April 3, 2008
On Monday, Rule Breakers pick CV Therapeutics (Nasdaq: CVTX ) presented preclinical data on its lead drug Ranexa at the American College of Cardiology (ACC) meeting.
Ranexa is already approved and marketed by CVT as a treatment for angina sufferers who are not responding to their current medications. CVT is also waiting to hear back from the FDA on its marketing applications to expand Ranexa's use into front-line angina, and for diabetics with coronary artery disease. The PDUFA review date for these two marketing applications is July 27, although it's anyone's guess whether the FDA can meet these review date goals. CVT suffered an FDA delay earlier this month with another drug.
The preclinical data on Ranexa that CVT announced on Monday was related to the drug's potential efficacy against type 2 diabetes, specifically Ranexa's ability to help control blood glucose levels. Although not a prerequisite for FDA approval, this information is important; the FDA also likes to understand how a drug works (its mechanism of action) when ruling on a compound. CVT surely hopes that the FDA will buy its argument and approve the new indication, so that it can compete -- in a limited subpopulation of diabetics -- against other diabetes treatments like GlaxoSmithKline's (NYSE: GSK ) Avandia and Eli Lilly' (NYSE: LLY ) and Amylin Pharmaceuticals' (Nasdaq: AMLN ) Byetta.
The ACC meeting actually included nine presentations related to Ranexa. Investors interested in an overview can type in Ranexa's generic name (ranolazine) in the search field here to read them. CVT's choice to spotlight the preclinical mechanism of action data in an ACC press release, rather than providing clinical trial results, should assure investors that the company announced nothing dramatic at the conference. Nonetheless, the company's touting of Ranexa's potential benefits and past clinical trial successes will only help publicize its drug, and perhaps grow its sales from last year's $67 million.