Vertex Pharmaceuticals Inc. (VRTX - Free Report) recently announced that the US Food and Drug Administration’s (FDA) Antiviral Drugs Advisory Committee voted unanimously (18-0) in favor of approving telaprevir as a treatment for hepatitis C virus (HCV), in both treatment-naïve and treatment-failed patients.
The FDA’s decision on telaprevir’s approval status is expected by May 23, 2011. We note that though the regulatory body is not required to follow the committee’s recommendation, it usually does so.
The drug is also under regulatory review in the European Union and Canada.
Vertex Pharma has exclusive US commercialization rights to telaprevir and has joined hands with Johnson & Johnson (JNJ - Free Report) and Mitsubishi Tanabe Pharma for the commercialization of the drug outside the US. While Johnson & Johnson is responsible for the commercialization of telaprevir outside North America and the Far East, Mitsubishi Pharma will market it in certain areas of the Far East including Japan.
Vertex Pharma recently reported positive results from two late-stage trials (REALIZE and ADVANCE). Both the 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 those 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 with 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 was conducted by Vertex Pharma to evaluate telaprevir in combination with pegylated-interferon and ribavirin, in patients 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 with those treated with pegylated-interferon and ribavirin alone.
We currently have a Neutral recommendation on Vertex Pharma. We expect investor focus to remain on the approvability of telaprevir.