UPDATE: Vertex Reports Strong Late-Stage Hepatitis-C Drug Data

Vertex Pharmaceuticals Inc. (VRTX) reported strong results from the first of three key late-stage studies of hepatitis-C treatment, telaprevir, showing success in three-quarters of patients using the drug for 12 weeks.

Shares were up 13% at $38.20 on the news after hours.

The study included 1,095 people infected with the genotype 1 strain of the virus, its most common form in the U.S. and Europe. The data show that 75% of those patients taking telaprevir for 12 weeks, along with a course of standard therapy that continued for at least another 12 weeks, had a sustained viral response, or SVR, which is essentially a cure for the liver disease.

Those patients in the control group, which received standard therapy of a combination of interferon injections and ribavirin pills over 48 weeks, achieved an SVR of 44%.

Notably, the majority of teleprevir patients, about 70%, with an SVR in the 12-week arm had a total course of therapy that was only 24 weeks. Depending on response, some patients took the other two drugs for up to 36 weeks after the initial 12-week course.

In another arm, which included an eight-week course of telaprevir, 69% of people achieved SVR.

The side effect profile of telaprevir's latest trial was consistent with that of earlier studies, with an improvement in discontinuation rates due to adverse events, including rash and anemia.

Vertex will report the data from two other large trials in the third quarter and will file for approval in the second half.

The company plans to market the drug itself in North America. Johnson & Johnson (JNJ) will help sell telaprevir overseas, with Mitsubishi Tanabe Pharma Corp. (4508.TO) holding rights in Japan and some other Asian countries.

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

The study, called Advance, was largely expected to be positive, but the strong SVR should further confidence in telaprevir's expected role in the lucrative but increasingly competitive hepatitis C market.

Last year, Johnson & Johnson projected the hepatitis C market would grow from $3.3 billion in 2008 to $7 billion in 2013, driven by sales of drugs like telaprevir.

Telaprevir is likely to face competition from Merck & Co.'s (MRK) boceprivir, which is on a similar development timeline, and many companies are developing hepatitis C treatments, including Bristol-Myers Squibb Co. (BMY), Gilead Sciences Inc. (GILD) and Roche Holding AG (RHHBY, ROG.VX).

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

(Joan E. Solsman contributed to this story)

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