Vivus, Inc. (VVUS) recently reported positive data from the SEQUEL study on its weight loss candidate, Qnexa. The 52-week SEQUEL study included 675 obese/overweight patients, who had two or more weight-related co-morbidities and an average baseline body mass index (BMI) of 36.1. SEQUEL is an extension study of patients who completed the 56-week CONQUER study.
The study data demonstrated a reduction in blood pressure and the need to use antihypertensive medications, along with improved lipid levels. The improvement in lipid levels resulted from significant weight loss in patients treated with Qnexa for two years as compared to those in the placebo arm.
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 trials for type II diabetes and obstructive sleep apnea.
Vivus recently had an End-of-Review meeting with the US Food and Drug Administration (FDA) in response to the agency’s Complete Response Letter for Qnexa, received in October 2010. At the meeting, the company discussed its plans to resubmit the New Drug Application (NDA) for Qnexa as a treatment for obesity. Vivus intends to make the resubmission by the end of 2011.
The company also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Qnexa in December 2010. A smooth review process could result in Qnexa receiving EU approval in late 2011.
Once approved, Qnexa will face competition from currently available obesity treatment orlistat, sold by Roche Holdings Ltd. (RHHBY) as Xenical and by GlaxoSmithKline plc (GSK) as Alli.
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.
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