Date: 2015-12-31
Type of information: Establishment of a new subsidiary in the EU
Compound: Stendra®/Spedra® (avanafil)
Company: Vivus (USA - CA) Auxilium Pharmaceuticals (USA - MA) Endo International (Ireland)
Therapeutic area: Men's health
Type agreement: distribution
Action mechanism: phosphodiesterase inhibitor. Stendra®/Spedra® belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis. As with other PDE5 inhibitors, Stendra® should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure. Avanafil is licensed from Mitsubishi Tanabe Pharma Corporation. 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 has granted an exclusive license to the Menarini Group through its subsidiary Berlin-Chemie AG to commercialize and promote Spedra® for the treatment of erectile dysfunction in over 40 European countries plus Australia and New Zealand . Vivus has granted an exclusive license to Sanofi to commercialize avanafil in Africa , the Middle East , Turkey , and the Commonwealth of Independent States (CIS) including Russia .
Disease: erectile dysfunction
Details: * On December 31, 2015, Vivus announced that it has been notified by Auxilium Pharmaceuticals, a subsidiary of Endo International, plc., of Auxilium\'s intention to return the U.S. and Canadian commercial rights for Stendra® (avanafil) to Vivus. Auxilium has provided its contractually obligated six-month notice of termination which, absent an agreement between Auxilium and VIVUS for an earlier date, will result in the termination of the license and supply agreement on June 30, 2016 . Vivus is now in the process of evaluating ways for maximizing the value of Stendra®. The company expects to make an announcement by the end of the first quarter of 2016 with its decision. * On October 11, 2013, Vivus announced the signing of an agreement providing Auxilium Pharmaceuticals, 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 FDA for the treatment of erectile dysfunction (ED). It is estimated that more than 50 percent of men over 40 years of age experience some degree of EDi. 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 2012ii. 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 effectsiii. 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 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 will also leverage digital media to reach a broader audience online. Vivus will continue to be responsible for the product\'s post-approval requirements in the U.S., including a potential label amendment based on the results of the TA-501 study 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 for the 200 mg dose and 12 minutes for the 100 mg dose after being taken.
Financial terms: 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.
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