Additional Analysis from Two-Year Sequel Study of QNEXA Featured at The 2011 Annual Scientific Meeting of The Obesity Society
MOUNTAIN VIEW, Calif., Sept. 29, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple abstracts will be presented at Obesity 2011, the 29th Annual Scientific Meeting of The Obesity Society, to be held October 1st to October 5th, 2011 in Orlando, Florida. The Obesity Society's Annual Scientific Meeting has grown to be one of the largest gatherings of obesity professionals worldwide.
The posters will be displayed in the Cypress Ballroom of the Orlando World Center Marriott on October 3, 2011 from 9:30 a.m. to 1:45 p.m. Eastern Time (ET) and from 3:00 p.m. to 6:30 p.m. ET. Authors will be available at the posters on October 3, 2011 from 12:30 p.m. to 1:30 p.m. ET.
Weight Loss With Controlled-Release Phentermine/Topiramate is Associated With Significant Reductions in Use of Concomitant Medications for Cardiometabolic Diseases Over 108 Weeks
W. Timothy Garvey, MD; Thomas Najarian, MD; Craig Peterson, MS
Weight Loss With Low-Dose, Controlled-Release Phentermine/Topiramate Correlates With Improvements in Liver Function in Overweight/Obese Adults With Elevated Alanine Aminotransferase
Samuel Klein, MD; Thomas Najarian, MD; Barbara Troupin, MD, MBA; Wesley W. Day, PhD
Severely Obese Adults Administered Controlled-Release Phentermine/Topiramate Maintained Their Weight Loss in the Second Year
Kishore M. Gadde, MD; David B. Allison, PhD; Peter Y. Tam, MBA; Barbara Troupin, MD, MBA
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.
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; 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 with development, 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.
Investor Relations: The Trout Group
Timothy E. Morris
Chief Financial Officer
SOURCE VIVUS, Inc.
Posted: September 2011