Portola Pharma (PTLA) to Update on Regulatory, Commercial Milestones and Discovery Pipeline

Portola Pharmaceuticals (Nasdaq: PTLA) 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 InformationTo 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.

You May Also Be Interested In

• Safe & Green (SGBX) Provides Update on Audit and Planned 10-K Filing
• Baozun Inc. (BZUN) Chairman Issues 2023 Letter to Shareholders
• Brainstorm Cell Therapeutics (BCLI) Announces Management Changes