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Neuromodulator: DaxibotulinumtoxinA for Injection

Our investigational neuromodulator product, DaxibotulinumtoxinA for Injection, is aiming to establish a new, premium, long-lasting neuromodulator category.

DaxibotulinumtoxinA for Injection is an investigational agent that has not been approved by the FDA. Anticipated approval in 2020.

The consumer experience has remained largely unchanged since botulinum toxin type A treatments were first introduced over 30 years ago. Once approved, we expect that people treated with DaxibotulinumtoxinA for Injection may achieve frown line correction with as few as two treatments per year.1

First and only neuromodulator product candidate with a proprietary peptide formulation

DaxibotulinumtoxinA combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.

150kD Botulinum Toxin Type A

Stabilizing Peptide Excipient

Buffers, Sugar and Polysorbate 20

DaxibotulinumtoxinA for Injection

DaxibotulinumtoxinA is developed and manufactured exclusively in the U.S.

Revance employs in-house, state-of-the-art manufacturing and analytics capabilities, and holds 418 issued patents in the US, EU, Latin America and Asia, as of December 31, 2019.

DaxibotulinumtoxinA for Injection has been evaluated in the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines

Based on results from the SAKURA program (SAKURA 1, 2, 3), we expect that people treated with DaxibotulinumtoxinA for Injection may achieve frown line correction with as few as two treatments per year.1

Subjects achieved a two-grade improvement in glabellar lines as assessed by with the patient and the investigator at week 4 after treatment.1

Response rate for DaxibotulinumtoxinA for Injection across the largest phase 3 program of an aesthetic neuromodulator in glabellar lines.1

*This data point represents percent of subjects achieving glabellar line severity of none/mild at week 4

24 weeks

The median time to loss of none or mild wrinkle severity in clinical trials with DaxibotulinumtoxinA for Injection.2

28 weeks

The median time to return to baseline wrinkle severity in the SAKURA program2

Aesthetics Clinical Program Update

  • PRECLINICAL
  • PHASE 1
  • PHASE 2
  • PHASE 3

Aesthetics — DaxibotulinumtoxinA for Injection

Glabellar (Frown) Lines Submit BLA Fall 2019, anticipate launch 2020
PHASE 3 COMPLETE
Forehead Lines
IN PHASE 2
Lateral Canthal Lines (Crow’s Feet)
IN PHASE 2
Upper Facial Lines
IN PHASE 2
PDUFA Target Action Date Nov. 25

Glabellar (Frown) Lines — A

In the first quarter of 2020, the FDA accepted for review the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. The BLA under review includes results from three Phase 3 trials (SAKURA 1,2,3), the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines. DaxibotulinumtoxinA for Injection has also been evaluated in a Phase 2 head-to-head, active comparator study (BELMONT). Revance anticipates potential product approval in the fourth quarter of 2020.

Forehead Lines — B

DaxibotulinumtoxinA for Injection is being evaluated in a Phase 2 open-label study for the treatment of moderate to severe dynamic forehead lines (frontalis) following glabellar line injection. An interim analysis from the study found that treatment with DaxibotulinumtoxinA for Injection substantially improved the appearance of forehead lines versus placebo at all doses tested 4 weeks after treatment and resulted in high patient satisfaction.3

Lateral Canthal Lines (Crow’s Feet) – C

DaxibotulinumtoxinA for Injection is being evaluated in a Phase 2 open-label study for the treatment of moderate to severe lateral canthal lines, commonly known as crow’s feet. Clinical data demonstrated positive efficacy results and that DaxibotulinumtoxinA for Injection was well tolerated.

Upper Facial Lines — A, B & C

Revance initiated a new open-label Phase 2 trial for treatment of the full upper face – glabellar (frown), lateral canthal (crow’s feet), and forehead lines combined – to understand the safety and efficacy, including potential dosing and injection patterns, of DaxibotulinumtoxinA for Injection. Topline results are anticipated in the fourth quarter of 2020.

For the latest information regarding our clinical development programs, please see our public filings with the Securities and Exchange Commission or visit clinicaltrials.gov.

Publications & Videos

DaxibotulinumtoxinA for Injection is an investigational product. It is currently undergoing clinical studies for both therapeutic and aesthetic indications.

References

  1. Carruthers JD, et al. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Results from Each of Two Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg. 2020;145(1):45–58. doi:10.1097/PRS.0000000000006327
  2. Fabi SG, et al. Results of a Large Open Label Safety Study of Daxibotulinumtoxina for Injection in Glabellar Lines. Podium presentation at 2019 ASDS. 26 October, 2019. Chicago, Illinois.
  3. Nowell Solish, et al. A Phase 2a Dose-Escalation Study to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection for the Treatment of Dynamic Forehead Lines Following Glabellar Line Injections: An Interim Analysis. Poster presentation at 2020 Annual Maui Derm for Dermatologists meeting. 25-29 January 2020. Maui, Hawaii.
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