Zacks_Analysts' Blog : More Data on Vertex's Incivek - Analyst Blog

Recently, Vertex Pharmaceuticals Inc. (VRTX) announced that data from a late-stage trial on Incivek (telaprevir) was published in the September edition of the New England Journal of Medicine. The ILLUMINATE trial was conducted in treatment-naïve patients with genotype 1 chronic hepatitis C (HCV).

In the study, the drug was given in combination with pegylated-interferon and ribavirin for the first 12 weeks. The study demonstrated that about two-thirds of patients responded early to Incivek combination treatment (at weeks 4 and 12) and were then randomly assigned to receive an additional 12 weeks or 36 weeks of treatment with pegylated-interferon and ribavirin alone. Additionally, high rates of sustained viral response (SVR) were achieved in patients in both treatment arms.

Earlier, in June, Vertex Pharma had reported data from two late-stage trials – ADVANCE and REALIZE – on Incivek. The data were published in the June edition of the New England Journal of Medicine.

The trial results demonstrated that HCV patients on Incivek combination therapy experienced a significant improvement in SVR rates, as compared to those who received pegylated-interferon and ribavirin alone.

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

We note that Incivek was approved in Canada last month and in the US in May 2011 for the treatment of HCV. Further, during the second quarter of 2011, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Incivek in the European Union (EU) as a treatment for HCV. Partner Johnson & Johnson (JNJ) anticipates a response from the European regulatory body in the third quarter of 2011. Following the approval, Incivek will be marketed in the EU and certain other territories under the brand name Incivo.

Vertex Pharma has exclusive US commercialization rights to Incivek and has joined hands with Johnson & Johnson 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.

Mitsubishi Tanabe filed for regulatory approval of Incivek in Japan in January 2011.

The drug, which faces competition from Merck & Co. Inc.’s (MRK) Victrelis, recorded sales of $74.5 million during the second quarter of 2011 (first quarter of the drug’s launch), and helped limit Vertex Pharma’s second quarter 2011 loss to 82 cents.

We currently have a Neutral recommendation on Vertex Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.