Kythera Biopharmaceuticals has acquired all rights outside of the U.S. and Canada to ATX-101, a proprietary formulation of a purified synthetic version of deoxycholic acid currently in late-stage development for the reduction of submental fat (double chin). In 2010, Kythera licensed the commercial rights to ATX-101 outside of the U.S. and Canada to Bayer Consumer Care.
"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," said Keith Leonard, Kythera's president and CEO. "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."
Bayer will receive $33 million in Kythera common stock, plus a $51 million note, payable no later than 2024. Bayer also is eligible to receive certain long-term sales milestone payments on annual sales outside of the U.S. and Canada.
For the past six 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 1,600 have been treated with ATX-101. In addition, positive and consistent results from multiple phase III trials were reported in the U.S. and Europe, and will provide the basis for regulatory submissions for approval of ATX-101. Kythera plans to file a NDA for ATX-101 with the FDA in the second quarter of 2014. In addition, KYTHERA plans to make multiple ex-U.S. regulatory submissions in the next 12 months. If approved, ATX-101 will be a first-in-class submental contouring injectable drug.