Forendo Pharma has entered into a definitive pharma licensing deal for the US development and commercialization rights for fispemifene to Apricus Biosciences.
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.
For further deal information visit Current Agreements (subscription required)
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