Kythera Biopharmaceuticals

Market position

Kythera's ATX-101/KYBELLA was described as the first and only approved non-surgical injectable treatment for contouring moderate to severe submental fullness, and at the time of the acquisition was the only injectable drug approved in the United States and Canada for reduction of submental fat, positioning it against invasive alternatives such as surgical rejuvenation and targeted liposuction and energy-based devices including lasers, radiofrequency, ultrasound and cryolipolysis.

The company applied a biotechnology-based approach to aesthetic medicine, offering a non-surgical, physician-administered injectable that destroys submental fat cells, in a category otherwise served by surgery, liposuction and energy-based devices.

Technology

ATX-101/KYBELLA is a synthetic, non-human and non-animal formulation of deoxycholic acid, a naturally occurring molecule that aids breakdown and absorption of dietary fat; injected subcutaneously it causes adipocytolysis, destroying fat cells so they can no longer store or accumulate fat. The pipeline also included setipiprant (KYTH-105) for androgenetic alopecia and ATX-202, a melanin-targeted program for vitiligo (discontinued).

Go-to-market

Products were commercialized as prescription treatments administered only by trained healthcare professionals in physician practices, supported by a large clinical development program and regulatory submissions across multiple countries.

Aesthetic medicine physicians and dermatologists administering in-office treatments, and their adult patients—both women and men—bothered by moderate to severe submental fullness.

Geography

U.S.-based (California; Westlake Village headquarters, earlier described as Calabasas) with approval in the United States, marketing authorization in Canada (BELKYRA), and regulatory submissions in Switzerland, Australia and the European Union.

History

The company was co-founded in 2005 by Nathaniel David, who served as Chief Science Officer. It raised multiple venture rounds, including a Series D in September 2011 that brought total funding to $108 million, and went public on NASDAQ (KYTH) in 2012. Its lead asset ATX-101 was approved by the FDA as KYBELLA on April 29, 2015 and launched on June 19, 2015, followed by Health Canada marketing authorization as BELKYRA and regulatory filings in Switzerland, Australia and the European Union. Allergan agreed to acquire the company in 2015 at $75 per share (80% cash, 20% Allergan stock per one report; the closing announcement described an all-cash transaction) for approximately $2.1 billion; the FTC granted early termination of the Hart-Scott-Rodino waiting period on July 27, 2015 and the acquisition closed on October 1, 2015.

Risks & controversies

KYBELLA carries clinical safety considerations: it is contraindicated where injection-site infection is present; marginal mandibular nerve injury (asymmetric smile or facial muscle weakness) was reported in trials (all cases resolved spontaneously, 1–298 days, median 44); dysphagia occurred in the setting of administration-site reactions (resolved in 1–81 days, median 3); and 72% of treated subjects experienced injection-site hematoma/bruising, with caution advised in patients with bleeding abnormalities or on antiplatelet/anticoagulant therapy. Use outside the submental region is not established or recommended. Merger completion had been subject to regulatory and stockholder approval conditions.