Table of Contents
MOUNTAIN VIEW, Calif. — VIVUS Inc. has signed an agreement giving Auxilium Pharmaceuticals Inc. the exclusive rights to market its erectile dysfunction (ED) drug Stendra in the United States and Canada.
VIVUS said the companies also have signed a commercial supply agreement in which VIVUS will be responsible for the manufacture and supply of Stendra (avanafil) to Auxilium for a mutually agreed term.
Under the license agreement, VIVUS can 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, chief executive officer of VIVUS. "We look forward to working with Auxilium as they prepare for launch later this year."
It is estimated that more than 50% of men over 40 years of age experience some degree of ED, VIVUS reported. The market opportunity for ED medical treatments continues to grow, with U.S. sales topping $2.9 billion last year.
"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," commented Adrian Adams, president and CEO of Auxilium. "The rapid onset of action of Stendra and its favorable side effect profile make it an exciting new entrant into the category."
Auxilium expects to begin its commercial launch of Stendra by the end of 2013, first with shipments of Stendra in December 2013, followed by promotional activities in early January. Stendra will be available through retail and mail order pharmacies, and Auxilium plans to offer programs that will help patients with out-of-pocket costs.
