Portola Pharmaceuticals, Inc. PTLA completed enrollment of patients in the pivotal phase III APEX study on betrixaban for extended-duration prevention of venous thromboembolism (VTE) in acute medically ill patients.
The study is being conducted in patients who have been hospitalized for serious medical conditions, such as heart failure, stroke, infection and pulmonary disease. Top-line data is expected at the end of the first quarter of 2016.
We remind the investors that last month, betrixaban was granted Fast Track designation by the FDA for the above indication. The company expects to submit a New Drug Application in the U.S. in the second half of 2016.
According to information provided by the company, in France, Germany, Italy, Japan, the U.S., the UK and Canada, it is estimated that 20 million patients who are acutely medically ill, are at a risk of developing VTE. Each year, more than 1 million VTEs and 150,000 VTE-related deaths occur in these countries.
Other products in the market that are approved for the prevention of blood clotting include Eliquis, Xarelto and Pradaxa, among others.
Meanwhile, the company continues to progress on its pipeline. Apart from betrixaban, the company is working on two candidates – cerdulatinib and andexanet alfa. Cerdulatinib is in a phase I/IIa proof-of-concept study for the treatment of patients with B cell leukemia or lymphoma with focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations.
The other candidate, andexanet alfa, is in a phase IV study as a universal antidote for patients receiving a factor Xa inhibitor anticoagulant who suffer a major bleeding episode or who may require emergency surgery. The phase IV study is being conducted to support a Biologics License Application, which the company plans to submit at the end of 2015.
Portola carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Spectrum Pharmaceuticals, Inc. SPPI and Nexvet Biopharma Public Limited Co. NVET, each sporting a Zacks Rank #1 (Strong Buy).
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