The new leased area will be used for commissioning a commercial scale production facility for GA Depot and is a scale-up to the current Israeli Ministry of Health (MOH) GMP approved facility the Company operates to supply the ongoing clinical trials (Phase II, III). The plant includes clean-room infrastructure that was constructed to a very high standard.
Ehud Marom, chairman and chief executive officer of Mapi said, “As we prepare for the future commercialization of GA Depot, which we believe has multi-billion dollar sales potential, we were happy find the right infrastructure and professionals at a convenient Jerusalem location and look forward to expanding our production footprint in the city. This is consistent with Mapi’s overall strategic plan to commercialize a market leading product for treating MS and manufacture it in Israel.”
GA Depot, a long-acting Glatiramer Acetate (Copaxone) injection is currently being investigated for treating relapsing remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). In April 2018 Mapi Pharma partnered with Mylan in an agreement which granted Mylan an exclusive license to commercialize GA Depot injection for relapsing multiple sclerosis. Under the terms of the agreement, Mapi will supply GA Depot to Mylan for commercial sale.