SAN DIEGO, Oct. 1, 2012 (GLOBE NEWSWIRE) -- Apricus Biosciences, Inc. ("Apricus Bio" or the "Company") (Nasdaq:APRI) (http://www.apricusbio.com) 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 this product and our assessment of our MycoVa™ clinical dossier, based on the re-analysis we did on the data from three Phase 3 clinical studies," said Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio. "At the Pre-NDS meeting, Health Canada supported the filing of a NDS seeking marketing approval in Canada based on the existing clinical data. We will continue to move forward with preparations for filing, approval, and commercialization of MycoVa™ in the Canadian market. The agreement with Health Canada on filing the NDS relates to the Company's second drug containing our proprietary NexACT® delivery technology and if approved further validates not only the value of our platform but its clinical effectiveness," continued Dr. Damaj.
Apricus Bio is currently partnered with Stellar Pharmaceuticals Inc. for the commercialization and marketing of MycoVa™ in Canada following receipt of regulatory approval by Health Canada. The Company is also currently seeking guidance re MycoVa™ from the European Medicines Agency for eventual submissions in that region.
MycoVa™ Clinical Development Program
In a 2009 Phase 3 clinical comparator study, MycoVa™ was found to be no less effective than Loceryl® in curing nail fungus. Loceryl® is currently the topical standard of care for onychomycosis in Europe. In this study, 1,029 patients with mild to moderate nail fungus were given either MycoVa™ (topical 10% terbinafine hydrochloride formulation) or Loceryl® (5% amorolfine nail laquer) for 48 weeks. The primary endpoint was a complete cure, and the secondary endpoints were killing the fungus and improving the appearance of the nail. A formal reanalysis of initial study results by the Company showed no significant difference in either primary or secondary endpoints between MycoVa™ and Loceryl®. Loceryl® is a registered trademark of Galderma.
MycoVa™ was also the subject of two Phase 3, randomized, double-blind, vehicle controlled, multicenter, parallel group studies to assess the efficacy, safety, and tolerability of MycoVa™. A combined, post-hoc analysis of these two Phase 3 clinical studies, completed by Apricus Bio in 2011, demonstrated statistically significant results in mycological cure, resulting in the eradication of nail fungus in favor of MycoVa™ treatment in patients that did not present with comorbid tinea pedis (athlete's foot).
More About MycoVa™
MycoVa™ is a topically applied formulation of terbinafine hydrochloride, a well-known medication for nail fungus, delivered with Dodecyl 2-(N,N dimethylamino)-propionate hydrochloride ("DDAIP-HCl"), Apricus Bio's proprietary NexACT® delivery technology, which enhances absorption of drugs through the skin and other barriers including the nail plate and nail bed. The Company believes MycoVa™ clinical trials have exhibited a significant mycological effect to eradicate the fungus and also has successfully demonstrated non-inferiority compared to Loceryl®, the current topical standard of care for onychomycosis in Europe. In addition, Apricus Bio believes the safety profile of topical terbinafine is significantly improved and much better tolerated than oral terbinafine, which is limited in use to some patients due to its potential for liver toxicity.
In the Company's view, MycoVa™ has distinct advantages over Loceryl® for nail fungus sufferers. MycoVa™ is simple and easy to apply, which could greatly improve patient compliance. The product is applied directly to the infected nails, typically at bedtime, accompanied by a simple washing with soap and water. The formulation allows significant amounts of the active ingredient to penetrate through the nail plate to the nail bed and surrounding area where fungus is located without significant systemic exposure.
Onychomycosis is a chronic persistent fungal infection of the nail bed resulting in thickening and discoloration of the nail, which sometimes can be accompanied by serious pain and disability. According to the Merck Manual, the worldwide incidence rate of onychomycosis is approximately 10%. As described by Iorizzo and Piraccini (2007), the incidence has been increasing due to diabetes, immunosuppression and an aging population. While occurring in approximately 2.6% of children younger than 18 years, it occurs in as much as 90% of the elderly population (eMedicine.medscape.com). As of 2008, Thomson Reuters Pharma had stated that the worldwide market was approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.
About Apricus Biosciences, Inc.
Apricus Bio (Nasdaq:APRI) is a pharmaceutical company that develops and markets innovative treatments that help large patient populations across numerous, high-demand therapeutic classes. The Company has four approved products and has developed a strong pipeline of multiple late-stage product opportunities. With commercial operations in both the U.S. and Europe (France), Apricus Bio generates revenues and growth from sales of its commercial products and by out-licensing, in certain territories, its pipeline products and NexACT® technology.
Apricus Bio's growth strategy is to acquire, develop, and commercialize new products through strategic partnerships. The Company currently has commercial partnerships with multiple large pharmaceutical companies including Novartis, Abbott Laboratories, Sandoz, Takeda, Warner Chilcott and Bracco, and co-promotes multiple products in France.
Apricus Biosciences is headquartered in San Diego, CA and is publicly traded on the NASDAQ under the ticker symbol APRI.
For further information on Apricus Bio, visit http://www.apricusbio.com, and for information on its subsidiary please visit http://www.nexmedusa.com. You can also receive information at http://twitter.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 develop its products and product candidates, to have its products and product candidates such as MycoVa™ receive patent protection and be approved by relevant regulatory authorities, to successfully commercialize such products and NexACT® product candidates and drug delivery technology and to achieve its 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.
CONTACT: Apricus Bio Investor Relations: David Pitts Argot Partners 212-600-1902 firstname.lastname@example.org
Source:Apricus Biosciences, Inc.