Dive Brief:

• The Food and Drug Administration this week approved Portola Pharmaceuticals' second generation manufacturing process for Andexxa, the company's reversal agent for Factor Xa inhibitors Eliquis and Xarelto. 
• The now OK'd manufacturing process should enable Portola to launch Andexxa more widely than it has been able to do to date, the company said. News of the FDA's green light pushed shares in Portola up by more than 14% before the New Year's day holiday. 
• Andexxa was first approved in May 2018 under the FDA's accelerated approval pathway. But Portola's original manufacturing process had limited roll-out of the drug to only about 40 hospitals and treatment centers. 

Dive Insight:

Clinical testing has found Factor Xa inhibitors like Johnson & Johnson's Xarelto (rivaroxaban) and Bristol-Myers Squibb and Pfizer's Eliquis (apixaban) to be safer and more effective than warfarin or enoxaparin for the prevention and treatment of thromboembolic conditions such as stroke, pulmonary embolism and venous thromboembolism (VTE).

However, these newer anticoagulants still come with bleeding risk. According to Portola, there were around 140,000 hospital admissions attributable to Factor Xa inhibitor-related bleeding in the U.S. during 2017.

As a result, several drugmakers have invested in developing Factor Xa reversal agents. Portola's one of the most advanced, having received approval for the first — and, so far, only — antidote indicated for patients treated with Xarelto or Eliquis who develop life-threatening or uncontrolled bleeding.

Battered by a number of setbacks, Portola's share price rose following the approval of Andexxa (coagulation factor Xa [recombinant] inactivated-zhzo). Share value slipped down, though, as the company awaited a go-ahead on Andexxa's new manufacturing process, and as it saw a delay in the European approval of the product.

"There were significant investor concerns about management's ability to execute, particularly in light of the Bevyxxa ramp and the recent delay of the EU application for Andexxa. The on-time approval of the [second-generation manufacturing process] should be a sigh of relief for investors and increase confidence in the management team and new CEO," Credit Suisse analyst Vamil Divan wrote in a Jan. 1 investor note.

According to Divan, Portola has almost two years' worth of supplies. The company expects to launch the second-generation product later this month, once the drug is packed and labeled. Portola will also add around 40 people to its current sales force of 78 reps.

Credit Suisse predicts a slower Andexxa uptake in the first quarter of 2019, with a continued ramp-up through 2019. The investment bank estimates sales of the drug to total about $110 million for the year. 

Portola is also hoping for more good news in 2019, as it waits for an opinion on its EU Andexxa dossier from the European Medicines Agency''s Committee for Medicinal Products for Human Use (CHMP), due Feb. 28.

"Portola believes [it is] on the same page as the CHMP despite the recent extension of the Andexxa review period. There have been no serious questions raised by the CHMP about the quality of the data; rather, the company believes the CHMP simply needed some more time to review the application given the sheer volume of data," Divan wrote.