Shares of Portola Pharmaceuticals, Inc. (PTLA - Free Report) rallied 14.2% on Dec 31 after the FDA approved the Prior Approval Supplement filing for large-scale Generation II manufacturing process for Andexxa. This approval will help the company to support broad commercial launch of the drug in the United States.
In May 2018, the FDA had approved Andexxa as an antidote in patients treated with Factor Xa inhibitors, Johnson & Johnson’s (JNJ - Free Report) Xarelto (rivaroxaban) or Bristol-Myers’ (BMY - Free Report) Eliquis (apixaban) to reverse anticoagulation in case of life-threatening or uncontrolled bleeding. The company is planning to initiate a full commercial launch of the drug this month.
Andexxa is the first and only FDA-approved antidote for patients treated with an anticoagulant agent. The drug enjoys both Orphan Drug and FDA Breakthrough Therapy designations in the United States.
Portola’s stock was down 49.4% in the past six months compared with the industry’s decline of 15.3%.
The company has stated in the press release that data from its Andexxa Early Supply Program has demonstrated significant need for a specific reversal agent in patients with life-threatening bleeding following treatment with an anticoagulant agent. Portola also stated that there is a significant demand for Factor Xa inhibitors for treating thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism. With rising use of these inhibitors, incidence of hospital admissions and deaths related to bleeding due to an anticoagulant has increased. In fact, nearly 140,000 patients were admitted to hospitals due to Factor Xa inhibitor-related bleeding in 2017.
Notably, Andexxa is also under review in the EU with the marketing authorization application (“MAA”) using the trade name of Ondexxya. In December 2018, the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) extended the review timeline of the MAA.
A list of questions has likely been issued by the CHMP related to data submitted for Ondexxya. The company will have to come up with a response by Jan 29, 2019. The reply will be assessed by the CHMP within the next 30 days, after which, the regulatory agency will declare its decision on Feb 28, 2019.
Portola continues to focus on addressing the committee’s queries and is planning for a potential approval in Europe by early next year.
Zacks Rank & Key Pick
Portola currently carries a Zacks Rank #2 (Buy). BioSpecifics Technologies Corp (BSTC - Free Report) is another top-ranked stock from the same space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have been revised upward from $2.38 to $2.78 for 2019 over the past 60 days. The company delivered positive earnings surprise in three of the trailing four quarters with the average beat being 17.04%. The stock has surged 35.4% in the past six months.
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