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6/5/2012 10:47:43 AM
LOS ANGELES--(BUSINESS WIRE)--KYTHERA Biopharmaceuticals, Inc. (KYTHERA) today announced that it has received a $15.8 million payment from Bayer Consumer Care AG (Bayer) under the terms of their August 2010 collaboration arrangement to develop and commercialize KYTHERA’s injectable drug candidate, ATX-101, outside the United States and Canada. In addition, KYTHERA received €14.1 million ($17.5 million) to fund certain further global development activities of ATX-101 under the terms of the collaboration arrangement. The payments were triggered by Bayer’s decision to pursue continued development and regulatory approvals for ATX-101 after receipt of positive results from pivotal European Phase III clinical trials.
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 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.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of more than EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
KYTHERA Biopharmaceuticals, Inc.
Erica Bazerkanian, (805) 300-9289
Heather Rowe, (818) 587-4559