FDA Nod for BAX's Hemophilia B Drug - Analyst Blog


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Recently, the US Food and Drug Administration (FDA) approved Baxter International Inc. 's ( BAX ) Rixubis for routine prophylactic treatment of Hemophilia B. This came as a major boost for the company's BioSciencebusiness.

Rixubis is the first recombinant factor IX (rFIX) to treat genetic disorder in 15 years and expands Baxter's product line for hemophilia treatments. The FDA approval complements the company's strategy to reduce bleeding disorders one patient at a time.

Hemophilia B or Christmas disease is a chronic disease resulting from the lack of generation of clotting factor IX, a naturally occurring protein in blood. The complications include bleeding episodes and hemophilic arthropathy (bleeding into a joint) leading to hospitalization. Rixubis was approved based on a pivotal Phase I/III study on 73 patients treated previously.

The market for Hemophilia B, the second most common type of hemophilia, is huge and rapidly growing. According to the latest data provided by World Federation of Hemophilia, more than 4,000 people in the U.S. and around 26,000 worldwide have been currently detected with Hemophilia B Thus, with Rixubis, the only FDA approved rFIX for routine prophylaxis and control of bleeding episodes, Baxter has a huge scope to capture this underpenetrated market.

Baxter is striving to expand its hemophilia business through the international expansion of its product line. The company is also trying to introduce recombinant therapy options for more hemophilia patients worldwide. In 2012, Baxter's ADVATE [Recombinant Human Coagulation Factor VIII for injection] for the control and prophylaxis of bleeding episodes with hemophilia A (congenital factor VIII deficiency) received regulatory approval in China.

In March, the company acquired the investigational hemophilia compound OBI-1 from Inspiration BioPharmaceuticals, Inc. and certain other OBI-1 related assets from Ipsen Pharma S.A.S. OBI-1 is a recombinant porcine factor VIII (rpFVIII) and is being investigated for treatment of bleeding in people with acquired hemophilia A and congenital hemophilia A patients with inhibitors.

Although we believe that the recent developments including a strong product line and several products in late stage clinical development are encouraging, we are concerned about relative stagnation in sales, a difficult outlook for hospital spending and tightening of reimbursement.

The stock currently carries a Zacks Rank #3 (Hold). However, Cryolife ( CRY ), Natus Medical ( BABY ) and Heartware International ( HTWR ), which carry a Zacks Rank #1 (Strong Buy), are expected to do well.

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