Apricus Biosciences Announces Approval of Vitaros® for the Treatment of Erectile Dysfunction in Argentina

SAN DIEGO, Sept. 08, 2016 -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, 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.

About Apricus Biosciences, Inc.

Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ commercial product, Vitaros^®, for the treatment of erectile dysfunction, is approved in Europe, the Middle East and Canada and is being commercialized in several countries in Europe. In September 2015, Apricus in-licensed the U.S. development and commercialization rights for Vitaros from Allergan. Apricus’ marketing partners for Vitaros include Recordati Ireland Ltd. (Recordati S.p.A.), Ferring International Center S.A. (Ferring Pharmaceuticals), Laboratoires Majorelle, Bracco S.p.A., Mylan NV and Elis Pharmaceuticals Ltd.  Apricus currently has one active product candidate, RayVa^™, its product candidate for the treatment of the circulatory disorder Raynaud’s phenomenon.

For further information on Apricus, visit http://www.apricusbio.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act, as amended. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things: references to potential Vitaros approvals and product launches by Apricus’ commercial partners in additional countries and the timing thereof; and the potential for Apricus to receive future milestone and royalty revenue. Actual results could differ from those projected in any forward-looking statements due to a variety of reasons that are outside of Apricus’ control, including, but not limited to: Apricus’ ability to have its product Vitaros be approved by relevant regulatory authorities in additional countries; Apricus’ dependence on its commercial partners to carry out the commercial launch of Vitaros in Argentina and other territories and the potential for delays in the timing of commercial launch; Apricus’ ability to obtain and maintain intellectual property protection for the product; Apricus’ ability to raise additional funding that it may need to continue to pursue its commercial and business development plans; competition in the ED market and other markets in which Apricus and its partners operate; and market conditions. These forward-looking statements are made as of the date of this press release, and Apricus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Readers are urged to read the risk factors set forth in Apricus’ most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q, and other filings made with the SEC. Copies of these reports are available from the SEC's website at www.sec.gov or without charge from Apricus.

CONTACT:   

Matthew Beck
[email protected]
The Trout Group
(646) 378-2933