Its expansion will be achieved by adding rFIXFc-XTEN to its collaboration agreement with Bioverativ
Swedish Orphan Biovitrum (Sobi) has announced 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.
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. We are pleased to engage with this product candidate designed for the subcutaneous treatment of haemophilia B,” said Milan Zdravkovic, Senior Vice President, Chief Medical Officer and Head of R&D 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.”
Haemophilia B is caused by reduced or absent factor IX activity, which is needed for normal blood clotting The World Federation of Hemophilia estimates that approximately 28,000 people are currently diagnosed with haemophilia B worldwide.
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.
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).
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.
Sobi is an international specialty healthcare company dedicated to rare diseases. Their 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.
Bioverativ is an independent, publicly-traded company headquartered in Waltham, Massachusetts. It was created as a spin-off from Biogen’s haemophilia business and separated from Biogen, effective February, 2017.