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"This has been an exciting year for VIVUS and Qnexa. Last month, we announced pivotal phase 3 data from two year-long obesity studies, EQUIP and CONQUER, demonstrating a favorable safety profile for Qnexa as well as unprecedented weight loss, impressive glycemic control, and significant improvements in cardiovascular and metabolic risk factors," stated Leland Wilson, president and chief executive officer of VIVUS. "The enthusiasm among physicians, patients and pharmaceutical companies for a new option capable of helping patients achieve such clinically meaningful results is significant."
Wilson added, "We are also delighted that Dr. Timothy Garvey, a leading expert in metabolic disorders recognized for his research in the metabolic, molecular, and genetic pathogenesis of insulin resistance, type 2 diabetes, and obesity will present data from our previously reported phase 2 diabetes study at the EASD annual meeting. This will be the first opportunity to share this data with the European medical and pharmaceutical community."
The data being presented is from the previously announced year-long phase 2 trial (DM-230) evaluating Qnexa in patients with type 2 diabetes. The study demonstrated that Qnexa significantly reduced patients' hemoglobin A1c (HbA1c), a key indicator of blood sugar control, by 1.6% and helped patients achieve and maintain significant weight loss. The study also showed that Qnexa had a positive impact on other risk factors associated with diabetes.
"While it is widely known that type 2 diabetes can be treated through weight loss, it is well recognized that the currently approved weight loss therapies have limitations," stated Dr. Garvey MD, Professor of Medicine and Chair of the Department of Nutrition Sciences at the University of Alabama at Birmingham. "The optimal diabetes therapy will not only enable patients to control their blood sugar by lowering glucose levels to the desired range, but will also help patients achieve meaningful weight loss. The HbA1c reduction observed with Qnexa is significant, as is the percent weight loss observed, not only because of the amount, but more importantly the ability to maintain the weight loss over a year. The robust and growing body of clinical data suggests that Qnexa has the potential to play an important role in diabetes management with respect to blood sugar control and sustained weight loss."
Following are details about the presentation:
45th Annual Meeting of the European Association for the Study of
Diabetes, September 30 - October 2, 2009, Messezentrum Wien, in Vienna,
Austria
Date and Time: Friday, October 2, 2009, 12 Noon, Vienna
Session: Novel Therapies for Type 2 Diabetes Mellitus
Presentation Title: "Treatment with VI-0521 (Phentermine and Topiramate)
Leads to One Year Durable Glycemic Benefit and Weight Loss in Subjects
with Type 2 Diabetes"
Abstract: 173
Location: Freud Hall
Presenter: W. Timothy Garvey, MD
About Qnexa
Qnexa (Q-NEX-uh) is a once-a-day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety - the two main mechanisms that impact eating behavior - in one capsule. Qnexa, an investigational drug, is being developed to address weight loss. In phase 2 and 3 clinical data to date, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors.
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), has recently completed phase 3 clinical trials for the treatment of obesity. 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 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.
Sheryl Seapy
949-608-0841
SOURCE VIVUS, Inc.
http://www.vivus.com
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