia 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
labelling, press releases and additional information about the company, please
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Sobi's partner receives notification of PDUFA extension for ALPROLIX
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