(VRTX) Vertex Pharmaceuticals Get Positive Data on Incivek

Vertex Pharmaceuticals Inc. (VRTX) recently reported data from two late stage trials – ADVANCE and REALIZE – on Incivek (telaprevir). The data were published in the June edition of the New England Journal of Medicine.

The trial results demonstrated that when patients suffering from chronic hepatitis C (HCV) were given Incivek combination therapy, they experienced significant improvement in sustained viral response (SVR) rates, as compared to those who received pegylated-interferon and ribavirin alone.

In the ADVANCE study, Incivek combination therapy demonstrated the aforesaid results in new patients, while the REALIZE study consisted of treatment-failed patients.

We note that in the ADVANCE study, majority of the patients treated with Incivek combination therapy completed the treatment in 24 weeks, which is half the time needed in the pegylated-interferon and ribavirin arm. Further, in the REALIZE study, the SVR rates were three-to-six-times higher in the Incivek arm compared to the pegylated-interferon and ribavirin arm.

Incivek was approved by the US Food and Drug Administration (FDA) last month as a treatment for HCV, in both treatment-naïve and treatment-failed patients. The drug is currently under regulatory review in the European Union and Canada. A response from the European regulatory body is expected in the second half of 2011.

Vertex Pharma has exclusive US commercialization rights to Incivek and has joined hands with Johnson & Johnson (JNJ) and Mitsubishi Tanabe Pharma for the commercialization of the drug outside the US. While Johnson & Johnson is responsible for the commercialization of Incivek outside North America and the Far East, Mitsubishi Pharma will market it in certain areas of the Far East including Japan.

Vertex Pharma faces competition for Incivek from Merck & Co.‘s (MRK) Victrelis (boceprevir), a similar protease inhibitor molecule, which was approved by the FDA recently. The drug has also been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

Meanwhile, companies like Boehringer Ingelheim, Gilead Sciences Inc. (GILD) and Roche Holdings Ltd. (RHHBY) have pipeline candidates for the treatment of HCV.

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

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