Additional Data From QNEXA Clinical Trials Presented at the European Congress on Obesity

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

Presentations to European Medical Community Highlight the Benefits of QNEXA Treatment Including:

- Prevention of Progression to Diabetes

- Sustained Weight Loss over Two Years, and

- Reduction in Cardiometabolic Risk

MOUNTAIN VIEW, Calif., May 31, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that multiple abstracts were presented over the weekend at the European Congress on Obesity (ECO) in Istanbul, Turkey.  ECO is the official obesity congress of The European Association for the Study of Obesity (EASO). ECO is regularly attended by more than 2500 participants from over 75 countries and is considered to be the most important annual scientific event on obesity in Europe.  

Highlights from the ECO presentations were as follows:

A poster presentation authored by W. Timothy Garvey, MD from the University of Alabama at Birmingham reported reductions in progression to type 2 diabetes and improvement in glycemic status in CONQUER patients that were ADA-defined as prediabetics at baseline.  Of the 2,487 patients in the CONQUER study, 1,119 were determined to have prediabetes.  In the prediabetics treated with QNEXA, hemoglobin A1c, fasting glucose and fasting insulin were significantly improved at week 56 (ITT-LOCF p<0.005 vs. placebo).  In the prediabetic population significantly more QNEXA treated patients achieved normal blood sugar levels (p=0.0016) and significantly more patients on placebo were progressed to type 2 diabetics as compared to the QNEXA treated patients (p=0.0253).  

"For this set of patients, QNEXA treatment led to benefits above and beyond losing weight.  The results highlighted by Dr Garvey showed that weight loss after 56 weeks of treatment led to an improvement in glycemic status and reduction of progression to type 2 diabetes.  This clinically important finding further strengthens the QNEXA benefit profile," added Barbara Troupin, MD, senior director of medical affairs for VIVUS.  

The CONQUER study included 2,487 patients that had two or more comorbidities studied over 56 weeks.  Patients were randomized to receive mid-dose QNEXA (498), top-dose QNEXA (995) or placebo (994).  All patients received lifestyle modification instruction.  QNEXA patients had significant weight loss at week 56 as compared to placebo (p<0.0001).  Least squares mean percent weight loss at week 56 was 9.8% top-dose, 7.8% mid-dose, and 1.2% placebo. The most common side effects were dry mouth, tingling, constipation, upper respiratory infection and runny nose.  

Dr Garvey also authored a poster that included the results of the SEQUEL study which showed that QNEXA treatment led to significantly greater weight loss as compared to placebo (p<0.0001, IIT-LOCF LS mean weight loss of 10.5% top-dose, 9.3% mid-dose, 1.8% placebo).  The differences between both treatment groups and placebo were significant starting at week 8.  Significantly more patients treated with QNEXA achieved greater than 5%, 10%, 15%, 20% weight loss in a dose-related fashion than placebo (p<0.0072).  Specifically categorical weight loss over two years was as follows:

Categorical Weight Loss from Baseline

 

 

 

 

 

 
 

 

5%

10%

15%

20%

 

Top-dose

79.3%

53.9%

31.9%

15.3%

 

Mid-dose

75.2%

50.3%

24.2

9.2%

 

Placebo

30.0%

11.5%

6.6%

2.2%

 
         


 

The SEQUEL study was a one year extension study of the CONQUER study.  676 patients were enrolled, with 574 (84.9%) of patients completing all study visits.  The percentages of patients completing study visits were similar between treatment groups.  Treatment with QNEXA was generally well tolerated with no new safety signals seen between week 56 and 108.  The most common treatment-emergent adverse events were upper respiratory infection, constipation, tingling, sinus infection and dry mouth.  Top-line results of SEQUEL were previously reported but the Garvey poster represents the first time the full data set has been presented to the European medical community.

"Double digit weight loss over two years was demonstrated with QNEXA," commented Peter Y. Tam, president of VIVUS, Inc.  "There were no new side effects observed in the second year and long-term treatment was well tolerated as evidenced by the completion rate of approximately 84% for both QNEXA doses."

Stephan Rossner, MD, PhD, Professor in Health Related Behavioral Science at Karolinska Institutet in Stockholm, gave an oral presentation which demonstrated that the degree of weight loss from QNEXA treatment was directly correlated with significant improvements in multiple obesity-related cardiometabolic risk factors.  Specifically, a comparative categorical analysis of CONQUER patients at week 56 demonstrated that patients achieving weight loss of greater than 10% and greater than 15%  had significantly greater improvements in several important cardiometabolic risk factors than patients who were only able to achieve weight loss of  5% to 10%.   For patients that achieved greater and 10% and 15% weight loss significant improvement was observed for waist circumference, blood pressure, triglycerides, HDL cholesterol and blood sugar (HbA1c and fasting glucose) as compared to patients with weight loss of 5% to 10%.  

"Traditional wisdom is that all you need to lose is 5-10% to see cardiovascular and metabolic improvements.  In Dr Rossner's presentation we can see that 5-10% weight loss has an impact on cardiometabolic risk factors but weight loss of 10-15% or >15% is statistically significantly greater," commented Wesley Day, vice president of clinical development for VIVUS, Inc.  "The incremental weight loss led to a doubling of the improvement for most risk factors reviewed.  The presentation supports our belief that the significant weight loss seen with QNEXA will lead to improvements in comorbidities."  

Copies of the posters and presentation are available on our website at www.vivus.com.  

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 completed its 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," "expect" 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.  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: May 2011

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