Date: 2015-09-20
Type of information: Licensing agreement
Compound: Vitaros™
Company: Allergan (Ireland) Apricus Biosciences (USA - CA)
Therapeutic area: Men's health
Type agreement: licensing
Action mechanism: Vitaros™ is a novel, on-demand topical cream for the treatment of erectile dysfunction and a new potential entrant into the U.S. ED treatment market. On February 3, 2009, Warner Chilcott, now a subsidiary of Allergan, acquired the U.S. rights to Vitaros from Apricus. Since that time, Vitaros has been approved by the European health authorities and by Health Canada, and is currently being promoted by Apricus' licensees throughout Europe.
Disease: erectile dysfunction
Details: * On September 10, 2015, Apricus Biosciences, a biopharmaceutical company advancing innovative medicines in urology and rheumatology,announced that it has licensed the U.S. development and commercialization rights for Vitaros™ from Allergan. Under the license agreement, Apricus will be responsible for all Vitaros development efforts in the United States. Upon the FDA acceptance of a New Drug Application (NDA) for Vitaros™, Allergan may elect to exercise its one time opt-in right to assume all future marketing and selling activities in the United States in exchange for certain financial considerations.
Financial terms: Under the terms of the agreement, Allergan granted Apricus exclusive rights to develop and commercialize Vitaros in the U.S in exchange for a $1 million upfront payment and a future $1.5 million regulatory milestone payable to Allergan. Upon FDA acceptance of the NDA for Vitaros, Allergan may elect to exercise a one-time opt-in right to assume all future marketing and selling activities in the United States. If Allergan exercises its opt-in right, Apricus may receive up to a total of $25 million in upfront and potential launch milestone payments, plus a double-digit royalty on net sales of Vitaros. If Allergan elects not to exercise its opt-in right, Apricus may commercialize Vitaros and in return will pay Allergan a double-digit royalty on net sales of Vitaros. Allergan retains the right to launch a future authorized generic under a profit share structure with Apricus.
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