The move follows an agreement signed in April 2018, under which Mylan acquired the global marketing rights to the therapy through an investment and partnership with the privately held Israeli firm. Mylan has not disclosed the size of its stake in Mapi Pharma.

A long-lasting formulation of the commonly used MS therapy Copaxone, GA Depot is a proposed once-monthly intramuscular injection for RRMS sufferers.

Mapi initiated the Phase 3 study last October to support a new drug application with the US Food and Drug Administration (FDA). In parallel, the pharma firm is also installing capacity to supply GA-Depot for commercial sale, pending FDA final approval.

According to Mapi, MS organizations estimate that 2.3 million people worldwide are living with the disease, which attacks the central nervous system. RRMS accounts for about 85% of initial MS diagnoses. The global market for MS drugs is forecast to expand at a compound annual growth rate of 6.7% to be worth $39 billion by end 2026, compared with $23 billion in 2018.

“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,” said Mylan president Rajiv Malik. “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 US, including Glatiramer Acetate 20 mg/mL and 40 mg/mL.”

GA Depot is also currently being tested in Phase 2 for primary progressive multiple sclerosis (PPMS).

Mylan is currently in the process of merging with Upjohn, a division of Pfizer. First announced on Jul. 29, 2019, the deal was cleared by European regulators in April 2020, but on condition Mylan sold certain products. The required divestments include generic products sold across 20 countries in Europe in areas such as cardiovascular, genito-urinary, musculoskeletal, nervous system and sensory organ diseases.

The deal is now expected to complete in the second half of this year, later than the original timing of mid-2020 because of the Covid-19 pandemic and associated delays in the regulatory review process. The companies announced last December that the new entity will be called Viatris.