Apricus Biosciences, Inc. announced 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.

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 AG; and Vitaros is a registered trademark in Canada held by Apricus Bio, and in the US held by Warner Chilcott Company.

Apricus Bio, a 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.