Bayer plans to submit its new hemophilia A treatment to regulators by year's end, following through on a roughly $700 million commitment to roll out next-generation treatments for the bleeding disease.
The company said it's on track to start the global approval process for BAY 81-8973, an upgrade to its blockbuster Kogenate treatment that can be produced without the need for any human or animal components, Bayer said. Like its predecessor, the new injection treats hemophilia A by replacing a key coagulation protein called factor VIII, helping patients' blood to clot normally and reducing the dangerous bleeds that characterize the disease.
BAY 81-8973 is one pillar of Bayer's sweeping plans for hemophilia, which include pouring nearly $700 million into two German manufacturing hubs that will pump out the company's new medicines once they're approved. Beyond its spruced-up Kogenate, Bayer is also working through Phase III on BAY 94-9027, a long-acting factor VIII replacement therapy that can be dosed as infrequently as once a week.
Thanks to the promise of more convenient--and likely costlier--injections, analysts expect the hemophilia market to reach above $11 billion by 2016, and Bayer is dialing up its budget in the field in hopes of playing a lead role in treating the disease.
But the German drugmaker will have to contend with a crowd of rivals working on better and longer acting new treatments. Leading the way is Biogen Idec ($BIIB), which in June won approval for the once-a-week Eloctate, a hemophilia A drug expected to peak at $1.5 billion a year. Baxter ($BAX) is planning a 2014 FDA application for BAX 855, a long-acting factor VIII replacement that wrapped up Phase III in August, trailed by Novo Nordisk ($NVO) and its N8-GP, expected to conclude late-stage development next year.
- read Bayer's release