Allergan Completes Acquisition of Kybella Maker Kythera
Allergan plc has successfully completed the acquisition of Kythera Biopharmaceuticals, Inc. Allergan acquired Kythera in an all-cash transaction valued at approximately $2.1 billion.
The acquisition of Kythera adds Kybella® (deoxycholic acid) injection, the first FDA approved non-surgical injection for improvement in the appearance of moderate to severe submental fullness in adults. Kybella is administered by a trained physician who injects the product under a patient's chin to destroy fat cells, improving the appearance of the patient's chin area. Up to six treatments may be administered per patient no less than one month apart, and each in-office treatment session lasts approximately twenty minutes.
"The completion of the Kythera acquisition is an important moment for Allergan and our world-class aesthetics business, adding highly differentiated products and development programs that enhance our product offering to global customers and their patients," said Brent Saunders, CEO and President of Allergan. "Kybella is a game-changing product in facial aesthetics, and builds on our leadership in the facial aesthetics market."
Kythera recently announced the submission of a Marketing Authorization Application (MAA) in the European Union (EU), seeking approval for ATX-101 (deoxycholic acid) injection as a treatment for the reduction of submental fat when the presence of submental fat has a psychological impact for the patient. Additionally, Allergan will pursue the relevant clinical trial requirements and the regulatory pathways to license and commercialize this treatment in other countries.
The acquisition also adds Kythera's development product setipiprant (KYTH-105), a novel compound for the prevention of androgenetic alopecia (AGA), or male pattern hair loss, as well as additional early-stage development candidates. Kythera has submitted an Investigational New Drug Application (IND) to the FDA for setipiprant for the treatment of AGA. Allergan plans to conduct a human proof-of-concept study to evaluate the efficacy and safety of setipiprant in male subjects with AGA.