SAN DIEGO, Sept. 9, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Dr. Bassam Damaj, Chairman, President and Chief Executive Officer, will present an overview of its wholly-owned subsidiary, NexMed (USA), Inc.'s Rx and Consumer Healthcare Divisions, at the 11th Annual Biotech in Europe Investor Forum on September 14, 2011 at 12:15 pm CEST, at the Hilton Zurich Airport Hotel in Zurich, Switzerland.
Dr. Damaj will provide an overview of Apricus Bio's Rx Division, including its partnership plans for Vitaros®, which was approved for marketing in Canada as a topical treatment for erectile dysfunction; the submission of regulatory filings for this product in the European Union and in Switzerland and the Company's planned submissions in certain Latin American countries. He will also discuss the fact that the Company is currently in negotiations for both individual and bundled partnership agreements relating to Canada and Europe, and is proceeding with manufacturing, scale-up and commercial batches of the drug for Canada. In addition, Dr. Damaj will discuss the regulatory progress of MycoVa™ (being developed for toe nail fungus, excluding Tinea Pedis) and its current commercial partnership efforts and progress.
An overview of the status of the Company's later stage Rx Division pipeline will also be provided, including: Femprox® for female sexual arousal disorder, PrevOnco® for human hepatocellular carcinoma (liver cancer) and RayVa™ for Raynaud's Syndrome.
Dr. Damaj's presentation will also include a review of the Company's Consumer Healthcare Division, which will focus on introducing drugs and medical devices in the U.S., Canada and other countries to consumers through: (1) the over-the-counter ("OTC') monograph compliance and similar Canadian OTC processes, (2) the 510(k) clearance procedure in the U.S. for certain topical and wound healing products regulated as medical devices, and similar international regulatory processes and (3) the abbreviated new drug application ("ANDA") approval procedure in the U.S. for generic drugs, and similar processes in other countries. In each of these instances, the Company will seek to combine its proprietary NexACT® technology, if found as an acceptable excipient by the U.S. Food and Drug Administration ("FDA"), with another drug or ingredient.
Management will also discuss its plans to introduce its OTC products into other countries, such as Canada, Europe and the Middle East upon receipt of regulatory approval from relevant authorities in those countries.
Apricus Bio is planning to utilize the FDA's 510(k) route to file for clearance for one of its wound healing products, now in development. Pursuant to the 510(k) process, the FDA has cleared certain topical creams that are considered by the agency to be medical devices. This medical device designation means that there is no active drug in the formulation. To the Company's knowledge, over the last few years, the FDA has cleared the following drugs through the 510(k) process: Atopiclair® (Graceway Pharmaceuticals), Eletone® (Ferndale Healthcare) and MimyX® (Stiefel Laboratories). These products are intended for the treatment of various dermatoses and are known as barrier creams because they help keep the skin hydrated, thus helping the healing process.
Apricus Bio is also considering utilizing the ANDA process in the U.S. for generic drugs that are exempt from having to conduct clinical trials (biowaiver) such as minoxidil, the active ingredient in Rogaine® (Pfizer), and to seek approval for drugs that have generic competitors and can integrate DDAIP, the main ingredient in its NexACT® technology, if it is found an acceptable excipient by the FDA.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego-based, revenue-generating, biopharmaceutical company, has leveraged the flexibility of its clinically-validated NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes.
Revenues and growth are driven from out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies worldwide. In addition, the Company is seeking to monetize its existing Rx Division product pipeline, including its first product, Vitaros®, approved in Canada for the treatment of erectile dysfunction, which is currently expected to be available on the Canadian market in 2011, as well as compounds in development from pre-clinical through Phase III, currently focused on Sexual Dysfunction, Oncology, Dermatology, Autoimmune, Pain, Anti-Infectives, Diabetes and Cosmeceuticals among others.
The Company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the Company's NexACT® technology to comply with the FDA's over-the-counter ("OTC") requirements, be cleared as 510(k) topical creams that are considered to be medical devices or approved as Abbreviated New Drug Applications ("ANDAs") as generic drugs. The Company will also seek to market such drugs through these similar procedures in foreign countries.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.com. You can also receive information at http://twitter.com/apricusbio and http://facebook.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 receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates, have its Rx Division products and product candidates such as Vitaros®, Femprox®, MycoVa™, RayVa™ and PrevOnco™ approved by relevant regulatory authorities and its Consumer Healthcare Division products either approved or cleared by relevant regulatory authorities or be in compliance with appropriate regulatory requirements, to successfully manufacture and commercialize such Rx Division products in the U.S., Canada, Europe and in other countries along with its Consumer Healthcare Division products including, over-the-counter products ("OTC"), 510(k) clearances or Abbreviated New Drug Applications ("ANDAs") and product candidates 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.
CONTACT: Apricus Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
