Exhibit 99.1
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Revance’s RT002 Demonstrates Unprecedented Efficacy and Duration
In Largest-Ever Aesthetic Neuromodulator Clinical Program
– In SAKURA 3, RT002 was well-tolerated across over 3,800 treatments in glabellar (frown) lines –
– The median time to return to baseline glabellar line severity was 28 weeks –
– RT002 represents the first long-acting neuromodulator, allowing for two or fewer treatments per year –
– Revance announces new trials in forehead lines and lateral canthal lines (crow’s feet) –
– Revance to host conference call at 8:30 am ET today –
NEWARK, Calif., December 4, 2018 - Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing next-generation neuromodulators for use in treating aesthetic and therapeutic conditions, today announced its long-acting neuromodulator DaxibotulinumtoxinA for Injection (RT002) with its proprietary stabilizing excipient peptide technology delivered positivetop-line results in alleviatingmoderate-to-severe glabellar (frown) lines in the SAKURA 3 Phase 3 open-label, long-term safety study. Completion of this study paves the way for Revance to submit a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA), which ison-track for the first half of 2019.
As a component of the largest clinical program of an aesthetic neuromodulator, the SAKURA 3 study included nearly 2,700 patients and more than 3,800 treatments. Patients received up to three treatments of RT002 and were followed for over a year and a half. Overall, the safety findings were consistent with the known safety profiles for currently available neuromodulators in aesthetics. Importantly, the rate of treatment-related adverse events decreased over successive treatments. For efficacy, based on investigator assessment, more than 95% of patients achieved a score of none or mild glabellar lines at maximum frown at Week 4 after each of three treatments. Measuring duration of effect, the median time to return to baseline glabellar line severity was 28 weeks. The median time to loss of none or mild wrinkle severity was 24 weeks. The SAKURA 3 results were consistent with those in the Phase 3 pivotal trials, SAKURA 1 and SAKURA 2.
“The results of this trial are exceptional since they demonstrate that RT002 has consistently and predictably produced long duration and high response rates and was well tolerated over successive treatments,” said SAKURA investigator Jean D. Carruthers, M.D., who has served as an investigator for multipleFDA-approved neuromodulators, and is a clinical professor at the University of British Columbia. “My study patients were thrilled with their appearance and the longevity RT002 delivered, and they can’t wait for this treatment option. I look forward to the possibility of providing my patients a new, unique neuromodulator that needs just two or fewer treatments a year.”
Dan Browne,co-founder, president and chief executive officer of Revance said, “We are very excited by these compelling new data, which support RT002 as a next-generation neuromodulator with highly differentiated characteristics. We look forward to working closely with the FDA to bring this important treatment to patients as soon as possible. The success of the SAKURA aesthetic trials, combined with our ongoing therapeutic studies in multiple neuroscience indications, drive our mission to become the leading innovator in neuromodulators.”