Apricus Biosciences Inc. has licensed the US development and commercialization rights for a novel selective estrogen receptor modulator (SERM), fispemifene, an investigational treatment for urological conditions in men, from Forendo Pharma, a private therapeutics company based in Turku, Finland. This license agreement combines Apricus’ expertise in men’s health with Forendo’s expertise in SERM drug discovery, to advance the development of fispemifene as an investigational treatment for urological conditions in men. Fispemifene is an oral once-daily, new chemical entity SERM. It is a tissue-specific SERM designed to treat secondary hypogonadism, chronic prostatitis, and lower urinary tract symptoms in men.

Under the terms of the agreement, Forendo and its advisors received an upfront license fee of $12.5 million comprised of a $5 million cash payment and the issuance of $7.5 million in Apricus common stock (approximately 3.6 million 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 $45 million, including for potential US Food and Drug Administration approval, as well as potential commercial milestone payments totaling up to $260 million, based on achieving specified annual net sales levels up to $1 billion in the US. 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 US as well as all future commercialization efforts in the US and its territories.

Apricus has secured $10 million in venture debt financing from Oxford Finance LLC and Silicon Valley Bank to fund the cash portion of the acquisition of fispemifene rights and to fund the Phase IIb clinical development program during 2015.

Source: Apricus Bioscience