Bayer Files Hemophilia A Drug Marketing Application in EU

The HealthCare segment at Bayer (BAYRY) announced that the company has submitted Marketing Authorization Application in Europe for BAY 81-8973, a recombinant Factor VIII compound. Bayer is looking to get BAY 81-8973 approved for the treatment of children and adults suffering from hemophilia A.

The company plans to submit regulatory application for the candidate in other countries in the coming months.

We believe that the approval of BAY 81-8973, will supplement Bayer’s portfolio that includes Kogenate FS, which is indicated for the treatment and prevention of bleeding in adults and children with hemophilia A.

We note Bayer has another hemophilia candidate, BAY 94-9027, in its pipeline. BAY 94-9027 is a site-specific PEGylated recombinant Factor VIII. BAY 94-9027 is currently being evaluated in phase III studies for the treatment and prophylaxis of bleeding in patients suffering from hemophilia A.

Several companies are developing treatments to address the hemophilia A market. In June this year, the FDA cleared Biogen Idec’s (BIIB) hemophilia A treatment, Eloctate (EU trade name: Elocta) for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults as well as children with hemophilia A. The European Medicines Agency has validated the Marketing Authorization Application of Elocta for the treatment of hemophilia A in Oct 2014.

Bayer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN) and AMAG Pharmaceuticals, Inc. (AMAG). While Amgen carries a Zacks Rank #1 (Strong Buy), AMAG Pharma carries a Zacks Rank #2 (Buy).

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