Positive results for KYTHERA and Bayer's ATX-101 in the reduction of "double chin"

Privately-held US biotech firm KYTHERA Biopharmaceuticals announced positive interim results from a Phase IIIb, multicenter, open-label study (ATX-101-11-26) to evaluate the safety and efficacy of ATX-101, an investigational injectable drug for the reduction of unwanted submental fat (SMF), commonly known as double chin.

The results, presented at the Late Breaking Research Symposium at the 71st  American Academy of Dermatology (AAD) annual meeting in Miami Beach, Florida, found that ATX-101 is well-tolerated and may be effective in reducing SMF by both clinician and patient reported outcome measures. The ATX-101 global clinical development program has enrolled more than 2,500 total patients, of which more than 1,500 have been treated with ATX-101.

Rights to ATX-101 were licensed to Germany’s Bayer (BAYN: DE) for an upfront payment of $43 million (The Pharma Letter August 31, 2010). Under the terms of that deal, KYTHERA may be eligible to receive cash payments on the achievement of certain development, manufacturing and commercialization milestones totaling up to $330 million, as well as tiered, double digit royalties on net sales.