Kythera Biopharmaceuticals said it holds full global rights to develop and commercialize ATX-101, a late-stage clinical drug candidate designed to reduce double chins in people, after acquiring all rights outside the U.S. and Canada from Bayer Consumer Care in a deal worth up-to-$84 million.
Bayer will receive $33 million in Kythera common stock, plus a $51 million promissory note payable no later than 2024. Bayer is also eligible for long-term sales milestone payments on annual sales outside of the U.S. and Canada, Kythera said.
Through its Intendis unit (since renamed Bayer HealthCare), Bayer licensed U.S. and Canadian rights to ATX-101 in August 2010, in return for a $43 million upfront payment and up to $330 million tied to undisclosed development, manufacturing and commercialization milestones. Bayer also agreed to pay Kythera tiered double digit royalties based on net sales in Intendis’ territories.
“While we believe ATX-101 will fulfill an unmet global need, Bayer's strategic focus has evolved since we licensed ATX-101 in 2010," Erica Mann, global president of Bayer HealthCare's Consumer Care Division, said in a statement. "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."
A purified synthetic version of deoxycholic acid, ATX-101 is a first-in-class submental contouring injectable drug that has been the focus of a global clinical development program. The program has enrolled more than 2,500 patients worldwide over the past six years, of which more than 1,600 have been treated with the adipolytic agent. Kythera has reported positive and consistent results from multiple Phase III trials in the U.S. and Europe—on which the company will base its eventual regulatory submissions for approval of ATX-101.
“While our primary focus remains filing our U.S. New Drug Application in the second quarter of 2014, we also plan to make multiple ex-U.S. regulatory submissions in the next 12 months,” added Keith Leonard, Kythera’s president and CEO. “I am confident in our ability to maximize the long-term global value of ATX-101.”
Seamus Fernandez, an analyst with Leerink Partners, wrote in a note to investors that the firm expects annual sales of ATX-101 to peak at $300 million or more once approvals are in place. He added that Kythera “may consider partnering” in China and Japan given the countries’ usual requirement of additional clinical trials.
"The $84 [million] price tag for an international filing-ready Phase III asset with little to no near-term cash outlay leaves plenty of headroom for a successful US launch and several potential [outside-the-U.S.] approvals,” Fernandez wrote. “[Kythera’s] management team's global regulatory & commercial expertise provides substantial incremental leverage and country-by-country potential approvals bolster [Kythera’s] 2015 catalysts beyond the U.S. filing.”