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news.Dipexium Pharmaceuticals has obtained a notice of allowance from the US Patent and Trademark Office for a patent that covers the new formulation of Locilex as a topical cream and for use to treat skin or wound infections.
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Consisting 1% of pexiganan acetate cream, Locilex is an antibiotic peptide formulated as a topical cream and is used for the treatment of skin or wound infections.
Dipexium co-managing partner David Luci said that this new patent allowance extends Locilex’s patent life in the US well beyond the currently issued patent and anticipated regulatory exclusivity periods.
"Second, we expect our PCT filing based on the allowed U.S application to eventually help us expand into major international markets such as Japan, China, Australia, Korea, Latin America and South America," Luci added.
The company is presently preparing for the initiation of Phase III clinical trial of Locilex in mild infections of diabetic foot ulcers, which will be conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) with initiation of enrollment targeted for the second half of 2013.
The patent which is to be issued from this application is expected to be a 20 year patent term which may last in June 2032.
The company has also filed an application under the Patent Cooperation Treaty which could extend the patent protections of the new patent to maximum of 120 countries worldwide.