CALABASAS, Calif., May 12, 2014 (GLOBE NEWSWIRE) -- KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin. Positive and consistent results from two pivotal Phase III trials – REFINE-1 and REFINE-2 – were reported in late 2013 and provide the basis for the NDA submission. In these trials, the majority of ATX-101 patients had a visible reduction in fat under the chin and reported significant improvement in the visual and emotional impact of treatment.
"Since we began evaluating ATX-101 through our global clinical development program, it has demonstrated positive results in reducing fat under the chin, paired with an excellent safety profile and high patient satisfaction," said Frederick Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA. "We feel that ATX-101 has the opportunity to address a true unmet need in the U.S. aesthetic marketplace. We are excited to submit this new drug application for the FDA's review."
The global facial aesthetics market is estimated to reach $4.7 billion annually by 2018. While the area under the chin is visually important to patients, there are no approved non-surgical options available to reduce submental fat, leaving the area undertreated and patients unsatisfied. A double chin can be a tell-tale sign of aging, making individuals look older and heavier than they are and negatively impacting their overall appearance. If approved, ATX-101 would be a first-in-class submental contouring injectable drug for patients seeking to reduce fat under the chin.
"ATX-101 is at the center of our global commitment to bring real innovation supported by great science and clinical rigor to the growing field of aesthetic medicine," says Keith Leonard, president and chief executive officer, KYTHERA. "The submission of this NDA represents another important milestone in the development of ATX-101 for the treatment of submental fat. If approved, ATX-101 will be the first non-surgical treatment for the reduction of submental fat, representing a new product category within facial aesthetics."
Beyond this NDA submission, KYTHERA also plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015. In March of this year, KYTHERA announced it acquired all rights to ATX-101 outside of the U.S. and Canada from Bayer Consumer Care AG, to which it had licensed the commercial rights for ATX-101 outside of U.S. and Canada in 2010.
ATX-101 is currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin. It is a proprietary formulation of a purified synthetic version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat.i ATX-101 treatment contours the area under the chin by destroying fat cells while leaving surrounding tissue largely unaffected.
For the past seven years, ATX-101 has been the focus of a global clinical development program that has enrolled more than 2,500 patients worldwide, of which more than 1,500 have been treated with ATX-101. ATX-101 has the potential to be a first-in-class submental contouring injectable drug if approved.
i Stryer L. Biosynthesis of membrane lipids and steroids. In: Biochemistry. New York, NY: WH Freeman and Co; 1995:691-707
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 currently in late-stage development for the reduction of submental fat, which commonly presents as a double chin, and is a potential first-in-class submental contouring injectable drug. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring.
To the extent that statements contained in this press release are not descriptions of historical facts regarding KYTHERA, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including the ability of ATX-101 to address a true unmet need in the U.S. aesthetic marketplace, the estimated future of the potential global facial aesthetics market, the potential of ATX-101 to be a first-in-class submental contouring injectable drug, KYTHERA's plans to make multiple ex-U.S. regulatory submissions by the second quarter of 2015. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, our substantial dependence on ATX-101, and other matters that could affect the availability or commercial potential of our drug candidate. KYTHERA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see KYTHERA's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 and its Annual Report on Form 10-K for the year ended December 31, 2013.
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