KYTHERA And Intendis Announce Initiation Of European Phase III Clinical Development Program To Evaluate ATX-101 For Reduction Of Submental Fat

KYTHERA Biopharmaceuticals, Inc. ("KYTHERA") and Intendis, Bayer HealthCare's dermatology business, announced the initiation of two European Phase III studies evaluating ATX-101, a first-in-class injectable adipolytic agent, for the reduction of localized fat under the chin (submental fat).


The two multi-center, randomized, double-blind, placebo-controlled, Phase III studies will enroll approximately 720 patients total to assess safety, tolerability and efficacy of ATX-101 versus placebo in the reduction of submental fat. The studies will assess multiple physician and patient-reported efficacy endpoints and are being conducted in approximately 64 centers across the United Kingdom, France, Germany, Belgium, Spain and Italy.


"I am delighted to be involved in the ATX-101 Phase III clinical development program, which I believe to be an important advancement in the area of aesthetic medicine," said Jean Paul Ortonne, MD, dermatologist and ATX-101 clinical investigator in France. "There is a huge demand for a safe, effective and approved injectable treatment for localized fat reduction. These Phase III studies are positive steps toward providing patients with a well-studied, clinically-proven treatment to reduce localized submental fat without surgery."


In two previously conducted ex-US Phase II studies, ATX-101 was well-tolerated and yielded statistically significant reduction of submental fat compared to placebo based on physician and patient assessments. Additionally, KYTHERA, in late 2010, completed a Phase IIB study in the United States and will be releasing data later in 2011.


"We are very pleased with the progress that has been made in Europe with ATX-101," said Keith Leonard, KYTHERA's President and CEO. "The initiation of these Phase III studies marks an important milestone in our collaboration with Intendis and further demonstrates the potential of ATX-101 as a first-in-class injectable drug for localized fat reduction."


"ATX-101 represents a promising product for Intendis to enter the growing aesthetic market," said Marc Lafeuille, President and CEO of Intendis. "We are very pleased to progress to Phase III development of ATX-101, where we are hopeful that the product will reduce localized submental fat as expected."


KYTHERA announced last August a licensing and development agreement granting Intendis commercialization rights to ATX-101 outside of the US and Canada. The strategic partnership deal, which could be worth up to $373 million, marked Intendis' entry into aesthetic dermatology. KYTHERA and Intendis are collaborating on the development of ATX-101 in Europe.


About ATX-101


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 anesthetic, 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. Three 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.

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