VIVUS, Inc., a pharmaceutical company, engages in the development and commercialization of therapeutic products to treat obesity, post-menopausal, and sexual health in women and men in the United States. Its investigational product pipeline includes Qnexa, which has completed a Phase II clinical trial for treating obesity; Testosterone MDTS that has completed Phase II study to treat hypoactive sexual desire disorder; Avanafil, which has completed Phase II clinical trial for the treatment of erectile dysfunction; and ALISTA that has completed Phase IIb study for the treatment of female sexual arousal disorder. The company also markets MUSE for the treatment of erectile dysfunction. The company was founded in 1991 and is headquartered in Mountain View, California.
Qnexa is not a brilliant developped drug, its rather a combination therapy of available generic drugs. In past dealing the company has bought an available drug as well for 15mln, ran trials for new indications and sold it in 2008 for 150mln. So although no great scientific endeavour, they do know how to run trials and a very business savvy management. The interesting part is the the sheer size of the potential market, with a lot of bigger competitors like Pfizer and Merck discontinuing their obesitas trials due to side effects and risks. Only a few competitors left now, of whihc Qnexa is one. And the company does intend to partner upon favourable data, likely after phase III results.
Clinical Trial details
Answers to FAQ about the SPA
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2. Does VVUS have an SPA for Qnexa?
VIVUS Completes Special Protocol Assessment Process for Qnexa Phase 3 Studies
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Nov. 5, 2007--VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced that it has successfully concluded communications with the U.S. Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process regarding key elements of the pivotal phase 3 clinical trials of Qnexa for the treatment of obesity and weight-related co-morbidities. The company and the FDA have 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.
"We are pleased by the FDA's supportive attitude toward our pivotal phase program for Qnexa. The dialog we have had with the FDA throughout the End of Phase 2 (EOP2) and SPA process has provided valuable guidance, especially on the FDA's current attitude about potential safety issues and the need for the sponsor to thoroughly assess safety issues prospectively. The SPA process has provided us with guidance that will help us navigate today's complex regulatory landscape," commented Wesley Day, Vice President Clinical Development of VIVUS. "We are not looking at the cosmetic effects of obesity; rather, we have designed our trials to study patients that are severely obese or that have co-morbidities which increase their risk of cardiovascular disease. We believe weight loss treatments that have minimal impact on co-morbidities such as blood pressure and blood glucose levels will have limited appeal to the medical community. Our study design will allow us to
properly characterize the safety and tolerability profile of Qnexa and to capture the benefits of treatment on obesity and weight-related co-morbidities."
About the Phase 3 Program
The phase 3 Qnexa program will include 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 proactively demonstrate the safety of Qnexa. The first study, known as EQUIP (OB-302), will enroll morbidly obese adult subjects with a body mass index ("BMI") of 35 or greater with controlled co-morbidities. The second trial, known as CONQUER (OB-303), will enroll 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 will evaluate the differences between treatments in mean percent weight loss from baseline to the end of the treatment period, and the differences between treatments in the percentage of subjects achieving weight loss of 5% or more.
The phase 3 program will also include a six-month confirmatory factorial study, known as EQUATE (OB-301), in obese subjects with BMI's from 30 to 45. This trial will evaluate two dose levels of Qnexa, compared to both placebo and the individual constituents of the combination. The primary endpoints will be similar to those evaluated in the pivotal studies.
Safety and tolerability of Qnexa will be determined by reporting adverse events, physical exam, clinical laboratory data, electrocardiogram, cognitive function tests, psychological assessments, and clinical assessment of clinical laboratory variables. The phase 3 studies will enroll approximately 4,500 subjects.
About a Special Protocol Assessment
A Special Protocol Assessment is a regulatory procedure by which the FDA can provide advice on the current thinking at the FDA regarding the evaluation of issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies associated with the development of products in human drug applications as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 379g(1)) (PDUFA products). The advice given by the FDA is not binding. For more information about the Agency's Special Protocol Assessment process see http://www.fda.gov/cder/guidance/3764fnl.htm.
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. VIVUS has three products that are positioned to enter phase 3 clinical trials. The pipeline includes: Qnexa™, for which a phase 2 study has been completed for the treatment of obesity; 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 the EvaMist NDA submission will be approved in a timely basis, or at all. 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, 2006 and periodic reports filed with the Securities and Exchange Commission.
CONTACT: VIVUS, Inc.
Timothy E. Morris, 650-934-5200
Chief Financial Officer
Ian Clements (SF), 415-392-3385
Brian Korb (NYC), 646-378-2923
SOURCE: VIVUS, Inc.