Apricus Biosciences Announces Completion Of Transfer Of The United Kingdom Marketing Authorization For Vitaros To Ferring Pharma
SAN DIEGO, Aug. 15, 2016 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. (APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that Ferring Pharmaceuticals, the Company’s new partner in the United Kingdom, has received the United Kingdom marketing authorization for Vitaros®.
“We are pleased that the transfer of the U.K. marketing authorization to Ferring has been completed and we look forward to the product’s continued growth in this major ED market,” said Richard Pascoe, Chief Executive Officer of Apricus. “This follows the previously announced transfer of the German marketing authorization, marking the second in a series of marketing authorization transfers to Ferring that we anticipate will occur later this quarter.”
Earlier this year, the Company expanded its exclusive Vitaros distribution agreement with Ferring International S.A. in Latin America to now 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 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.
*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 the timing of planned launches or re-launches of Vitaros® in various countries by Apricus’ commercial partners, including the United Kingdom, the timing of transfers of any marketing authorizations, 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 or re-launch of Vitaros in the United Kingdom and other territories and the potential for delays in the timing of commercial launches or re-launches; Apricus’ dependence on its former commercial partners to complete the marketing authorization transfers; 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.
“We are pleased that the transfer of the U.K. marketing authorization to Ferring has been completed and we look forward to the product’s continued growth in this major ED market,” said Richard Pascoe, Chief Executive Officer of Apricus. “This follows the previously announced transfer of the German marketing authorization, marking the second in a series of marketing authorization transfers to Ferring that we anticipate will occur later this quarter.”
Earlier this year, the Company expanded its exclusive Vitaros distribution agreement with Ferring International S.A. in Latin America to now 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 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.
*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 the timing of planned launches or re-launches of Vitaros® in various countries by Apricus’ commercial partners, including the United Kingdom, the timing of transfers of any marketing authorizations, 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 or re-launch of Vitaros in the United Kingdom and other territories and the potential for delays in the timing of commercial launches or re-launches; Apricus’ dependence on its former commercial partners to complete the marketing authorization transfers; 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.