Tuesday April 05, 2011 18:39:01 EDT
By: Zacks Equity Research
Vertex Pharmaceuticals Inc. (VRTX) recently reported positive results from two late-stage trials REALIZE and ADVANCE. Both trials were conducted to evaluate telaprevir in combination with pegylated-interferon and ribavirin as a treatment for chronic hepatitis C.

The REALIZE study was conducted with chronic hepatitis C patients whose prior treatment with pegylated-interferon and ribavirin relapsed, or who had a partial or null response. Data from the trial demonstrated that patients treated with telaprevir-based combination therapy achieved superior rates of sustained viral response (viral cure) compared to those treated with pegylated-interferon and ribavirin alone. Vertex Pharma added that the safety and tolerability profile of the treatment regimen was similar to earlier phase III trials of telaprevir.

The ADVANCE trial evaluated telaprevir in combination with pegylated-interferon and ribavirin in patients who were tested for IL28B genotype. Data from the trial demonstrated that patients treated with telaprevir-based combination therapy achieved higher improvement in sustained viral response compared to those treated with pegylated-interferon and ribavirin alone.

We note that telaprevir has priority review status in the United States, Canada and European Union, for the treatment of patients with genotype 1 chronic hepatitis C. The US Food and Drug Administration (FDA) has set May 23, 2011, as the target date for telaprevir.

Vertex Pharma has a partnership agreement with Johnson & Johnson (JNJ) for the development and commercialization of telaprevir outside the US. Vertex Pharma has retained the US rights to the drug.

We currently have a Neutral recommendation on Vertex Pharma, which is supported by a Zacks #3 Rank (short-term Hold rating).



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