Kythera Biopharmaceuticals, Inc. (Kythera ) and Intendis, Bayer HealthCare’s dermatology business, announced that they 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.”

ATX-101 is a first-in-class injectable drug being studied for the reduction of small volumes of fat, including submental fat. It is based on a well-studied endogenous molecule with unique features including selectivity for adipocytes and rapid clearance. This minimally invasive procedure, done with little or no anaesthetic, has the promise to yield consistent and meaningful clinical results. Clinical studies to date have demonstrated that ATX-101 may effectively reduce localized fat deposits, and is safe and tolerable. Two randomized, double-blind, placebo-controlled, phase 2 studies with ATX-101 in the reduction of submental fat and two phase 1 pharmacokinetic and histology studies have been successfully completed.

Submental fat is a localized subcutaneous fat deposit located immediately beneath the chin and jawline. In the rapidly growing market of minimally invasive, non-surgical facial rejuvenation, the reduction of facial fat deposits to restore and reshape the jawline remains one of the largest unmet patient needs. According to a recent national, multi-centre, clinical evaluation of more than 385 BOTOX and dermal filler patients, 78 per cent of patients had a measurable excess of submental fat. Currently, there are no FDA approved drugs to reduce excess localized fat.

Kythera Biopharmaceuticals, Inc. is a privately held, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel prescription products for the aesthetic market.

Intendis is an integrated pharmaceutical business headquartered in Berlin, Germany. As part of Bayer HealthCare, Intendis is completely dedicated to dermatology and focuses on the development and marketing of high quality, innovative topical therapies, targeted to treat skin disorders.

The Bayer Group is a global enterprise with core competencies in the fields of healthcare, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.