SAN DIEGO, Aug. 8, 2011/PRNewswire/ -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq: APRI) announced today that it will file for market authorization to sell its erectile dysfunction drug, Vitaros®, in Latin America. The Company also stated that it has engaged the services of Quintiles Global Regulatory Affairs, a leading international regulatory consultancy, to prepare its regulatory filings for Vitaros® for marketing approval in the following Latin American countries: Mexico, Brazil, Argentina, Colombia, Chile and Peru. "By preparing to file in Latin America, we are moving forward with our plan to make Vitaros® available worldwide," noted Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio.
According to IMS Health Data (2010), the potential market size for Vitaros® for ED in Brazil, alone, is approximately $347 million.
Apricus Bio has already prepared the necessary regulatory document -- known as the Electronic Common Technical Document ("ECTD") -- to file for approval of Vitaros® for ED throughout Latin America. Quintiles, a fully integrated biopharmaceutical company offering commercial, consulting and capital solutions worldwide, including a network of 22,000 professionals in 60 countries, will provide additional guidance and regulatory advice in order to facilitate the filings in each country. Specifically, Apricus Bio will utilize the services of Quintiles Global Regulatory Affairs, comprised of an experienced and dedicated team of approximately 45 regulatory experts, with decades of experience working with international regulatory agencies--especially those in Latin America.
Apricus Bio currently expects that its first regulatory filing in Latin America will be made within eight to 10 weeks. A number of other filings will be submitted on or abut the same time. Approval requirements and timelines differ across the six countries.
"We believe that the opportunities to sell our product in this region are great, and the potential market sizes are substantial," Damaj said. "The Company is now in the process of negotiating with a number of international and regional pharmaceutical companies with sales and marketing teams in such countries for commercialization partnerships throughout Latin America."
Apricus Bio received marketing approval for Vitaros® as a first-line treatment for ED from Health Canada in November 2010 for sales of the product in that country. In April 2011, the Company filed a marketing application in the European Union, under the Decentralized Procedure ("DCP"), for Vitaros® for the treatment of ED. Under the DCP, approval in a Reference Member State means that a drug may be sold in all of the European Union countries that were filed with the DCP as Concerned Member States. In July 2011, Apricus Bio filed for regulatory approval with Swissmedic, the Swiss Agency for Therapeutic Products for marketing of Vitaros® in that country.
About Vitaros® and the ED Market
The current leading drugs for erectile dysfunction are Viagra®, Cialis® and Levitra®, which are taken in pill form and work by inhibiting an enzyme called PDE5.
There is still a need for new, safe and effective treatments, however, especially for those patients who cannot or do not respond well to oral medication. Vitaros® differs from Viagra®, Cialis® and Levitra® in two ways. Instead of a pill, Vitaros® is applied directly to the penis as a cream. The topical application helps to reduce side effects and offers men who do not do well with the existing drugs a patient-friendly alternative.
Second, Vitaros® operates by a different biochemical mechanism than oral ED medications. It contains a previously marketed ED drug known by the chemical name of alprostadil. When absorbed through the skin, alprostadil directly boosts blood flow, thereby causing an erection within minutes, which the Company believes is much faster than the results from the currently marketed oral treatments.
Alprostadil is currently marketed as an injectable drug or as a suppository inserted into the urethra. The key innovation behind Vitaros® is combining alprostadil with Apricus Bio's NexACT® delivery technology, which allows the drug to pass through the skin and makes the treatment much easier to apply.
In clinical studies, Vitaros® worked in patients suffering from mild to severe ED, including men who did not respond to Viagra®. The side effects reported were localized and transient. "We believe that Vitaros® will be an attractive alternative to the oral PDE5 inhibitors for many patients with erectile dysfunction," stated Damaj.
Viagra® is a registered trademark of Pfizer, Inc.; Cialis® is a registered trademark of Lilly, USA; Levitra®, is a registered trademark of Bayer A.G.; and Vitaros® is a registered trademark in Canada held by Apricus Bio, and in the U.S. held by Warner Chilcott Company.
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 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 further development products and product candidates such as Vitaros®, to have its products and product candidates such as Vitaros® approved by relevant regulatory including those in the following Latin American countries: Mexico, Brazil, Columbia, Argentina, Peru and Chile, to successfully commercialize such products 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.
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