Portola Pharmaceuticals (PTLA 19.05, -0.47, -2.41%) jumped sharply higher (+14%)
late in the trading day on Monday when the company announced its receipt of positive
news from the FDA. Portola is a commercial-stage biopharma focused on
therapeutics that could significantly advance treatment in the fields of
thrombosis (blood clotting) and other hematologic diseases.
The company had thus far received FDA approval for two medicines. One of these, the one that is relevant to Portola’s recent headlines, is Andexxa, an antidote -- per the company, the first and only of its kind -- for patients that have been treated with anticoagulants rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The other, Bevyxxa, is approved as the first and only oral, once-daily Factor Xa inhibitor for the prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness. Included in the company’s pipeline is cerdulatinib, a Syk/JAK inhibitor for the treatment of hematologic cancers.
On Monday, Portola announced that the FDA approved its Prior Approval Supplement for its second generation Andexxa antidote. This is important because it allows for a broad commercial launch of the product in the U.S. Previously, Andexxa received both Orphan Drug and FDA Breakthrough Therapy designations, and it was initially approved in May of 2018 using the FDA's pathway for Accelerated Approval.
Andexxa, as mentioned above, is an antidote indicated for patients that had been treated with certain direct Factor Xa inhibitors in instances when anticoagulation must be reversed, as when anticoagulation has led to life-threatening or otherwise uncontrolled bleeding. The product meets significant need for a specific reversal agent that can address life-threatening bleeding, which has accompanied rapid growth in the use of Factor Xa inhibitors. These inhibitors have come into favor given comparison of their safety and efficacy profiles to those of other anticoagulants like enoxaparin and warfarin in preventing and treating thromboembolic conditions including stroke, pulmonary embolism, and VTE; with this growth has come a related increase in the incidence of hospital admissions and deaths related to bleeding, anticoagulation’s major complication. In the U.S. alone, there were approximately 140,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding in 2017. With this newest approval for Andexxa, Portola will be able to stock hospitals nationwide, better serving a population of patients across the U.S. that could be vulnerable to such complications.
Looking ahead, Portola, with this approval, plans to soon initiate a broad commercial launch for Andexxa, targeting a launch this month.. Portola is also expecting a CHMP opinion on andexanet alfa, with potential for European approval of andexanet alfa in 1H19. There will also be an upcoming end-of-Phase 2 meeting and determination of regulatory path forward for cerdulatinib in 1Q19.
The stock has been trending lower for much of the past year, going from $55 in late January 2018 to closing below $20 on Monday, so this was some welcome good news for Portola shareholders. The company recently made a strategic change to prioritize Andexxa, including this Generation 2 approval. The early feedback from Portola's first full quarter of prioritizing Andexxa sales gives PTLA confidence in the significant long-term potential of this drug.
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