New formulation patent expands intellectual property protection for ATX-101, a first-in-class, injectable drug under clinical investigation for the reduction of fat under the chin
LOS ANGELES--(BUSINESS WIRE)-- KYTHERA Biopharmaceuticals, Inc. (KYTHERA), a privately-held biotechnology company focused on the development and commercialization of prescription products in aesthetic medicine, announced today that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a pharmaceutical formulation patent application that covers ATX-101, a first-in-class, injectable drug under clinical investigation for the reduction of submental (under the chin) fat. The patent to be issued from this allowed application, titled "Formulations of Deoxycholic Acid and Salts Thereof," carries a patent term to at least 2030. Similar applications have been filed with the European Patent Office (EPO) and the Patent Cooperation Treaty (PCT).
“This is an important addition to our existing patent portfolio and strengthens our ability to protect our proprietary technology as we continue rigorous and controlled testing of ATX-101 to understand its potential as a breakthrough treatment for patients who seek a non-surgical alternative to reduce the fat under their chin,” said Keith Leonard, KYTHERA’s President and CEO. “We are focused on building on our strong patent protection as we further investigate the long-term safety and efficacy profile of ATX-101.”
The forthcoming pharmaceutical formulation patent is the fifth patent the USPTO has issued in relation to ATX-101. KYTHERA either owns or has exclusively licensed these ATX-101 patents. Two of the patents, exclusively licensed from LA Biomed, relate to methods for non-invasive removal of localized fat deposits using deoxycholic acid, the Active Pharmaceutical Ingredient (API) in ATX-101. KYTHERA owns two other patents that relate to a unique process of manufacturing synthetic deoxycholic acid, the API used in ATX-101 drug product. In addition to these five U.S. patents, KYTHERA also has 11 additional patents outside the U.S., including two European patents that cover non-surgical methods of removing localized fat accumulation using deoxycholic acid. KYTHERA currently has more than 70 pending worldwide patent applications and is preparing to file additional new patent applications to further strengthen its market exclusivity position.
ATX-101 is a first-in-class injectable drug being studied for the reduction of localized fat. ATX-101 is a proprietary formulation of deoxycholate, a well-studied endogenous compound that is present in the body to promote the natural breakdown of dietary fat. ATX-101 reduces subcutaneous fat through localized fat cell membrane disruption followed by elimination from the treated area. This mechanism may enable a non-surgical alternative for the reduction of subcutaneous fat. Clinical studies to date have demonstrated that ATX-101 is well tolerated and may effectively reduce localized fat in the submental (under the chin) area. Three randomized, double-blind, placebo-controlled, Phase 2 studies with ATX-101 in the reduction of submental fat and four Phase 1 studies (pharmacokinetic, histology, lipid and tolerability) have been successfully completed. Also, two Phase 3 randomized, double- blind, placebo-controlled studies are ongoing in Europe in collaboration with the Dermatology unit of Bayer, who has licensed the development and commercialization rights to ATX-101 outside of the U.S. and Canada.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic market. KYTHERA’s lead clinical program, ATX-101, is focused on the reduction of submental (under the chin) fat. The company also has active research programs with focused interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at www.kytherabiopharma.com.
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INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical