VIVUS, Inc. Release: QNEXA® Data Featured at the American Diabetes Association’s 71st Scientific Sessions

MOUNTAIN VIEW, Calif., June 27, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple posters were presented at the American Diabetes Association (ADA) meeting on June 26th and 27th, 2011, in San Diego, CA. The ADA Scientific Sessions is the world’s largest and most prestigious diabetes meeting. Top-line results from the CONQUER and SEQUEL studies have been previously reported, but the ADA presentations represent the first time detailed glycemic results have been presented to medical professionals that specialize in diabetes.

Donna Ryan, MD,Associate Executive Director for Clinical Research at Pennington Biomedical Research Center, Baton Rouge, LA, presented findings on June 26th on diabetes prevention in pre-diabetic patients from the two-year SEQUEL study, showing greater weight loss in this important pre-specified population (11.1% and 12.7% weight loss at two years with QNEXA mid and top dose, respectively, compared to 2.2% weight loss with placebo; ITT-LOCF, P<0.0001). Patients treated with QNEXA top dose experienced significant improvements in blood sugar, fasting glucose and fasting insulin levels, with more than 50% of patients achieving normal glucose levels. In addition, there were significantly more patients in the placebo group that progressed to becoming diabetic as compared to the group treated with the top dose of QNEXA. (Poster #1887-P)

On June 26th, Robert Kushner, MD, Clinical Director at Northwestern University Comprehensive Center on Obesity in Chicago, IL shared an analysis from the SEQUEL study of long-term weight loss in type 2 diabetic patients with QNEXA and the resulting improvement in glycemic biomarkers. Diabetics treated with both QNEXA doses lost 9.0% of their baseline body weight after two years of treatment, compared to 2.0% in the placebo group (ITT-LOCF, P<0.001). Glycemic parameters in the type 2 diabetic patients were improved, and patients on QNEXA top dose achieved this benefit without any additional requirement for concomitant diabetic medications while placebo-treated subjects had smaller numerical glycemic improvements and statistically significant relative increases in need for diabetes medications (P=0.013). (Poster# 1906-P)

On June 27th, during a guided audio tour, Timothy Garvey, MD, Professor of Medicine and Chair of the Department of Nutrition Sciences at University of Alabama Birmingham, presented data from the one-year CONQUER study showing that QNEXA treatment in metabolic syndrome patients lead to significant weight loss as compared to placebo (8.7% and 10.8% mid and top dose, 2.0% placebo, LOCF, P<0.0001). Metabolic syndrome is defined as having at least three of the following criteria: large waist circumference, high triglycerides, low HDL, high blood pressure, and excess blood sugar. In addition, the weight loss experienced in the metabolic syndrome patients treated with QNEXA led to a resolution of metabolic syndrome at nearly twice the rate as those on placebo (24% vs 12.7%; P<0.0001). (Poster # 1875-P)

About QNEXA Controlled Release Capsules

QNEXA [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors when used in combination with a diet and lifestyle modification program.

About the CONQUER Study

The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States. The average baseline BMI of the study population was 36.6 kg/m2 and baseline weight was 227 pounds. The study was a randomized, double-blind, placebo-controlled, 3-arm, prospective trial with patients randomized to receive once-a-day treatment with mid-dose QNEXA, top dose QNEXA or placebo. Patients had a 4-week dose titration period followed by 52 weeks of treatment. Throughout the 56-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day. Patients were actively managed to standard of care for weight-related co-morbidities, which included the ability for physicians to adjust or alter medications for these conditions, including in the placebo group.

About the SEQUEL Study

SEQUEL (OB-305) was a double-blind, placebo-controlled, three-arm, prospective study. Patients continued receiving the same treatment assignment to which they had been randomized in the CONQUER study in a blinded fashion: either once-daily treatment with top-dose QNEXA (n=295), mid-dose QNEXA (n=153), or placebo (n=227). The SEQUEL study was a 52-week extension study for a subset of patients who completed the 56-week CONQUER study. The total study period was 108 weeks. SEQUEL included 675 obese or overweight patients, all of whom had two or more weight-related co-morbidities and an average baseline BMI of 36.1. Throughout the 108-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day.

About VIVUS

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead investigational product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by U.S. and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial QNEXA NDA on October 28, 2010. QNEXA is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has completed phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing and substance of our response to the FDA’s requests from the End of Review meeting; our response to, and continued dialogue with, the FDA relating to matters raised in the FDA’s CRL; the timing and results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy; the FDA’s interpretation of and agreement with the information VIVUS submitted and may submit relating to teratogenicity and cardiovascular safety; the FDA’s interpretation of the data from our SEQUEL study, or OB-305; the FDA’s requests, if any, to conduct additional prospective studies or retrospective observational studies or to provide further analysis of clinical trial data; the review and questions from the EMA and CHMP on the MAA; substantial competition; the impact on future sales based on specific indication and contraindications contained in the label and the extent of the Risk Evaluation and Mitigation Strategies program; uncertainties of litigation and intellectual property and patent protection; reliance on sole-source suppliers; limited sales and marketing resources and dependence upon third parties; risks related to the development of innovative products; risks related to the failure to obtain FDA or foreign authority clearances or approval; noncompliance with FDA or foreign regulations; and our dependence on the performance of our collaborative partners. As with any pharmaceutical in development, there are significant risks in the development, the regulatory approval, and commercialization of new products. There are no guarantees that our response to the FDA’s CRL or the results of the retrospective observational study of fetal outcomes in infants born to mothers exposed to topiramate during pregnancy and subsequent meetings and communications will be sufficient to satisfy the FDA’s safety concerns, that the FDA will not require us to conduct any additional prospective studies or retrospective observational studies, or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statements. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ending December 31, 2010, and periodic reports filed with the Securities and Exchange Commission.

SOURCE VIVUS, Inc.