Apricus Biosciences (APRI) Reports Vitaros Approval in Argentina to Treat ED

September 8, 2016 7:10 AM EDT

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

This is the twenty-fourth country in which the product has been approved, including 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 Vitaros has received its first approval in Latin America,” said Richard Pascoe, Chief Executive Officer of Apricus. “This approval, along with the registration filings in Mexico and Columbia, marks an important milestone for Apricus as we seek to build a global Vitaros brand. I want to congratulate our colleagues at Ferring for their efforts in building the Vitaros franchise in major markets throughout Europe and Latin America, and we look forward to Ferring obtaining additional regulatory approvals and driving revenue through additional product launches this year and next.”

Earlier this year, the Company expanded its exclusive Vitaros distribution agreement with Ferring in Latin America to include Germany, Austria, Belgium, Denmark, Finland, Iceland, Luxembourg, Norway, the Netherlands, Sweden, Switzerland and certain countries in Asia (previously Sandoz’s territories), the United Kingdom (previously Takeda’s territory) and Korea. Under the terms of the agreement, Apricus has received a total of $4.5 million in upfront payments from Ferring, in addition to a regulatory milestone payment of $1.6 million. Apricus is eligible to receive up to an additional $28 million in regulatory, launch and sales milestones, plus royalties on future net sales.

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