Sanofi plots clinical trial to widen Multaq use

Sanofi-Aventis' (NYSE: SNY) heart drug Multaq may not have taken the market by storm, but the French drugmaker has plans to change that. Now approved for atrial fibrillation or atrial flutter, the drug will be tested in a new, large-scale trial in patients with permanent atrial fibrillation. The aim is to show that Multaq is effective against cardiovascular episodes such as stroke and heart attack in patients with irregular heartbeats.

"This is a trial of major significance since no anti-arrhythmic drug has ever been shown to reduce major morbidity and mortality in permanent AF patients in a large-scale clinical trial," Dr. Stuart Connolly, one of the principal investigators, tells Reuters. Known as PALLAS, the trial will involve 10,800 patients in 43 countries and compare Multaq with placebo.

Sanofi launched Multaq last year, and now markets the drug in the U.S. and several European countries. Touted by analysts as a potential blockbuster, the drug has been slow picking up steam; it racked up just 24 million euros ($30.4 million) in Q1 sales. Despite the slow start, Sanofi sees the drug as one of its best hopes for sales growth as it preps for generic competition for some of its biggest products.

According to Sanofi, permanent atrial fibrillation affects 50 percent of patients with AF, and these patients are "at a high risk of major adverse cardiovascular events." Success with these patients could open up a big new market for Multaq. "The initiation of the Pallas trial confirms our strong belief in Multaq and our commitment to improve AF patient well-being and overall cardiovascular health," Marc Cluzel, EVP of research at Sanofi, says in a statement. "We are looking forward to first patient enrollment ... in the third-quarter 2010."

- see the release from Sanofi
- read the Reuters piece
- get more from Dow Jones