Published: Thu, October 05, 2017
Markets | By Noel Gibbs

Mylan says FDA approves its generic multiple sclerosis treatment

Mylan says FDA approves its generic multiple sclerosis treatment

Shares of the Natco Pharma surged 20% and got locked in the upper circuit on Wednesday after its USA marketing partner received FDA approval for Natco Pharma's generic Glatiramer Acetate.

Shares of Natco Pharma jumped as the company's partner, Mylan NV, has got USFDA approval to launch the much awaited generic version of multiple sclerosis drug Copaxone in the American market.

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

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Copaxone is majorly prescribed MS treatment for relapsing forms of MS in the United States.

AB rated alternatives can be substituted by the pharmacist in place of the branded version, while non-AB rated alternatives can only be suggested by the doctor.

The manufacturer's Abbreviated New Drug Application included data demonstrating that its injected products have the same active ingredient, dosage form, route of administration and strength as their branded counterpart.

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One analyst on Wall Street said that the FDA approval represents a big positive for this story and will significantly lower the risk and increase support to the earnings per share for Mylan for 2017 and 2018. This means that the company could receive a 180 days of generic drug exclusivity, but a decision on this hasn't been mad yet.

Glatiramer Acetate Injection will be supplied as 20mg/mL and 40mg/mL solution for SC injection in single-dose prefilled syringes.

Approximately 400,000 individuals in the USA have MS and relapsing MS accounts for 85% of initial MS diagnoses, it added. This is a generic version of Teva Pharmaceutical Industries Ltd (ADR)'s (NYSE:TEVA) Copaxone.

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She adds that the company is also offering a patient support programme, Mylan MS Advocate, which will focus on access to the therapy and adherence to the regimen. Currently, one out of every 13 prescriptions filled in the US - brand-name or generic - is a Mylan product.

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