Vertex Investors Balk at New Study Plans

A speedier-than-expected regulatory filing for Vertex Pharmaceuticals' (VRTX Quote) hepatitis C drug appears less likely after the company disclosed plans Monday for a new phase III study of the drug.

Investors have been hoping that Vertex and partner Johnson & Johnson (JNJ Quote) could seek regulatory approval for telaprevir in 2009 based on data from existing clinical trials in treatment-resistant patients.

However, the companies posted details of a new phase III study of telaprevir in treatment-resistant hepatitis C patients on the ClinicalTrials.gov Web site Monday. The disclosure dampened investor outlook for a quick telaprevir filing.

If Vertex cannot file telaprevir with the U.S. Food and Drug Administration in 2009, the filing will likely come in the second half of 2010 after studies of the drug in treatment-naïve hepatitis C patients are completed. ...