San Diego-based Apricus Biosciences Inc. announced that it has acquired $10 million in financing to purchase licensing from Finland-based Forendo Pharma to develop and commercialize an investigational treatment for urological conditions in men.
Forendo’s treatment involves a selective estrogen receptor modulator (SERM) called fispermifene. By acquiring licensing for fispermifene, Apricus is combining its expertise in men’s health with Forendo’s established leadership in SERM drug discovery.
Fispemifene is an oral drug taken once-daily with a unique profile that is ideally suited for use in men. Fispemifene is a tissue-specific SERM designed to treat secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms in men. Apricus anticipates starting a Phase 2b clinical trial during the first half of 2015.
"The in-licensing of fispemifene in the U.S. is a transformative event for Apricus,” said Apricus CEO Richard Pascoe. “It marks the achievement of a primary corporate objective of diversifying our pipeline with a complementary drug candidate targeting multiple indications in urology, while building upon the clinical and commercial success of Vitaros, our marketed drug for erectile dysfunction. Importantly, Apricus has funded this major step using an attractive combination of equity, valued at a premium to our current stock price, and venture debt with a four-year term."
To fund the clinical trial, development and acquisition of rights for fispermifene, Apricus secured $10 million in venture debt financing from Oxford Finance LLC and Silicon Valley Bank.
Under the terms of the agreement, Forendo and its advisers 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 U.S. 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 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.