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

SAN DIEGO, Oct. 26, 2016 -- Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today 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.

About Recordati

Established in 1926, Recordati is an international pharmaceutical group, listed on the Italian Stock Exchange (Bloomberg REC IM), with a total staff of around 4,000, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Recordati is headquartered in Milan, Italy, with operations in the main European countries, in Russia, in other Central and Eastern European countries, in Turkey, in the United States of America and in North Africa. An efficient field force of medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses for its territories. Recordati is committed to the research and development of new drug entities within the urogenital therapeutic area and of treatments for rare diseases.

For further information, please visit the Recordati website: www.recordati.com.

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 Canada and certain countries in Europe, Latin America and the Middle East 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), 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.

*Vitaros^® is a registered trademark of NexMed International Limited. Such trademark is registered in certain countries throughout the world and pending registration in the United States.

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, including Greece; the potential for the product to achieve commercial success generally or in any specific territory, including Greece; the potential for Apricus to receive future milestone and royalty revenue; the ability of Apricus to achieve profitability based on Vitaros revenue growth; and the timing of approval, if any, by the Food and Drug Administration (FDA) of Vitaros in the United States. 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 or grow sales of Vitaros in various territories, such as Recordati in its territory, and the potential for delays in the timing of commercial launches; competition in the ED market and other markets in which Apricus and its partners operate; 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; Apricus’ ability to obtain FDA and other requisite governmental approval for Vitaros; the fluctuation of currency exchange rates; the potential for adverse reactions to the product; 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 LLC
(646) 378-2933