Mylan and Mapi Pharma Partner on Once Monthly Glatiramer Acetate Drug for Relapsing-Remitting MS

April 10, 2018

Mylan and Mapi Pharma announced today that the two companies will partner on the development and commercialization of GA Depot, a long-acting Glatiramer Acetate product. Mylan is acquiring global marketing rights to the product. GA Depot is a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis.

Mapi Pharma has completed an open-label Phase II clinical trial and is preparing to commence a pivotal Phase III clinical trial to support marketing applications. Results from a Ph II study were released in Oct of 2017.

The results indicated that GA Depot is well tolerated and reached its primary safety endpoints. Secondary endpoints included the relapse rate during the study compared to the relapse rate observed in the 12 months prior to study entry during which these patients were treated with Copaxone. The relapse rate during the study was comparable to the reported rate over the previous one-year period (during which patients were treated with Copaxone).

Prof. Aaron Miller, Professor of Neurology, Icahn School of Medicine at Mount Sinai Hospital, NY, and the Coordinating PI for Mapi’s Phase III trial with GA Depot, said, “GA Depot offers a monthly injection versus the daily or thrice-weekly injections of glatiramer acetate sold in the market today. If the Phase III results replicate those of Phase II, GA Depot is expected to significantly improve the mode of treatment for patients with MS by significantly reducing the number of injections, easing the treatment burden and increasing patient compliance.”

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