Newark firm touts better form of Botox
Revance Therapeutics’ lead asset is a new form of botulinum toxin, akin to the best-selling wrinkle eraser, Botox, but with a key difference, durability, according to CEO Daniel Browne.
Recent results in a late-stage study may back up his claim. The Newark drug developer plans to use that durability claim to expand into previously untapped markets rather than just challenging Botox and its maker, Allergan, Browne said in an interview.
When pressed on how his company could drive expansion in a field where Botox has been dominant for nearly three decades, Browne talks about moving into new therapeutic areas that Allergan hasn’t dipped into yet, like plantar fasciitis, a common cause of heel pain in runners and overweight patients. Revance is expected to report results from a mid-stage study in plantar fasciitis before the year ends.
Revance plans to use cash from a recent stock offering for more research and development, as well as to speed along development of a program in cervical dystonia, a painful and underdiagnosed condition that causes a person’s head to twist to one side. The Food and Drug Administration awarded Revance an orphan drug designation for the program.
Browne also envisions tapping into the aesthetic market by winning over women who may have been on the fence about starting multiple repeat injections with Botox. Millennials and men are another target market for Revance, the CEO said. For fresh-faced Millennials, the pitch could be using the wrinkle reducer as a preventive treatment to stop them before they start.
But Millennials don’t need to open their wallets or dip into their bitcoin just yet. RT002, Revance’s experimental therapy, isn’t likely to get Food and Drug Administration approval and be available at plastic surgeons’ offices before 2020.
That time line didn’t stop shares in Allergan from sliding on Dec. 5. That’s when small-cap company Revance reported results from two late-stage trials that showed that RT002 kept wrinkles between the eyebrows from returning for about six months on average, longer than Botox, whose label states it lasts about three to four months. That’s potentially good news for trypanophobics, who want to look younger but hate needles.
Revance does have its detractors. Analysts from Wells Fargo to Morgan Stanley rushed to Allergan’s defense, saying the drop in shares of the Irish company, which has U.S. offices in New Jersey, was “overdone.” Morgan Stanley saw patients’ own assessments of RT002’s effectiveness as similar to those reported by patients receiving Botox treatment. The scales used to compare patient responses were different, with Botox using an eight-point scale and RT002 a four-point scale. It “may be marginally easier for Botox,” to show a difference, Morgan Stanley wrote.
Allergan also scoffed at the reports, with a spokesman writing in an email shortly after the results were made public that “the Revance Phase 3 results reported for RT002 don’t support a longer duration claim.”
Browne countered: “Allergan has never by any scale been able to get beyond 16 weeks; we were able to get beyond 24 weeks on multiple scales.”
Analysts have also pointed out that Revance’s dose is double Botox’s 20 units, but “a unit of Revance is not a unit of Botox,” says Browne, pointing to medical literature written in part by Allergan’s chief scientific officer for Botox, Mitchell Brin. The article says dose response data for Botox in wrinkles between the eyebrows “showed that 20 units was not statistically different from 30 or 40 units, but that 10 units was statistically significantly less effective.”
Still it’s not a zero-sum game, Browne said. Shorter-acting products like Botox could be “complementary” to what he sees as the next-generation neuro-modulators. A longer-acting product could provide patients “better outcomes and pharmacoeconomics.” Ultimately, “the label matters,” and for Revance investors, they’ll just have to wait until a few years to see that.