Vertex wins an expedited review of telaprevir app

The FDA has granted an expedited review for Vertex's hepatitis C therapy telaprevir, setting up a likely horse race with Merck's boceprevir to see which can hit blockbuster status first.

The FDA is scheduled to hand down a decision on telaprevir by May 23, giving it potential lead over Merck's boceprevir. Boceprevir is also up for an expedited decision from the agency, which the FDA scheduled early this month.

Back at the JP Morgan event in San Francisco, Vertex CEO Matthew Emmens presented a picture of self confidence about telaprevir, a drug that has demonstrated significant efficacy in eliminating signs of hepatitis C. Analysts generally give telaprevir a solid edge over boceprevir as the better of the two therapies. But Emmens said that with three million untreated patients to target, there's ample room for both new therapies. And he also didn't seem fazed by the prospect of taking on Merck with a newly organized sales force.

"Having started two sales forces from scratch... we went up against companies ten times our size and had a larger market share in the end," he told the JP Morgan audience. He plans to do it again.

- check out the Vertex release
- here's the Reuters story