With a sizable milestone payment from its partner Mylan, Revance has stepped up efforts to launch contenders in the Botox space.
Revance received a milestone payment of $30 million from Mylan that fortifies the company in developing a biosimilar to Botox (onabotulinumtoxinA), and clinical trials are moving forward for a novel drug that also would compete with Botox, according to the company’s second quarter earnings report.
The payment comes after the 2 companies decided in June to move forward with their biosimilar development program and file an application for the candidate drug with the FDA under the 351(k) pathway.
Mylan and Revance originally signed a deal to co-develop the product in February 2018, which included an upfront payment of $25 million from Mylan. But in September 2019, the companies amended their agreement to allow Mylan an extended period to decide if it would move forward with the development program.
Revance’s Other Botox Competitor
Revance is also working to develop a novel botulinum toxin type A molecule (daxibotulinumtoxinA) in hopes that it also can compete with Botox.
In June, Revance announced positive results from 2 phase 2a studies on the performance of daxibotulinumtoxinA in treating forehead lines, frown lines, and crow’s feet. “The studies evaluated a range of doses and, while not powered to provide clinical significance, at least 1 dose in each study demonstrated a measurable treatment effect,” which included a reduction in wrinkle severity in 100% of patients at 4 weeks, the company said.
In the company’s 2020 second quarter earnings report, Revance said that it had finished enrollment for its ASPEN phase 3 clinical program, which consists of 2 trials that will evaluate the safety and efficacy of daxibotulinumtoxinA for the treatment of cervical dystonia.
Topline results from the one of those studies, ASPEN-1, are expected to be reported in the fall of 2020, Revance said. Topline results are a summary of initial findings and are typically followed by more detailed information later.
Separately, Revance said topline results of a placebo-controlled phase 2 trial of daxibotulinumtoxinA in patients with plantar fasciitis also are expected by the fall.
Additionally, enrollment has been completed for the company’s JUNIPER phase 2 trial testing the safety and efficacy of daxibotulinumtoxinA for the treatment of upper limb spasticity in adults as a result of stroke or brain injury.
The company chose to end the recruitment period early and complete the study with the 83 individuals enrolled at the cutoff, as it had growing concerns of how the coronavirus disease 2019 pandemic would affect enrollment and the scheduling of in-person study visits. Revance said that it expects to have initial results from this trial in early 2021.
Revance’s Quarterly Performance
Overall, Revance saw revenues of $0.3 million for the second quarter of 2020 with no revenue recognized for the same period in 2019. The company saw an uptick in revenues for the first 6 months of 2020, generating a total of $0.4 million compared with $0.3 million from the same period in 2019.
The company had a net loss for the 3- and 6-month periods just ended: $60.6 million and $122.5 million, respectively.
Revance also saw an increase in research and development expenses during the previous quarter compared with the second quarter of 2019 ($27.1 million vs $25.5 million) and during the first 6 months of 2020 versus the first 6 months of 2019 ($66.9 million vs $49.5 million).