MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--VIVUS, Inc. (NASDAQ: VVUS - News), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has completed enrollment in the final of three phase 3 studies of Qnexa™ in overweight and obese patients with co-morbidities including hypertension, dyslipidemia, or type 2 diabetes. The CONQUER study (OB-303) enrolled patients with a Body Mass Index (“BMI”) ranging from 27 to 45 and at least two additional co-morbidities. The co-primary endpoints for this study are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.
“Obesity is a major epidemic that significantly contributes to early death due to cardiovascular disease, diabetes, and cancer. Our phase 3 program is designed to evaluate weight loss in these patients and potential benefit on their co-morbidities,” commented Leland Wilson, president and chief executive officer at VIVUS. “Completing enrollment for a 4,500-patient phase 3 program ahead of schedule is a major accomplishment for our development team at VIVUS. We are now poised to complete these studies by the middle of next year.”
About the CONQUER study
In the CONQUER study, approximately 2,500 subjects will be treated at approximately 93 centers throughout the United States. Patients undergo a 4-week dose escalation period followed by 52 weeks of treatment. The study is 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 strength Qnexa (15 mg phentermine/92 mg topiramate CR) or placebo. Randomization is stratified by gender and diabetic status, and at least 20% of the subjects are male. Subjects are instructed to follow a simple diet and lifestyle modification program throughout the study. VIVUS has completed the Special Protocol Assessment (“SPA”) process for this trial with the U.S. Food and Drug Administration (FDA). Under the SPA process, the Company and the FDA reached agreement on study design features that will be employed throughout the entire phase 3 program, including the co-primary endpoints of the study, scope and size of the patient population, specific safety assessments, inclusion/exclusion criteria, duration of the trials and the statistical method for analyzing the co-primary study endpoints. More information about the trial can be found at www.clinicaltrials.gov.
About the Phase 3 Program
The phase 3 Qnexa program includes two pivotal, double blind, placebo-controlled, multi-center studies in distinct populations that will compare Qnexa to placebo during a 56-week treatment period. The studies are designed to prospectively demonstrate the safety and efficacy of Qnexa. The first study, known as EQUIP (OB-302), has enrolled approximately 1,250 morbidly obese adult subjects with a Body Mass Index (“BMI”) of 35 or greater with or without controlled co-morbidities. The second trial, known as CONQUER (OB-303), has enrolled overweight and obese adult subjects with BMI’s from 27 to 45 and at least two co-morbid conditions, such as hypertension, dyslipidemia and type 2 diabetes. The co-primary endpoints for these studies are the mean percent weight loss and the percentage of subjects achieving weight loss of 5% or more.
The phase 3 program also includes a six-month confirmatory factorial study, known as EQUATE (OB-301), in obese subjects with BMI’s from 30 to 45. This trial is designed to evaluate two dose levels of Qnexa, compared to placebo and the individual constituents in Qnexa. The primary endpoints will be similar to those evaluated in the pivotal studies.
Safety and tolerability of Qnexa will be determined by reports of adverse events, physical exam, clinical laboratory data, electrocardiogram, cognitive function tests, psychological assessments, and clinical assessment of clinical laboratory variables. The phase 3 program has enrolled approximately 4,500 subjects.
About a Special Protocol Assessment
Under the Special Protocol Assessment (SPA) process, a sponsor may seek the FDA’s agreement on the design and analysis of a clinical trial intended to form the primary basis of an efficacy claim. If the FDA agrees in writing, its agreement may not be changed after the trial begins except in limited circumstances, such as the FDA determining that a substantial scientific issue essential to determining safety or effectiveness of the product was identified after the trial had begun. If the outcome of the trial is successful, the sponsor will ordinarily be able to rely on it as the basis for approval with respect to effectiveness. While we have received the FDA’s agreement on SPAs for the phase 3 Qnexa trials, there can be no assurance that the trials will have a successful outcome or that we will ultimately receive FDA approval for this product. For more information about the FDA’s Special Protocol Assessment process, see http://www.fda.gov/cder/guidance/3764fnl.htm.
About VIVUS
VIVUS, Inc. is a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products. The current portfolio includes investigational products addressing obesity and sexual health. The pipeline includes: Qnexa™, which is in phase 3 for obesity and phase 2 for diabetes; Testosterone MDTS®, for which a phase 2 study has been completed for the treatment of Hypoactive Sexual Desire Disorder (HSDD); and avanafil, for which a phase 2 study has been completed for the treatment of erectile dysfunction (ED). MUSE® is approved and currently on the market for the treatment of ED. For more information on clinical trials and products, please visit the company’s web site at 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, 2007 and periodic reports filed with the Securities and Exchange Commission.
Contact:
VIVUS, Inc. Timothy E. Morris, 650-934-5200 Chief Financial Officer or Trout Group Ian Clements (SF), 415-392-3385 or Brian Korb (NYC), 646-378-2923
Source: VIVUS, Inc.
