Mapi to Establish New Sterile Production Plant for GA Depot

Mapi Pharma Ltd., a late-stage clinical development biopharmaceutical company has signed a long term lease agreement at the Har-Hotzvim Hi-Tech Park in Jerusalem to establish a new sterile production plant for GA Depot injectable products. The 50,000 sq.-ft. plant was previously part of Omrix Biopharmaceuticals, Inc., a Johnson & Johnson Company, and was an FDA-approved facility.

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.

-----------------------------------------------------------------------
Editor's Note:

If you have any suggestion to the content, 

please email: Julia.Zhang@ubmsinoexpo.com