Portola Pharmaceuticals’ CEO to Step Down
Portola Pharmaceuticals chief executive officer, William Lis, plans to retire as both chief executive and board member. He will officially leave the company on August 1, 2018. Afterward, he will stay in an advisory role.
The company’s board plans an active search for a replacement. Meanwhile, it has appointed John Curnutte and Mardi Dier as interim co-presidents in addition to their current positions. Curnutte is the company’s executive vice president, Research and Development. Dier is Portola’s chief financial officer.
“We would like to express our sincere appreciation for Bill’s achievements as CEO,” said Hollings Renton, Portola’s board chairman, in a statement. “Under his leadership, Portola completed its initial public offering, advanced multiple innovative compounds through clinical development and received U.S. FDA approval for two life-saving medicines. We wish him well in future endeavors. Portola is at an important inflection point in its history as the Company turns its focus to the successful launches of Andexxa and Bevyxxa, and a potential third medicine progressing to late-stage development. We are committed to bringing on board a new CEO with strong global commercial experience and the demonstrated expertise to build on our excellent foundation and lead Portola through its next exciting chapter.”
The company’s Andexxa (andexanet alfa) received approval from the U.S. Food and Drug Administration (FDA) in early May. It is used to treat life-threatening or uncontrolled bleeding, and is an antidote for blood thinners rivaroxaban and apixaban. The drug had been rejected by the FDA in August 2016, requesting more information mostly related to manufacturing activities. It also wanted more data related to including edoxaban and enoxaparin in the label.
It was approved under the FDA’s Accelerated Approval pathway based on the change from baseline in anti-Factor Xa activity in healthy volunteers. As a part of that pathway, continued approval may be contingent on post-marketing data showing improvement in hemostasis in patients.
Factor Xa inhibitors are increasingly used as anticoagulants to treat thromboembolic conditions like strokes, pulmonary embolism and venous thromboembolism (VTE). The traditional treatment is warfarin or enoxaparin, but the Factor Xa inhibitors have better efficacy and safety profiles. However, because of the increased use, hospital admissions and deaths related to uncontrolled bleeding have risen. Andrexxa is used to counteract the effect of the Factor Xa inhibitors.
The company had announced plans to launch the drug in early June under an Early Supply Program with Generation 1 product. A broader commercial launch is planned in early 2019 once the FDA approves the company’s Generation 2 manufacturing process.
The drug is also being reviewed by the European Medicines Agency (EMA). In February, the EMA’s Committee for Medicinal Products for Human Use (CHMP) cast a positive recommendation vote. A formal decision is expected by CHMP by the end of this year, with the European Commission (EC) expected to make a final decision in early 2019.
In a statement about his retirement, Lis said, “I am incredibly proud of what we have accomplished at Portola, and I know the best is yet to come. Our launches of Andexxa and Bevyxxa are ongoing with strong data and labels, and we recently presented encouraging new interim data for our SKY/JAK inhibitor, cerdulatinib. I look forward to working closely with the board, John and Mardi during the transition, and I want to thank our entire team for their hard work and dedication, which has brought Portola to where it is today—with significant potential to meaningfully improve the lives of patients.”