BAY94-9027 effective in Phase III PROTECT VIII trial for Haemophilia A - Bayer

Bayer HealthCare has announced positive results from the Phase III PROTECT VIII trial evaluating the company�s investigational site-specific PEGylated recombinant human factor VIII compound BAY94-9027. The study met its primary objective of protection from bleeds with fewer infusions. In the study, the site-specific PEGylated factor VIII provided protection from bleeds when used prophylactically every seven days, every five days, and twice per week. The compound was also effective for treatment of acute and breakthrough bleeds with 91 percent of events resolved with one or two infusions.

The current standard treatment for severe Haemophilia A is regularly scheduled prophylactic infusion of factor VIII to keep levels high enough to prevent bleeding. Due to the short half-life of currently marketed factor VIII products, prophylaxis may require treatment as often as every other day. Bayer�s compound is engineered to extend the circulating half-life while preserving full biologic activity through site-specific pegylation.

Bayer plans to submit marketing authorization applications to regulatory authorities in the U.S., Europe and other countries in the second half of 2015.