MOUNTAIN VIEW, Calif., Oct. 11, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS) today announced the signing of an agreement providing Auxilium Pharmaceuticals, Inc. (Nasdaq:AUXL) the exclusive rights to market STENDRA ™ (avanafil) in the United States and Canada. The parties also simultaneously signed a Commercial Supply Agreement pursuant to which VIVUS will be responsible for the manufacture and supply of STENDRA to Auxilium for a mutually agreed term. STENDRA is an oral therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of erectile dysfunction (ED). Under the license agreement, VIVUS is eligible to receive up to $300 million based on certain regulatory and sales milestones, including an upfront licensing fee of $30 million and a $15 million payment contingent upon a potential label amendment regarding onset-of-action, in addition to royalties on product sales.
"Auxilium is the ideal partner for STENDRA, with an established sales force and excellent relationships with physicians responsible for men's health," stated Seth H.Z. Fischer, CEO of VIVUS. "We look forward to working with Auxilium as they prepare for launch later this year."
It is estimated that more than 50 percent of men over 40 years of age experience some degree of ED i. Prevalence of the condition 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); prostatectomy, and spinal cord injuries. The market opportunity for ED medical treatments continues to grow, with U.S. sales exceeding $2.9 billion in 2012 ii. About one half of men being treated with currently available PDE5 inhibitors are dissatisfied with the results of that treatment and tend to switch among the products in pursuit of better efficacy or less side effects iii."We believe STENDRA complements our current portfolio of testosterone replacement therapy and ED products, further broadening our men's health care franchise in a very large market segment consisting of patients that tend to switch among products," said Adrian Adams, chief executive officer and president of Auxilium. "The rapid onset of action of STENDRA and its favorable side effect profile make it an exciting new entrant into the category."