Business & Finance
Alprolix Cleared in the EU for Haemophilia B
13 May 2016 - - The European Commission has approved Alprolix (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union member states and maintained its orphan designation, Sweden-based biotechnology company Swedish Orphan Biovitrum AB (STO: SOBI) and US-based Biogen (NASDAQ: BIIB) said.

Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic injections.

It is indicated for both on-demand and prophylaxis treatment of people with haemophilia B in all ages.

Prophylactically, it can be administered with an initial dose every seven days or every ten days with the ability to adjust the dosing interval based on individual response.

The EC's approval of Alprolix was based on results from two global phase 3 clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for haemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12.

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

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.

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 2015, Sobi had total revenues of SEK 3.2bn (USD 385m) and about 700 employees.

Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases.

Founded in 1978, Biogen is one of the world's oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative haemophilia therapies.
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