WESTLAKE VILLAGE, Calif., Feb. 4, 2015 (GLOBE NEWSWIRE) -- KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced its submission to Australia's Therapeutic Goods Administration (TGA) for ATX-101 (deoxycholic acid), its potential first-in-class treatment for improving submental fullness associated with submental (under the chin) fat. This milestone in KYTHERA's ATX-101 global development program follows regulatory applications in the U.S., Canada and Switzerland.
"KYTHERA is committed to making ATX-101 available in key markets to treat submental fullness, an often-cited yet under-addressed condition that can occur regardless of a person's weight," said Keith Leonard, president and chief executive officer, KYTHERA. "We plan additional submissions to regulatory authorities in other countries during the remainder of this year."
The application in Australia is supported by results from two pivotal Phase III trials: REFINE-1 and REFINE-2. Data from the trials, first reported in 2013, demonstrated that 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.
The global facial aesthetics market is estimated to reach $4.7 billion annually by 2018.
About KYTHERA
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 clinical 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. The Dermatology and Ophthalmic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review KYTHERA's New Drug Application (NDA) for ATX-101 (deoxycholic acid) for "improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults" on March 9, 2015. The FDA has determined the NDA will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. KYTHERA also maintains an active research interest in hair and fat biology, pigmentation modulation and facial contouring. Find more information at www.kytherabiopharma.com.
Forward Looking Statements
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 aesthetic marketplace, the estimated future of the potential global facial aesthetics market, the potential for ATX-101 to fulfill an unmet need as a first in class submental contouring drug for patients in Australia, KYTHERA's plans to make additional ex-U.S. regulatory submissions in 2015 and the expected PDUFA action date. 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 September 30, 2014 and its Annual Report on Form 10-K for the year ended December 31, 2013.