Valeant Pharmaceuticals International said a key drug undergoing testing has proven to be similiarly effective at treating hepatitis C as its fading flagship ribavirin.
The Costa Mesa-based drug maker also said it has enrolled patients in a third-phase study of Viramidine. A filing of a new drug application with the Food and Drug Administration could follow the third phase.
“We are excited about Viramidine’s potential and look forward to continuing the phase three pivotal trials, which both finished enrollment in record time,” said Chief Executive Timothy Tyson in a release.
Valeant’s study, conducted through the liver transplant program at the California Pacific Medical Center in San Francisco, involved 180 patients with chronic hepatitis C.
The company has a lot riding on Viramidine. Ribavirin has been Valeant’s key product but has lost sales of late as competiting drugs have taken away sales.
The second-phase trial of Viramidine, meanwhile, has led to a lawsuit against the drug maker from a Bay area woman who alleges she suffered brain damage and permanent disabilities.
In her complaint, Linda Iacovetta said that while seeking treatment for hepatitis C at California Pacific, she was encouraged to be in the trial, which looked at how Viramidine and pegylated interferon worked in concert to fight the liver disease.
Iacovetta’s suit said that she was on the drug combination for five months in 2003. She alleged that Valeant and California Pacific doctors who conducted the trial failed to warn users of the risks of taking the drug.
Valeant spokesman Jeff Misakian said earlier this week that Iacovetta’s complaint was “completely without merit,” but didn’t comment further because it is active litigation.
