SAN DIEGO, March 18, 2013 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com), today provided an update regarding ongoing corporate activities and announced that its Annual Report on Form 10-K for the quarter and year ended December 31, 2012 has been filed with the Securities and Exchange Commission earlier today. As previously announced, the Company will host its fourth quarter and year end 2012 financial results conference call today, March 18, 2013 at 1:00 PM ET.
Rusty Ray, Chairman of the Board of Apricus Bio stated: "The Board continues to believe that the greatest opportunity for shareholder value creation remains in the development and commercialization, through strategic partnerships, of the Company's primary pipeline assets, particularly Vitaros® and Femprox® for male and female sexual health. To realize this value, the Company's recent activity has been centered on ensuring that our resources are properly aligned with our corporate objectives. We look forward to a number of important milestones throughout 2013, including the full commercial launch of Vitaros® in Canada, regulatory progress with both Vitaros® and Femprox® in key territories throughout the world, and the announcement of additional strategic partnerships."
Refocused Strategy on Vitaros® and Femprox®
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Announced new corporate strategy focused on Vitaros® and Femprox®. In January 2013, Apricus Bio announced its corporate goals for 2013, which includes focusing its corporate strategy and resources on commercializing its lead product Vitaros® (alprostadil 0.3% topical cream), for the treatment of erectile dysfunction ("ED"), and on further developing through clinical trials its lead product candidate, Femprox® (alprostadil 0.4% topical cream), for the treatment of female sexual arousal disorder ("FSAD"). Both products utilize Apricus Bio's proprietary NexACT® transdermal delivery platform.
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Ceasing of funding of French Subsidiaries. In March 2013, Apricus Bio announced that, as part of its effort to focus resources on its lead assets, it intends to cease financing its French subsidiaries, Finesco SAS, Scomedica SAS and NexMed Pharma SAS. The strategic decision to cease financing its French subsidiaries follows a decrease in the unit's operating performance resulting from recently enacted pricing policies affecting drug reimbursement in France and the subsequent, related loss of certain contract sales agreements.
- Divestiture of oncology supportive care business. In January 2013, Apricus Bio announced its plans to seek a buyer for its oncology supportive care products, which include the rights to Totect® (dexrazoxane for injection) for the treatment for extravasation from intravenous anthracycline chemotherapy in the U.S. and the Americas, and the U.S. co-promotion rights to Granisol® (granisetron HCl oral solution) for the prevention of nausea and vomiting associated with certain emetogenic cancer therapies and radiation. Each of these products is now commercially available and marketed in the U.S. The planned divestiture will allow Apricus Bio to better align its resources with its stated corporate objectives.
Key Upcoming Milestones
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Commercial Launch of Vitaros® in Canada through Abbott Laboratories. Apricus Bio is actively supporting Abbott with their pre-launch efforts, and continues to expect that a full launch will occur in the first half of 2013.
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European approval decision for Vitaros® in Europe via the Decentralized Procedure ("DCP"). A decision regarding the approval of Vitaros® in Europe via the DCP with Netherlands as the Reference Member State is expected to occur in the first half of 2013, followed by national phase approvals in each of the major markets of Europe. Marketing of Vitaros® can then be initiated in each country by Apricus Bio's commercialization partners. In Europe, existing ED products currently generate over $1 billion dollar in sales and Apricus Bio believes a significant portion of the market remains untreated or undertreated.
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Obtain feedback from regulatory agencies and initiate next clinical steps for Femprox®. In 2013, Apricus Bio expects to announce feedback from its meetings with Health Canada and the U.S. FDA, as well as its plan for Femprox® clinical development going forward.
- Secure additional Vitaros® partnerships. Vitaros® is now partnered in key markets around the world, including the U.S., Canada, Germany, the United Kingdom, Italy, the Gulf countries, certain other countries in the Middle East and Israel. The Company is looking to secure partnerships in the remaining major global markets.
Conference Call Information
The call can be accessed in the U.S. by dialing 877-407-8031 and outside of the U.S. by dialing 201-689-8031 and asking the conference operator for the Apricus Bio Conference Call. The teleconference replay will be available for one week by dialing in the U.S. 877-660-6853 and outside of the U.S. by dialing 201-612-7415. Replay passcode 410469 is required for playback. The conference call will also be webcast live at http://www.investorcalendar.com/IC/CEPage.asp?ID=170645. The webcast replay will be available for three months.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, large-market therapeutic classes including male and female sexual health. The Company has one approved product, Vitaros®, for the treatment of erectile dysfunction, which will be marketed in Canada by Abbott Laboratories, and Femprox®, a product candidate, for the treatment of female sexual arousal disorder, which successfully completed a nearly 400-subject Phase III study in China.
For further information on Apricus Bio, visit http://www.apricusbio.com. You can also receive information at http://twitter.com/apricusbio.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, its ability to further develop its product Vitaros® for erectile dysfunction , and product candidates Femprox® for Female Sexual Arousal Disorder among others; to have its product and product candidates receive additional patent protection and be approved by relevant regulatory authorities in Europe, the United States and Canada and in other countries; to successfully commercialize such product and product candidates and other NexACT® product candidates and drug delivery technology; to sell its oncology supportive care business or assets to a third party or parties; to cease funding to its French subsidiaries and to have such subsidiaries reorganize or liquidate successfully; and to achieve its other development, commercialization and financial goals. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's 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 or without charge from the Company.