Revance Highlights Recent Regulatory Progress and Provides Anticipated 2019 Milestones - Seite 2

“We have a strong conviction in our ability to create a biosimilar to BOTOX under the 351(k) pathway,” said Abhay Joshi, PhD, Revance’s chief operating officer. “Pending FDA agreement on a biosimilar development path, we expect to work with Mylan to continue the analytical similarity program and conduct clinical trials necessary for approval.”

RT002 INJECTABLE 2019 CLINICAL MILESTONES

“In 2019, we will have an extensive and active clinical pipeline – a total of six programs for RT002 injectable that address over half of the current $4 billion global neuromodulation market,” said Browne. “In aesthetics, while we pursue a U.S. regulatory approval in glabellar lines, we plan to initiate a study in the first quarter for forehead lines in conjunction with treatment of the glabellar complex, followed mid-year with a study in lateral canthal lines, also known as crow’s feet. These trials will help determine the injection pattern and dosage for treatment of the upper face. In therapeutics, we have done a major expansion into neuroscience indications. We are pleased to announce that in late December we dosed the first patients in Phase 2 clinical trials for RT002 in both plantar fasciitis and adult upper limb spasticity. We now have clinical programs in three therapeutic areas actively recruiting patients.”

ASPEN Phase 3 Program for Treatment of Cervical Dystonia – Enrollment progressing to plan

The company initiated a Phase 3 program for patients with cervical dystonia in the second quarter of 2018. Patients with cervical dystonia suffer from painful, embarrassing twisting movements of the neck, often impairing their ability to work, drive and perform activities of daily living. The program consists of two trials. First, a randomized, double-blind trial, with a high dose, low dose and placebo group. Post-treatment, patients will be followed for a maximum of 36 weeks. Second, an open-label, long-term safety trial, with patients receiving up to four treatment cycles of RT002 injectable over a 52-week observation period. Each trial, conducted at multiple sites in the United States, Canada, and Europe, is expected to enroll a total of approximately 300 patients, with a majority of patients expected to roll-over from the pivotal into the long-term safety trial. Treatment using neuromodulators for cervical dystonia was estimated in 2017 to be a $200 million global opportunity. The company expects to complete enrollment by early 2020.