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Apricus Biosciences Announces the Launch of Vitaros® for the Treatment of Erectile Dysfunction in Lebanon by Elis Pharmaceuticals

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SAN DIEGO, 2016-12-27 13:00 CET (GLOBE NEWSWIRE) --

Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced the launch of Vitaros®, Apricus’ novel on-demand topical cream for the treatment of erectile dysfunction (“ED”), in Lebanon by Elis Pharmaceuticals Ltd. (“Elis”).

Richard Pascoe, Chief Executive Officer of Apricus, commented, “We are pleased to announce the first launch of Vitaros by Elis and look forward to their performance in the highly attractive Middle East ED market, which they estimate at approximately $200 million.  With this most recent launch, Vitaros is now commercially available in Lebanon, plus the existing nine EU countries.  Moreover, we expect another ten or more product launches across Europe, Latin America and the Middle East during the first half of next year by our various commercialization partners.  Looking forward, our key strategic goals continue to be achieving profitability through Vitaros revenue growth and obtaining Vitaros FDA approval in the United States in 2018.”

In January 2011, Apricus signed an exclusive license agreement with Elis to market Vitaros in the Gulf States and part of the Middle East, including Lebanon, Syria, Jordan, Iraq and Yemen. Under the terms of the agreement, Apricus has received an upfront payment of $100,000 and a regulatory milestone payment of $100,000 as the result of the Lebanon approval.  Apricus is also eligible to receive up to an additional $1.9 million in milestone payments on future sales, plus tiered double-digit royalties in the low to high teens based on Elis’ net sales of the product.

Vitaros is a new entrant in this ED treatment market, 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 an alternative for patients, but particularly those with complications that preclude them from using the orally delivered systemic treatments or who prefer to avoid the injectable forms of alprostadil.

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 certain countries in Europe and the Middle East. 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; the potential for the product to achieve commercial success generally or in any specific territory, including Lebanon, and 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’ dependence on its commercial partners to carry out the commercial launch or grow sales of Vitaros in various territories, such as Elis in its territory, and obtain additional product approvals; 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; Apricus’ ability to negotiate and enter into acceptable terms for new licensing agreements; 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
         mbeck@troutgroup.com
         The Trout Group LLC
         (646) 378-2933

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