Mylan N.V. (MYL - Free Report) 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 - Free Report) 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.
Mylan’s stock has gained 9.9% in the last six months, as against the industry’s decline of 10.1%.
Mylan has one of the largest product portfolios among all generic pharmaceutical companies. With the acquisition of the Topicals Business, Mylan gained a complementary portfolio of approximately 25 branded and generic topical products, including an active pipeline of approximately 25 products as well as established United States sales and marketing infrastructure targeting dermatologists. The Topicals Business added to Mylan an integrated manufacturing and development platform along with a leading topicals-focused contract development and manufacturing organization.
Mylan is also exploring the world of biosimilars. The company formed a partnership with Biocon and also has a collaboration agreement with Momenta Pharmaceuticals (MNTA - Free Report) . The company also received an FDA approval for a biosimilar version of Roche Holdings’ (RHHBY - Free Report) Herceptin.
Mylan carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here..
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