Press release -
Sobi’s collaboration partner Biogen Idec files marketing authorisation application for Elocta™ (rFVIIIFc) in Europe
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that Biogen Idec has submitted a Marketing Authorisation Application (MAA) for Elocta (rFVIIIFc) to the European Medicines Agency (EMA). Sobi has an exclusive opt-in right to assume final development and commercialisation of Elocta in Europe, Russia, the Middle East and Northern Africa.
The MAA filing with the EMA triggers the formal opt-in right, giving Sobi approximately two months to exercise its option.
Elocta is a long-acting recombinant factor VIIIFc fusion protein product candidate for people with haemophilia A. Elocta is the approved European trade name for rFVIIIFc, also known as Eloctate™ in the U.S., Canada, and Australia, where it is approved for the treatment of hemophilia A.
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About Haemophilia A
Haemophilia
A is a rare, chronic, genetic disorder in which the ability of a person’s blood
to clot is impaired, due to missing or reduced levels of a protein known as
factor VIII. People with haemophilia A experience recurrent and
extended bleeding episodes that cause pain and irreversible joint damage. Some
of these bleeding episodes can be life-threatening. According to the World
Federation of Hemophilia, an estimated 142,000 people worldwide are identified
living with haemophilia A.[1]
Prophylactic injections of factor VIII can temporarily replace the clotting
factor necessary to control bleeding and prevent new bleeding episodes.
About the Biogen Idec and Sobi Collaboration
Biogen Idec
and Swedish Orphan Biovitrum (Sobi) are collaborators in the development and
commercialisation of Elocta/Eloctate for haemophilia A. Biogen Idec leads
development, has manufacturing rights, and has commercialisation rights in
North America and all other regions in the world excluding the Sobi territory.
Sobi has the right to opt in to assume final development and commercialisation
in Europe, including Russia, the Middle East and Northern Africa.
[1] World Federation of Hemophilia. Annual Global Survey 2012. http://www1.wfh.org/publications/files/pdf-1574.pdf. Accessed January 28, 2014.
Topics
- Health, Health Care, Pharmaceuticals
Categories
- haemophilia
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 Inflamma-tion and Genetic diseases, with two late stage biological development projects within Haemophilia. 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 2013, Sobi had total revenues of SEK 2.2 billion (€253 M) and about 550 employees. The share (STO: SOBI) is listed on NASDAQ OMX Stockholm. More infor-mation is available at www.sobi.com.
For more information please contact
Media relations
Oskar Bosson, Head of Communications
T: +46 70 410 71 80
oskar.bosson@sobi.com
Investor relations
Jörgen Winroth, Vice President, Head of Investor Relations
T: +1 347-224-0819, +1 212-579-0506, +46 8 697 2135
jorgen.winroth@sobi.com
