Sobi's partner Biogen Idec expects mid-2014 US launch of ELOCTATE®
Swedish Orphan Biovitrum AB's (publ) (Sobi) partner Biogen Idec today, at the
Credit Suisse Global Healthcare Conference in Phoenix, stated that the US Food
and Drug Administration (FDA) has requested additional information pertaining to
process validation of certain steps in the manufacturing process for ELOCTATE.
As a result, Biogen Idec expects a PDUFA extension for ELOCTATE and the company
is now planning for a mid-2014 commercial launch in the US based on on-going
discussions with the FDA. Sobi believes that this updated timeline for FDA
approval is unlikely to impact planned European approval timelines.
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About the Fc Fusion Technology Platform
ELOCTATE is a clotting factor under development using Biogen Idec's novel and
proprietary monomeric Fc fusion technology, which makes use of a naturally
occurring pathway that delays the breakdown of factor in the body and cycles it
back into the bloodstream, resulting in a longer circulating half-life. Fc
fusion technology is used in seven FDA-approved products for the treatment of
chronic diseases including rheumatoid arthritis, psoriasis and platelet
disorders. Biogen Idec is the first and only to apply this proprietary
technology to haemophilia.
About Haemophilia A
Haemophilia A is a rare, inherited disorder in which the ability of a person's
blood to clot is impaired. Haemophilia A occurs in about one in 5,000 male
births annually and is caused by having substantially reduced or no factor VIII
activity, which is needed for normal blood clotting. People with haemophilia A
experience bleeding episodes that can cause pain, irreversible joint damage and
life-threatening haemorrhage. Injections of factor VIII can restore the
coagulation process, 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
A. Currently, prophylaxis in haemophilia A typically requires injections three
times per week or every other day to maintain a sufficient circulating level of
clotting factor.
About the Biogen Idec and Sobi Collaboration
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development
and commercialization of ELOCTATE in haemophilia A and 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@sobi.com E: jorgen.winroth@sobi.com
