Vertex, J&J to Begin New Telaprevir Study

Vertex Pharmaceuticals(VRTX Quote) announced Tuesday an agreement with regulators in the U.S. and Europe that greenlights the company and partner Johnson & Johnson(JNJ Quote) to begin a new phase III study of their experimental hepatitis C drug telaprevir.

The new study will test telaprevir with standard combination therapy in 650 hepatitis C patients who could not be cured with the currently approved drugs for the disease, pegylated interferon and ribavirin. These are difficult to treat patients, including patients known as "null responders," which means they did not respond at all to previous treatments.

Vertex and Johnson & Johnson, which are co-developing telaprevir, posted an outline of this new study, dubbed REALIZE, on the ClinicalTrials.gov Web site in June. Vertex shares fell at that time because the new phase III trial suggested that an early regulatory approval filing for telaprevir in 2009 for treatment-resistant patients was not in the cards. ...