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Portola Pharmaceuticals to Webcast Corporate Update on January 12, 2016
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
- 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
FDAif results are positive in the second half of 2016.
- Launch betrixaban in 2017 pending positive APEX results and approval.
Andexanet alfa – an
- Completed a BLA submission, which is awaiting acceptance for filing; the
FDAassigned a PDUFA date of August 17, 2016under 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.
- Expanded R&D efforts into other areas, including the early research of oral PCSK9 inhibitors.
To access the live investor webcast on
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
Investor Contact: Ana Kapor
Portola Pharmaceuticalsir@portola.com Media Contact: Julie Normart W2O Groupjnormart@w2ogroup.com