Baxter International Inc. BAX recently revealed positive efficacy and safety data from its Phase III clinical trial evaluating BAX 817 – an investigational recombinant factor VIIa (rFVIIa) for hemophilia A or B patients who develop inhibitors to the treatment.
Following the release of this positive data on Mar 13, shares of Baxter climbed 0.6% to close at $67.36 the same day. Shares continued their uptrend the next day as well and rallied 1.6% to close trading at $68.43.
Development of inhibitors is one of the most significant challenges in treating hemophilia. Inhibitors are antibodies that the immune system develops in response to replacement therapy. The antibodies destroy not only the factor concentrate infused but also the small percentage of factor protein that the body was producing naturally.
Thus, development of inhibitors may place hemophilia patients at increased risk for life-threatening complications resulting from difficult-to-treat bleeding episodes.
Baxter conducted the prospective study to assess the safety and efficacy of BAX 817 in patients with hemophilia A or B who developed inhibitors over a 6-month period using on-demand therapy. The trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens, with an overall success rate of 92%.
The company plans to present full data from the trial, including additional efficacy and safety outcomes, at a medical meeting later in 2015. Baxter also plans to initiate regulatory submissions associated with manufacturing expansions which are currently underway.
If approved, BAX 817 will broaden the existing portfolio of hemophilia and inhibitor treatments within Baxter’s biopharmaceutical business, including FEIBA and the recently approved OBIZUR for acquired hemophilia A.
We note that Baxter has an impressive product pipeline with improved existing products and new product development. The company also continues to expand its product portfolio by winning approvals for new drugs and products, particularly designed for hemophilia treatment.
Last month, Baxter disclosed additional efficacy and safety data from its Phase III pivotal study evaluating BAX 855 – an extended half-life, recombinant factor VIII (rFVIII) protein used for the treatment of hemophilia A. Baxter expects an FDA approval for the same in 2015. Currently, Baxter is continuing with its pediatric studies on BAX 855, upon completion of which, it expects to file for marketing authorization with the European Medicines Agency in 2016.
Although an innovative product pipeline is the key growth catalyst for Baxter, we believe that intense competition in the hemophilia space and lackluster hospital spending are major concerns. Additionally, lower reimbursements for medical products and services could result in pricing pressure and decreased demand for the company’s products.
Moreover, foreign currency volatility is another factor which is expected to significantly hurt the company’s overall results, particularly in 2015.
Zacks Rank
Currently, Baxter carries a Zacks Rank #4 (Sell). Better-ranked medical product stocks include Abaxis ABAX, LeMaitre Vascular Inc. LMAT and Phibro Animal Health Corp. PAHC. All three stocks sport a Zacks Rank #1 (Strong Buy).
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