Valeant hep C drug fails pivotal trial, again

Valeant Pharmaceuticals announced that its hepatitis C drug Viramidine performed worse than a standard therapy in its second of two Phase III trials. Volunteers taking Viramidine registered a 40 percent sustained viral response rate compared to 55 percent of the participants taking ribavirin. But researchers noted that volunteers taking a higher dose of Viramidine registered higher response rates without an increase in anemia. And they underscored that Viramidine appeared safer than ribavirin in the study. Valeant CEO Timothy Tyson noted that the data looks a lot like the returns from their first Phase III trial and added that researchers were preparing a higher dose study. In addition, Tyson said that the company would look for a partner to develop the drug if they launch a new Phase III trial next year.

The data arrived just hours after Valeant announced that the SEC had begun a probe into stock trades made this spring around the time it released data from a Phase III trial of Viramidine that sent its stock into a swoon. Investigators are also probing stock option grants and the biotech's efforts to recover bonuses paid to former CEO Milan Panic, who was fired in 2002.

- see the release on the trial data
- check out this report from The Los Angeles Times on the probe