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VIVUS Announces QNEXA Presentations at the European Association for the Study of Diabetes (EASD) Annual Meeting

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

 

 

 

 

 

MOUNTAIN VIEW, Calif., Sept. 21 /PRNewswire/ -- VIVUS, Inc. (Nasdaq: VVUS) today announced that data on QNEXA(R), an investigational drug candidate, are featured in two poster presentations at the 46th Annual Meeting of the European Association for the Study of Diabetes, being held September 20-24, 2010 in Stockholm, Sweden.

Following are details about the poster presentations:

European Association for the Study of Diabetes 46th Annual Meeting in Stockholm, Sweden

 

 

 
 

Presenter:

W. Timothy Garvey, MD      

 

Authors:

W. Timothy Garvey, M.D., Barbara Troupin, M.D., Wesley W. Day, Ph.D.

 

Title:

"Once-daily, low-dose, controlled-release phentermine/topiramate results in significant clinical improvements in overweight/obese patients with type 2 diabetes (Abstract # A-10-1824-EASD; Poster session 068 Obesity: Mechanisms and Therapies I – Presentation 774)"

 

Time/Date:

Tuesday, September 21, 2010 1:30 - 2:30 pm CET (with presenters);

 

 

Posters on display until Thursday, September 23, 2010 2:30 pm CET

 

 

 
 

Presenter:

Professor Luc Van Gaal      

 

Authors:

W. Timothy Garvey, M.D., Barbara Troupin, M.D., Wesley W. Day, Ph.D.

 

Title:

"Phentermine/topiramate combination therapy significantly improves glucose impairment in overweight/obese patients (Abstract # A-10-2497-EASD; Poster session 068 Obesity: Mechanisms and Therapies I – Presentation 773)"  

 

Time/Date:

Tuesday, September 21, 2010 1:30 -2:30 pm CET (with presenters);

 

 

Posters on display until Thursday, September 23, 2010 2:30 pm CET

 
   


 

About QNEXA Controlled Release Capsules

QNEXA [kyoo-nek-suh] is an investigational drug 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 together 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 submitted a New Drug Application (NDA) to FDA in December 2009 seeking approval of QNEXA for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. An action date has been set for October 28, 2010.

About Obesity

Approximately one-third of American adults (more than 72 million people) are obese, and many more are overweight with co-morbidities. Obesity is a chronic condition defined by having excess body fat. Obesity significantly increases the risk of developing many different diseases and health conditions, including type 2 diabetes, hypertension, metabolic syndrome, cardiovascular disease, some cancers and osteoarthritis. According to a report in The Lancet in 2009, morbid obesity shortens life expectancy by approximately 10 years, and moderate obesity shortens it by approximately 3 years.

In August of this year, the Centers for Disease Control and Prevention (CDC) called attention to the "major public health problem" of obesity by issuing a national report citing the lack of progress against goals established 10 years ago by the federal government. The CDC reported that all 50 states failed to meet the "Healthy People 2010" goal of lowering the obesity rate to 15%, and some states actually reported a significant increase in obesity rates.

About VIVUS

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and an NDA has been filed and accepted by the FDA, with an action date of 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 is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. 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," "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, 2009 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

 

 

 

 
 

 

Media Relations:

GolinHarris

 

 

 

Susan Brophy

 

 

 

sbrophy@golinharris.com

 

 

 

312-729-4359

 
     


 

SOURCE VIVUS, Inc.

CONTACT: Timothy E. Morris, Chief Financial Officer of VIVUS, Inc., +1-650-934-5200; or Investor Relations, Brian Korb of The Trout Group, +1-646-378-2923, bkorb@troutgroup.com; or Media Relations, Susan Brophy of GolinHarris, +1-312-729-4359, sbrophy@golinharris.com, both for VIVUS, Inc.
 

Web Site: http://www.vivus.com
 

Posted: September 2010

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