NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- VIVUS, Inc. , a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, today reported the glycemic findings from EQUATE (OB-301), a phase 3 trial evaluating Qnexa(TM) in non-diabetic, obese patients. After 28 weeks of treatment, blood sugar levels, as measured by hemoglobin A1c (HbA1c), were lower in the patients treated with Qnexa, while the patients in the placebo group had a significant increase in their HbA1c levels (p<0.0001). The placebo-adjusted reductions in HbA1c for patients taking Qnexa were 0.11 percent and 0.10 percent for the full-dose and mid-dose groups (p<0.0001). If HbA1c trajectories during this study were maintained, the average placebo-treated patient would develop diabetes, per guidelines established by the American Diabetes Association (ADA), in approximately eight years. Patients treated with Qnexa had weight loss of 9.2% and 8.5% on the full-dose and mid-dose of Qnexa as compared to weight loss of 1.7% in the placebo group (p<0.001). These findings (abstract 119-OR) are being presented by Louis Aronne, MD, Clinical Professor of Medicine at Weill-Cornell University and Director of New York Presbyterian Hospital's Comprehensive Weight Control Program, and a lead investigator in the study, at the 69th Scientific Sessions of the ADA. The podium presentation will take place during the Novel Diabetes Treatments in Development in Humans Session from 4:00-6:00 local time.
Dr. Aronne stated, "Obesity is the leading cause of type 2 diabetes. Studies have shown that type 2 diabetes can be treated effectively in most patients with significant weight loss. People with weight problems have a disease that can be treated; obesity is more about biology and not a person's lack of will power, and we are in desperate need of more effective tools to help our patients combat this disease and the other serious medical conditions that arise as a result of weight gain. These study results suggest that Qnexa is a promising pharmaceutical therapy to assist patients in achieving weight loss and to halt the progression towards type 2 diabetes. While the study was designed as an obesity trial, the positive impact on glycemic endpoints suggests potential health benefits in the non-diabetic obese population."
"Data from DM-230 showed that treatment with Qnexa will lower HbA1c in diabetic patients, but we now know that for patients that have not been diagnosed with diabetes, Qnexa treatment can prevent increases in HbA1c levels. Obesity is the common cause of type 2 diabetes and other metabolic and cardiovascular diseases. In this study, treatment with Qnexa arrested progression to diabetes completely. These data highlight the important but often underappreciated potential of treating the major cause of diabetes before the disease becomes apparent," said Leland Wilson, president and chief executive officer of VIVUS. "We expect the CONQUER study, a large ongoing phase 3 study that includes diabetic and pre-diabetic subjects, will further demonstrate the efficacy of Qnexa for weight loss and effective management of glycemic control in diabetic and non-diabetic patients."
"The clinical program has been carefully designed to test the safety and efficacy of Qnexa in a wide range of healthy and co-morbid obese patients. With the high hurdles of benefit/risk set by regulatory and reimbursement authorities, it's not enough for a drug to demonstrate weight loss; new obesity drugs should have the potential for impacting an important down-stream consequence of obesity, diabetes. We are excited to see the results of the first phase 3 trial supporting this goal," said Wesley Day, Ph.D., vice president clinical development at VIVUS.
About the EQUATE Study (OB-301)
The EQUATE study (OB-301) included 756 obese patients (599 females and 157 males) across 32 centers in the United States. The average baseline BMI of the study population was 36.3 kg/m2 and baseline weight was 101.3 kg. The study was a randomized, double-blind, placebo-controlled, prospective trial with subjects randomized to receive once-a-day treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramate CR), full-dose Qnexa (15 mg phentermine/92 mg topiramate CR), the respective phentermine and controlled-release topiramate constituents, or placebo. Patients had a four-week dose titration period followed by 24 weeks of treatment. Subjects were asked to follow a hypocaloric diet representing a 500-calorie/day deficit and advised to implement a simple lifestyle modification program.
The study found that nearly two-thirds (66%) of patients treated with Qnexa lost 5 percent or more of their initial body weight at the drug's full dose, 62 percent for mid-dose and 15 percent for placebo. The proportion of Qnexa patients losing 10 percent or more of their initial body weight was 41 percent for full-dose, 39 percent for mid-dose and 7 percent for placebo. Nearly one-fifth (19%) and 15 percent of the patients lost at least 15 percent of their body weight on the full-dose and mid-dose of Qnexa as compared to 2 percent for the placebo group. Results were evaluated using ITT-LOCF, the method of analysis required by the U.S. Food and Drug Administration.
Qnexa was well-tolerated, with no drug-related serious adverse events. The most common adverse events reported for the full-dose, mid-dose and placebo group were tingling, dry mouth, altered taste and constipation. The completion rate for the study overall was 70 percent.
About Obesity
More than 300 million people worldwide and approximately 30 percent of American adults (more than 60 million people) are obese, a chronic condition defined by having excess body fat. As the second leading cause of preventable death, obesity directly contributes to numerous life-threatening conditions including diabetes, cardiovascular disease, hypertension and stroke. Experts agree that even a modest weight loss of five percent of weight, maintained over time, can bring significant health benefits by lowering blood pressure and reducing the risk of diabetes and heart disease.
About Pre-Diabetes and HbA1c levels
Pre-diabetes is a condition where blood glucose levels are higher than normal but not yet high enough for the patient to be diagnosed with diabetes. Blood glucose levels are considered to be normal when Fasting Plasma Glucose (FPG) is below 100 mg/dL. There are 57 million people in the United States and 314 million worldwide who have pre-diabetes. Recent research has shown that long-term damage to the body, especially the heart and circulatory system, may already be occurring during pre-diabetes. Baseline HbA1c levels were 5.48 percent and 5.42 percent for the full-dose and mid-dose groups. The ADA guidelines suggest that HbA1c levels should be 7.0 percent or lower.
About Qnexa (TM)
Qnexa (Q-NEX-uh) is a proprietary, low dose, controlled release formulation of phentermine and topiramate that simultaneously addresses both appetite and satiety -- the two main mechanisms that impact eating behavior -- in one daily capsule. Qnexa, an investigational drug, is an obesity therapy being developed to address type 2 diabetes as well as weight loss. In phase 2 and phase 3 clinical trials to date, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors. Qnexa is well tolerated, with no drug-related serious adverse events reported to date.
About VIVUS
VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health. The company's lead product in clinical development, Qnexa(TM) is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (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 http://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, 2008 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 646-378-2923 650-934-5200 Media Relations: Pure Communications, Inc. Jennifer Torres 312-624-9802
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; or Media Relations: Jennifer Torres of Pure Communications,
Inc., +1-312-624-9802, both for VIVUS, Inc.
Web Site: http://www.vivus.com/
