Mylan surprises analysts, Teva with long-delayed Copaxone approvals

Mylan surprises analysts, Teva with long-delayed Copaxone approvals

Mumbai: Shares of Natco Pharma Ltd hit the upper circuit of 20% on Wednesday as its partner Mylan N.V. has received approval from the US Food and Drug Administration (FDA) for generic version of multiple sclerosis drug copaxone. Mylan said it expected to start shipping the generic drug very soon and that the FDA approval letter said the company might be eligible for 180 days exclusivity on the drug.

The approval came as a surprise one day after the federal regulatory agency announced it would be introducing a number of new measures that would cut the amount of time generic versions of complex drugs have to reach the market in its effort to address rising costs in pharmaceuticals.

"Mylan has invested tens of millions of dollars over many years to bring this medicine to market", CEO Heather Bresch said.

Teva's Copaxone is used to treat patients with relapsing forms of multiple sclerosis. "Our commitment to the MS patient community extends beyond bringing generic versions of these products to market".

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It's worth pointing out that Mylan's glatiramer acetate injection is a substitutable generic version of Teva's Copaxone. The drug will only be available via prescription. "Mylan also is offering comprehensive patient support services to help patients access therapy as quickly as possible and adhere to a treatment regimen that fits their needs". The generic version is coming to a market of about 400,000 USA patients with MS - 85% of whom suffer from a relapsing form.

Several companies have already developed their own versions of Copaxone (glatiramer acetate), but it is a lucrative market with a great deal of scope: the branded product is the most prescribed treatment for relapsing forms of MS in the U.S., with sales in the billions of dollars.

According to the company, 1 of every 13 prescriptions filled in the United States is a Mylan product.