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to get better after the standard treatment.
Telaprevir must be combined with a pair of standard drugs, pegylated interferon alpha and ribavirin, which have to be taken for almost a year, and cause flu-like symptoms that make patients feel miserable. The Vertex drug is eagerly awaited by physicians and patients because it has shown in earlier trials that it can almost double the cure rate for patients when added to standard therapy, and cut the duration of therapy in half for patients who are new to treatment. If approved, the product could generate $2.6 billion in U.S. sales as soon as 2013, according to the investment firm Cowen & Company.
Vertex is running pivotal clinical trials that it hopes will clear the way for the U.S. market introduction of telaprevir in 2011, which could potentially give it the first-mover advantage against deep-pocketed competitors like Schering-Plough and Roche. But besides being first, Vertex wants to set the highest bar for therapy, by recruiting the most difficult patients to treat—the so-called null responders who didn’t see any improvement on prior therapy. If it can confirm the results from this preliminary study in an ongoing pivotal study of 650 patients, called Realize—that it can truly cure more than half of the null responders—then Vertex could have a significant advantage that it hopes will give physicians great confidence in its drug for all kinds of patients.
“It’s important to keep in mind that this was a small study, there was no control, so it has those weaknesses,” says Robert Kauffman, Vertex’s chief medical officer. “But it really does suggest to us that we are on the right track in our ongoing Phase III trial. If those results are confirmed in the Phase III trial, then this will be a real advance in treatment.”
Still, there are caveats. One of the important things that Vertex learned from this smaller study, known as ‘107, is that the tough-to-treat patients need to stay on a full 48-week long combination regimen with the interferon and ribavirin. That’s how long patients need to take the existing drugs now, Kauffman says.
This was a point of a lot of discussion within the company, because one of telaprevir’s big advantages in the so-called “naïve” patient population was that it allows patients to cut their course of therapy down to 24 weeks, meaning they don’t have to endure the flu-like symptoms for nearly as long as with the standard therapy. The pivotal study for naïve patients is still designed to test that supposed advantage, but Vertex has found that tougher-to-treat patients are better off staying on the full 48-week long regimen, and enduring all that goes with it, to achieve the clinical cure rates, Kauffman says.
“The null responders really do respond more slowly. They have to stick with the regimen longer,” he says.
This latest batch of data came out too late to be presented at this weekend’s upcoming meeting of the American Association for the Study of Liver Diseases in Boston, Kauffman says. Vertex has other data that it expects to announce in Boston from telaprevir studies, he says.
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