Westlake Village, Calif., March 9, 2015 – KYTHERA Biopharmaceuticals, Inc. (NASDAQ: KYTH) announced today that the U.S. Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to support the approval of ATX-101 (deoxycholic acid) injection for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults, which is often referred to as a double chin. If approved, ATX-101 would be a first-in-class submental contouring injectable drug.
"We are pleased that the FDA advisory committee recognized the importance of providing patients with a clinically-proven treatment option specifically developed to contour submental fullness, a much-cited yet undertreated facial aesthetic complaint," said Frederick C. Beddingfield, III, M.D., Ph.D., chief medical officer, KYTHERA Biopharmaceuticals. "We look forward to working with the FDA as they continue their review of ATX-101 with the goal of providing patients with the first and only approved non-surgical treatment for submental fullness."
The committee's recommendation, although not binding, will be considered by the FDA as it continues its review of ATX-101. If approved by the FDA, KYTHERA anticipates launching ATX-101 in the second half of 2015.
"This milestone demonstrates our commitment to developing first-in-class aesthetic products through a focus on scientific rigor and innovation," said Keith Leonard, president and CEO, KYTHERA Biopharmaceuticals. "At KYTHERA, we remain focused on investing in novel treatments that will allow aesthetic physicians to better meet the needs of their patients."
ATX-101 is a patented formulation of a pure, non-animal derived version of deoxycholic acid, a naturally occurring molecule in the body that aids in the breakdown of dietary fat. ATX-101 has been the subject of 19 clinical studies involving more than 2,600 patients covering a span of ages (19-65) and BMI (18-40). A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in May 2014 and has a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015. Additionally, KYTHERA has submitted regulatory filings in Canada, Switzerland and Australia. If approved, ATX-101 would be a less-invasive, non-surgical option for the treatment of submental fullness.
About Submental Fullness
Submental fullness is an oft-cited, yet undertreated, condition that can detract from an otherwise balanced and harmonious facial appearance[i] – leading to an older and heavier look.[ii]Submental fullness can affect adults of all ages and weight. Influenced by multiple factors, including aging and genetics, submental fullness is often resistant to diet and exercise. According to a 2014 survey by the American Society for Dermatologic Surgery, 68 percent of consumers are bothered by submental fullness.[iii]
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. In addition to its lead product candidate ATX-101, KYTHERA also licensed the worldwide rights to setipiprant, an early-stage potential treatment for hair loss. KYTHERA's longer-term strategy is to leverage its biotechnology and aesthetics experience to expand its product portfolio and pipeline. Find more information at www.kythera.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 be a first-in-class submental contouring injectable drug, potential anticipated launch of ATX-101 in the second half of 2015, the ability of ATX-101 to be a less-invasive, non-surgical option for the treatment of submental fullness, and expectations regarding our longer-term strategy. 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 Annual Report on Form 10-K for the year ended December 31, 2014.
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[i] Swift A, Remington K. BeautiPHication: a global approach to facial beauty. Clin Plast Surg. 2011; 38:347-77.
[ii] Dayan S. Neck rejuvenation. In: Hirsch, Aesthetic Rejuvenation: A Regional Approach. 1st ed. New York, NY: McGraw Hill Professional Publishing; 2008: 123-147.
[iii] American Society for Dermatologic Surgery 2014 Consumer Survey on Cosmetic Dermatologic Procedures (N=8,315); Exact survey language was, "How bothered are you by excess fat under the chin/neck?"