ATX-101 is at present in late stage clinical trials for the reduction of submental fat or double chin. The drug is a proprietary formulation of a purified synthetic version of a deoxycholic acid, a naturally occurring molecule in the body which helps in the breakdown of dietary fat.
Erica Mann, global president of Bayer HealthCare’s Consumer Care Division, said “While we believe ATX-101 will fulfill an unmet global need, Bayer’s strategic focus has evolved since we licensed ATX-101 in 2010. Our decision to take an equity position in Kythera is a testament to our belief in the potential for ATX-101, and will allow us to participate in Kythera’s future success.”
The company will receive $33 million in Kythera common stock under the new agreement, with an additional $51 million promissory note payable no later than 2014. Bayer will also be eligible to receive specific long-term sales milestone payments on annual sales of the drug outside the U.S. and Canada.
Keith Leonard, KYTHERA president and CEO, said “We are very pleased to acquire all rights to ATX-101 outside the U.S. and Canada, giving us full global rights to develop and commercialize ATX-101. We appreciate Bayer’s investment in the ATX-101 global development program over the past four years. During that time we strengthened our financial position and assembled a senior executive team with global aesthetic development and commercialization expertise. I am confident in our ability to maximize the long-term global value of ATX-101.” Leonard said the company will prioritize the filing of a New Drug Application in the second quarter of 2014 but also plan to produce several ex-U.S. regulatory submissions in the following 12 months.