Vertex Gears up for Big Liver Disease Conference

10/29/08Follow @xconomy

Vertex Pharmaceuticals is preparing to unveil some long-awaited data that will show just how well its drug is performing for some of toughest-to-treat hepatitis C patients.

I spoke with Vertex’s chief commercial officer, Kurt Graves, to do some pre-game reporting for the American Association for the Study of Liver Disease’s annual meeting October 31 through November 4 in San Francisco. The Cambridge, MA-based biotech company (NASDAQ: VRTX) and competitors from Schering-Plough and Roche will be facing some intense scrutiny by Wall Street analysts at this meeting. So I figured it’s a good time to look at what’s already known about Vertex’s experimental drug, telaprevir, and what to expect.

As a reminder, telaprevir is aiming to be a first-in-class protease inhibitor against hepatitis C, a chronic liver disease. The drug is being watched closely because it has the potential to change the standard of treatment for the disease. Patients currently are prescribed almost a yearlong regimen of pegylated interferon alpha and ribavirin, which cures about one-third of them. Telaprevir, when added to those drugs, can almost double that cure rate, and shorten the regimen to just under six months, previous studies have shown. Telaprevir can also kill the virus for large numbers of patients who have failed on a prior course of therapy. If these findings are confirmed in ongoing Phase III trials and the drug is approved by the FDA, it could generate $2.6 billion in U.S. sales in 2013, according to Rachel McMinn, an analyst with Cowen & Co. in San Francisco.

Analysts at this upcoming meeting are also going to carefully scope out the competition, namely Schering Plough’s boceprevir and Intermune and Roche’s ITMN-191. Based on the abstracts submitted in advance of the meeting, which provide a partial picture of what’s to come, Vertex says it remains confident. “We’re not seeing any antiviral that’s as good or better than telaprevir,” Graves says. “Telaprevir is still setting the standard.”

Here’s what to watch from Vertex:

—Prove 3. This study of telaprevir for patients who failed on previous therapy, released in June, found that 60 of 115 patients (52 percent) who got the Vertex drug along with the standard drugs had no signs of the virus after about three months of follow-up after finishing treatment, the company said. Only 9 out of 114 patients (8 percent) on the standard drugs did that well at an interim three-month analysis. That measurement isn’t directly comparable because those patients were undergoing a longer course of treatment, the company said. The key here is that liver experts and the FDA only consider a patient cured after the virus is wiped out for a full 24 weeks, or about six months. Vertex will present more follow-up data at the conference, Graves said, but he wouldn’t say whether it will actually include that critical 24-week cure rate. “Historically we haven’t seen a big difference between the 12-week and 24-week,” Graves says.

—The ’107 study. This trial, also in patients who didn’t respond to previous treatment, found that telaprevir killed the virus in 49 of 60 patients, or 82 percent, after four weeks. When an early peek at that study’s results were released in March, it drove Vertex shares up 28 percent in one day, the single-biggest gain in the company’s history. Nothing has been presented publicly on this study since April, when Vertex showed it at the European Association for the Study of the Liver meeting in Milan, Italy. This trial has had more time for follow-up data to emerge, from more patients, and it will be released at the meeting, Graves says.

—C208. This trial is all about convenience. This study looks at whether a twice-daily dose of telaprevir is as good as the original three-times-a-day dosing regimen. This could provide a convenience advantage over Schering-Plough’s boceprevir, which is taken three times a day, Graves says. “It’s important for patients and clinicians, and also for competitive reasons,” he says.

Vertex, and many of the leading physicians, will also keep their eyes open at this meeting for innovative new treatments that are at earlier stages of development than telaprevir. Two different types of antiviral drugs, polymerase inhibitors and NS5A inhibitors, are being tested along with telaprevir to see if they can help boost the cure rates even higher, Graves says. “Can we get rid of interferon and ribavirin while we improve cure rates?” Graves said. “That’s the ultimate goal, and the next major step forward.”

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  • Jim

    I am somewhat surprised that TMC435350 from Medivir/J&J is not mentioned as being a potential competitor for Telaprevir. Once daily should be a great advantage and so far all available data by far exceeds that of Telaprevir.

  • The Man

    It’s 2-3 years behind TVR and still in the early stages of development. Considering the vast expanse of the Phase II graveyard, it still has a long way to go.