Vertex Unveils Positive Telaprevir Data

Ending months of anticipation, Vertex Pharmaceuticals unveiled the first set of data from a Phase III trial of telaprevir, a protease inhibitor for the treatment of hepatitis C. The company is expected to submit for regulatory approval later this year, and launch the drug in 2011. Vertex said that 75% of genotype-1 patients—viewed as the toughest to treat--who received 12 weeks of telaprevir treatment on top of the current standard of care (48 weeks of pegylated interferon and ribavirin) were cured of the infection. Only 44% of patients in the control arm, which received only the standard of care, were cured after 48 weeks. Leerink Swann analyst Seamus Fernandez told investors the results set an "impressively high bar" for treatment in HCV. Importantly, adding the drug to the standard of care will lessen the total treatment time for many HCV patients. In addition to not being very effective, many people can’t tolerate the harsh side effects associated with interferon and ribavirin. Physicians liken the 48-week regimen to living with a nasty flu for a year. In hopes of halving the number of weeks on interferon and ribavirin, Vertex conducted what is called a “response-guided trial.” If the virus was sufficiently quelled after four weeks with the telaprevir addition, patients went on to receive just 24 weeks total of therapy. The company said “the majority” of patients received just 24 weeks of treatment. That 24-week figure is a critical one. Merck is hot on Vertex’s heels with its own protease inhibitor, boceprevir. Both companies are expected to launch their drugs next year, and with similarly mild safety issues, analysts say the drug that can shut down the disease the quickest will win. Merck is also conducting a response-guided study and at its R&D day said a retrospective look at its Phase II data suggests patients can be successfully treated in 24 weeks with boceprevir. BMO Capital Markets analyst Jason Zhang was dead on with his estimates for the drug. As we wrote earlier this month: Zhang expected the Phase III data to show a sustained viral response (the equivalent of a cure) of 75% of patients receiving telaprevir. His guess for telaprevir’s biggest competitor, Merck’s boceprevir? 74% sustained viral response. We’ll have to wait and see how close he comes on that figure, as Merck has been vague about when its Phase III results will be released. The big pharma firm has only said that it expects to present the data at an upcoming conference. My guess? We will likely be waiting for the American Association of Liver Disease’s annual shindig, also known as “The Liver Meeting,” in October. For Vertex, the Phase III success is a major step in its 15-year long quest in bringing telaprevir to market. Zhang expects it to capture over half the U.S. and European HCV market, bringing in $3.6 billion in peak sales in 2013.

Author: Lisa Jarvis

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