RVNC stock moved higher in morning trade on January 10, 2020, after the company announced a new distribution agreement.
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company pioneering new innovations in neuromodulators for aesthetic and therapeutic indications, today announced the signing of a U.S. distribution agreement with TEOXANE SA , making Revance the exclusive commercialization partner of the Swiss company’s modern and innovative Resilient Hyaluronic Acid® (RHA®) technology. Revance will be holding a conference call and webcast at 8.30 a.m. ET today to discuss the agreement, strategic rationale, and commercialization plans.
TEOXANE’s RHA® 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 was designed using a patented crosslinking method that preserves the hyaluronic acid network for correction of moderate-to-severe dynamic facial wrinkles and folds. The formulation optimizes strength, stretch and tissue integration. Filler injections with RHA® gels have been shown to be safe and well tolerated.2
Revance believes the RHA® dermal filler line, in combination with the company’s next-generation neuromodulator, DaxibotulinumtoxinA for Injection (DAXI), will position the company to be the innovation leader in the $2 billion U.S. facial injectable market.
The agreement also includes a fourth product, RHA® 1, currently in clinical trials in the U.S. with FDA approval anticipated in 2021, and includes an ongoing collaboration with TEOXANE SA for a robust pipeline of additional indications and next-generation dermal filler technologies. Additionally, the agreement contains 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 agreed to issue 2.5 million shares of Revance common stock to TEOXANE SA.
“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,” said Mark Foley, President and Chief Executive Officer of Revance. “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.”
“We are eager to introduce U.S. physicians and consumers to our exciting, highly differentiated RHA® range of dermal fillers,” said Valérie Taupin, Founder and Chief Executive Officer of TEOXANE SA. “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.”
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. According to Dustin Sjuts, Chief Commercial Officer, Aesthetics and Therapeutics, “We’re excited to partner with TEOXANE SA to launch this innovative Swiss technology in the U.S. Their next-generation, novel filler portfolio, sold in combination with DAXI, will position Revance as the premium brand in the U.S. aesthetics facial injectable market.”
Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 7659336; or from the webcast link in the investor relations section of the company’s website at: www.revance.com. A replay of the call will be available beginning January 10, 2020 at 8:30 a.m. PT/11:30 a.m. ET to January 11, 2020 at 8:30 a.m. PT/11:30 a.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 7659336. The webcast will be available in the investor relations section on the company’s website for 30 days following the completion of the call.
On December 5, 2019, Revance Therapeutics announced the publication of the pooled data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 studies (SAKURA 1 and SAKURA 2) evaluating Revance’s long-acting neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI) for the treatment of moderate to severe glabellar (frown) lines. The pooled results were published in the Journal of the American Academy of Dermatology (JAAD).
The SAKURA 1 and SAKURA 2 studies were identical in design and evaluated the safety and efficacy of a single administration of DAXI. The data showed that the primary endpoint of a 2-point composite response at week 4 was achieved in 73.8% of patients in the pooled DAXI group versus 0.5% in the pooled placebo group (p<0.0001 [difference of 73.5%, 95% CI: 69.2%–77.9%]). The proportion of responders to DAXI was similar regardless of whether baseline glabellar line severity had been moderate (75.4%) or severe (71.2%).
“I am very pleased by these results, particularly because the median time to return to baseline wrinkle severity was 27.1 weeks, which could translate to approximately two treatments per year,” said co-author Dr. Nowell Solish, Cosmetic Dermatologist and Director of Dermatologic Surgery at the University of Toronto.
The pooled results were consistent with the findings from the earlier dose-ranging Phase 2 BELMONT study which demonstrated that DAXI for injection offers high response rates in the treatment of glabellar lines with a median duration of response of 24 weeks.
“In addition to showing superior efficacy compared to placebo in the SAKURA pivotal studies, DAXI was observed to have a 24 week duration of effect and a greater than 90% response in patients beginning at week 1, while being generally well tolerated, all of which are important attributes for neuromodulator products,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “The acceptance of the pooled data in the Journal of the American Academy of Dermatology (JAAD) further emphasizes the strength of the SAKURA Phase 3 clinical trial program.”
Among 609 subjects enrolled in both SAKURA 1 and SAKURA 2, pooled data showed DAXI was significantly more effective than placebo in reducing glabellar line severity and subjects maintained none or mild glabellar line severity for a median of 24 weeks. DAXI was also generally well tolerated and no new safety signals were observed.
The SAKURA program is the largest Phase 3 aesthetic neuromodulator program ever conducted for the treatment of glabellar frown lines. Additional results from the SAKURA 1 and 2 studies were recently published in Plastic and Reconstructive Surgery (PRS) and results from SAKURA 1, 2 and 3 were presented at the American Society for Dermatologic Surgery 2019 (ASDS) Annual Meeting in Chicago.
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