Sobi's partner Biogen Idec receives notification from FDA of PDUFA date extension for ALPROLIX(TM)
(Thomson Reuters ONE) -
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 approval timelines.
- - -
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 in hemophilia.
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.
About Sobi
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
visit www.biogenidec.com.
For more information - not
for publication
Sobi:
Media relations Investor relations
Oskar Bosson, Head of Jörgen Winroth, Vice President, Head of Investor
Communications Relations
T: +46 70 410 71 80 T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
E: oskar.bosson(at)sobi.com E: jorgen.winroth(at)sobi.com
Sobi?s partner receives notification of PDUFA extension for ALPROLIX:
http://hugin.info/134557/R/1747005/588194.pdf
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Source: Swedish Orphan Biovitrum AB (publ) via GlobeNewswire
[HUG#1747005]
Unternehmensinformation / Kurzprofil:
Datum: 02.12.2013 - 13:30 Uhr
Sprache: Deutsch
News-ID 321737
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contact information:
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