Below is the transcript of the corporate presentation of Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) held on Monday, January 12, 2015, 12:00 p.m. PT. The company presented the results from the first part of the Phase 3 ANNEXA study, which is evaluating the safety and efficacy of Andexanet Alfa with the Factor Xa inhibitor Xarelto (Rivaroxaban). They also announced the start of the ongoing second part of the confirmatory clinical trial.
Portola Pharmaceuticals, Inc. (NASDAQ:PTLA)is a bio pharmaceutical company operating in the United States. The company develops therapeutic products in the fields of thrombosis, hematologic disorders, and inflammation. It is developing andexanet alfa for patients who are on Factor Xa inhibitors who are having major bleeding episodes or would require immediate surgery.
William Lis – Chief Executive Officer,Portola Pharmaceuticals, Inc.
Alexander Gold – Senior Vice President, Clinical Development, Portola Pharmaceuticals, Inc.
Thank you for joining the Portola Pharmaceuticals conference call. I will now pass the call to Bill Lis, CEO of Portola.
William Lis, Chief Executive Officer, Portola Pharmaceuticals, Inc.
Good afternoon and thank you to what we are calling our second annual off Broadway presentation at J.P. Morgan. I am going to go through slides and then we will have a question-and-answer following.
Here is our forward-looking statement. Where were we at Portola? We are continued to be excited about the ability to advance this company’s breakthrough products, specifically in the area of blood clot and blood cancers. We expect to advance them to the market independently. We have three wholly-owned potentially ground breaking products that focused on hospital and specialty-based markets discovered by Portola scientists. The management team which continues to grow in building our capabilities to build an enduring company is proven. We have done this before.
What is exciting is there is near-term pivotal data some of which we have presented over the last week and what we expect over 2015 and 2016 in preparation for a number of FDA filings of these products over the next few years.
Here are the slides. I will say what I have continued to say about this slide. It is late stage. It is unique because we have taken a biomarker, a genetic approach for the clinical development of all of our programs. Betrixaban, our oral Factor Xa inhibitor is now 65% enrolled in its pivotal Phase 3 clinical trial. We expect to report data early next year and file the NDA for this drug if successful next year. Andexanet Alfa, our FDA-designated breakthrough therapy has now completed and reported two of a series of Phase 3 clinical trials designed for conditional approval.
Also, just today, we announced the start and the design of the confirmatory Phase 4 clinical trial in agreement with the FDA. Now, we have a total package for the filing for the accelerated approval. We expect to file a BLA this year and launch this drug next year as our first product.
Cerdulatinib, our compound that targets B-cell pathway of blood cancers is unique. The mechanism of action of this drug is unique. We think we are starting to see some of the clinical activity that we projected we would see by targeting two important stimulating pathways in many of these hematologic cancers. We just announced that we are advancing this into the expansion phase of the clinical trial. As you look at this, you could start to see the setup of a series of commercially improved products. One in 2016, one in 2017 and then potentially one very soon thereafter. We also have the Syk-selective partnership with Biogen Idec that continues at a very slow phase.
What is going to drive value for us? It is the continued execution on our milestones. We demonstrated a significant number of achievements in 2015. Betrixaban with its enrollment. We had three positive safety reviews. The FDA has allowed us to amend the protocol to increase the probability of success based on using a bio marker for the primary analysis, patients that are enrolled based on a bio marker. In February, we will do a futility analysis on this clinical trial. If successful, we believe that will give us momentum towards the completion and the read out of the clinical trial.