Apricus Biosciences has secured US development and commercialisation rights for a selective estrogen receptor modulator (SERM), fispemifene, from Finland-based Forendo Pharma.
Fispemifene is an oral once-daily chemical entity SERM, which was developed to treat urological conditions in men.
Apricus Biosciences CEO Richard Pascoe said: "The in-licencing of fispemifene in the US is a transformative event for Apricus.
"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."
As part of the deal, Forendo and its advisors received an upfront license fee of $12.5m.
Forendo will receive additional potential clinical and regulatory milestone payments of up to $45m, including for potential FDA approval, as well as potential commercial milestone payments of more than $260m. These payments are based on achieving specified annual net sales levels of up to $1bn in the US.
The tissue-specific SERM fispemifene was designed to treat secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms in men.
Apricus noted that two US-based Phase II trials showed clinical proof of concept for the treatment of male secondary hypogonadism.
During the first half of 2015, the company intends to start a Phase IIb trial to confirm the optimal fispemifene doses to treat men with secondary hypogonadism.
The trial will also assess improvements in symptoms commonly associated with low serum testosterone levels, as well as lower urinary tract symptoms in ageing men.