Generic pharmaceutical company Mylan N.V. (Nasdaq: MYL) and Israeli drug development company Mapi Pharma Ltd. today announced that they will partner on the development and commercialization of GA Depot, a long-acting (slow release) Glatiramer Acetate (generic Copaxone for the treatment of multiple sclerosis) product. Mylan is acquiring global marketing rights to the product.
If brought successfully to market GA Depot would require a once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis, or RRMS. Branded and generic Copaxone currently on the market require three-weekly injections.
Mylan president Rajiv Malik said, "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."
He added, 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."
Mapi Pharma chairman and CEO Ehud Marom said, "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."
Ness Ziona based 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 US Food and Drug Administration (FDA), 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.
Branded Copaxone earmned Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) Revenue of $3.8 billion in 2017 although this is expected to fall sharply following the introduction of generic competition by Mylan.
Mapi Pharma had planned an IPO on Nasdaq in 2015 but later withdrew. The company's main shareholders include Ehud Marom, Shavit Capital and Marius Nacht and Dr. Yair Schindel's aMoon Fund.
Published by Globes [online], Israel business news - www.globes-online.com - on April 10, 2018
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