April 11, 2018, 06:26:00 PM EDT By Zacks Equity Research, Zacks.com
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Mylan N.V. MYL announced that it has inked an agreement with Israel-based Mapi Pharma Ltd.
Both companies have teamed up for the development and commercialization of GA Depot, a long-acting Glatiramer Acetate product. Mylan also acquired the global marketing rights of the product.
We note that GA Depot is a proposed once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis (“MS”), or RRMS. Mapi Pharma has completed an open-label phase II trial. The company is also preparing to commence phase III trials to support marketing applications. Both companies are preparing to submit an investigational new drug application to the FDA, as well as other global health authorities.
We remind investors that Mylan already has experience in the Glatiramer Acetate market.
In October 2017, Mylan launched the generic version of Teva’s TEVA Copaxone 40 mg/mL which is indicated for the treatment of patients with relapsing forms of MS. Mylan’s partner in Europe, Synthon, also received marketing authorization approval in Europe for Glatiramer Acetate Injection 40 mg/mL.
An estimated 2.3 million people on a worldwide basis are living with MS. Nearly 1 million people are living with MS in the United States. RRMS accounts for approximately 85% of initial MS diagnoses.
The deal with Mapi Pharma will further strengthen the company’s presence in the MS market.
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