Apricus Biosciences, Inc.
Apricus Biosciences Announces Approval of Vitaros(R) for the Treatment of Erectile Dysfunction in Lebanon
SAN DIEGO, 2016-07-27 13:00 CEST (GLOBE NEWSWIRE) --
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the Republic of Lebanon Ministry of Public Health has granted market approval to Vitaros®, a topical cream indicated for the treatment of patients with erectile dysfunction. Apricus has an exclusive license agreement with Elis Pharmaceuticals (“Elis”) for the commercialization of Vitaros in the United Arab Emirates, Oman, Bahrain, Qatar, Saudi Arabia and Kuwait (the “Gulf States”) and part of the Middle East.
This is the twenty-third country in which the product has been approved, including Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, 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 the Middle East,” said Richard Pascoe, Chief Executive Officer of Apricus. “Moreover, we look forward to Elis’ launch of Vitaros in Lebanon, and additional launches this year by other commercial partners in countries where the product has been approved, but is not currently marketed.”
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 from Elis. Apricus is eligible to receive a regulatory milestone payment of $100,000 as the result of this approval, which the Company expects to receive this quarter, as well as up to $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.
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 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 the timing of planned launches of Vitaros®in various countries by Apricus’ commercial partners 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 Lebanon and other territories and the potential for delays in the timing of commercial launch; 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.
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