Recently, encouraging data were published on Vivus, Inc.’s ([stock]VVUS[/stock]) weight loss candidate, Qnexa, in the journal, The Lancet. The 56-week late stage study (CONQUER: n=2,487) evaluated the safety and efficacy of Qnexa in overweight/obese patients suffering from high blood pressure, high cholesterol or type II diabetes.
Data from the study, conducted across 93 sites in the US, revealed significant improvements in cardiovascular and metabolic disease risk factors in patients on being treated with Qnexa compared to those treated with a placebo.
We note that Vivus is evaluating Qnexa as a potential treatment for weight loss, type II diabetes and obstructive sleep apnea. The candidate is in mid-stage development for type II diabetes and obstructive sleep apnea.
We note that in October 2010, the US Food and Drug Administration (FDA) issued a complete response letter to Vivus for Qnexa for obesity. On receiving the CRL, Vivus had an end-of-review meeting with the FDA in January 2011. The company intends to resubmit the new drug application for Qnexa for the indication by the end of 2011.
Vivus also filed a Marketing Authorization Application with the European Medicines Agency for Qnexa in December 2010. A smooth review process could result in Qnexa receiving EU approval in late 2011.
Neutral on Vivus
We currently have a Neutral recommendation on Vivus, which is supported by a Zacks #3 Rank (short-term Hold rating). We expect investor focus to remain on Vivus’ future course of action for its erectile dysfunction candidate, avanafil, and Qnexa’s approval for weight loss.
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