Ferring Pharmaceuticals purchased ex-U.S. assets and rights to Apricus Biosciences’ on-demand topical erectile dysfunction therapy cream Vitaros® (alprostadil) for potentially $12.7 million. Ferring is already Apricus’s commercialization partner for Vitaros in Latin America and specified European and Asian territories. The drug has now been approved in 26 countries outside of the U.S., most recently, in Mexico, in January.
Under terms of the asset purchase deal, Ferring will pay Apricus $11.5 million upfront, up to another $700,000 relating to product inventory, and $500,000 in asset transfer fees. The Swiss firm will shoulder complete responsibility for all Vitaros-related activities outside the U.S. and for coordinating with existing non-U.S marketing partners. San Diego-based Apricus retains all U.S. rights to Vitaros.
“This transaction reflects the continued execution of our corporate strategy of developing, obtaining regulatory approval for, and partnering novel topical prescription treatments in areas of significant unmet need,” said Apricus CEO, Richard Pascoe. “Moreover, this transaction will allow us to focus our financial resources on obtaining U.S regulatory approval for Vitaros, accelerate the advancement of our clinical pipeline, strengthen our balance sheet with nondilutive capital, extinguish our existing debt facility, eliminate certain future ex-U.S. Vitaros liabilities, and lower our quarterly operating expenses by approximately 30%.”
Apricus also confirmed that it is on track to resubmit the Vitaros NDA to the FDA during Q3 of 2017. The U.S. regulator had refused to approve Apricus back in 2008, suggesting that additional analyses of existing clinical and nonclinical data were required. In November 2016, Apricus reported that following more recent feedback from the FDA, and with available clinical and nonclinical data used to obtain ex-U.S. approval of Vitaros, it was confident of a viable regulatory pathway for resubmitting the NDA, and said it believed it could adequately address the DDAIP [dodecyl 2-(N,N-dimethylamino)-propionate] safety and partner transference risk noted in the original Complete Response Letter (CRL). Apricus also noted that the FDA has now classified Vitaros as a drug–device combination, and so any additional conditions relating to the product’s approval would need to be discussed with the Office of Product Quality.
The Apricus pipeline includes RayVa™, a topical alprostadil cream in Phase II development for treating Raynaud’s phenomenon secondary to systemic sclerosis.