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Bayer Files Hemophilia A Drug Marketing Application in Japan - Analyst Blog

Zacks Equity Research
Updated

The HealthCare segment at Bayer BAYRY announced that the company has submitted a Marketing Authorization Application in Japan for BAY 81-8973, a recombinant factor VIII compound. Bayer is looking to get BAY 81-8973 approved for the treatment of patients suffering from hemophilia A.

The company has submitted regulatory application for the candidate in the U.S. and EU for the treatment of hemophilia A.

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

We note that 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, currently in phase III, is being developed for patients suffering from hemophilia A.

Several companies are developing treatments to address the hemophilia A market. Currently approved drugs in the hemophilia A market include Biogen Idec’s BIIB Eloctate for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults as well as children with hemophilia A.

Bayer carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector are Emergent BioSolutions, Inc. EBS and Acorda Therapeutics, Inc. ACOR. While Emergent BioSolutions holds a Zacks Rank #1 (Strong Buy), Acorda carries the same Zacks Rank as Bayer.

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