ATX-101 has completed Phase II studies in the reduction of submental fat.

Intendis, Bayer HealthCare’s dermatology business, obtained rights to Kythera Biopharmaceuticals’ lead product candidate, ATX-101, outside the U.S. and Canada for $43 million. ATX-101 is currently in clinical development for the reduction of localized fat under the chin. Kythera will be eligible to receive up to $330 million if certain development, manufacturing, and commercialization milestones are met. Additionally, Kythera will receive tiered double-digit royalties based on net sales in Intendis’ territories.

“As a business fully dedicated to dermatology, we are well aware of the changing needs that dermatologists are facing in their daily practice,” says 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.”

Intendis will collaborate with Kythera to execute the currently planned ex-U.S. Phase III trials that are expected to start in Europe later this year. ATX-101 is an 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 features including selectivity for adipocytes and rapid clearance. Two randomized, double-blind, placebo-controlled, Phase II studies with ATX-101 in the reduction of submental fat and two Phase I studies have been successfully completed.

“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,” notes Keith Leonard, Kythera’s president and CEO. “Moreover, their footprint either directly or through the Bayer family of companies provides a strong commercial presence worldwide. 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.”

Kythera is focused on the discovery, development, and commercialization of novel prescription products for the aesthetic market. Its clinical pipeline comprises programs in adipolysis (ATX-101), facial contouring (ATX-104), and pigmentation modulation (ATX-202).

Intendis is headquarted in Berlin and is completely dedicated to dermatology as part of Bayer HealthCare. It concentrates on the development and marketing of topical therapies for skin disorders. The current product portfolio is composed of treatments for eczema disorders including atopic dermatitis as well as psoriasis, acne, rosacea, hemorrhoids, and fungal skin infections.

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