Bayer tees up its new hemophilia drug for an FDA submission

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

Suggested Articles

Fifteen of the 22 patients in a gene therapy trial no longer needed transfusions, while the remainder needed fewer transfusions.

Argos Therapeutics is ending its kidney cancer trial and mulling options, including a merger or sale, to stay alive.

CNS Pharma says berubicin is the first anthracycline drug to cross the blood-brain barrier and could transform treatment of the highly invasive brain tumor.