Forendo Pharma Announces the US Licensing of Fispemifene

Forendo Pharma Oy has announced that it has entered into a definitive agreement to out-license the US development and commercialization rights for fispemifene to Apricus Biosciences Inc. Forendo is entitled to success driven milestone payments totaling up to of $305 million plus sales royalties. Karolinska Development has an ownership of 21 percent in Forendo Pharma.

Under the terms of the agreement, Apricus will make a $5 million upfront cash payment to Forendo, and will transfer approximately 3.6 million Apricus common shares, representing $7.5 million in value based on the 360-day average market price of the Apricus stock. The agreement includes additional potential clinical and regulatory milestones payments to Forendo for up to $45 million, including FDA approval, as well as commercial milestone payments totaling up to $260 million based on achieving specified annual net sales of fispemifene levels up to $1 billion in the US.

Apricus will also pay tiered double-digit royalties based on net sales once the product is commercialized. Apricus will be responsible for the clinical development and costs of the program, as well as all future commercialization in the US. Apricus anticipates 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, and provide proof-of-concept data to evaluate the anti-estrogenic and anti-inflammatory effects on the lower urinary tract and prostate in aging men.

Fispemifene is an oral once-daily, novel tissue-specific selective estrogen receptor modulator (“SERM”) with a unique profile to treat both secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms affecting in men. Fispemifene acts as an antiestrogen at the level of the hypothalamic pituitary axis, inhibiting the negative feedback of estrogen. Two successful US-based Phase II trials have demonstrated clinical proof-of-concept for the treatment of male secondary hypogonadism, without exhibiting the negative effects on prostate health associated with testosterone replacement therapies.

“Having previously developed and partnered two SERMS that are approved and marketed in the US, we are excited to work with the Apricus team, which has a demonstrated track record of innovation within men’s health and a strategy committed to addressing the unmet needs of these patients. Fispemifene, a unique SERM targeted for use in men, will offer both patients and physicians a differentiated alternative for treating urological conditions in ageing men”, said Risto Lammintausta, CEO, Forendo Pharma.

“The in-licensing of fispemifene in the United States is a transformative event for Apricus, signifying the achievement of a key corporate objective to build upon our current development pipeline with a complementary, mid-staged clinical program”, stated Richard Pascoe, CEO, Apricus Biosciences.

“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” said Bruno Lucidi, CEO, Karolinska Development.