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News Breaks
August 4, 2014
08:18 EDTAPRIApricus Biosciences announces launch of topical
Apricus Biosciences announced the launch of Vitaros, Apricus' novel topical on-demand treatment for erectile dysfunction, or ED, by the Sandoz Division of the Novartis Group of Companies, in Sweden. According to the most recent estimates, the European Erectile Dysfunction Market in 2013 was above $1.3B, and analyst estimates for ex-US Vitaros sale are approximately $300M at peak. Apricus continues to receive multiple commercial product orders of Vitaros from its partners, and is currently manufacturing multiple product batches through its contract manufacturer in Canada to support launches in Europe. The commercialization of Vitaros has been fully licensed to these partners, with Apricus positioned to earn tiered double-digit royalties and more than $200M in potential milestone payments.
News For APRI From The Last 14 Days
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October 20, 2014
06:13 EDTAPRIApricus Biosciences to host conference call
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05:27 EDTAPRIApricus licensed U.S. development, commercialization rights for fispemifene
Apricus Biosciences announced that it has licensed the U.S. development and commercialization rights for a novel selective estrogen receptor modulator, or SERM, fispemifene, an investigational treatment for urological conditions in men, from Forendo Pharma, a private therapeutics company based in Finland. This license agreement combines Apricus' expertise in men's health with Forendo's established leadership in SERM drug discovery, to advance the development of fispemifene as an investigational treatment for urological conditions in men. Under the terms of the agreement, Forendo and its advisors received an upfront license fee of $12.5M comprised of a $5M cash payment and the issuance of $7.5M in Apricus common stock; approximately 3.6M shares priced at the 360-day average market price of $2.08 per share. The agreement includes additional potential clinical and regulatory milestone payments to Forendo of up to $45M, including for potential FDA approval, as well as potential commercial milestone payments totaling up to $260M, based on achieving specified annual net sales levels up to $1B in the U.S. Apricus will also pay tiered low double-digit royalties based on net sales once the product is commercialized. Apricus will be responsible for the clinical development of fispemifene in the U.S., as well as all future commercialization efforts in the U.S. and its territories.
October 13, 2014
07:13 EDTAPRIApricus Biosciences awarded U.S. patent for RayVa
Apricus Biosciences announced that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application Serial Number 14/110,348. The patent application generally is directed to methods and compositions for treating Raynaud's phenomenon, including claims related to treating Raynaud's phenomenon that is secondary to systemic sclerosis. Raynaud's phenomenon secondary to systemic sclerosis affects an estimated three to five percent of people in the U.S., disproportionately affecting women and currently has no approved therapy in the U.S., representing an unmet medical need. The FDA has indicated that Apricus' RayVa™ product may qualify for priority review, given the unmet medical need and lack of approved products to treat secondary Raynaud's phenomenon. The FDA will determine if the RayVa New Drug Application qualifies for priority review following its submission, which could occur as early as 2017.

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