VIVUS, Inc. (NASDAQ: VVUS), a pharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today announced it has initiated a second pivotal Phase 3 study of avanafil, its investigational new drug for the treatment of erectile dysfunction (ED). Avanafil is a next-generation, fast-acting, selective, investigational oral phosphodiesterase type 5 (PDE5) inhibitor.

The study, REVIVE-Diabetes (TA-302), is a multicenter, randomized, double-blind, placebo-controlled trial and will evaluate the safety and efficacy of avanafil in the treatment of ED in men with type 1 or type 2 diabetes. Subjects who meet the inclusion criteria will undergo a four-week non-treatment run-in period followed by 12 weeks of treatment. The co-primary endpoints of the study will be improvement in erectile function as measured by changes in the sexual encounter profile (SEP) questions 2 and 3, and improvement in erectile function as measured by the erectile function domain score of the International Index of Erectile Function (IIEF). The SEP is a self-administered patient diary and the IIEF is a patient questionnaire; both are used as standard diagnostic tools to assess erectile dysfunction. REVIVE-Diabetes is the second of three planned pivotal studies in the avanafil Phase 3 development program.

“There has not been a new treatment option for men with ED in more than five years,” stated Andrew McCullough, MD, associate professor of clinical urology, NYU School of Medicine and REVIVE-Diabetes clinical investigator. Early data suggest that avanafil may provide a fast-acting therapy with a short half-life, which, if approved, may represent a noteworthy advance for the millions of men living with ED and searching for new options.”

Diabetes is one of the most common causes of ED; clinical data suggest that at least 50 percent of diabetic men will experience difficulties with erectile function. Men with diabetes are up to three times more likely to have ED than non-diabetic men and appear to experience it earlier in life. The significance of ED increases with the severity and duration of diabetes as well as with advanced age.

“Evidence suggests that there is room for significant improvement in the current treatment of ED,” Charles Bowden, MD, senior director, clinical development for VIVUS. “We’re pleased with the promising results demonstrated thus far with avanafil, and with the momentum behind our Phase 3 program. Enrollment in our first pivotal study, REVIVE, initiated in December to evaluate avanafil in ED, is ongoing. REVIVE-Diabetes will be conducted at many of the same sites as REVIVE.”

It is expected that this study will enroll approximately 375 patients at about 30 sites in the United States. Subjects are instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. REVIVE-Diabetes will study two doses of avanafil. More information about the trial can be found at http://www.clinicaltrials.gov.

As previously disclosed, VIVUS has entered into a $30 million funding collaboration with Deerfield Management to fund the Phase 3 program.

About Erectile Dysfunction

Erectile dysfunction, or ED, the inability to attain or maintain an erection sufficient for intercourse, was reported by 35% of men between the ages of 40 to 70 in the United States, according to an independent study, with the incidence increasing with age. ED, frequently associated with vascular problems, is particularly common in men with diabetes and in those who have had a radical prostatectomy for prostate cancer. PDE5 inhibitors, which inhibit the breakdown of cyclic guanosine monophosphate, have been shown to be effective treatments for ED.

Worldwide sales in 2008 of PDE5 inhibitor products for ED were estimated, based on reports from the companies that market these products, to be in excess of $3.7 billion, including approximately $1.9 billion in reported sales of Viagra, approximately $1.5 billion in reported sales of Cialis and approximately $300 million in reported sales of Levitra. VIVUS believes that based on the aging baby boomer population and the desire to maintain an active sexual lifestyle, the market for PDE5 inhibitors will continue to grow.

Avanafil Phase 2 Data

VIVUS previously reported positive results from the Phase 2 studies of avanafil. Following a four-week, non-treatment, run-in period, 284 patients were treated for 12 weeks with placebo or avanafil at various doses. The primary endpoints used to assess treatment efficacy included the percentage of erections sufficient for vaginal penetration and the percentage of erections lasting long enough for successful intercourse. Avanafil produced erections sufficient for vaginal penetration on 76, 79, 80 and 84 percent of sexual attempts on the 50, 100, 200 and 300 mg doses, respectively (p<0.05). Erections lasting long enough for successful intercourse were achieved on 54, 59, 62 and 64 percent of attempts, respectively (p<0.0001). Patients were instructed to attempt sexual intercourse 30 minutes after taking avanafil, with no restrictions on food or alcohol consumption. Avanafil was well tolerated at all doses, with headache being the most commonly recorded adverse event. There were no reports of visual disturbances. Previous studies have suggested that avanafil may be taken twice a day for those patients that desire sexual intercourse more frequently than once per day.

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™, 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™ for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE® (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, 2007 and periodic reports filed with the Securities and Exchange Commission

VIVUS

Pfizer’s inaugural Asia Pacific Sexual Health and Overall Wellness (AP SHOW) survey has uncovered staggering levels of sexual dissatisfaction, with 60% of men and around 60% of women in Australia saying they are not very satisfied with their sex lives.

Erectile Dysfunction (ED) continues to be a key cause of dissatisfaction. The AP SHOW survey, conducted in 13 Asia Pacific nations, found that men with ’suboptimal erections’, (erections that are not as hard as they could be) are less satisfied with sex and other aspects of the sexual experience.

There is also evidence of an association between optimal erectile function and men’s and women’s overall outlook on life, attitudes about sex and men’s sexual health and performance.

54% of men with optimal erectile function say that it is ‘very true’ that they feel good about their relationships compared to 47% of men with suboptimal erections. Among women, this difference is significantly more pronounced - 65% of women whose partners have optimal erection function say that it is ‘very true’ that they feel good about their relationships, compared to only 32% of women whose partners have suboptimal erections.

The survey also found that men and women who are ‘completely’ or ‘very satisfied’ with sex are more than three times more likely to feel good about their relationships and life overall compared to those who are only ’somewhat’ or ‘not at all satisfied’ with sex.

It is an area where GPs can make a significant difference, yet as few as 30% of men with ED seek help from their doctor. [i]

Dr Rosie King, Sexual Health Physician, Sydney Centre for Sexual and Relationship Therapy, Sydney, Australia said, “A person’s willingness to talk about sexual health and performance is heavily influenced by diverse cultural beliefs and practices - most patients and even doctors are uncomfortable initiating such discussions. Therefore, a great many people remain untreated.”

“GPs are aware of the importance of erectile function to the overall health and wellbeing of male patients and their partners. So, overcoming communication barriers about sexual health is crucially important,” said Dr King. “The more physicians discuss sexual problems, the more comfortable they’ll be.”

“If a GP suspects a patient may have erection problems, there are sensitive ways to broach the subject. GPs can also help patients know that they are willing to discuss these issues even before they enter the consulting room by creating an open practice environment.”

This might include placing brochures on sexual health and ED in the waiting room, offering a questionnaire that patients can fill out while waiting for their consultation or displaying posters in the waiting area and examination rooms to indicate a GPs interest in the sexual wellbeing of their patients.

“When talking about sexual health topics with patients, it is extremely important to establish a rapport that enables an open discussion. During such discussions, it is important to communicate several key points to a patient with suboptimal sexual performance including:

- GPs do treat sexual health and that sexual health is an important part of general health. Satisfactory sexual health and performance is associated with emotional wellbeing and overall good health.

- Suboptimal erections are a common problem, affecting more than 50% of men aged 40 to 70 years [ii].

- Erection problems and suboptimal erections are not a normal part of aging. An older male has just as much right to normal sexual functioning as younger men.

- Suboptimal erections can be due to an underlying illness or medication, and is not always due to psychological factors alone. Suboptimal erections often have a mixed aetiology, both organic and psychological. Concomitant physical disease is an important cause of suboptimal erections.

- Effective and convenient treatments are available and international medical consensus has affirmed that in suitable patients with suboptimal erections or ED, oral medications should be the first-line treatment. [iii]

Notes

- Data from 3,957 sexually active men and women (2,016 males and 1,941 females), from the general public, was gathered for this survey1 This included 101 males and 108 females surveyed nationwide in Australia.

- The AP SHOW survey respondents were aged between 25-74 years and had had sexual intercourse at least once in the past 12 months, (female respondents had to have sex with a member of the opposite sex)

- The 13 Asian countries/regions surveyed included Australia, China, Hong Kong, India, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, Taiwan, Thailand, and New Zealand

- Face-to-face interviews (a self completed questionnaire), were conducted in China, India, and Thailand
- An online self-administered method was used in Australia, Hong Kong, Indonesia, Japan, Malaysia, the Philippines, Singapore, South Korea, Taiwan, and New Zealand

- The AP SHOW survey was conducted from May to July 2008, by Harris Interactive, an independent market research company, and was sponsored by a non-restricted, educational grant from Pfizer Global Pharmaceuticals

References:
1 Data on file, Pfizer Global Pharmaceuticals.

About Pfizer Australia

Pfizer Australia is the nation’s leading research-based health care company, investing over $A50m in local research and development annually. It develops, manufactures and markets innovative medicines for both humans and animals. For more information visit http://www.pfizeraustralia.com.au

Source
Amy O’Hara
Media Communications Assistant
Public Affairs & Policy
Pfizer Australia
http://www.pfizeraustralia.com.au