Vivus Inc. (VVUS) recently presented multiple abstracts at the European Congress on Obesity. The presentations were related to studies (CONQUER and SEQUEL) on the company’s type II diabetes candidate — Qnexa.
The CONQUER trial enrolled 2,487 patients on type II diabetes, and demonstrated reductions in progression of type II diabetes and improvement in glycemic status among patients who were dosed with Qnexa compared with those on placebo.
Of the 2,487 patients in the study, 1,119 were prediabetic. Among the prediabetic patients, the ones treated with Qnexa experienced a significant improvement in hemoglobin A1c (a measure of blood glucose), fasting glucose and fasting insulin at week 56 as compared with those on placebo. Additionally, a higher number of patients on Qnexa achieved normal blood sugar levels.
The CONQUER study also demonstrated that patients on Qnexa (mid- and top-dose) showed increased weight loss after 56 weeks of treatment as compared with those on placebo.
Vivus also presented data from the SEQUEL study, which is a one-year extension study of the CONQUER trial. The SEQUEL study enrolled 676 patients. It was noted in the SEQUEL study that treatment with Qnexa led to considerably higher weight loss as compared with placebo.
Earlier, in April, Vivus had reported top-line results from SEQUEL study, conducted on 676 obese/overweight patients, who had two or more weight-related co-morbidities and an average baseline body mass index (BMI) of 36.1.
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.
In January, Vivus 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 (GSK) as Alli.
Neutral on Vivus
We currently have a Neutral recommendation on Vivus, which carries a Zacks #3 Rank (short-term Hold rating). We expect investor focus to remain on Vivus’ future course of action for erectile dysfunction candidate, avanafil and Qnexa’s approval.
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