Mylan and Mapi ally on glatiramer acetate
Mylan is teaming up with Israeli firm Mapi Pharma to develop and commercialise a long-acting glatiramer acetate product, Mapi’s ‘GA Depot’ candidate. Subject to approval from the Israeli Innovation Authority, the partnership sees Mylan acquire global marketing rights for the once-monthly injection for treating relapsingremitting multiple sclerosis (RRMS).
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Fresh from a $20m investment from partner Viatris, Mapi Pharma has announced significant progress in its Phase III trial for a long-acting version of Copaxone, which is to be filed through the FDA’s 505(b)(2) hybrid pathway.
Mylan has invested a further $20m in a monthly glatiramer acetate depot product being developed by partner Mapi for submission via the 505(b)(2) route in the US.
Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.