Many patients can’t stand to take the two drugs used in those standard treatments, pegylated interferon and ribavirin, because they cause flu-like side effects, need to be taken almost a year, and only offer a cure about one-third of the time.
“We’re in a position to be first, our drug can be used for all hepatitis C treatment-failure patients, and we’re likely to be used in a 24-week regimen, not a 48-week regimen,” Graves says. “We think we’re in a good position.”
It’s hard to say precisely how many more patients might be eligible to receive telaprevir if the Realize trial is a success. Among treatment-failure patients, an estimated 30 percent are non-responders to standard therapy, while the rest generate some sort of response that isn’t good enough or doesn’t last, Graves says.
Roche’s contender is being co-developed with Brisbane, CA-based Intermune, and is called ITMN-191. It is still in the earlier stages of development, although Roche recently paid its partner a $15 million milestone payment, and Roche has said it plans to move into the middle stage of clinical trials. Those companies have experimented with a once-daily or twice-daily dose that could be more convenient than either the Vertex or Schering-Plough drugs, which are made to be taken three times a day. Vertex is also looking to protect its flank there, by running a test called C208 to see if a twice-daily form of telaprevir can be shown equivalent to the regular form.
Wall Street will tune in next to the American Association for the Study of Liver Diseases meeting in November, where Vertex is expected to present more data on telaprevir trials in front of an audience of leading physicians. If the data look good, then Vertex shouldn’t have much trouble enrolling patients in the Realize trial. It will still be at least a couple years before we know for sure whether today’s strategy will pay off with greater market share in what’s shaping up to be a feisty new pharmaceutical market.
