SOUTH SAN FRANCISCO, Calif., Feb. 20, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated a positive trend vote on the Marketing Authorisation Application (MAA) for andexanet alfa, a Factor Xa-inhibitor reversal agent, and a negative trend vote for betrixaban, an oral, once-daily Factor Xa inhibitor.
Portola will host a webcast and conference call on Tuesday, February 20, 2018 at 5:00 p.m. ET (2:00 p.m. PT) to provide additional details on the regulatory status of both products in Europe.
“We are very pleased with the favorable outcome of the oral explanation for andexanet alfa, and remain confident in our path forward to approval,” said Bill Lis, chief executive officer of Portola. “The Committee has requested additional data, which could delay the CHMP opinion until the fourth quarter, but we will be working with the CHMP in the coming weeks to further clarify their request and the impact on timing. In the meantime, we look forward to presenting important new data from the ANNEXA-4 trial during a late-breaker session at next month’s American College of Cardiology meeting.”
Portola is seeking conditional approval for andexanet alfa for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.
Andexanet alfa is also currently under review by the U.S. Food and Drug Administration (FDA) with an anticipated action date of May 4, 2018. New interim data from the Company’s ongoing Phase 3b/4 trial of andexanet alfa (ANNEXA-4) will be presented on Monday, March 12, 2018 during a Late-Breaking Clinical Trial Session at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18).
The CHMP communicated a negative trend vote for betrixaban for the prevention of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE. A negative trend vote means it is unlikely that the CHMP will adopt a positive opinion on the Company’s MAA at the formal CHMP decision vote scheduled for March 2018, and that additional steps would be needed to gain marketing approval in Europe.
The CHMP’s position is that betrixaban efficacy is acknowledged in the APEX trial, but uncertainties remain regarding a positive benefit risk, which is not supported by a second confirmatory study, biological plausibility for betrixaban in another approved indication or external support within the class from other Factor Xa inhibitors, which are not approved for the acute medically ill population.
The FDA approved betrixaban in June 2017 under the trade name Bevyxxa®.
“We are disappointed with the Committee’s interpretation on betrixaban given the unmet medical need, the clinically meaningful outcomes of the APEX trial and the broad label we received to treat acute medically ill patients in the U.S.,” said Lis. “We are considering our next steps in Europe. In the meantime, we remain focused on the U.S. launch of Bevyxxa. As the first and only anticoagulant approved as a single-drug regimen from hospital admission to home (35-42 days) to prevent major thromboembolic events related to VTE, Bevyxxa has the potential to have a major public health impact on millions of patients in the U.S. and beyond.”
Conference Call Details
The live conference call, scheduled for Tuesday, February 20, 2018 at 5:00 p.m. ET, can be accessed by phone by calling (844) 452-6828 from the United States and Canada, or 1 (765) 507-2588 internationally, and using the passcode 2966018. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. For more information, visit http://www.portola.com and follow the Company on Twitter @Portola_Pharma.
This announcement contains forward-looking statements, including statements relating to Portola Pharmaceuticals’ expectations regarding the regulatory status of betrixaban and andexanet alfa. These statements are subject to significant risks and uncertainties, and actual results could differ materially from those projected. These risks and uncertainties include, without limitation, risks and uncertainties related to the regulatory process for betrixaban and andexanet alfa in Europe. Risks and uncertainties relating to Portola Pharmaceuticals and its business can be found in the “Risk Factors” section of Portola Pharmaceuticals’ Quarterly Report on Form 10-Q for the third quarter of 2017, which was filed with the SEC on November 9, 2017. Portola Pharmaceuticals cautions investors not to place undue reliance on the forward-looking statements contained in this release. Portola Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Portola Pharmaceuticals’ expectations.
Source:Portola Pharmaceuticals, Inc.