Dive Brief:
- The chief operating officer of Portola Pharmaceuticals, Tao Fu, has resigned effective September 21, 2018 "to pursue opportunities outside the company." Fu will remain a consultant until March 1, 2019 to support the transition.
- The company is now without two key roles after CEO William Lis announced his retirement in June 2018, and stepped down on August 1, 2018.
- Mardi Dier, interim co-president and CFO, will lead the company’s commercial activities, including the ongoing launches of the anticoagulant reversal agent Andexxa and anticoagulant Bevyxxa.
Dive Insight:
Things look challenging at the upper levels at Portola with two big gaps now in top management.
Portola did not cite any specific reason for Fu's departure, nor where he was going. It comes at a busy time at the company, in the midst of launches of its first two commercial products.
Andexxa (andexanet alfa), a universal oral or injectable Factor Xa inhibitor antidote, finally cleared approval in May 2018 as a reversal agent to Pfizer's and Bristol-Myers Squibb's Eliquis (apixaban) and Johnson & Johnson's Xarelto (rivaroxaban), both anticoagulants. This followed a three month pushback on approval from the Food and Drug Administration, just a month before the initial Prescription Drug User Fee Act date.
Bevyxxa (betrixaban), on the other hand, picked up its approval in June 2017, for prophylaxis of venous thromboembolism (VTE) in high risk adult hospitalized patients.
"During this transitional period, our top priority remains the Andexxa Early Supply Program, which we launched in May and is continuing to gain momentum, and we are implementing a focused commercial strategy for Bevyxxa," said Mardi Dier, interim co-president and CFO.
Neither drug has gotten off to a fast start. According to Portola's second quarter 2018 results, Bevyxxa, which launched in January 2018, brought in $33,000 in product revenue, and Andexxa, which began an early supply program in May 2018, had revenue of $2.2 million.
Currently, Andexxa is only available in a few treatment centers as Portola works to secure regulatory approval for a new, large-scale production process. This is inching closer as, last week, the company submitted a "prior approval supplement" to the FDA for manufacturing clearance.
Portola has a number of other milestones coming up, including the hoped-for U.S. approval of the large-scale Generation 2 Andexxa manufacturing process, European approval of andexanet alfa, and the potential regulatory path forward for the company's lead pipeline drug, cerdulatinib.