Portola Pharmaceuticals Enters into $50 Million Loan Agreement with Bristol-Myers Squibb and Pfizer for Continued Development of AndexXa™ (andexanet alfa)
SOUTH SAN FRANCISCO, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced it has signed a $50 million loan agreement with Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) that provides additional funding toward development and clinical studies of AndexXa™ (andexanet alfa), an investigational compound that is a potential antidote for Factor Xa inhibitors.
“This agreement reflects the commitment and support of the andexanet alfa program by our long-standing partners BMS and Pfizer and helps Portola to continue moving rapidly toward our goal of gaining regulatory approval in 2017,” said Tao Fu, chief commercial and business officer of Portola. “We are committed to working with the FDA to bring AndexXa to market as patients currently have no approved antidote available to reverse Factor Xa inhibitors.”
Under the terms of the agreement, Bristol-Myers Squibb and Pfizer will each loan Portola $25 million. The principal and interest will be repaid primarily through royalties on AndexXa commercial sales. No shares, warrants, options or other equity components were or will be issued in connection with the loan. The non-secured loan does not involve any transfer of patent ownership or licenses.
AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. On August 17, 2016, Portola received a Complete Response Letter from the FDA regarding its Biologics License Application for AndexXa. Portola expects to resubmit the BLA in 2017.
Portola previously entered into two separate clinical collaboration agreements with Bristol-Myers Squibb and Pfizer to support Phase 2 and registrational studies of andexanet alfa in the United States and Europe. Bristol-Myers Squibb and Pfizer also have a collaboration agreement with Portola to develop and commercialize andexanet alfa in Japan. Portola retains all rights, including full commercial and financial rights, for andexanet alfa outside of Japan.
AndexXa (andexanet alfa), an investigational drug, is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus potentially allowing for the restoration of normal hemostatic processes. AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity – the anticoagulant mechanism of these agents.
AndexXa is currently being evaluated in the ongoing Phase 3b/4 ANNEXA™-4 study in patients with Factor Xa inhibitor-associated acute major bleeding. Results of a preliminary analysis of interim data were presented in a Late-Breaking Science Hot Line session at the European Society of Cardiology 2016 Congress and published simultaneously online by The New England Journal of Medicine.
In the EU, the European Medicines Agency (EMA) is reviewing the Marketing Authorization Application for andexanet alfa for reversal of Factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery. A decision is expected in 2017.
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 is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (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 www.portola.com and follow the Company on Twitter @Portola_Pharma.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the timing of our development efforts for andexanet alfa and the projected need for a Factor Xa inhibitor antidote. Risks that contribute to the uncertain nature of the forward-looking statements include the risk that our data fail to demonstrate safety and efficacy of andexanet alfa to the satisfaction of the FDA or similar regulatory authorities outside the United States, such as the EMA, and the risks that we will not successfully manufacture andexanet alfa on a commercial scale or be able to obtain the capital needed to fund our operations. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q, which was filed on November 7, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Ana KaporPortola Pharmaceuticalsir@portola.com
Julie NormartW2O Groupjnormart@w2ogroup.com
Portola Pharmaceuticals, Inc.