VIVUS Announces Qnexa Abstract Presentation at the 7th International Congress on Coronary Artery Disease
The primary objective of the study was to evaluate changes in body weight. The weight loss data from this study had been previously reported. Dr. Gadde's poster presentation focused on the cardiovascular outcomes of patients in the study; specifically, changes in blood pressure (BP), lipids and C-reactive protein (CRP). Two hundred obese patients (mean BMI of 38.6) were randomly assigned to placebo (PBO), phentermine (PHN), topiramate (TPM), or Qnexa for 24 weeks. The results showed that mean changes in body weight (kg) for placebo, phentermine, topiramate, and Qnexa were reductions of 2.2, 5.3, 6.6, and 11.4, respectively (p less than 0.0001). The changes in cardiovascular risk factors from the study were as follows: -0-
CV Risk Factor PBO PHN TPM Qnexa P value ------------------------------------ ----- ------ ----- ------ ------- Waist circumference, cm -6.4 -6.8 -8.0 -12.6 .001 Systolic BP, mm Hg -1.7 -1.1 -5.2 -6.4 .008 Diastolic BP, mm Hg -1.3 -0.1 -3.6 -4.6 .037 Triglycerides, % 4.4 -0.3 -8.9 -15.2 .011 Total cholesterol, % -2.4 -5.3 -5.7 -9.2 .024 LDL cholesterol, % -1.2 -4.8 0.7 -5.2 .051 C-reactive protein, mg/dL 0.0 -0.1 -0.4 -0.2 .003
"While the weight loss data had been previously reported, this is the first time the cardiovascular data has been featured in a prestigious cardiovascular conference such as ICCAD. We are very encouraged by Dr. Gadde's presentation of the cardiovascular risk factor data and welcome the opportunity to share the Qnexa phase 2 results to the international cardiology community," said Leland F. Wilson, president and chief executive officer of VIVUS. "By complementing the phase 2 Qnexa results on weight-loss, this cardiovascular data goes further into confirming the importance of treating obesity as a leading cause of cardiovascular disease."
About Dr. Gadde
Kishore M. Gadde, M.D. was the principal investigator of the phase 2 trial for Qnexa. Dr. Gadde is a physician at Duke University Medical center in Durham, North Carolina where he is the Director, Obesity Clinical Trials Program, Department of Psychiatry.
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity and sexual health. VIVUS has three products that are positioned to enter phase 3 clinical trials. The pipeline includes: Qnexa(TM), for which a phase 2 study has been completed for the treatment of obesity; Testosterone MDTS(R), for which a phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); and avanafil, for which a phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE(R) is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company's web site at 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," "estimated" and "intend," among others. These forward-looking statements are based on VIVUS' current expectations and actual results could differ materially. 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, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful 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 statement. Investors should read the risk factors set forth in VIVUS' Form 10- K for the year ended December 31, 2006 and periodic reports filed with the Securities and Exchange Commission.
Timothy E. Morris, 650-934-5200
Chief Financial Officer
The Trout Group
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Posted: October 2007