Apricus Biosciences Announces Korean Patent Approval for MycoVa(TM) for Nail Fungus
- CEO Foresees Expanded Asian Patent Coverage for MycoVa(TM) Product
Specifically, the Korean Patent Office recently issued a “notice of allowance” for the Company's patent application, entitled, “Antifungal Nail Coat and Method of Use.” Once issued, this will represent the fifth patent that Apricus Bio has received in Asia for MycoVa™ for onychomycosis, and the first in South Korea for this product. The patent will provide the Company with patent protection for MycoVa™ and its use for nail fungus in South Korea until March 2024.
“We are excited about the further expansion of our MycoVa™ patent portfolio in South Korea and Asia,” said Dr. Bassam Damaj, Chairman, President and Chief Executive Officer of Apricus Bio. “Our prior patent expansion for MycoVa™ in the U.S. and Europe, combined with a reanalysis of the data from an earlier Phase III study on MycoVa™, has led us to seek guidance from the regulatory authorities in the U.S. and Europe to file for marketing approval in those countries. We look forward to eventually expanding these regulatory filings internationally to certain other countries, such as those in Asia, in which we currently plan to develop future commercial partnerships.”
Apricus Bio currently holds 17 patents related to the treatment of nail fungus, with 12 patent applications pending, and has patent protection for its underlying NexACT® technology used in the nail fungus treatment in South Korea, Asia, as well as in a number of other countries and regions.
About MycoVa™
MycoVa™ combines an existing, approved drug for nail fungus, terbinafine, with the NexACT® technology that enhances the absorption of the drug through the skin. In January 2011, the Company announced that an additional analysis showed that MycoVa™ is as effective for the treatment of nail fungus as the current European standard of care for topical therapy, Loceryl® (an ointment made by Galderma).
In June 2011, the Company announced that based on a reanalysis of its Phase III trials for its MycoVa™ product for treating onychomycosis (nail fungus), it is revisiting its regulatory strategy for the drug and will seek guidance from regulatory authorities in the U.S. and Europe. A combined post-hoc analysis of two randomized, double-blind, vehicle controlled, multicenter, parallel group Phase III studies to assess the efficacy, safety and tolerability of MycoVa™ demonstrated statistically significant results in primary and secondary efficacy endpoints in favor of active treatment in patients who did not present with comorbid tinea pedis (athlete's foot), as these patients are considered at higher risk of reinfection.
The advantage of Apricus Bio's MycoVa™ product is that it is easy to apply, and is therefore expected to improve patient compliance. MycoVa™ is applied to the infected nails, typically at bedtime, with minimal preparation, such as simply washing with soap and water. The formulation allows significant amounts of the drug 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 has stated that the worldwide market is approximately $2.8 billion in size and is expected to grow to approximately $2.9 billion by 2014.
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 Rx Division 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.
The Company is also developing its Consumer Healthcare Division by developing a number of drugs that utilize the Company‘s NexACT® technology to comply with the FDA’s over-the-counter (“OTC”) requirements, be cleared as 510(k) topical creams that are considered to be medical devices or approved as Abbreviated New Drug Applications (“ANDAs”) as generic drugs. The Company will also seek to market such drugs through these similar procedures in foreign countries.
For further information on Apricus Bio, visit http://www.apricusbio.com and for information on its subsidiary please visit www.nexmedusa.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 receive issued patents on its NexACT® technology and products, develop such patented technology into product candidates in South Korea, other parts of Asia and in other countries, have its Rx Division products and product candidates such as MycoVa™ approved by relevant regulatory U.S., European, South Korean and other Asian country authorities and its Consumer Healthcare Division products either approved or cleared by relevant regulatory authorities or be in compliance with appropriate regulatory requirements, to successfully manufacture and commercialize such Rx Division products in the U.S., Europe, South Korea and other Asian countries along with its Consumer Healthcare Division 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.
Contact
Apricus Biosciences, Inc.
Edward Cox, V.P.
Corporate Development & Investor Relations, Apricus Bio, Inc.
+1 (858) 848-4249
Send Email
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
Send Email