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HERTFORDSHIRE, England and PITTSBURGH and NESS ZIONA, Israel — Mylan N.V. and Mapi Pharma Ltd. announced that the two companies will team 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, or RRMS. Multiple sclerosis (MS) organizations have estimated that 2.3 million individuals are living with MS worldwide. In the U.S., preliminary results of an MS prevalence study by the National MS Society estimate that nearly 1 million people are living with MS. Relapsing-remitting MS accounts for approximately 85% of initial MS diagnoses.
Mylan president Rajiv Malik said in a statement: “Improving the lives of MS patients around the world is one of Mylan’s primary goals. We recognize 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. We appreciate the opportunity to work with Mapi Pharma and its successful and proven founder, Ehud Marom, and we believe that our teams are well poised for a successful collaboration as we work through the remaining clinical and regulatory phases to bring this important product to market.”
Mylan Chairman Robert Coury added: “Over the past several years, I have observed firsthand the strength and resilience of Israel’s business and scientific community as well as its strong workforce. The country’s scientific research leadership is renowned worldwide, and Mylan’s partnership and collaboration with Mapi Pharma represents the most recent example of our continued commitment to invest and maintain strong relationships in Israel. I am particularly grateful for Mapi Pharma CEO and Chairman Ehud Marom’s leadership in this transaction. I look forward to the positive impact this MS product will have for patients worldwide.”
Ehud Marom, chief executive officer and chairman of Mapi Pharma Ltd, commented, “As one of Israel’s leading biotech companies, we are pleased and excited to have partnered and collaborated with Mylan in bringing this very important new product to the millions of MS patients around the globe. 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.”
Mapi Pharma has strong research capabilities in the development of long-acting depot injections. Mylan brings to this collaboration its regulatory expertise, unique global commercial platform and significant experience in launching other Glatiramer Acetate injection products. The partnership is subject to approval by the Israeli Innovation Authority.
Mapi Pharma has completed a prospective one-year, open-label Phase II clinical trial. Mapi Pharma and Mylan are in the process of preparing to submit an investigational new drug application to the U.S. Food and Drug Administration, as well as other global health authorities, and to commence a pivotal Phase III clinical trial to support a new drug marketing application under the 505(b)(2) regulatory pathway.
