REVANCE THERAPEUTICS: THE PRESTIGE MEDICAL AESTHETIC BIOTECH
Revance is a Silicon Valley-based biotechnology company daring to make a difference by focusing on innovative aesthetic and therapeutic offerings, featuring its next-generation investigational neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI). The company is progressing a portfolio of products and service across aesthetic medicine and underserved therapeutic specialties, including dermatology, plastic surgery, neurology, orthopedics and pain management. The market opportunity for Revance is estimated to be more than $6 billion, growing to over $10 billion by 2025.
Next-Generation Products for the Reduction of Wrinkles
Revance’s trajectory to commercial success begins with the first real innovation in the botulinum toxin segment more than 30 years. The company’s lead investigational drug candidate is DaxibotulinumtoxinA for Injection, a unique formulation that combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin type A that does not contain human or animal-based components. Based on the company’s SAKURA Phase 3 clinical results, DaxibotulinumtoxinA for Injection is expected to deliver long-lasting correction of frown lines with as few as two treatments per year. Short-acting neuromodulators, such as BOTOX® Cosmetic, usually require three to four treatments per year to maintain their wrinkle reduction effect.
Revance anticipates U.S. regulatory product approval for this initial indication in the fourth quarter of 2020. Meanwhile, DaxibotulinumtoxinA for Injection is also being evaluated in a Phase 2 open-label studies for the treatment of forehead lines, crow’s feet and for the full upper face. These trials will provide dermatologists and plastic surgeons an expanded body of knowledge on the performance of DaxibotulinumtoxinA for Injection in treating lines and wrinkles.
Premium Facial Injectables Combined with an Innovative Fintech Payment Platform
The company will enter the aesthetics market in the back half of 2020, ushering in a new “prestige” aesthetic category. While awaiting approval of DaxibotulinumtoxinA for Injection in frown lines, the company signed an exclusive U.S. agreement with Swiss company TEOXANE SA to distribute an innovative line of hyaluronic acid gels called the RHA® Collection of dermal fillers. These three FDA approved products, RHA® 2, 3 and 4, are the first and only dermal fillers approved for the correction of dynamic wrinkles and folds. Dermal fillers and neurotoxins are highly synergistic products, often used in combination by physicians to provide patients a more flawless and youthful appearance.
To augment its strong aesthetics product portfolio and offer a unique set of digital services to aesthetic practices, Revance recently acquired HintMD, an integrated fintech platform. The HintMD payment processing platform streamlines the patient checkout process, plus enables the integration of personalized subscription plans, loyalty programs and other services. Revance will use a single sales force to access aesthetics practices to sell both its facial injectables and the fintech platform beginning in the third quarter of this year.
Together these Revance offerings of DaxibotulinumtoxinA for Injection, RHA® Collection of dermal fillers and the HintMD payment processing platform promise to transform both the practice and patient experience and provide the company access to a $2.5+ million market opportunity in U.S aesthetic practices, with significant opportunities worldwide.
The Additional Opportunity for DaxibotulinumtoxinA for Injection is in Therapeutics
Many people don’t realize that neurotoxins are used to treat a wide array of debilitating diseases and afflictions, related to muscle movement disorders and pain. Currently, DaxibotulinumtoxinA for Injection is poised to make a difference with three key clinical studies set to read out in Cervical Dystonia (CD), adult Upper Limb Spasticity (ULS) and Plantar Fasciitis (PF). To address poor muscle control and spasms, CD and ULS patients are routinely treated with botulinum toxin A injections. However, the majority of patients treated with today’s short-acting neuromodulators experience early recurrence of pain and debilitating symptoms before the next scheduled treatment cycle. Revance will issue important clinical trial results, along with duration of effect data, in two muscle movement disorders in the next six months.
Pain relief presents another novel potential indication for DaxibotulinumtoxinA for Injection. Initially, Revance is pursuing the use of DaxibotulinumtoxinA for Injection in Plantar Fasciitis (PF), the most common cause of persistent and excruciating pain in the heel and bottom of the foot. Revance plans to share results of its Phase 2 clinical trial for the management of PF before the end of 2020.
DaxibotulinumtoxinA for Injection is made in the U.S.A., at the company’s Newark, California, corporate headquarters. Revance’s technical capabilities and neurotoxin cell line led to a collaboration and license agreement with Mylan to develop a biosimilar to BOTOX® and BOTOX® Cosmetic. The clinical program for the biosimilar will extend through 2024, and following acceptance, an FDA approval could lead to access for all 14 approved indications for BOTOX®, benefiting Revance with significant milestone payments and royalties on sales.
In summary, this is a pivotal time at Revance. The innovative biotech firm has created a compelling offering for aesthetic practices and is on the brink of commercialization. Revance is well capitalized with more than $500 million in cash and investment (as of the end of first quarter 2020) to appropriately launch its premium products and services, complete the current clinical trials and fund operations into 2023.
“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
BOTOX® is a registered trademark of Allergan, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.