Shares of Portola Pharmaceuticals, Inc. PTLA plunged 29.2% after the company reported unfavorable top-line data from the phase III APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) study on betrixaban.
The APEX study evaluated the superiority of extended-duration anticoagulation with oral betrixaban, in comparison to Sanofi’s SNY injectable Lovenox (enoxaparin), for the prevention of venous thromboembolism (VTE), or blood clots, in acute medically ill patients.
Patients in the study were divided into three groups – Cohort 1 (consisting of 62% of the overall study population); Cohort 2 (comprising of 91% of the overall population); and the overall population.
Data from the study demonstrated that the primary efficacy in Cohort 1 narrowly missed the required threshold. Primarily efficacy of the other two groups, however, met their respective criteria. Meanwhile, the study failed to show any statistical difference in major bleeding between the betrixaban and Lovenox arms across all groups. The company plans to present data from the APEX study at the International Society on Thrombosis and Haemostasis (ISTH) Congress in May.
Portola also stated that it anticipates filing a New Drug Application (NDA) for betrixaban later this year. We note that in Oct 2015, the FDA had granted Fast Track designation to betrixaban for extended-duration prevention of VTE, or blood clots, in acute medically ill patients.
In the G7 countries, an estimated 20 million acute medically ill patients are at risk of developing VTE either in the hospital or following discharge. Moreover, despite the use of injectable enoxaparin in hospitals, over 1 million VTEs and 150,000 VTE-related deaths in acute medically ill patients occur in each year.
Portola currently has a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are AMAG Pharmaceuticals, Inc. AMAG and Emergent BioSolutions, Inc. EBS, both sporting a Zacks Rank #1 (Strong Buy).
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