Data From QNEXA Sequel Study Featured at the 47th EASD Annual Meeting

MOUNTAIN VIEW, Calif., Sept. 16, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple abstracts were presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal.  The presentations highlighted the long-term beneficial effects of QNEXA treatment in metabolically-impaired patients with prediabetes, diabetes, and metabolic syndrome.

The QNEXA presentations included:  

• Decreased Progression to Diabetes in Subjects With Prediabetes After 2 Years of Treatment With Controlled-Release Phentermine/Topiramate, authored by W. Timothy Garvey, MD, et al.
• Long-Term Weight Loss With Controlled-Release Phentermine/Topiramate Reverses Metabolic Syndrome and Improves Associated Traits, authored by Hermann Toplak, MD, et al.
• Long-Term Glycaemic Effects of Weight Loss With Low-Dose, Controlled-Release Phentermine/Topiramate in Overweight/Obese Subjects with Diabetes, authored by Luc F. Van Gaal, MD, et al.

Highlights from the EASD presentations are as follows:

A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported that patients treated over two years with QNEXA had significant reductions in the progression to type 2 diabetes and improvement in glycemic status. Of the 675 patients in the two-year SEQUEL study, 316 were determined to have prediabetes at baseline. In the prediabetic sub-group treated with QNEXA, all glycemic parameters were significantly improved at week 108 (ITT-LOCF; P<0.05 vs. placebo). Progression to diabetes was reduced in the prediabetic sub-group with top-dose QNEXA vs. placebo (P=0.0125).  

Luc Van Gaal, MD from the University of Antwerp in Belgium and Lawrence Cheskin, MD from Johns Hopkins University Weight Management Center authored a poster showing long-term QNEXA data on glycemic effects in type 2 diabetic patients (N=145) from the two-year SEQUEL study. In the SEQUEL diabetic sub-group, greater percent weight loss was achieved with QNEXA when compared to placebo at week 108 (9.0% in the mid- and top-dose QNEXA and 2.0% placebo within the diabetic sub-group P≤0.0003). Within the diabetic sub-group, improvements were seen in fasting glucose, fasting insulin and hemoglobin A1c in the QNEXA-treated groups. The QNEXA-treated patients also had reduced utilization of concomitant antidiabetic medications as compared to placebo (P=0.0130).  

A poster presentation by Dr. Hermann Toplak from the Medical University of Graz, Austria focused on long-term QNEXA treatment, sustained weight loss, reversal of metabolic syndrome and improvements in associated traits. Of the 675 patients enrolled in SEQUEL, 451 (66.8%) met the criteria for metabolic syndrome. Average percent weight loss at week 108 within the metabolic syndrome sub-group was 11.1% mid-dose QNEXA, 12.2% top-dose QNEXA and 2.8% placebo (P<0.0001 vs. placebo). The percentage of patients demonstrating resolution of metabolic syndrome was significantly higher within the QNEXA treatment arms at week 108 [22.4% mid-dose (P=0.0031), 27.6% top-dose (P<0.0001)] vs. 9.2% with placebo. Conversely, the percentage of patients without metabolic syndrome at baseline, who progressed to metabolic syndrome at week 108, were higher in the placebo group at 60% vs. 23% with top-dose QNEXA (P= 0.0050).    

In all three analyses, the safety profile was consistent across subpopulations and the most common adverse events seen were upper respiratory infection, constipation, tingling, runny nose and dry mouth.

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 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 US 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 submitted an NDA for 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 or FORTRESS; 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.