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Revance to Present Clinical Data on the Efficacy and Safety Profile of DAXXIFY™ (DaxibotulinumtoxinA-lanm) for Injection at the 2022 American Society for Dermatologic Surgery (ASDS) Annual Meeting

October 10, 2022

-- Subgroup analysis from SAKURA 3 demonstrating the safety and efficacy of DAXXIFY™ in black patients --

-- High level of satisfaction in DAXXIFY™ patients who achieved the elimination of glabellar lines, consistent across subgroups --

NASHVILLE, Tenn.--(BUSINESS WIRE)--Oct. 10, 2022-- Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced today it will present two video abstracts featuring DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection at the American Society for Dermatologic Surgery (ASDS) Annual Meeting taking place in Aurora, CO, from October 6-10, 2022.

“The research we are presenting at the ASDS Annual Meeting demonstrates the efficacy and safety profile of DAXXIFY™ for all patients irrespective of skin type, while also highlighting the high degree of patient satisfaction with DAXXIFY™ treatment outcomes,” said Conor Gallagher, PhD, Vice President of Medical Affairs and Scientific Innovation at Revance. “These presentations highlight Revance’s continued commitment to advancing innovation and setting a new standard in facial aesthetics treatments for both providers and the patients they serve.”

Video recordings of lead authors presenting both abstracts will be available to view in the exhibition hall during designated break times.

Video Presentations:

  • Title: DaxibotulinumtoxinA for Injection Demonstrates Consistent Safety and Efficacy in Black Subjects: Subgroup Analysis from a Large, Open-Label, Repeat-Dose Study
  • Authors and Affiliations: Cheryl Burgess, Valerie Callender, Charles Boyd, Jessica Brown, Conor J. Gallagher, Center for Dermatology and Dermatologic Surgery, Washington, DC, USA; Callender Center for Clinical Research, Glenn Dale, MD, USA; Boyd Beauty, Birmingham, MI, USA; Revance Therapeutics, Inc., Nashville, TN, USA
  • Title: Desirability and Consistency of Elimination of Glabellar Lines Following Treatment with DaxibotulinumtoxinA for Injection
  • Authors and Affiliations: Shannon Humphrey, Sabrina Fabi, Derek Jones, Todd Gross, Conor Gallagher, Roman Rubio, Humphrey Cosmetic Dermatology, Vancouver, British Columbia, Canada; Cosmetic Laser Dermatology, San Diego, CA; Skin Care and Laser Physicians of Beverly Hills, Beverly Hills, CA; Revance Therapeutics, Inc., Newark, CA, Blue Obsidian, LLC, Mountain View, CA

The above presentations will be available for the duration of the ASDS conference and available on-demand for 60 days post-meeting. Complete abstracts, details on presentation times and schedules can be found on the ASDS website. Please visit www.asds.net for the latest information.

About DAXXIFY™

DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting peptide-formulated neuromodulator product for use in adults for the temporary improvement of moderate to severe frown lines (glabellar lines).1-7 DAXXIFY™ has the ability to deliver year-long results for patients with potentially only two treatments per year and has been proven to be effective, and generally safe and well tolerated.2,8-10* DAXXIFY™ is powered by a cell-penetrating peptide technology (Peptide Exchange Technology™), Revance's proprietary, synthetic, 35-amino-acid stabilizing excipient with a highly positive charge, and is free of human serum albumin or animal-based components.1,2,7 Manufactured exclusively in the U.S., DAXXIFY™ is the first true innovation in neuromodulator product formulation in over 30 years.

Revance has evaluated this neuromodulator formulation in other Phase 2 clinical studies in aesthetics, including the full upper face, forehead lines and crow’s feet as well as in therapeutic indications, including cervical dystonia and upper limb spasticity. Learn more at RevanceAesthetics.com.

* At least 50% of patients treated with DAXXIFY™ in SAKURA 1 and 2 had none or mild frown lines per investigator or patient assessments for 24 weeks and 23.9 weeks (6 months) or longer (respectively) after treatment.

Please see DAXXIFY™ important safety information below and full Prescribing Information, including Boxed Warning and Medication Guide.

About Revance

Revance is a commercial stage biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that elevate patient and physician experiences. Revance’s aesthetics portfolio of expertly created products and services, including DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection, the RHA® Collection of dermal fillers, and OPUL®, the first-of-its-kind Relational Commerce platform for aesthetic practices, deliver a differentiated and exclusive offering for the company’s elite practice partners and their consumers. Revance has also partnered with Viatris Inc. to develop a biosimilar to BOTOX®, which will compete in the existing short-acting neuromodulator marketplace. Revance’s therapeutics pipeline is currently focused on muscle movement disorders including evaluating DaxibotulinumtoxinA for Injection in two debilitating conditions, cervical dystonia and upper limb spasticity.

Revance is headquartered in Nashville, Tennessee, with additional office locations in Newark, Pleasanton and Irvine, California. Learn more at www.Revance.com or connect with us on LinkedIn.

“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.

IMPORTANT SAFETY INFORMATION for DAXXIFY™ (daxibotulinumtoxinA-Ianm) injection

DAXXIFY™ may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of DAXXIFY™:

  • Problems swallowing, speaking, or breathing due to weakening of associated muscles can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms that include loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

Do not receive DAXXIFY™ if you are allergic to any of the ingredients in DAXXIFY™ (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®/BOTOX® Cosmetic), abobotulinumtoxinA (DYSPORT®), incobotulinumtoxinA (XEOMIN®) or prabotulinumtoxinA-xvfs (JEUVEAU®); or have a skin infection at the planned injection site.

DAXXIFY™ dosing units are not the same as, or comparable to, any other botulinum toxin product.

Tell your healthcare provider about all your medical conditions, including any side effects from botulinum toxin products, including dry eye; breathing, swallowing, bleeding, or heart problems; plans to have surgery; weakness of forehead muscles; drooping eyelids; have had surgery on your face; are pregnant or breastfeeding or plan to become pregnant or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using DAXXIFY™ with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your healthcare provider that you have received DAXXIFY™ in the past.

Especially tell your healthcare provider if you have received any other botulinum toxin product in the last 4 months or any in the past, and exactly which product you received (such as BOTOX®, BOTOX® Cosmetic, MYOBLOC®, DYSPORT®, XEOMIN®, or JEUVEAU®). DAXXIFY™ may cause serious side effects, including allergic reactions (such as itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint), heart problems (such as irregular heartbeat and heart attack), and eye problems (including dry eye, reduced blinking, and corneal problems). Tell your healthcare provider or get medical help right away if you experience a serious side effect. No serious adverse events of distant spread of toxin effect associated with dermatologic use of DAXXIFY™ have been reported in clinical studies at the dose of 40 Units for glabellar lines. The most common side effects of DAXXIFY™ include headache, eyelid drooping, and loss of ability to move the muscles in your face.

These are not all the possible side effects of DAXXIFY™. For more information, see the full Prescribing Information including Boxed Warning, and refer to the Medication Guide or talk with your doctor. To report side effects associated with DAXXIFY™, please call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

APPROVED USE

DAXXIFY™ is a prescription medicine that is injected into muscles and used in adults to temporarily improve the look of moderate to severe frown lines between the eyebrows.

Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, safety, efficacy and duration of DAXXIFY™; development of a biosimilar to BOTOX® with our partner, Viatris; statements about our business strategy, timeline and other goals, plans and prospects; and the outcomes for and experiences of patients; constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: our ability to successfully commercialize DAXXIFY™ and to continue to successfully commercialize the RHA® Collection of dermal fillers and OPUL®; the results, timing, costs, and completion of our research and development activities and regulatory approvals; our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, future revenues, capital requirements, our financial performance and the economics of DAXXIFY™, the RHA® Collection of dermal fillers and OPUL®; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products and services, the aesthetics market, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability and the ability of our partners to manufacture supplies for DAXXIFY™ and our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY™, the RHA® Collection of dermal fillers, OPUL® and our drug product candidates, if approved; reports of adverse events or safety concerns involving DAXXIFY™ or the RHA® Collection of dermal fillers; the timing and cost of commercialization activities; the proper training and administration of our products by physicians and medical staff; our ability to expand sales and marketing capabilities; the status of commercial collaborations; changes in and failures to comply with privacy and data protection laws; our ability to effectively manage our expanded operations in connection with the acquisition of Hint, Inc; our ability to continue obtaining and maintaining intellectual property protection for DAXXIFY™ and our drug product candidates; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; the volatility of our stock price; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-K filed with the SEC on February 28, 2022 and including, without limitation, our Form 10-Q for the quarter ended June 30, 2022, filed with the SEC on August 9, 2022. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

SOURCES

  1. Data on File. Draft DAXXIFY™ Package Insert. Newark, CA: Revance Therapeutics, Inc, 2022.
  2. Fabi SG, Cohen JL, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open-label, phase 3 safety study. Dermatol Surg. 2020. doi:10.1097/DSS.0000000000002531
  3. Xeomin. Prescribing Information. Merz Pharmaceuticals GmbH; 2020.
  4. Dysport. Prescribing Information. Ipsen Biopharmaceuticals, Ltd; 2020.
  5. Jeuveau. Prescribing Information. Evolus, Inc; 2020.
  6. Botox Cosmetic. Prescribing Information. Allergan, Inc; 2020.
  7. Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011; 683:553
  8. Carruthers JD, Fagien S, 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.
  9. Bertucci V, Solish N, et al. DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2). J Am Acad Dermatol. 2020;82(4):838-845.
  10. Green JB, Mariwalla K, Coleman K, et al. A large, open-label, phase 3 safety study of daxibotulinumtoxinA for injection in glabellar lines: a focus on safety from the SAKURA 3 study. Dermatol Surg. 2020. doi:10.1097/DSS.0000000000002463

 

Media
Revance Therapeutics, Inc.:
Sara J. Fahy
Media@revance.com

Investors
Revance Therapeutics, Inc.:
Jessica Serra, 626-589-1007
Jessica.serra@revance.com

or

Gilmartin Group, LLC.:
Laurence Watts, 619-916-7620
laurence@gilmartinir.com

Source: Revance Therapeutics, Inc.