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UPDATE 2-InterMune gives promising mid-stage data on hep C drug
April 14, 2010 / 12:41 PM / in 8 years

UPDATE 2-InterMune gives promising mid-stage data on hep C drug

* Says 88 pct patients showed virologic response on 300 mg

* Says 89 pct show response on 600 mg

* Serious adverse events were balanced

* Shares touch 8-year high

(Adds details, analyst comment; updates stock movement)

By Krishnakali Sengupta

BANGALORE, April 14 (Reuters) - U.S. biotechnology company InterMune Inc ITMN.O reported encouraging results from a mid-stage trial of its experimental treatment for hepatitis C, sending its shares to their highest in eight years.

The company said serious adverse events were generally balanced across all treatment groups in the interim analysis of the study on danoprevir, which is being co-developed with Roche Holding AG ROG.VX.

In November, InterMune had said it would discontinue testing in its 900 mg dose arm following elevated levels of ALT, an enzyme that indicates problems with the liver. [ID:nBNG443851]

“After November, I had completely written the drug off, but with today’s data they (InterMune) are back on the game,” said analyst Brian Skorney of ThinkEquity LLC.

Results from the study showed that the drug delivered virologic response in 88 percent of patients treated with 300 mg dosage for 12 weeks.

The company said 89 percent of the patients showed virologic response in the 600 mg dosage arm.

Analyst Skorney said he was impressed with the data, although tackling ALT elevation would be the biggest concern.

The company said in the treatment groups, ALT elevation occurred generally between weeks six to eight or later and this was reversible after the drug was discontinued.

The 12-week study in patients with chronic hepatitis C compared a combination of danoprevir and two standard-of-care anti-viral drugs with a dummy combination.

InterMune said it was now focused on making the critical dose and regimen selection decision for the development of the drug.

“Although ALT elevation is a problem that will be hard to overcome and a liver-toxic drug in hepatitis C is a hard sell, the real driver today was the feasibility of the drug for the treatment of hepatitis C,” analyst Skorney said.

“The question now is to see whether it can completely eliminate ALT elevation.”

InterMune shares were up 39 cents at $48.32 in morning trade Wednesday on Nasdaq. They touched a high of $49.05 in early trade. (Reporting by Krishnakali Sengupta; Editing by Vinu Pilakkott and Gopakumar Warrier)

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