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1172 Castro Street Mountain View, CA 94040-2552 USA phone:(650) 934-5200 fax:(650) 934-5389
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| Symbol |
VVUS |
| Exchange |
NASDAQ |
| Founded |
1950 |
| Employees |
133 |
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| www.vivus.com
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| Research Sector |
Biotech Specialty Pharma |
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| Summary Description |
| Therapeutics: obesity, sexual health |
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| Management |
| Leland F. Wilson, Chief Executive Officer; Peter Y. Tam. President; Wesley W. Day, Ph.D.. Vice President, Clinical Development; Guy P. Marsh, Guy P. Marsh, vice President of U.S. Operations & General Manager; Timothy E. Morris, Vice President, Finance & Chief Financial Office |
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| Keywords |
| obesity, diabetes, sleep apnea, phentermine, topiramate |
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| Description |
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VIVUS, Inc. is a drug-development company dedicated to the development and commercialization of next-generation therapeutic products addressing obesity and sexual health. Analysts speculate that the potential market for obesity ranges from $5 billion to $10 billion annually, the potential market for an effective diabetes therapy that causes weight loss is in excess of $2 billion, and the indications targeted by VIVUS' sexual health products each represent a projected market greater than $1 billion annually. |
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| Products / Services |
VIVUS' leading drug candidate, Qnexa, is being developed to treat obesity and type 2 diabetes.
Avanafil is being developed to treat erectile dysfunction.
Luramist (Testosterone MDTS) is being developed to treat hypoactive sexual desire disorder in women.
MUSE is currently on the market as a minimally invasive treatment for erectile dysfunction.
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| Technology / Differentiation |
VIVUS current and investigational drug candidates in development encompass patented proprietary formulations and novel delivery systems.
Qnexa is a proprietary therapeutic formulation and dosing regimen that incorporates the active ingredients from two previously approved products with demonstrated weight loss properties: phentermine and topiramate. Qnexa appears to induce significantly greater weight loss than either individual compound. Clinical trials conducted with Qnexa have demonstrated superior efficacy and a significantly improved adverse event profile as compared to either active agent alone or other currently available therapeutic options.
Qnexa may be the first obesity therapy to address type 2 diabetes as well as weight loss. Fasting plasma glucose levels were reduced in subjects treated with Qnexa from 176 mg/dL to 133 mg/dL, as compared to a decrease from 171 mg/dL to 145 mg/dL for the placebo group (p=0.02). Over 56 weeks, subjects treated with Qnexa also lost 9.4% of their baseline body weight, or 20.5 pounds, as compared to 2.7%, or 6.1 pounds, for the placebo group (p<0.0001). Subjects treated with Qnexa had reductions in blood pressure, triglycerides and waist circumference.
Pre-clinical and clinical data suggest that avanafil:
- is highly selective to PDE5, which may result in a
favorable side effect profile
- has a shorter plasma half-life than the current commercially
available PDE5 inhibitors; and
- is fast-acting.
Luramist� is a small, easy-to-use, hand-held transdermal spray containing testosterone and proprietary skin penetration enhancers. The Luramist spray allows for discreet application, unlike patches that are visible and topical gels that can be messy.
Phase 2 studies evaluating Luramist showed a statistically significant improvement in the number of satisfying sexual events in pre-menopausal patients with HSDD. |
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| Market / Customers |
More than 300 million people worldwide and approximately 30% of American adults (more than 60 million people) are obese.
Nearly 250 million people worldwide and nearly 24 million people in the United States have diabetes.
Analysts speculate that the potential market for an obesity treatment ranges from $5 billion to $10 billion annually; the potential market for an effective diabetes treatment that causes weight loss is in excess of $2 billion.
The market for therapeutics to address men's sexual health is one of the fastest growing pharmaceutical sectors.
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| Competitors / Substitutes / Alternatives |
Includes but is not limited to Roche, Abbott Labs, and Pfizer, Inc.
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| Strategy |
VIVUS has strategic alliances with pharmaceutical companies for development and commercialization of products in the area of sexual dysfunction.
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| Status |
| The four investigational drug candidates (Qnexa for obesity, Qnexa for diabetes, Avanafil, and Luramist) are in late stages of clinical development. The company plans to file an NDA for the Qnexa treatment for obesity at the end of 2009. |
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