Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) today will provide a corporate update and report its financial results for the quarter ended June 30, 2013.
“In the second quarter, we completed a successful IPO, raising approximately $126 million in net proceeds, which will allow us to develop our two late-stage thrombosis programs and a dual Syk-JAK inhibitor for hematologic cancers,” said William Lis, chief executive officer of Portola. “We continue to advance our pivotal Phase 3 APEX Study of betrixaban in acute medically ill patients, where we could potentially be the first Factor Xa inhibitor to market in an area of significant unmet medical need. Additionally, we achieved important milestones in our investigational Factor Xa inhibitor antidote program, including presenting Phase 2 data that demonstrated for the first time clinically that an antidote can reverse the anticoagulation effect of a Factor Xa inhibitor. With the clinical collaboration agreement that we entered into with Daiichi Sankyo this quarter to conduct a Phase 2 study of (pINN) andexanet alfa* (formerly PRT4445) and edoxaban, we now have collaboration agreements in place with all of the pharmaceutical companies that have Factor Xa inhibitors on the market or in clinical development, while retaining all rights to our program.”
- Completed a successful IPO, raising approximately $126 million in net proceeds.
- Appointed Peter Strumph to the newly created position of vice president, technical and clinical operations. Mr. Strumph led the same functions previously at CV Therapeutics in support of the successful development and commercialization of Ranexa® (ranolazine) and Lexiscan® (regadenoson).
- Completed a series of discussions with the U.S. Food and Drug Administration (FDA), including an end of Phase 2 meeting yesterday, regarding the clinical and manufacturing paths forward for andexanet alfa.
- Portola remains confident that it can develop andexanet alfa under an expedited approval pathway that will allow the Company to bring this important product to market as soon as possible to address a major unmet medical need. Final agreement is pending submission of the Phase 3 protocol, which Portola plans to submit later this year in anticipation of initiating these studies in the first half of 2014.
- Portola signed an agreement earlier this year with Lonza Group Ltd. to develop a commercial-scale manufacturing process for andexanet alfa. The Company plans to implement changes at Lonza to initiate BLA-enabling studies with a manufacturing process that will allow it to launch andexanet alfa pursuant to an expedited approval. To improve the cost of goods further, additional process changes will be implemented later into the commercial process, either in the initial BLA or as a supplemental BLA.
- Presented positive data from a Phase 2 proof-of-concept study of andexanet alfa at the 2013 Congress of the International Society on Thrombosis and Haemostasis, demonstrating reversal of the anticoagulant activity of Bristol-Myers Squibb’s and Pfizer’s Factor Xa inhibitor Eliquis® (apixaban).
- 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. Portola retains all global development and commercialization rights for andexanet alfa.
- Presented positive data from a Phase 1 single ascending dose study of andexanet alfa at the Arteriosclerosis, Thrombosis and Vascular Biology 2013 Scientific Sessions.
- Complete a futility analysis in 2014 of the pivotal 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 (VTE) in high-risk, acute medically ill patients. Portola is on track to complete APEX enrollment in mid-2015.
- Report data from the ongoing Phase 2 study of andexanet alfa and the Factor Xa inhibitor XARELTO ® (rivaroxaban) in the fourth quarter of 2013.
- Initiate a Phase 3 pivotal study in the first half of 2014.
- Report data from additional Phase 2 studies of andexanet alfa and other Factor Xa inhibitors, including edoxaban and betrixaban, and enoxaparin.
- Submit an Investigational New Drug (IND) application to the FDA in 2013 for this novel, oral, dual Syk-JAK inhibitor program, which will target patients with genetically-defined hematologic cancers, including chronic lymphocytic leukemia and non-Hodgkin lymphoma.
- Initiate a Phase 1/2 clinical study of PRT2070 in 2013.