Israeli late clinical stage drug development company Mapi Pharma Ltd. today announced an additional $20 million investment from Mylan. This brings to $40 million the amount Mylan has invested in support of continued Phase III clinical study progress to bring to market Glatiramer Acetate (GA) Depot (generic Copaxone) a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
Mapi Pharma hopes to manufacture delayed release Copaxone that can be taken once a month, instead of three times a week with the current version. Mapi chairman and CEO Ehud Marom is a former head of Teva's Copaxone development team.
In October 2019, Mapi Pharma initiated the Phase III study 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 US Food and Drug Administration (FDA). The study enrollment has been progressing well with more than 170 patients dosed across 56 sites. Mapi is also building capacity at its facility to supply GA-Depot for commercial sale, pending final approval by the FDA.
Mapi chairman and CEO Ehud Marom said, "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. Through this partnership, and based on the excellent progress to date in launching the Phase III study and enrolling patients, we are confident in our ability to successfully bring to market our GA-Depot product." Mylan president Rajiv Malik said, "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."
Published by Globes, Israel business news - en.globes.co.il - on June 15, 2020
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