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Portola Pharmaceuticals Reports Third Quarter Financial Results And Provides Corporate Update

SOUTH SAN FRANCISCO, Calif., Nov. 5, 2013 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (Nasdaq:PTLA) today will provide a corporate update and report its financial results for the third quarter ended September 30, 2013.

"Throughout this year, we demonstrated our continued ability to execute on our strategic plan and reconfirm our long-term commitment to building an enduring growth company," said William Lis, chief executive officer of Portola. "We believe we have an exciting portfolio of wholly-owned product candidates. Our lead agent, betrixaban, is being developed as an anticoagulant for the prevention of fatal blood clots in acute medically ill patients. Andexanet alfa has the potential to be a first-in-class reversal agent for anticoagulated patients experiencing a fatal bleed or requiring emergency surgery. And PRT2070 is a unique oral dual kinase inhibitor being evaluated in patients with hematologic cancers, including those with genetically-defined and difficult-to-treat subtypes. With the proceeds from our recently completed follow-on equity offering, we are well positioned to advance these assets to value-creating milestones planned for 2014 and 2015, including Phase 3 APEX data for betrixaban, Biologics License Application filing for andexanet alfa, and proof-of-concept data for PRT2070."

Recent Events Corporate
  • Completed a follow-on equity financing on October 22, 2013, raising approximately $100 million in net proceeds for the Company. With the follow-on offering, the Company now plans to advance andexanet alfa to a BLA filing and expand the scope of the PRT2070 Phase 2 proof-of-concept study to include additional cancer types.
  • Appointed Mark Gossett as senior vice president of commercial to build, lead and develop the commercial organization. He has more than 25 years of experience commercializing important medicines, including the multi-billion dollar anticoagulant Lovenox ® (enoxaparin).

  • Continued to enroll patients in the global Phase 3 APEX study (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban), which is evaluating betrixaban for hospital and post-discharge prevention of venous thromboembolism in high-risk, acute medically ill patients. The independent data monitoring committee for this study held its second meeting in August and recommended that the Company proceed with the study as planned.

Andexanet alfa (PRT4445*)
  • Announced new findings from a Phase 2 proof-of-concept study of andexanet alfa administered as a bolus plus continuous infusion for up to two hours. Results showed a rapid and near complete reversal of the anticoagulation effect of the Factor Xa inhibitor Eliquis ®, which was sustained for the duration of the infusion.
  • Presented data at the 2013 European Society of Cardiology Congress demonstrating that andexanet alfa reduced blood loss in anticoagulated animals experiencing an active bleed by reversing Factor Xa inhibitor activity.
  • Completed an end-of-phase 2 meeting with the Food and Drug Administration regarding the clinical and manufacturing paths forward for andexanet, and based on those discussions, the Company plans to pursue an Accelerated Approval pathway.
  • Entered into a collaboration agreement with Daiichi Sankyo for a Phase 2 program to evaluate andexanet alfa in reversing the anticoagulant activity of the investigational Factor Xa inhibitor edoxaban.

  • Initiated and began enrollment in a Phase 1/2 proof-of-concept clinical study of the oral dual Syk-JAK inhibitor PRT2070 in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia, including those patients who have progressive or relapsed disease, genetically-defined subtypes or acquired mutations.

Planned Upcoming Milestones Betrixaban
  • Complete a futility analysis in 2014 of the Phase 3 APEX Study. Portola remains on track to complete APEX enrollment and report data in mid-2015.

Andexanet alfa
  • Report data from two Phase 2 studies of andexanet alfa and the Factor Xa inhibitors XARELTO ® (rivaroxaban) and Lovenox ® (enoxaparin) over the next two quarters.
  • Initiate a pivotal Phase 3 study and Phase 4 confirmatory study in 2014, while concurrently working on manufacturing transfer and process development changes at Lonza Group.

  • Report proof-of-activity data from the Phase 1/2 clinical study in 2014.

Third Quarter Financial Results

Collaboration revenue for the third quarter of 2013 was $2.8 million earned under the Company's collaborations with Bristol-Myers Squibb Company and Pfizer Inc., Bayer Pharma AG and Janssen Pharmaceuticals, Inc., Daiichi Sankyo, Inc. and Lee's Pharmaceutical (HK), Ltd. Collaboration revenue for the third quarter of 2012 was $0.7 million earned under the Company's collaboration with Novartis AG, which was terminated effective July 1, 2012.

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