For primarily development-stage drugmakers like Vertex Pharmaceuticals
Vertex's second-quarter financial results were not particularly interesting. The drugmaker continued burning through its cash faster than MC Hammer. Current assets were down over $165 million in the first half of the year to $660 million, and expensive pivotal phase 3 studies for hepatitis C (HCV) treatment telaprevir are yet to start.
The more interesting information in the earnings release came when Vertex announced new data for telaprevir -- additional results from its Prove 1 phase 2 study. In patients who completed 12 weeks of combination telaprevir therapy plus the standard of care treatment followed by another 12 weeks on just the current standard of care for HCV treatment, less than 10% had relapsed after an additional 12-week follow-up period.
This low rate of relapse following just a half year of treatment provides further evidence of the potential for telaprevir to shorten the duration of time that genotype 1 HCV patients have to be on therapy in order to potentially be cured of their HCV infection.
Normally patients have to take 48 weeks of the currently approved treatments to see if the drugs, Pegasys from Roche or Peg-Intron from Schering-Plough
Vertex is still likely several years away from any potential telaprevir regulatory approval in the U.S. Phase 3 studies are expected to begin at the end of the year and will likely track patients over at least 48 weeks, which means data won't be available until 2009 at the earliest. If Vertex needs to rely on its phase 3 studies for regulatory approval, then that means telaprevir won't be on the market until late 2010 at the earliest. Even with that long timeline shares of Vertex aren't expensive when you consider the drug's sales potential or what shares of peer companies like Elan
Vertex and PDL BioPharma are Rule Breakers selections.You can check out all our recommendations as well as get access to our message boards and exclusive content with a 30-day free trial.