Mylan has entered a deal to gain global marketing rights for Mapi Pharma’s long-acting glatiramer acetate product, GA Depot, being developed to treat multiple sclerosis (MS).
The companies will work together to develop and commercialise the drug candidate, which is being formulated as a once-monthly injection for relapsing-remitting MS.
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The candidate has already undergone a prospective open-label Phase II clinical trial and the companies plan to submit an investigational new drug application.
The application will be supported by data from an upcoming pivotal Phase III trial.
Mapi Pharma CEO and chairman Ehud Marom said: “GA Depot is expected to significantly improve the mode of treatment for patients with MS by reducing the number of injections, easing the treatment burden and increasing patient compliance.
“We look forward to working with Mylan to bring this important drug to MS patients.”
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By GlobalDataThe partnership will combine Mylan’s regulatory expertise, global commercial platform and experience in other glatiramer acetate injection product launches with Mapi’s research capabilities for making long-acting depot injections.
Mylan president Rajiv Malik said: “We recognise that medication convenience is very important to the MS community, and we believe that GA Depot, once approved, will provide an important and welcomed treatment option.
“GA Depot also will add to our already-strong portfolio of central nervous system products.”
