Apricus Biosciences Announces Intent to File NDS for MycoVa in Canada

Apricus Biosciences

announced today its intent to file a New Drug Submission ("NDS") in Canada for MycoVa™, the Company's topical treatment for onychomycosis. On July 18, 2012, Apricus Bio participated in a pre-NDS meeting with Health Canada, the agency responsible for approving drugs in Canada. Based on the agency's review of the submitted data package for MycoVa™, Health Canada concurred that the re-analysis of existing Phase 3 development program data by disease severity is acceptable to support an NDS filing and review in Canada. In multiple Phase 3 clinical studies, the Company's MycoVa™ product successfully demonstrated its ability to kill nail fungus and improve the appearance of the nail, but it did not meet its primary endpoint: complete cure. Given these results, Health Canada has agreed to review in the NDS the use of these successful secondary endpoints re-analyzed by disease severity to demonstrate the efficacy of MycoVa™. Apricus Bio expects to file the New Drug Submission ("NDS") for MycoVa™ in the fourth quarter of 2013 once the accelerated stability is completed at its new manufacturer. "Our meeting with Health Canada confirms the value of