Sobi™ expands haemophilia B development portfolio by adding rFIXFc-XTEN to its collaboration agreement with Bioverativ

Swedish Orphan Biovitrum AB (publ) (Sobi™) today announces that it has elected to add a novel product candidate (rFIXFc-XTEN) for the potential treatment of haemophilia B to the company’s collaboration agreement with Bioverativ.

Sobi has the right to include the rFIXFc-XTEN fusion molecule into its collaboration agreement with Bioverativ. By making a one-time payment to Bioverativ Sobi gains an opt-in right to participate in the final development and commercialisation of this product candidate. The opt-in right may be exercised by Sobi in connection with the submission of the marketing authorisation application for rFIXFc-XTEN with the European Medicines Agency.

In September 2014, Sobi elected to add the rFVIIIFc-VWF-XTEN fusion molecule for the potential treatment of haemophilia A to its collaboration agreement with Bioverativ.

 “Sobi is committed to help address the unmet needs for people affected by haemophilia and we are pleased to engage with this innovative product candidate which has been designed for the subcutaneous treatment of haemophilia B,” says Milan Zdravkovic, Senior Vice President, Chief Medical Officer, and Head of Research & Development at Sobi. “We are inspired by the collaboration we have with Bioverativ to support people living with haemophilia. We have a longstanding relationship and this decision further adds to our common aspirations.”

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About haemophilia B
Haemophilia B is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting.[i] The World Federation of Hemophilia estimates that approximately 28,000 people are currently diagnosed with haemophilia B worldwide.[ii]

People with haemophilia B may experience bleeding episodes in joints and muscles that cause pain, decreased mobility and irreversible joint damage. In the worst cases, these bleeding episodes can cause organ bleeds and life-threatening haemorrhages. Injections of factor IX temporarily replace clotting factors necessary to resolve bleeding and, when used prophylactically, to prevent new bleeding episodes.i

About the Sobi™ and Bioverativ collaboration
Sobi and Bioverativ collaborate on the development and commercialisation of Alprolix and Elocta/ELOCTATE®. Bioverativ has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory, and has manufacturing responsibility for ELOCTATE and Alprolix. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets).

Bioverativ was created as a spin-off from Biogen’s haemophilia business and separated from Biogen effective February 1, 2017. Bioverativ is an independent, publicly-traded company, headquartered in Waltham, Massachusetts, USA. During a temporary transition period, which includes time to allow Bioverativ to establish certain licenses and consents related to ELOCTATE® and ALPROLIX, each of Bioverativ and Biogen will have a relationship to the products.

About Sobi™
Sobi is an international specialty healthcare company dedicated to rare diseases. Sobi’s mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primarily focused on Haemophilia, Inflammation and Genetic diseases. Sobi also markets a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies. Sobi is a pioneer in biotechnology with world-class capabilities in protein biochemistry and biologics manufacturing. In 2016, Sobi had total revenues of SEK 5.2 billion (USD 608 M) and about 760 employees. The share (STO: SOBI) is listed on Nasdaq Stockholm. More information is available at www.sobi.com.

This information is information that Swedish Orphan Biovitrum AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Linda Holmström, Senior Communications Manager, at 08:15 am CET on 16 February 2017.

[i] World Federation of Hemophilia. About Bleeding Disorders – Frequently Asked Questions. Available at: http://www.wfh.org/en/page.aspx?pid=637#Difference_A_B. Accessed on: January, 13, 2017.

[ii] World Federation of Hemophilia. Report on the Annual Global Survey 2013. Available at: http://www1.wfh.org/publications/files/pdf-1591.pdf. Accessed on: January 13, 2017. 

Swedish Orphan Biovitrum AB
Postal address SE-112 76 Stockholm, Sweden
Phone: 46 8 697 20 00     www.sobi.com