Apricus Biosciences (APRI) Says Apricus Approved in Greece

October 26, 2016 7:07 AM EDT

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Apricus Biosciences, Inc. (Nasdaq: APRI) announced that Greece has granted Apricus’ commercialization partner, Recordati, market approval for Vitaros®, an on-demand topical cream indicated for the treatment of patients with erectile dysfunction.

This is the twenty-fifth country in which the product has been approved, including Argentina, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Lebanon, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.

“We are very pleased that Recordati has received another Vitaros approval within its territory. Recordati continues to aggressively expand the Vitaros brand in Europe with commercial efforts ongoing in six countries,” said Richard Pascoe, Chief Executive Officer of Apricus. “For the remainder of this year and into 2017, we will continue to focus on growing Vitaros revenue through licensing and new launches, seeking Vitaros U.S. regulatory approval and managing our expenses in an effort to achieve profitability.”

In February 2014, Apricus signed an exclusive license agreement with Recordati to market Vitaros in Spain, Russia, Turkey, Ireland and certain other European and African countries and received an upfront payment of $2.4 million. Under the terms of the agreement, Apricus is eligible to receive up to approximately $38.6 million from Recordati in additional milestones, plus double-digit tiered royalties in the ten to twenty percent range based on Recordati’s net sales of the product in the territory.

Vitaros is a new entrant into these ED treatment markets, offering a product profile making it appealing to certain patients. Vitaros is a topical ED cream that delivers rapid onset (generally five to thirty minutes) and treatment duration of approximately one to two hours. Vitaros’ local delivery provides a first line alternative to oral treatment. In addition to patients who prefer topical treatment as their first treatment option, patients with complications that preclude them from using orally delivered systemic treatments can benefit from Vitaros.

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