SAN DIEGO, March 31, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI), announced today that the Mexican Patent Office ("MPO") will grant an additional patent for Vitaros®, the Company's topical alprostadil-based cream for the treatment of erectile dysfunction ("ED").
The MPO issued a "notice of allowance" for the patent entitled, "Topical Stabilized Prostaglandin E Compound Dosage Forms," which is expected to be granted within a few months. Upon receipt, the new patent will provide Apricus Bio patent protection for Vitaros® for ED until 2026. It will be the sixth patent that Apricus has received in Mexico for the technology underlying the product for this indication.
"The issuance of this patent provides strong intellectual property protection for Vitaros® for erectile dysfunction and we believe it enhances our product's present value," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio. "Vitaros® for ED is now protected in multiple countries by issued patents and we are continuing our efforts to expand our patent portfolio for this important medical innovation. We are also engaged in discussions with potential partners in Latin America to license and commercialize Vitaros® for ED in certain countries in that region."
About Vitaros® for Erectile Dysfunction
Vitaros®, for ED, has been approved by Health Canada for marketing and sales in that country and Apricus Bio is currently in discussions with major pharmaceutical companies to license and commercialize the product in Canada. In addition, the Company has licensing and commercialization agreements with companies for future marketing and sales of Vitaros® for this indication in Italy, the Gulf Countries and parts of the Middle East and also Israel and the Palestinian territories and is in discussions with potential partners in other international markets.
The Vitaros® product for ED incorporates Apricus Bio's proprietary postdermal and permeation enhancer using its NexACT® technology. It is a topically-applied cream that the Company believes may be one of the fastest acting drugs currently approved for ED.
Apricus Bio feels that Vitaros® has many advantages over other currently marketed products for the treatment of ED. First, the Company believes that it is 'on-demand,' in that patients normally see results more quickly than with oral drugs such as Viagra®, Cialis® and Levitra®. Second, there are no known restrictions on use of Vitaros® for ED by patients with cardiac, hypertension or prostectomy issues, as there appear to be with the oral drugs for erectile dysfunction such as Viagra®, Cialis® and Levitra® for example, for patients who have cardiac risk and are taking drugs that contain nitrates or alpha blockers. Thus, it is the Company's belief that patients who have prostectomies or with hypertension are not allowed to use those drugs. Third, the oral drugs appear to have a lesser effect with patients who take satomines or drink alcohol. With Vitaros®, there are no restrictions as to what a patient can eat or drink while using the product. Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lily USA, LLC; and Levitra® is a registered trademark of Bayer Corporation.
Erectile dysfunction is estimated to affect approximately 50% of the male population between the ages of 18 and 49 in Latin America increasing to 70% among men aged 50 years or older (Becher and Glina 2002). According to 2010 data from IMS, the size of the market for ED drugs in Mexico is currently estimated as being between $175 million to $200 million per year.
About Apricus Biosciences, Inc.
Apricus Bio, a San Diego based revenue-generating pharmaceutical 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 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.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiaries please visit www.nexmedusa.com or www.bio-quant.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 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.
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