Portola wins FDA green light for Bevyxxa supply, clearing way for anticoagulant's launch

The FDA has given the nod to Portola’s current inventory of anticoagulant Bevyxxa.

Portola Pharmaceuticals can go full throttle on its Bevyxxa launch, now that the FDA has blessed its inventory for distribution. The holdup followed Bevyxxa's June approval and put the antiocoagulant behind in its bid for blockbuster sales.

Triggered by a glitch in the drug's production process that left traces of a polymer in the finished product, the delay had Portola investors nervous and executives scrambling for a solution.

Since then, the company has been gearing up a new process similar to that used in its clinical trials. The inventory had been manufactured using a seed process, and the company is now switching to a nonseed process instead.

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The agency's signoff came ahead of an expected Jan. 30 action date and allows Portola to begin distributing Bevyxxa to its approved population, acute medically ill patients at high risk of venous thromboembolism (VTE).

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Now, the company is in final preparations for that rollout. "Portola is targeting an early January launch, and does not anticipate any supply shortages through 2018," Credit Suisse analyst Vamil Divan, M.D., wrote after the FDA move Tuesday.

“As the first and only anticoagulant approved as a single-drug regimen administered in the hospital and following discharge, … Bevyxxa has the potential to impact public health in the U.S. and beyond,” Bill Lis, Portola’s chief executive, said in a statement.

The company began working with the FDA to return to a no-seed manufacturing process as well as allow for a new specification change to the existing inventory. The idea was to win approval to release that supply and use it until batches could be manufactured using the no-seed process.

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It wasn't Portola's only manufacturing problem. Its Factor Xa anticoagulant AndexXa—which reverses the effects of Bayer and Johnson & Johnson's Xarelto and Bristol-Myers Squibb and Pfizer's Eliquis, an important development for treating emergency bleeds—was turned back by the FDA last year after the agency raised questions about its manufacturing process.

The company is now expecting an AndexXa approval early next year, Divan noted, so it'll be a big 2018 for the small drug developer, and investors—and potential M&A suitors—will be watching closely. "It is not often you see a small company like Portola launch its first two products in the same quarter, let alone two that we see as having blockbuster potential," the analyst said in his Tuesday note. "The ability to drive sales growth in both products simultaneously will be the key to Portola's value in 2018."

Divan's firm is predicting a rapid uptake early on for AndexXa as hospitals stock the product for emergency rooms and then a leveling-off of growth. For Bevyxxa, it's expecting "a more gradual ramp," Divan said.