GI's Benefix Approved By EMEA

Genetics Institute has been granted European Medicines Evaluation Agencyapproval for its recombinant Factor IX product Benefix (nonacog alpha), a clotting factor used to treat hemophilia B. The drug will be marketed in Europe by Baxter.

Since the advent of recombinant Factor VIII for the treatment of hemophilia A, the hemophilia B patient population has been anxiously awaiting the availability of a similar treatment which, unlike plasma-derived products, is inherently free from the risk of blood-borne pathogens such as HIV, hepatitis viruses and parvovirus.

Benefix was the first product to meet this need and was launched in the USA in February at an average wholesale price of $1.18 per unit, an eight cent per unit premium to the plasma derived products. It is available in 250, 500 and 1,000 unit vials. A launch in Europe is not scheduled until the first half of 1998. Meantime, positive feedback has been received from the Canadian regulatory authorities, and a launch there is also scheduled for 1998.