Teoxane Laboratories with Revance Therapeutics, Inc., Exclusive U.S. Distribution Agreement for Dermal Fillers
Global aesthetic manufacturer Teoxane Laboratories announces Exclusive U.S. Distribution Agreement of FDA-Approved RHA Dermal Fillers with Revance Therapeutics, Inc.
Geneva, Switzerland, 10th January 2020 – Teoxane SA, Swiss laboratories specializing in Hyaluronic Acid dermal fillers, announced today the signing of an exclusive U.S. distribution agreement with Revance Therapeutics, Inc. (Nasdaq: RVNC), making Revance the exclusive commercialization partner of the Swiss company’s modern and innovative Resilient Hyaluronic Acid® (RHA®) preserved network technology
TEOXANE’s RHA® Portfolio and the Distribution Agreement
Under the distribution agreement announced today, Revance will gain immediate and exclusive rights to commercialize TEOXANE’s RHA® line of fillers in the U.S., starting with the U.S. Food and Drug Administration (FDA)-approved RHA® 2, RHA® 3, and RHA® 4 products, which include lidocaine.
The RHA® line provides physicians with a broad range of uniquely designed gels for individualized treatment in the face. The RHA® line is the ﬁrst range of Hyaluronic Acid ﬁller with rheological properties speciﬁcally designed to follow the expression of the face. It contains a unique and innovative technology that preserves the natural chains of the hyaluronic acid molecules to create a gel of the highest purity and mimics the natural hyaluronic acid within our skin. The RHA line was designed using a patented crosslinking method that preserves the hyaluronic acid network for correction of moderate-to-severe dynamic wrinkles and folds.
The agreement also includes a fourth product in Teoxane’s portfolio, RHA® 1, expected to gain FDA approval in 2021, and includes an ongoing collaboration with Revance to provide a robust pipeline of additional indications and next-generation dermal filler technologies. Additionally, the agreement gives to Revance a right of first negotiation to access TEOXANE’s novel cosmeceutical line that incorporates its propriety RHA® technology.
In consideration for the U.S. distribution rights for all of the above mentioned, Revance has issued 2.5 million shares of Revance common stock to TEOXANE SA.
Revance has begun the build-out of a U.S. commercial organization and is targeting the introduction of the TEOXANE RHA® fillers in the second quarter of 2020, followed by the launch of DAXI, upon regulatory approval, in the second half of 2020
“We are eager to introduce U.S. physicians and consumers to our exciting, highly differentiated RHA® range of dermal fillers. The combination of our RHA filler range with Revance’s cutting-edge neuromodulator, DAXI, will create a premium facial injectable portfolio that we believe will be unrivaled in the industry. TEOXANE SA and Revance have a shared passion for innovation, quality and excellence in aesthetic results.”
"This is a transformational deal for Revance, giving us access to the fast-growing, billion-dollar U.S. dermal filler market, with a line of highly differentiated fillers that are complementary to our first and only, long-lasting neuromodulator. Valérie Taupin is a pioneer in the dermal filler market and her company, TEOXANE SA, is dedicated to creating new innovations and providing high-quality HA products to the aesthetic market. Importantly, both these RHA® fillers and DAXI have the potential to deliver unique customer experiences. This deal provides commercial synergies, organizational leverage and fast-tracks the build-out of our sales organization. It also creates a broad foundation from which to launch DAXI upon anticipated approval later this year."
About Revance Therapeutics, Inc.
Revance Therapeutics is a Silicon Valley-based biotechnology company, pioneering new innovations in neuromodulators for aesthetic and therapeutic indications. Revance’s lead product candidate, DaxibotulinumtoxinA for Injection (DAXI), 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 DAXI in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DAXI 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, with plans to study migraine. Revance is dedicated to making a difference by transforming patient experiences.
For more information www.revance.com.
“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 but are not yet commercialized in the United States. 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 and RHA® 3 clinical study G140028: Study 1302: A Controlled, Randomized, Double- Blinded, Within-Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA 2 and TEOSYAL® RHA 3 versus Juvéderm® Ultra XC in the Treatment of Moderate to Severe Nasolabial Folds.
RHA® 4 clinical study G140106: Study 1402: A Controlled, Randomized, Double- Blinded, Within Subject, Multicenter, Prospective Clinical Study of TEOSYAL® RHA 4 versus Perlane-L® in the Treatment of Moderate to Severe Nasolabial Folds.
Report, Rheological characterisations of hyaluronic acid gels. Rheonovia (University of Grenoble, France)