Baxter International Inc. (BAX) recently announced the approval of its Hemophilia A drug – OBIZUR – by the U.S. Food and Drug Administration (FDA). OBIZUR, cleared for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), will be commercially available in the U.S. in the coming months. The same is currently under regulatory review in Europe and Canada.
The FDA granted OBIZUR an orphan-drug status and its review was prioritized based on AHA’s classification as a rare disease and the potential for the treatment to address an important unmet medical need.
Offering the ability to measure factor VIII activity in the body, OBIZUR will likely provide physicians with an objective marker of hemostasis that can prevent overdosing.
The FDA approval was based on the findings of a global Phase 2/3 clinical trial, which yielded positive efficacy and safety data in all 57 patients administered with OBIZUR. According to Baxter, a positive response, such as a reduction or stop in bleeding and clinical improvement, within 24 hours after the initial infusion was observed in all 28 patients evaluated for efficacy. Meanwhile, 86% of such patients had successful treatment of the initial bleeding episode.
Last month, Baxter won two FDA approvals for HYQVIA and RIXUBIS. Notably, HYQVIA is a subcutaneous treatment for adult patients with primary immunodeficiency, while RIXUBIS is used for routine prophylactic treatment, control and prevention of bleeding episodes in children with hemophilia B.
In its recently reported third-quarter 2014 results, Baxter revealed double-digit growth and continued strong demand for its hemophilia therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] and FEIBA (an inhibitor therapy).
For the fourth quarter of 2014, Baxter expects revenues to grow 3%, barring the impact of foreign currency. The company also anticipates adjusted earnings in the range of $1.30 to $1.33 per share. The current Zacks Consensus Estimate of $1.32 lies within the guided range.
For full-year 2014, Baxter projects revenue growth of 11% to 12%, up from the prior range of 10% to 11%, excluding the impact of foreign exchange. However, the company slashed its adjusted earnings per share guidance to $4.86 to $4.89 from $5.10 to $5.20. The Zacks Consensus Estimate of $4.88 lies within the guided range.
Currently, Baxter carries a Zacks Rank #5 (Strong Sell).
Better-ranked stocks in the medical products industry include GW Pharmaceuticals plc (GWPH), ZELTIQ Aesthetics, Inc. (ZLTQ) and Abaxis, Inc. (ABAX). While both GW Pharmaceuticals and ZELTIQ Aesthetics sport a Zacks Rank #1 (Strong Buy), Abaxis carries a Zacks Rank #2 (Buy).
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