SAN DIEGO, April 5, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) (http://www.apricusbio.com) announced today that Chairman, President and Chief Executive Officer, Dr. Bassam Damaj, was recently interviewed by WallStreetCorner.com, a New York-based FINANCIAL publication. The interview is available at http://wallstreetcorner.com/daily.html.
In the interview, Dr. Damaj provided an update on Apricus Bio's recent developments and plans. He noted that, based in San Diego, Apricus Bio is a revenue-generating pharmaceutical company. Its clinically-validated NexACT® drug delivery technology enables multi-route administration of new and improved compounds across numerous therapeutic classes. Revenues and growth are driven from out-licensing of its technology for the development and commercialization of those compounds to pharmaceutical and biotechnology companies worldwide.
Apricus is also monetizing its existing product pipeline, including its lead product, Vitaros®, approved in Canada in November 2010 for the topical treatment of erectile dysfunction, and which is expected to be available on the Canadian market later this year. The company's pipeline also includes compounds in development from the pre-clinical stage through Phase III. These drugs are focused on sexual dysfunction, oncology, dermatology, autoimmune, pain, anti-infectives, diabetes, cosmaceuticals, and others.
Dr. Damaj noted that the company is in late-stage discussions with several major pharmaceutical companies in Canada to commercialize its lead product, Vitaros®, in that market, and currently expects to sign a commercial partnership for Canada in Q2 2011. Apricus Bio expects to sign additional commercialization partnership deals in the second half of 2011 and anticipates receiving royalty revenues from sales of the product possibly during the second half of 2011 or the first half of 2012, Dr. Damaj said.
"We also plan to file for approval for Vitaros® in Europe in the first half of 2011," said Dr. Damaj. "Further, our expectation is to sign a commercialization partnership similar to Canada for a number of the major European countries in 2011. We have already signed a partnership in Italy with Bracco, whereby we expect to receive €750,000 before the end of Q2 2011. We believe that if Vitaros® is approved in Europe in late 2012, we will begin to receive royalty revenues beginning in 2013 for the major markets described above," he added.
In the interview, Dr. Damaj pointed out that Apricus Bio also holds the worldwide rights to Femprox®, a topical treatment for female sexual dysfunction. Like Vitaros®, it contains a previously approved sexual dysfunction drug, alprostadil. Apicus Bio's proprietary NexACT® technology allows medication to be delivered topically, through the skin, for fast efficacy and fewer side effects than oral medications.
Regarding Femprox®, Dr. Damaj said, "We have already completed one Phase II trial in the U.S. and one Phase III study in close to 400 women in outside the U.S., which achieved a 44% positive response rate as compared to a placebo. We plan to meet with the U.S. Food & Drug Administration in order to agree on the planned Phase III clinical program required for marketing approval in the U.S. We are also planning to meet with Canadian agency officials to seek guidance as to whether the current Phase III trial will be sufficient for filing a New Drug Submission ("NDS") in Canada."
As for the size of the market for Femprox®, Dr. Damaj stated, "To our knowledge, there aren't any approved products in any major market to treat female sexual arousal disorder, a persistent or recurring inability to attain, or maintain adequate sexual excitement, causing personal distress. It is estimated that there are approximately 50 million potential sufferers in the U.S. alone, according to Fitzheny and Sandberg in 2005. The market value in the U.S. could exceed $4 billion, with only 15% of patients captured on therapy."
Asked to provide an overview of Apricus Bio, Dr. Damaj said, "We currently focus our efforts on new and patented pharmaceutical products. They are mostly based on our patented drug delivery technology known as NexACT®. We leverage the know-how of our CRO (Clinical Research Organization) business to assist in our product and NexACT® technology development. In 2010, through the acquisition of Bio-Quant, we expanded our R&D capabilities with NexACT® into the areas of oncology, inflammation, immunology, and metabolic diseases."
In addition, Dr. Damaj said, "We intend to continue our efforts developing topical treatments based on the application of the NexACT® technology to drugs: (1) previously approved by the U.S. Food and Drug Administration; (2) with proven efficacy and safety profiles; (3) with patents expiring in the near term, or expired; and, (4) with proven market track records and potential."
"Other products in the Apricus Bio pipeline include PrevOnco™, for liver cancer and MycoVa™ for the treatment of fungal nail infection (onychomycosis)," Dr. Damaj noted.
In addition, Dr. Damaj said that Apricus Bio has recently appointed a Sexual Dysfunction Clinical Advisory Board. "It consists of such key opinion leaders as Irwin Goldstein, M.D., Jed Kaminetsky, M.D., and Ajay Nehra, M.D. We are pleased that Drs. Goldstein, Kaminetsky and Nehra have agreed to serve on this new Board. Their expertise will be key to helping us move forward with our Femprox® program as well as in the development of other products in the male and female sexual dysfunction field," Dr. Damaj added.
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 obtain and/or develop products from its patented technology and to successfully enter into partnership, licensing or commercialization agreements for its Vitaros® product for erectile dysfunction and its NexACT™ platform technology. 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.
Apricus Biosciences, Inc.
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