KYTHERA Biopharmaceuticals, Inc. and Intendis, Bayer HealthCare’s dermatology business, have entered into a licensing agreement granting Intendis rights to KYTHERA’s lead product candidate, ATX-101, outside of the US and Canada. ATX-101, a first-in-class investigational drug, is currently in clinical development for the reduction of localized fat under the chin (submental fat).
Under the terms of the agreement, KYTHERA will receive an upfront payment of $43 million and may be eligible to receive up to $330 million for certain development, manufacturing and commercialization milestones. Additionally, KYTHERA will also receive tiered double digit royalties based on net sales in Intendis’ territories. The agreement encompasses all potential indications with KYTHERA to retain development and commercialization rights to ATX-101 in the US and Canada.
Intendis, Bayer HealthCare’s dermatology business, will be collaborating with KYTHERA to execute the currently planned ex-US Phase 3 clinical trials that are expected to start in Europe in late 2010.
“In evaluating multiple partners, we were particularly impressed with Intendis’ vision and commitment to building a new franchise in aesthetic medicine to complement their existing business in dermatology. Moreover, their footprint either directly or through the Bayer family of companies provides a strong commercial presence worldwide,” said Keith Leonard, KYTHERA’s President and CEO. “Based on the results we have seen from the two Phase 2 studies, we believe ATX-101 has the potential to become an important tool for physicians and their patients. We are convinced that the long-standing partnership that Intendis has established with dermatologists worldwide is an excellent basis for the successful introduction of ATX-101 outside the United States.”
“As a business fully dedicated to dermatology, we are well aware of the changing needs that dermatologists are facing in their daily practice,” said Marc Lafeuille, President and CEO of Intendis. “As a first-in-class candidate being studied for minimally-invasive fat reduction, we see ATX-101 as a strong growth opportunity and an excellent entry point into the aesthetic dermatology business. The agreement with KYTHERA will allow us to fully leverage both our long-standing expertise in pharmaceutical development, as well as our strong foothold with the dermatologist.”