Surprise! FDA Clears Launch For Portola's Potential Multibillion-Dollar Drug Next Month

The U.S. Food and Drug Administration continues to hand out some early Christmas presents to pharma companies. This week, Portola Pharmaceuticals said the agency approved its Prior Approval Supplement (PAS) for Bevyxxa (betrixaban) ahead of its scheduled Jan. 30, 2018 action date.

With the PAS approval, Portola will now be able to begin distributing its current product inventory. In June, the U.S. Food and Drug Administration (FDA) approved Bevyxxa. Portola initially planned to launch Bevyxxa by November. However, there were some issues with the company’s manufacturing process which resulted in the delay. The FDA was originally scheduled to rule on the PAS last month, but then pushed the time back by 60 days.

Now it appears the company will be able to roll out the product in January. Portola Chief Executive Officer Bill Lis did not provide a timeline in the company announcement, but indicated the company was ready to get Bevyxxa in the hands of patients in the New Year. The company has a sales team in place to hit the ground running with the new treatment option that could generate $2 billion in annual revenue by 2023.

Portola’s drug is the only anticoagulant approved for hospital and extended duration prophylaxis of 35 to 42 days of venous thromboembolism (VTE) in adult patients who have been hospitalized for an acute medical illness. Patients who have suffered from heart failure, pulmonary disease or stroke are often immobile and bedridden for a lengthy period. As such, they are susceptible to developing venous thromboembolism, or blood clots. The Portola drug is intended for patients who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE, according to the company.

Bevyxxa, a factor Xa inhibitor, is a once-daily pill. It is designed for use in a hospital setting as well as at home as part of post-hospitalization care regimen. There is no competition in the home setting. Most VTEs occur at home.

"VTEs result in approximately 100,000 deaths annually in the U.S. in acute medically ill patients -- and they are preventable. As the first and only anticoagulant approved as a single-drug regimen administered in the hospital and following discharge for a treatment duration of 35-42 days, Bevyxxa has the potential to impact public health in the U.S. and beyond, if approved in other countries," Lis said in a statement.

Writing in The Motley Fool, analyst Todd Campbell said Portola’s Bevyxxa has the ability to "reshape an important market." Campbell said the Portola drug could displace the standard of care treatment Lovenox for VTE patients. Despite the use of Lovenox, marketed by Sanofi, Campbell said there are still about 100,000 VTE patient deaths each year out of a large market of 24 million acutely ill patients hospitalized annually in the G7 countries.  He said that at its peak Lovenox earned about $3 billion before it lost patent protection.

"…so Bevyxxa has a good shot at becoming a top seller," Campbell said.

While Portola will begin the New Year with a potential blockbuster drug hitting the streets, Campbell said the FDA is set to rule on another company product in February. The FDA is scheduled to make a decision on AndexXa, factor Xa reversal agent, on Feb. 3. If it’s approved, Campbell said it will be the only drug on the U.S. market that can be used to halt anticoagulant activity among factor Xa drugs. With a potential patient population of about 90,000 people in the U.S. on factor Xa drugs who experience a major bleeding event, Campbell said AndexXa could also be a blockbuster.

Since the FDA’s decision earlier this week, shares of Portola have shot up from $47.49 to this morning’s price of $56.36 as of 9:43 a.m.