NEWARK, Calif.--(BUSINESS WIRE)--Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company’s field force is established and will begin introducing its prestige aesthetics portfolio, including the RHA® Collection of dermal fillers, resilient hyaluronic acid, and the HintMD financial technology (fintech) platform, in the United States (U.S.) in September.1
Revance Commercial Launch
Revance is ready to execute its first commercial product portfolio launch with the completion of onboarding and training processes for their 100+ field force team.
The company plans to approach prestige aesthetic practices across the U.S., offering its first premium products and services, the RHA® Collection of dermal fillers, along with an integrated fintech platform, HintMD. The same commercial infrastructure is anticipated to roll out DaxibotulinumtoxinA for Injection for the treatment of glabellar lines upon FDA approval later this year. Revance has recently concluded the RHA® Collection PrevU early clinical experience education and training program for select practices ahead of the consumer launch of the RHA® Collection and plans to share observations in the near future.
“Revance is positioned to re-energize the aesthetics industry with the creation of a prestige category of innovative products and services and elevated customer and patient experiences available through select practices. Our commercial team, comprised of industry experts with decades of aesthetics and commercial experience, is now trained and in position to execute Revance’s first commercial launch,” said Dustin S. Sjuts, Chief Commercial Officer. “We are delighted to be entering the market with the RHA® Collection, the latest innovation in HA technology, and an integrated fintech platform designed to transform existing payment processing ecosystems and improve both aesthetics practice economics and patient experiences. We plan to follow with our lead investigational candidate DaxibotulinumtoxinA for Injection after its anticipated approval, which is just around the corner.”
RHA® Collection of Dermal Fillers Clinical Study Results
The RHA® Collection of dermal fillers represent the latest advancement in HA filler science and are designed with a crosslinking method that preserves the hyaluronic acid network to more closely mimic natural HA found in the skin. The gels are designed to be resilient and adapt to facial movement, which may provide a natural look at rest and in motion.2-5 The safety and efficacy of RHA® dermal fillers are well established, having been demonstrated through clinical studies, which have been published and presented globally, including:
18-Month Head-to Head European Clinical Study Published in Dermatologic Surgery
In an 18-month, head-to-head, randomized and controlled study published in Dermatologic Surgery, RHA® 2, 3, 4 were evaluated for efficacy, durability and safety versus other available comparator gels on the market for the treatment of nasolabial folds (NLF). Results showed: 6
- Overall physician preference for RHA® Collection products due to ease of injection and product placement, immediate results, and results after massage of the injected tissue
- High levels of improved satisfaction immediately after injection and in the long-term for both investigators and participating subjects
- Fewer touch-ups were needed by (or at) day 14 with gels in the RHA® Collection (26.7% versus 35.6% with comparators)
- Better long-term improvement of NLF volume with gels in the RHA® Collection based on 3D skin topography measurements.
European Clinical Experience and Tissue Integration Analysis Published in Journal of Drugs in Dermatology
Observations from clinical experience included7:
- RHA® fillers blend well into wrinkles and folds with excellent tissue integration
- RHA® 2 and RHA® 3 fillers could be used effectively in the superficial and mid-dermis for the treatment of perioral and marionette lines
- RHA® 4 filler, when used for volumizing, injected very easily and, during the follow-up period, the treated areas remained supple and treatment results natural looking.
U.S. FDA Approval Supported by Two 15-Month Studies Published in Dermatologic Surgery and the Journal of Cosmetic Dermatology
In 2017, the FDA approved the RHA® Collection based on data from two U.S. studies, each a 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial.2-4 Results included:5, 8
- More than 90% of patients were satisfied or very satisfied with their results 12 months after treatment
- Sustained clinical effectiveness, with over 80% of patients still maintaining a clinically meaningful response at 15 months
- Favorable long-term safety profile, with no delayed-onset adverse events reported.
The most frequent treatment-related adverse events reported in the U.S. clinical trials with RHA® 2, RHA® 3, and RHA® 4 were injection site firmness: 27.8%, 25.3%, 37.5%, lumps/bumps: 20.8%, 27.7%, 37.5%, tenderness: 9.7%, 13.3%, 15.8%, and injection site swelling reported in 8.3%, 12.0% and 19.2% of patients respectively. 2-5, 8
The RHA® Collection is now available to select practices. Interested healthcare professionals are encouraged to visit RHACollection.com to receive product information and updates on the RHA® Collection.
About Dermal Fillers in the United States
Dermal fillers are injected into the superficial and deep layers of the skin to restore volume, smooth lines, provide facial lift and contour, plump the lips or improve the appearance of facial scars commonly caused by acne. Hyaluronic acid (HA) dermal fillers represent 88% of the total U.S. dermal filler market and are the second most frequently performed non-surgical aesthetic treatment after neuromodulator injections. The American Society of Aesthetic Plastic Surgery (ASAPS) reported HA dermal filler procedures have increased by more than 58% since 2014, with an estimated 810,240 HA dermal filler procedures performed in 2018.9
Hyaluronic acid is naturally found in the body, primarily in the skin, joints and connective tissue. With age, human skin loses its ability to produce HA, resulting in loss of volume, firmness and elasticity. HA dermal fillers are manufactured from synthesized hyaluronic acid crosslinked to significantly enhance durability in the skin. These products can restore lost volume for six to 12 months or longer before the body gradually and naturally absorbs the HA.10 Most HA dermal fillers also contain lidocaine to help minimize discomfort during and after treatment.
The U.S. dermal filler market is estimated to be $1.1 billion in 2019 and is expected to double to $2.2 billion by 2026.11
RHA® Approved Use
The RHA® collection of fillers is for injection into the facial tissue for the correction of dynamic facial wrinkles and folds that are moderate to severe, such as nasolabial folds, in adults 22 or older.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any RHA® injectable gel formulation? Do not receive if you have a history of multiple severe allergies or severe allergic reactions; if you are allergic to lidocaine or gram-positive bacterial proteins; or if you have a bleeding disorder.
What precautions should I discuss with my doctor?
- Tell your doctor if you are pregnant or breastfeeding, as the safety of these products for use during pregnancy or while breastfeeding has not been studied
- Tell your doctor if you have a history of excessive scarring, keloid formations or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
- Tell your doctor if you are planning laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
- Tell your doctor if you are on immunosuppressive therapy used to decrease your immune response, as use of these products may result in an increased risk of infection
- Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site
- The safety and effectiveness of RHA® fillers in areas other than those indicated have not been established in U.S. clinical studies
- Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
- Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment
What are possible side effects?
The most commonly reported side effects included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching.
One of the risks with using these products is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring. As with all skin injection procedures, there is a risk of infection and recurrence of herpetic eruptions.
To report a side effect with any RHA® product, please call Revance at (877) 373-8669. Please visit RHACollection.com or talk to your doctor for more information. Available by prescription only.
Revance Therapeutics and the Revance logo are registered trademarks of Revance Therapeutics, Inc. RHA is a registered trademark of TEOXANE SA.
©2020 Revance Therapeutics®, Inc.
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.
About TEOXANE SA
TEOXANE Laboratories, a private company, was established in Geneva in 2003, by Madame Valérie Taupin and specializes in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. As a result of this uncompromising commitment to innovation, quality and patient satisfaction, TEOXANE Laboratories is now among the top hyaluronic acid-based dermal filler manufacturers in the world, with products sold across more than 90 countries.
Moreover, with its scientific expertise, TEOXANE is one of the first Swiss laboratories offering a range of innovative cosmeceutical care formulated with cross-linked hyaluronic acid from its patented process, RHA resilient hyaluronic acid®. The cosmeceutical range TEOXANE is designed for patients who have undergone aesthetic medical procedures and continue their skin care with a targeted cosmetic routine designed specifically for them.
For more information go to www.teoxane.com.
This press release contains forward-looking statements, including statements related to Revance’s financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. 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 Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form 10Q filed with the SEC on August 6, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
- RHA® is a trademark of TEOXANE SA. RHA® 2, RHA® 3, RHA® 4 are products of TEOXANE SA. They are class III medical devices and have received FDA approval. The United States Federal law restricts these devices to sale by or on the order of a physician or license practitioner. RHA® 2, RHA® 3 and RHA® 4 are indicated for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. RHA® 2, RHA® 3, and RHA® 4 are sterile gels containing crosslinked hyaluronic acid in physiological buffer and 0.3% lidocaine hydrochloride to reduce pain on injection. RHA® 2, RHA® 3 and RHA® 4 are contraindicated in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine. Please refer to the Instructions for Use (https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002C.pdf). It is the practitioner’s full responsibility to read and inform the patient about contraindications, warnings, precautions, risks and benefits.
- RHA®2 Directions for Use Patient Information
- RHA®3 Directions for Use Patient Information
- RHA®4 Directions for Use Patient Information
- Monheit G, Kaufman-Janette J, Joseph JH, Shamban A, Dover JS, Smith S. Efficacy and Safety of Two Resilient Hyaluronic Acid Fillers in the Treatment of Moderate-to-Severe Nasolabial Folds: A 64-Week, Prospective, Multicenter, Controlled, Randomized, Double-Blinded, and Within-Subject Study [published online ahead of print, 2020 Mar 24]. Dermatol Surg. 2020;10.1097/DSS.0000000000002391. doi:10.1097/DSS.0000000000002391
- Rzany B, Converset-Viethel S, Hartmann M, et al. Efficacy and Safety of 3 New Resilient Hyaluronic Acid Fillers, Crosslinked With Decreased BDDE, for the Treatment of Dynamic Wrinkles: Results of an 18-Month, Randomized Controlled Trial Versus Already Available Comparators. Dermatol Surg. 2019;45(10):1304-1314. doi:10.1097/DSS.0000000000001971
- Micheels P, Sarazin D, Besse S, Eliasd B. Comparison of Two Swiss-Designed Hyaluronic Acid Gels: Six-Month Clinical Follow-Up. J Drugs Dermatol. 2017;16(2):154-161.
- Kaufman-Janette J, Taylor SC, Cox SE, Weinkle SH, Smith S, Kinney BM. Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study [published online ahead of print, 2019 Aug 24]. J Cosmet Dermatol. 2019;10.1111/jocd.13100. doi:10.1111/jocd.13100
- https://www.surgery.org/sites/default/files/ASAPS-Stats2018_0.pdf ASAPS-Stats2018-Proof5e - surgery.org
- DRG – Medtech 360 "Aesthetic Injectables | Market Analysis | US | 2019", Medical Insights – "The Global Aesthetics Market Study – XVII", ASPS – "Plastic Surgery Statistics" (2019 report)