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Vertex Reports Success In Second Major Hepatitis Drug Study

Vertex Pharmaceuticals Inc. (VRTX) reported the success of the second of three key late-stage studies of hepatitis-C treatment, telaprevir, essentially curing 72% of patients using the drug.

The study, a supplement to the larger studies intended to support teleprevir's approval, showed there was no benefit to extending treatment to 48 weeks from 24 weeks in the majority of patients. The results are notable because they improve the sustained viral response, or SVR, which is essentially a cure for the liver disease, and shorten the length of therapy for most patients.

Vertex shares recently slid 2.3% to $36.14 on a down day for the market so far. The study's success was largely expected as investors watch for the data of all three studies, the last of which is coming in September, to gauge telaprevir's place in a competitive hepatitis C market. Vertex's shares, up 11% since late July, rose 2.3% in the wake of news of the first study's success in May.

Hepatitis C is a blood-transmitted virus that causes liver inflammation and can lead to cirrhosis, cancer and liver failure.

The current standard therapy, a combination of pegylated-interferon injections and ribavirin pills over 48 weeks, achieves an SVR in up to about 50% of patients, according to the Centers for Disease Control.

The latest study, called Illuminate, included 540 people infected with the genotype 1 strain of the virus, its most common form in the U.S. and Europe.

The trial is considered supplemental, as it is a single-armed study with no patient group taking a placebo, as they do in the other late-stage studies.

In the Illuminate trial, all patients received telaprevir for 12 weeks with standard therapy, with interferon and ribavirin continuing for another 12 weeks.

The results showed a cure for 72% of all patients in the trial. For the 65% of patients showing an early response to the drug, those on a 24-week regimen showed a 92% SVR rate and a 48-week group achieved SVR in 88% of patients. The relapse rate in the short regimen was 5.7%, compared with 1.9% in the longer group.

Vertex plans to complete its marketing application to the Food and Drug Administration before the end of the year. The company plans to market the drug itself in North America, while Johnson & Johnson (JNJ) will help sell telaprevir overseas, with Mitsubishi Tanabe Pharma Corp. (4508.TO) holding rights in Japan and some other Asian countries.
 
 

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