SOUTH SAN FRANCISCO, Calif., Jan. 08, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (Nasdaq: PTLA ) today announced that it will host an investor webcast to review its recent achievements and corporate and product milestones over the next year. The webcast, which will take place on Tuesday, January 12, at 7 a.m. Pacific Time (10 a.m. Eastern Time), will coincide with the 34th Annual J.P. Morgan Healthcare Conference in San Francisco.
During the investor event, Portola's senior management team will provide updates on the following clinical, regulatory and commercial milestones for its three wholly-owned product candidates as well as its discovery pipeline.
Betrixaban -- a U.S. Food and Drug Administration (FDA)-designated Fast Track oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. If approved, it will be the first oral anticoagulant to treat the approximately 24 million acute medically ill patients hospitalized in the G7 countries each year:
- Provide topline results from the 7,500-patient pivotal Phase 3 APEX Study at the end of first quarter of 2016.
- Submit an NDA to the FDA if results are positive in the second half of 2016.
- Launch betrixaban in 2017 pending positive APEX results and approval.
Andexanet alfa – an FDA-designated Breakthrough Therapy in development for patients treated with a direct or indirect Factor Xa inhibitor when reversal of anticoagulation is needed, such as in life-threatening or uncontrolled bleeding or for emergency surgery/urgent procedures; if approved, will be the first universal antidote for Factor Xa inhibitor anticoagulants:
- Completed a BLA submission, which is awaiting acceptance for filing; the FDA assigned a PDUFA date of August 17, 2016 under an Accelerated Approval pathway.
- Launch andexanet alfa in the second half of 2016 pending approval.
Cerdulatinib – an oral, dual Syk/JAK kinase inhibitor that inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies; in development to treat patients with hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies:
- Completed once-daily dosing in the Phase 1 dose-escalation part of the ongoing Phase 1/2a study in patients with relapsed/refractory B-cell malignancies who have failed multiple therapies. Concentration exposure plateau has been reached.
- Exploring alternate dosing regimens, including twice-daily dosing where higher exposure levels have been observed.
Discovery Pipeline
- Expanded R&D efforts into other areas, including the early research of oral PCSK9 inhibitors.
Webcast Information To access the live investor webcast on Tuesday, January 12, at 7 a.m. Pacific Time (10 a.m. Eastern Time), go to the Investor Relations section of the company's website at http://investors.portola.com . A replay will be available for 30 days following the live event.
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 its three wholly-owned programs using novel biomarker and genetic approaches that may increase the likelihood of clinical, regulatory and commercial success. These programs include betrixaban, an oral, once-daily Factor Xa inhibitor being evaluated in the APEX Phase 3 study for prophylaxis of venous thromboembolism; 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.
Forward-looking Statements 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 likelihood of clinical, regulatory and commercial success of our product candidates; our projected timing of clinical, regulatory and commercial milestones with respect to our product candidates; the ability of our product candidates to significantly advance the field of thrombosis and benefit patients; the potential for anticipated corporate and product milestones to impact our business; our valuation of, and potential payments under, licensing and collaboration agreements; and our R&D efforts. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Portola's estimates regarding its ability to initiate and/or complete its clinical trials; the success of Portola's clinical trials and the demonstrated efficacy of Portola's product candidates to the satisfaction of regulatory authorities; the accuracy of Portola's estimates regarding its expenses and capital requirements; regulatory developments in the United States and foreign countries; we enter into collaborations that place certain aspects of the development of andexanet alfa out of our direct control; Portola's ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Portola's most recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, which was filed on March 2, 2015, and Quarterly Report on Form 10-Q, which was filed on November 9, 2015. All forward-looking statements contained in this press release speak only as of the date on which they were made. Portola undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact: Ana Kapor Portola Pharmaceuticals ir@portola.com Media Contact: Julie Normart W2O Group jnormart@w2ogroup.com
