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Multiple Presentations Featuring Long-term QNEXA Data at the American Diabetes Association 71st Scientific Sessions

Update: Qsymia (phentermine/topiramate) Now FDA Approved - July 17, 2012

Additional Data from the SEQUEL Study Includes Diabetes Prevention Data and Impact of Weight Loss on Comorbidities

MOUNTAIN VIEW, Calif., June 22, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple abstracts have been accepted for presentation at the upcoming American Diabetes Association (ADA) meeting to be held June 24th to June 28th, 2011, at the San Diego Convention Center, San Diego, CA.  Timothy Garvey, MD, Professor of Medicine and Chair of the Department of Nutrition Sciences at UAB, will present his findings on the impact of QNEXA treatment on metabolic syndrome.  Donna Ryan, MD, Associate Executive Director for Clinical Research at Pennington Biomedical Research Center, will present her findings on the prevention of diabetes and normalization of fasting glucose in prediabetics after two years of QNEXA treatment.  Lastly, Robert Kushner, MD, Clinical Director at Northwestern University Comprehensive Center on Obesity (NCCO), will share his analysis of long-term weight loss with QNEXA and the resulting improvement in glycemic biomarkers.  

Top-line results from the SEQUEL study have been previously presented but the ADA presentations represent the first detailed presentation of glycemic data to ADA members.  Details on the presentation times are as follows:

Sunday, June 26, 2011 – General Poster Session II, Abstract # 1875-P, Presentation time 12:00-14:00 (local time)

Monday, June 27, 2011 – Pharmacologic Treatment of Obesity, Abstract # 1875-P, Guided Audio Tour, Presentation time 13:00-14:00 (local time)

Authors:  W. Timothy Garvey, MD; Robert R. Henry, MD; Craig A. Peterson MS; Charles H. Bowden, MD

Title:  WEIGHT LOSS WITH CONTROLLED-RELEASE PHENTERMINE/TOPIRAMATE (PHEN/TPM CR) REVERSES METABOLIC SYNDROME (METS) AND IMPROVES ASSOCIATED TRAITS

Sunday, June 26, 2011 – General Poster Session II, Abstract # 1887-P, Presentation time 12:00-14:00 (local time)

Authors:  Donna H. Ryan, MD; W. Timothy Garvey, MD; Barbara Troupin, MD, MBA; Wesley Day, PhD

Title:  DIABETES PREVENTION AND NORMALIZATION OF FASTING GLUCOSE IN SUBJECTS WITH PREDIABETES USING CONTROLLED-RELEASE PHENTERMINE/TOPIRAMATE (PHEN/TPM CR) IN A 2 YEAR WEIGHT LOSS INTERVENTION

Sunday, June 26, 2011 – General Poster Session II, Abstract # 1906-P, Presentation time 12:00-14:00 (local time)

Authors:  Robert F. Kushner, MD; W. Timothy Garvey, MD; Barbara Troupin, MD, MBA; Wesley Day, PhD

Title:  LONG-TERM WEIGHT LOSS AND IMPROVEMENT IN GLYCEMIC PARAMETERS WITH LOW-DOSE, CONTROLLED-RELEASE PHENTERMINE/TOPIRAMATE (PHEN/TPM CR)

All posters will be displayed in Hall B – Poster Hall, General Poster Session II on Sunday, June 26th between 12:00-14:00 (local time). In addition, the poster titled, "Weight Loss with Controlled-Release Phentermine/Topiramate (PHEN/TPM CR) Reverses Metabolic Syndrome (MetS) and Improves Associated Traits" will be featured in a Guided Audio Tour on Monday, June 27th between 13:00-14:00 (Hall B – Poster Hall).

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 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.

CONTACT:  


 

 
 

 

 

 
 

VIVUS, Inc.

Investor Relations:

The Trout Group

 

Timothy E. Morris


 

Brian Korb

 

Chief Financial Officer


 

bkorb@troutgroup.com

 

650-934-5200


 

646-378-2923

 
     


 

SOURCE VIVUS, Inc.

Web Site: http://www.vivus.com
 

Posted: June 2011

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