fr   en
Agreement



Browse by date
Or search by keyword
Date: 2010-08-30
Biotech partner: Kythera Biopharmaceuticals (USA)
Pharma Partner: Intendis (Bayer HealthCare’s Dermatology Unit - Germany)
Type of agreement: * licensing
Compound: ATX-101 This adipolytic agent is based on an undisclosed well-studied endogenous molecule with unique features including selectivity for adipocytes and rapid clearance. It has been designed to reduce small volumes of facial fat through aesthetics’ applications first-in-class injectable drug being studied for the reduction of small volumes of fat, including submental fat.
Disease area: reduction of small localized volumes of fat, including submental fat (under the chin).
Development phase: Phase II 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 II studies with ATX-101 in the reduction of submental fat and two Phase I pharmacokinetic and histology studies have been successfully completed. clinical development for the reduction of localized fat under the chin.
Nature of the agreement: Kythera Biopharmaceuticals 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.
Intendis, will be collaborating with Kythera to execute the currently planned ex-US Phase III clinical trials that are expected to start in Europe in late 2010.
Under the terms of the agreement, Intendis will receive the exclusive rights to commercialize ATX-101 outside of the United States and Canada. It will also 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.
Intendis currently plans to launch the product in selected markets in Europe, Asia and Latin America starting in 2014.
The agreement encompasses all potential indications with Kythera to retain development and commercialization rights to ATX-101 in the US and Canada.
Financial terms of the agreement: Under the terms of the agreement, Kythera will receive an upfront payment of $43 million (€ 34 million) and may be eligible to receive up to $330 million (€ 251 million) for certain development, manufacturing and commercialization milestones. The US company will also receive tiered double digit royalties based on net sales in Intendis’ territories.


Go back to previous page