Mapi Pharma announced an additional $20 million investment from Mylan in support of continued Phase 3 clinical study progress to bring to market in the U.S. Glatiramer Acetate (GA) Depot, a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
In October 2019, Mapi Pharma initiated the Phase 3 study1 for relapsing-remitting multiple sclerosis, or RRMS, which is a 1,000 patient pivotal clinical study designed to support a New Drug Application (NDA) with the U.S. Food and Drug Administration. To date, the study enrollment has been progressing well with more than 170 patients dosed across 56 sites. In parallel, Mapi is also building capacity at its facility to supply GA-Depot for commercial sale, pending final approval by the FDA.
Multiple sclerosis (MS) organizations have estimated that 2.3 million individuals are living with MS worldwide. In the U.S., a study funded by the National MS Society estimates that nearly 1 million people are living with MS. Relapsing-remitting MS accounts for approximately 85% of initial MS diagnoses. According to recent market research, the global multiple sclerosis drugs market was worth US$23 billion in 2018 and is anticipated to expand at a CAGR of 6.7%, and reach US$39 billion by the end of 2026.
“Mapi Pharma and Mylan share a commitment to improve the lives of MS patients, and I am pleased that Mylan has expressed its continued confidence in our development program for GA-Depot for RRMS,” said Ehud Marom, Chairman and CEO of Mapi. “Through this partnership, and based on the excellent progress to date in launching the Phase 3 study and enrolling patients, we are confident in our ability to successfully bring to market our GA-Depot product.”
“Mylan is committed to meeting unmet needs by continuing to leverage its partnerships, scientific and commercial expertise and global platform to advance new treatment options for patients living with MS. Through this latest equity participation in Mapi, we are further strengthening our partnership and remain highly confident in the science and the progress of the program behind this long-acting GA product. We look forward to the Phase 3 study outcomes and are committed to bringing GA Depot to market at the earliest opportunity in order to bolster our already comprehensive MS offering in the U.S., including Glatiramer Acetate 20 mg/mL and 40 mg/mL,” Mylan President Rajiv Malik said.