Vivus has signed an agreement providing Auxilium Pharmaceuticals the exclusive rights to market Stendra (avanafil) in the U.S. and Canada. The companies also signed a commercial supply agreement by which Vivus will be responsible for the manufacture and supply of Stendra to Auxilium. Stendra is an oral therapy approved by the FDA for the treatment of erectile dysfunction (ED).
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.
It is estimated that more than 50% of men over age 40 experience some degree of ED. 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. About one half of men being treated with currently available PDE5 inhibitors are dissatisfied with the results and tend to switch among products in pursuit of better efficacy or fewer side effects.
Auxilium expects to begin its commercial launch of Stendra by the end of 2013, with shipments in December followed by promotional activities in January 2014 with its Primera sales force, which consists of 150 representatives currently devoted to strategic targeting of urologists, endocrinologists and certain high prescribing primary care physicians. Auxilium also will leverage digital media to reach a broader audience online.