Biotech
Vertex Unveils More Promising Hep C Drug Data
04/24/08 - 12:14 AM EDT
"What we're showing here is unprecedented but early viral response data that gives us an indication that we have the only drug in our class with the potential to offer some of these patients a cure," said Kurt Graves, Vertex's chief commercial officer, speaking from the EASL meeting in Milan. Schering-Plough also has run studies of its hepatitis C drug boceprevir in treatment-resistant patients, but the results so far have not been as strong as those seen Thursday with telaprevir. Vertex is running a separate, larger study of telaprevir in treatment-resistant patients known as PROVE 3. Interim results from this study will start to flow into Vertex in May, although public disclosure of the data likely will wait until after the company meets with the U.S. Food and Drug Administration. Thursday's positive results from Study 107 strongly hint at likewise positive results from PROVE 3, leading to some speculation that Vertex may seek an early FDA approval. Graves deferred such talk, stating that any discussion of a telaprevir filing based on PROVE 3 (and Study 107) data is premature. Telaprevir is a pill designed to attack hepatitis C by inhibiting the protease enzyme, one of the key enzymes the virus uses to copy itself. This "direct antiviral" approach differs from current hepatitis C drugs, which boost the immune system's ability to tamp down and eliminate the virus. Phase III studies of telaprevir in newly diagnosed hepatitis C patients are ongoing, with data expected in mid-2010. Vertex shares closed Wednesday down 3.9% at $25.95.
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