In Brief: Alpha Therapeutic's AlphaNineSD

Executive Summary

Alpha Therapeutic's AlphaNineSD: Solvent Detergent Treated/Virus Filtered Factor IX product for prevention and control of bleeding in Hemophilia B patients approved by FDA June 7, the Los Angeles-based company announced July 11. The product is the first plasma-derived coagulation factor concentrate to incorporate more than one method of viral reduction, the company says. Previously AlphaNine was only solvent detergent treated. The new Factor IX now also includes a nanofiltration process for removing viruses. The two processes together reduce HIV-1 by 12 logs, HIV-2 by 6 logs, non-lipid-enveloped agents by 4 logs and markers for hepatitis B and C by 5 logs, Alpha Therapeutic notes. The new version of AlphaNine will be available in July. Alpha Therapeutic announced in March that is also has implemented additional product lot testing of the final product container as another safety step. Alpha Therapeutics sold 80 mil. units of AlphaNine last year..