6 June 2016 - - Swedish specialty healthcare company Swedish Orphan Biovitrum AB (STO: SOBI) has launched the first sales of Alprolix in Germany following the recent approval of the extended half-life therapy Alprolix by the European Commission for the treatment of haemophilia B, the company said on Monday.

Alprolix is the first and only recombinant factor IX Fc Fusion protein therapy for haemophilia B in the EU, offering people with haemophilia prolonged protection against bleeding episodes.

It is indicated for both on-demand and prophylaxis treatment of people with haemophilia B of all ages. Alprolix may be administered prophylactically with an initial dose every seven days or 10 days with the ability to adjust the dosing interval based on individual response.

Alprolix is a recombinant clotting factor therapy developed for haemophilia B by fusing factor IX to the Fc portion of immunoglobulin G subclass 1, or IgG1 (a protein commonly found in the body).

This technology enables Alprolix to use a naturally occurring pathway to prolong the time the therapy remains in the body. While Fc fusion has been used for more than 15 years, Sobi and Biogen are the first companies to utilise it in the treatment of haemophilia.

Alprolix is currently approved for the treatment of haemophilia B in the United States, European Union, Canada, Japan, Australia, New Zealand, and other countries, to provide prolonged protection from bleeds.

As with any infused protein, allergic type hypersensitivity reactions and development of inhibitors may occur following administration of Alprolix.

Sobi and Biogen collaborated on the development and commercialisation of Alprolix for haemophilia B.

The Swedish company has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia and most Middle Eastern markets). Biogen leads development and manufacturing for Alprolix and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

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 Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of speciality 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 2015, Sobi had total revenues of SEK 3.2bn (USD 385m) and approximately 700 employees.