Seelos Therapeutics Inc (SEEL)

[LilBirdy]

Look out Latin America here we come! Next stop... Worldwide!

Apricus Biosciences to File for Market Authorization to Sell Vitaros(R) for Erectile Dysfunction in Latin America
Potential Market Size for Vitaros(R) for Erectile Dysfunction in Brazil, Alone, is Approximately $347 Million, Based on IMS Health Data (2010)


tweet
Email
Print
Companies:Apricus Biosciences, Inc.
Related Quotes
Symbol Price Change
APRI 3.40 -0.35

Press Release Source: Apricus Biosciences, Inc. On Monday August 8, 2011, 10:03 am EDT
SAN DIEGO, Aug. 8, 2011 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI - News) announced today that it will file for market authorization to sell its erectile dysfunction drug, Vitaros(R), 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(R) 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(R) 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(R) 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(R) 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(R) as a first-line treatment for ED from Health Canada in November 2011 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(R) 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(R) in that country.