Forendo Pharma, a Karolinska Development portfolio company, said today it has licensed to Apricus Biosciences the U.S. development and commercialization rights for the male urological conditions compound fispemifene, in a deal that could generate up to $305 million plus royalties for the licensor.

Fispemifene—the first selective estrogen receptor modulator designed only for men—is an oral once-daily, novel tissue-specific selective estrogen receptor modulator (“SERM”) indicated to treat secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms.

Fispemifene is designed to act as an anti-estrogen at the level of the hypothalamic pituitary axis, resulting in increased testosterone production in the testes, which in turn restores circulating testosterone levels to within, but not beyond, normal levels.

According to the companies, two successful U.S.-based Phase II trials have demonstrated clinical proof-of-concept for the treatment of male secondary hypogonadism, effectively normalizing low testosterone levels, without exhibiting the negative effects on prostate health associated with testosterone replacement therapies.

Going forward, Apricus will be responsible for the clinical development and costs of the program, as well as all future commercialization in the U.S.  Apricus expects to commence a Phase IIb clinical trial during the first half of 2015 to confirm the optimal fispemifene doses to treat men with secondary hypogonadism—as well as provide proof-of-concept data to evaluate the anti-estrogenic and anti-inflammatory effects on the lower urinary tract and prostate in aging men.

“The in-licensing of fispemifene in the U.S. 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,” Apricus CEO Richard Pascoe said in a company statement.

Pascoe added that the licensing deal also builds upon Apricus’ clinical and commercial success of its marketed drug Vitaros, approved to treat erectile dysfunction in Europe and Canada, and commercialized in several countries in Europe.  Apricus markets Vitaros through several partners, including Abbott Laboratories and Takeda Pharmaceutical.

Apricus agreed to pay a $12.5 million “license fee” consisting of $5 million cash upfront and $7.5 million in Apricus shares—about 3.6 million common shares priced at the 360-day average market price of $2.08 per share.

Forendo could receive from Apricus up to $45 million in payments tied to clinical and regulatory milestones, including FDA approval; and up to $260 million in commercial milestone payments tied to achieving specified annual net sales of fispemifene levels up to $1 billion in the US.  Apricus also said it agreed to pay Forendo tiered “low double-digit” royalties based on net sales once the product is commercialized.

“The agreement combines Forendo’s established leadership in SERM drug discovery with Apricus’ expertise in men’s health, and  further underpins the potential for fispemifene to improve quality-of-life for the millions of men affected with hypogonadism and other male urological conditions,” added Bruno Lucidi, CEO, Karolinska Development, which owns 21% of Forendo.

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