Revance Highlights Recent Regulatory Progress and Provides Anticipated 2019 Milestones

Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced updates on meetings with the U.S. Food and Drug Administration (FDA), the initiation of two new Phase 2 clinical trials for DaxibotulinumtoxinA for Injection (RT002) in therapeutic indications, commercial collaborations, and details on certain anticipated clinical and regulatory milestones in 2019.

“Revance is entering 2019 with tremendous momentum on multiple fronts,” said Dan Browne, president and chief executive officer at Revance. “We have an exciting ensemble of late-stage clinical trials underway for our next-generation neuromodulator and are operating a U.S.-based, commercial-scale drug substance and drug product facility to manufacture a broad range of proprietary neuromodulation formulations. We also have an active collaboration for the introduction of RT002 in China and another to develop a biosimilar to BOTOX. Strategically, as we anticipate entering the market with RT002 in 2020, we intend to set a new standard in neuromodulators, focused on providing patients with the ability to safely alleviate the appearance of frown lines with just two or fewer treatments per year.”

REGULATORY UPDATE AND MILESTONES

In December of 2018, the company completed its pre-Biologics Licensing Application (BLA) meeting with the FDA for its submission of DaxibotulinumtoxinA for Injection (RT002) in the treatment of glabellar (frown) lines. According to Browne, “With the unprecedented SAKURA 3 Phase 3 open-label clinical program in glabellar lines successfully concluded, we have completed all the necessary clinical trials for our long-lasting neuromodulator RT002 and we are busy finalizing steps to submit our application to the FDA for regulatory approval. We remain confident in our ability to gain approval with a differentiated label and to build a meaningful neuromodulator business based on innovation, best-in-class performance, and improved patient outcomes.”

In February of 2018, Revance announced a collaboration and license agreement with Mylan N.V. on a biosimilar to BOTOX. Revance has since performed detailed analytical (structural and functional) characterization and comparability testing of its product to the reference product for the Biosimilar Initial Advisory Meeting (BIAM). In concert with Mylan, Revance submitted its BIAM briefing package to the FDA to develop the biosimilar to BOTOX under a 351(k)-development pathway, and was granted a face-to-face meeting in the first quarter of 2019.