Valeant hepatitis C drug misses efficacy target

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Valeant hepatitis C drug misses efficacy target

13th September 2006

By Routledge

Valeant Pharmaceuticals International has reported that its hepatitis C drug Viramidine did not meet efficacy goals in a second late-stage trial, although the treatment has proved to be safe.

The California-based company is developing Viramidine for use in treating chronic hepatitis C in combination with pegylated interferon, which Valeant hoped to prove would be as efficacious as the current therapy, without the side effects.

Although the trial confirmed the safety advantages of the drug, with anemia rates significantly lower in patients treated with Viramidine, the study did not show the drug to be effective, the company said.

As a result, the company is initiating a mid-stage trial to evaluate the efficacy of Viramidine at higher doses. Based on a 12-week interim analysis of this study, the company will decide whether to begin a third phase 3 study at the appropriate higher dose indicated by the phase 2b study. The company will seek to co-develop the product should it decide to pursue another phase 3 registration trial next year.

The company also announced the issuance of a US patent for Viramidine for use in the treatment of hepatitis C, which will not expire until 2020.

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