Intendis and KYTHERA Enter Licensing and Development Agreement on Adipolytic Agent for Aesthetic Dermatology Use

Tuesday, Aug 31, 2010

Intendis and KYTHERA Enter Licensing and Development Agreement on Adipolytic Agent for Aesthetic Dermatology Use
Bayer’s dermatology subsidiary Intendis prepares to enter aesthetics segment / Joint development of first-in-class injectable drug for minimally invasive facial fat reduction

Berlin, August 30, 2010 - Bayer HealthCare’s dermatology business Intendis and KYTHERA Biopharmaceuticals, Inc. today announced an agreement to develop and commercialize ATX-101; an adipolytic agent designed to reduce small volumes of facial fat through aesthetics’ applications. A Phase III study for the reduction of localized fat under the chin (submental fat) is expected to start in 2010 in Europe. Under the terms of the agreement, Intendis will receive the exclusive rights to commercialize ATX-101 outside of the United States and Canada and will collaborate with KYTHERA in the execution of the development ex-North Amerika. KYTHERA retains the rights to develop and commercialize ATX-101 in the United States and Canada.

"As a business fully dedicated to dermatology, we are aware of the changing needs that dermatologists face in their daily practice," said Marc Lafeuille, President and CEO of Intendis. "As a first-in-class candidate being studied for minimally invasive fat removal, 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."

"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 for a strong commercial presence worldwide," said Keith Leonard, KYTHERA’s president and CEO. "Based on the results we have seen from the two Phase II studies, we believe in ATX-101’s potential to significantly augment the currently available offering of fillers and injectables that dermatologists have at their disposal today. 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 North America."

The upcoming Phase III study and subsequent development work will be coordinated by Intendis in close cooperation with KYTHERA. It is planned that Intendis will obtain the marketing authorizations outside the United States. Intendis currently plans to launch the product in selected markets in Europe, Asia and Latin America starting in 2014. Under the terms of the agreement KYTHERA will receive an upfront payment of US $ 43 million (EUR 34 million). Additionally, KYTHERA may be eligible to receive cash payments upon achievement of certain development, manufacturing and commercialization milestones totaling up to US $ 330 million (EUR 251 million) and tiered, double digit royalties on net sales.

Source: Intendis