After Portola Pharmaceuticals (NASDAQ:PTLA) reported mixed results recently from a phase 3 trial of a key drug, its share price tumbled. However, Betrixaban's late-stage study data may not spell the end to the drug's chances at commercialization, and even if it does, Portola Pharmaceuticals still has a pending FDA decision on Andexanet Alfa approaching in August. Can Portola Pharmaceuticals shares get back on their feet? Find out in this clip from the Motley Fool's Industry Focus: Healthcare podcast.
A full transcript follows the video.
This podcast was recorded on March 30, 2016.
Kristine Harjes: I think we owe our listeners an update on Portola Pharmaceuticals, which we covered a month ago. What has happened since then?
Todd Campbell: It was a busy month. We anticipated that it would be, right? We knew that they had a study that was going on for a drug that is designed to prevent blood clots in medically ill patients. We knew that the data from that trial was going to get released probably by the end of March. Sure enough, that happened. Unfortunately, it wasn't the slam dunk that investors were hoping for.
Harjes: Yeah. The stock itself lost 29% in one day when this study was released. I can honestly say I was pretty shocked.
Campbell: Yeah. It's disappointing. Full disclosure, I'm a shareholder. I haven't made any changes to my position since the news came out. With that being said, bear that in mind -- there are some reasons to think that all is not lost for the drug and for the company.
Harjes: All right. Just as a quick recap, the drug that we're talking about that caused this share price decline is Betrixaban, which was definitely the drug with the larger market opportunity, but is actually, for me at least, not quite the reason that I became interested in the company to begin with. There is still hope, not only for Betrixaban, but for this other drug, which is Andexanet Alfa. If you're interested and you're not sure what we're talking about go check out our episode from pretty much exactly a month ago, probably four episodes ago. We dig in a little bit more about Portola. Or shoot us an email if you have any questions: email@example.com.
Yeah, Todd you mentioned that you haven't made any changes to your position, I haven't either, I'm also a shareholder. I'll remind everybody that people on the show: We could have interest in the stocks that we talk about, and we do. The Motley Fool also could have formal recommendations for or against them. Don't buy or based solely on what you hear or what Todd and I say that we're doing. Definitely do your own research. But yeah, we wanted to give you all the heads up that there was new news about Portola since we did talk about them.
Campbell: Yeah. Kristine I think -- just really quickly, because we've got a lot to talk about today, just to give people a flavor for what we're talking about as far as it being disappointing: It was a huge trial, 7,500 people. The way the trial was designed was a little bit odd; in order to test the entire group to see how well the drug did, it had to first be statistically significant in improving blood clots in an intent-to-treat population, which was about 62% of the 7,500 people in the study. You needed to have p-value, which is a measure of significance, of .05 or less to test the greater group. They came in at .054.
Close enough where they still tested the entire group, and across the entire universe of patients it was definitely below .05, but that still cast a little bit of doubt of how the FDA would view that information when Portola goes ahead and files for approval later this year. Of course, there's question marks there on this drug, and then like you said, there's also Andexanet Alfa which would be, if approved in August, the first reversal agent for Factor Xa anticoagulants. That's big because Factor Xa coagulants are raking in $4 billion a year in sales. That's on restricted use of them, because there is no antidote yet.
Harjes: Right. Essentially, all is not lost with this company, but it was disappointing news, to hear that Betrixaban didn't perform quite as well as we had been hoping. I personally still see a lot of upside to this stock, but it's definitely a "hang tight and keep your eye on the news" sort of situation.