Revance Therapeutics has released late-stage data for a wrinkle-reducing drug that rivals Botox. If it reaches the market, the Bay Area biotech plans to go head-to-head with the giant in this field: Allergan.
Revance $RVNC reported on two Phase III clinical trials of its drug, an injectable botulinum toxin coined RT002. The drug was tested against frown lines — those wrinkles that show up between your eyebrows. RT002 lasted for six months, while Botox generally only lasts for three to four months. The study met its primary and secondary endpoints in the two Phase III trials.
RT002 could threaten Allergan’s $AGN top-selling drug, which is likely why the giant’s stock has slipped 2 percent on the news this morning. Botox has brought in $2.3 billion in global sales for the drugmaker during the first nine months of this year.
But critics say RT002 may not be as much of a threat to Botox as Revance hopes. Allergan followed up the news with a statement kicking back at the smaller company’s data.
“We do not believe this data will support a longer duration claim as the only composite data (2-point improvement, none or mild, and both investigator and patient) is at 30 days not at 6 months,” an Allergan spokesperson wrote in an email.
Biotech analyst Umer Raffat at Evercore expressed similar reservations in a research note he sent out after the Revance news.
“It’s also clear that Revance product tracks better than Botox on duration… by at least a month-plus,” Raffat wrote. “With that said, is Revance going to get an every 6 month claim on label? I think there’s a case to be made for that, but that’s not a layup.”
Revance’s stock is up 36 percent in pre-market trading Tuesday.
“These results demonstrate it is scientifically and clinically possible to create a significantly longer-acting neuromodulator,” said Dan Browne, co-founder, president and CEO of Revance, in a statement. “We look forward to providing patients and healthcare professionals with what we believe is a new, next-generation, long-acting neuromodulator for the treatment of glabellar lines.”
Revance plans to submit a Biologics License Application in the first half of 2019 and, if approved, launch RT002 in the US in 2020.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 44,100+ biopharma pros who read Endpoints News by email every day.Free Subscription