Portola's Betrixaban Study Design Published - Analyst Blog

Portola Pharmaceuticals PTLA announced the publication of the design and rationale of the phase III APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) study on betrixaban in the American Heart Journal. Portola's shares gained more than 6% following the news.

Betrixaban is being developed for in-hospital and post-discharge prevention of venous thromboembolism (VTE) or blood clots, in patients hospitalized for medical conditions like heart failure, stroke, infection and pulmonary disease. The study will be evaluating the composite of asymptomatic proximal deep venous thrombosis, symptomatic deep venous thrombosis, non-fatal pulmonary embolism or VTE-related death through day 35.

The safety outcome of the study is the occurrence of major bleeding. Portola is enrolling patients for the phase III study and expects to complete the enrolment process by the end of 2015. Portola intends to complete futility analysis of the APEX study early next year. The company expects the Data Safety Monitoring Committee review process on betrixaban by the end of the year.

We note that Portola also has another thrombosis candidate, andexanet alfa, in its pipeline, apart from betrixaban. Last month, the company initiated a phase III study on the candidate in combination with Bristol-Myers Squibb Company BMY and Pfizer Inc.'s PFE factor Xa inhibitor, Eliquis. The study will evaluate the combination to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are suffering a major bleeding episode or who require emergency surgery.

We are encouraged by Portola's progress with its pipeline. We expect investor focus to remain on its pipeline going forward.

Portola carries a Zacks Rank #3 (Hold). A better-ranked stock is Regeneron Pharmaceuticals, Inc. REGN, which carries a Zacks Rank #1 (Strong Buy).