May 31, 2012
New patent covering synthetic deoxycholic acid will expand intellectual property protection for ATX-101
LOS ANGELES, May 31, 2012 – KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application that claims synthetic deoxycholic acid or pharmaceutically acceptable salts thereof, including the synthetic form that is used in ATX-101, a potential first-in-class, injectable drug under clinical investigation for the reduction of submental fat, which commonly presents as an undesirable “double chin.”
“The allowance of this patent application claiming certain forms of synthetic deoxycholic acid adds an additional patent asset to our ATX-101 patent portfolio, a portfolio that already includes patents related to method of use, formulation and manufacturing processes,” said Keith Leonard, KYTHERA’s President and CEO. “We are pleased to add a compound claim to our intellectual property protection as we continue to investigate the safety and efficacy of ATX-101.”
The patent that is issuable from this allowed application, Serial No. 12/541,045, titled "Synthetic Bile Acid Compositions and Methods," is projected to expire in 2028. Once issued, this forthcoming compound patent will be the sixth patent the USPTO has issued in relation to ATX-101. In addition to these U.S. patents, KYTHERA has over 70 issued or allowed patents outside the U.S., including patents in the major markets of Europe covering non-surgical methods of removing localized fat accumulation using deoxycholic acid. KYTHERA also has more than 70 pending worldwide patent applications and is preparing to file additional new patent applications to further strengthen its intellectual property portfolio.
ATX-101 is a potential first-in-class injectable drug candidate under clinical investigation for the reduction of localized fat. ATX-101 is a proprietary formulation of synthetic sodium deoxycholate, a well-characterized component of human bile that is naturally occurring in the body and promotes the breakdown of dietary fat. ATX-101 is designed to be a locally-injected drug that causes proximal, preferential destruction of adipocytes, or fat cells, with minimal effect on surrounding tissue. Based on clinical trials conducted to date, ATX-101 has exhibited significant, meaningful and durable results in the reduction of submental fat, which commonly presents as an undesirable “double chin.” These results correspond with patient satisfaction measures demonstrating meaningful improvement in perceived chin appearance.
In August 2010, Bayer Consumer Care AG signed a licensing and collaboration development agreement with KYTHERA, thereby obtaining development and commercialization rights to ATX-101 outside of the United States and Canada. KYTHERA initiated its pivotal Phase III clinical program, with planned enrollment of 1,000 patients, for ATX-101 in the United States and Canada in March 2012 and expects to report results from these trials in 2013. These trials are expected to form the basis for a new drug application for approval of ATX-101 in the United States and Canada.
About KYTHERA Biopharmaceuticals, Inc.
KYTHERA Biopharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic medicine market. KYTHERA’s product candidate, ATX-101, is a potential first-in-class, injectable treatment currently in Phase III clinical development for the reduction of submental fat, which commonly presents as an undesirable “double chin.” KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at http://www.kytherabiopharma.com.