VIVUS Announces SPEDRA (avanafil) Approval in Europe

VIVUS, Inc.

(the "Company") today announced that the European Commission (EC) has adopted the implementing decision granting marketing authorization for SPEDRA™ (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in April 2013. SPEDRA, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade. The global market for ED therapies was approximately $5.5 billion in 2012. "SPEDRA represents another significant regulatory approval for VIVUS; it is a tremendous accomplishment both for the Company and for our European team. The unique characteristics of SPEDRA will offer the estimated 20 million European ED patients an important treatment option," said Peter Tam, president of VIVUS, Inc. "We recently announced positive results from a multicenter, placebo-controlled study, TA-501. In this study, ED patients achieved statistically significant improvement over placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse as early as 10 minutes following administration for the 200 mg dose and 12 minutes following administration for the 100 mg dose. We believe the recent study results along with the EU approval significantly enhance the value of the avanafil franchise and will be attractive to potential partners worldwide." "Approval of this NCE for ED is another important drug development milestone for VIVUS," stated Wesley Day, PhD, vice president of clinical development for VIVUS, Inc. "SPEDRA's approval is a testament to the expertise and dedication of our European team of advisors and consultants. The US and EU approvals will support submissions in a number of countries throughout the world. We also extend our thanks to Mitsubishi Tanabe Pharma Corporation, our partner in this effort." The MAA incorporated results from three placebo-controlled, randomized, double-blind, multicenter studies: REVIVE, which included 646 men from the general population with ED, REVIVE-Diabetes, which included 390 men with diabetes, and REVIVE-RP, which included 298 men following radical prostatectomy. Also contained within the MAA were the results from the year-long safety study, TA-314, which included 712 continuation patients from the REVIVE and REVIVE-Diabetes studies. Previously reported highlights from the avanafil development program include: All doses tested, 50 mg, 100 mg and 200 mg, met each of the co-primary efficacy endpoints; Erections sufficient for penetration (SEP2) were observed in 77% and 63% of avanafil patients at the 200 mg dose, compared to 54% and 42% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively; Successful intercourse (SEP3) was achieved in 57% and 40% of avanafil patients at the 200 mg dose, compared to 27% and 20% of placebo patients in the REVIVE and REVIVE-Diabetes studies, respectively; Significant improvement in erectile function as measured by IIEF-EF domain score was observed for all doses in avanafil-treated patients; Across all avanafil Phase 3 studies, successful intercourse (SEP3) was observed in some avanafil-treated patients as early as 15 minutes after dosing; The most common adverse reactions (greater than or equal to 2%) include headache, flushing, nasal congestion, nasopharyngitis, and back pain; and There were no drug-related serious adverse events reported in the studies. Positive topline results were reported on June 19, 2013 from a separate multicenter, placebo-controlled study, TA-501, designed to assess the efficacy of STENDRA™ in approximately 15 minutes. In the study, STENDRA patients achieved statistically significant improvement over placebo in the mean proportion of attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes following administration for the 200 mg dose and 12 minutes following administration for the 100 mg dose. The study randomized 440 patients with mild to severe ED, was conducted at 30 sites in the United States, and included both diabetic and non-diabetic patients. The average age of men in the study was 58, most of whom had previously used other ED therapy. The design required patients to use a stopwatch to record the timing of sexual activity. The most common drug-related side effects were headache and nasal congestion. There were no drug-related serious adverse events reported in the study. These study results will be submitted to an upcoming medical meeting and to the U.S. Food and Drug Administration (FDA) and the EMA in support of an amendment to the STENDRA and SPEDRA labeling. ED affects an estimated 52 percent of men between the ages of 40 and 70. Prevalence increases with age and can be caused by a variety of factors, including medications (anti-hypertensives, histamine receptor antagonists); lifestyle (tobacco, alcohol use); diseases (diabetes, cardiovascular conditions, prostate cancer); and spinal cord injuries. Left untreated, ED can negatively impact relationships and self-esteem, causing feelings of embarrassment and guilt. However, about half of men being treated with currently available PDE5 inhibitors are dissatisfied with treatment. About Avanafil STENDRA, or avanafil, is approved by the FDA for the treatment of erectile dysfunction, or ED, in the U.S. VIVUS, through collaboration arrangements with third parties, intends to market and sell STENDRA in the U.S. and under the trade name SPEDRA in the EU and other territories outside the U.S. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation (MTPC). VIVUS owns worldwide development and commercial rights to avanafil for the treatment of sexual dysfunction, with the exception of certain Asian Pacific Rim countries. VIVUS is currently in discussions with potential partners to commercialize STENDRA in the United States and other territories throughout the world. It is recommended that STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit www.Stendra.com.