Vivus to Roll Out Key Obesity Drug Data

In 2005, Vivus released data from a pilot study in 200 obese patients that resulted in an 8% weight loss, adjusted for placebo, in patients taking Qnexa for six months. Moreover, side effects were all mild to moderate.

This pilot study of Qnexa was conducted entirely at Duke University's obesity research clinic, which has a reputation for achieving superior results. Therefore duplicating the Qnexa weight-loss data in a larger trial conducted at multiple sites is an important milestone for Vivus.

In the next week or so, Vivus will release top-line results from the first of three phase III studies, known as EQUATE. This study enrolled more than 700 patients and will compare the weight loss after six months of Qnexa against a placebo and Qnexa's individual components taken as monotherapy.

Adam Cutler, biotech analyst at Cannacord Addams, says the EQUATE study is the first big test for Qnexa because it will provide a more robust picture of the drug's efficacy and safety than the previous pilot study conducted at Duke.

"The Duke study set a high bar for Qnexa, so while I don't expect EQUATE to come through with exactly the same results, I do expect weight loss that it almost as good -- call it high single digits," he says. Cutler has a buy rating on Vivus and a $12 price target. Vivus is not an investment banking client of Cannacord.

In a note sent to clients this week, Rodman & Renshaw's Jason Butler put Qnexa's magic weight-loss number from the EQUATE study at 8% to 8.5%, placebo adjusted.