Vertex Pharmaceuticals Inc. (VRTX) recently reported positive data from a mid-stage study (PROVE 2) on Incivek (telaprevir), when dosed in combination with pegylated-interferon and ribavirin for the treatment of patients with the IL28B CC genotype hepatitis C. The data demonstrated that patients on Incivek combination therapy achieved 100% viral cure after 12 weeks of treatment.
Vertex Pharma also announced its plans to initiate patient enrollment in a phase IIb study, which will evaluate an interferon-free treatment in patients with genotype 1 hepatitis C.
We note that Incivek is currently marketed in the US and Canada for the treatment of hepatitis C virus (:HCV). The drug is available as Incivo outside the US and the Far East, and as Telavic in Japan.
Further, Vertex Pharma is presently studying the drug for additional indications and also in combination with other treatments. Last month, the company reported positive interim data from a mid-stage study on Incivek when dosed in combination with pegylated-interferon and ribavirin in people co-infected with genotype 1 HCV and human immuno deficiency virus (:HIV).
The data demonstrated that after 12 weeks of treatment with the Incivek combination therapy, 74% of the patients experienced undetectable HCV, while 45% of the patients dosed only with pegylated-interferon and ribavirin had undetectable HCV. The study also showed that Incivek was well tolerated with HIV drugs – Gilead Sciences Inc.’s (GILD) Atripla and Bristol-Myers Squibb Co.’s (BMY) Reyataz.
We currently have a Neutral recommendation on Vertex Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. We believe that the approval of Incivek for any of the aforementioned indications would boost the drug’s sales, which came in at $950.9 million in 2011 (Read our full earnings coverage at: Incivek Catalyst at Play for Vertex). Moreover, Vertex Pharma expects Incivek revenues in the range of $1.5 - $1.7 billion in 2012.
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