Natco Pharma rallies 20% on USFDA approval for Copaxone

Natco Pharma rallies 20% on USFDA approval for Copaxone”

The US Food and Drug Administration (FDA) approved its marketing partner Mylan for Natco Pharma's generic of multiple sclerosis treatment Glatiramer Acetate, for the 20 mg/mL and 40 mg/mL versions.

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

The approval is granted to Glatiramer Acetate in strengths of 40 mg/ml and 20 mg/ml and the product is substitutable generic version of Teva's Copaxone, Natco Pharma said in a regulatory filing today.

Mylan says it will begin shipping the product soon - although FDA has not yet said whether it will have 180 days of exclusivity for the 40mg/mL version. The FDA is hopeful that the introduction of more competition should help to curb the rising cost of medicines.

Meanwhile, Dr. Reddy's Laboratories Ltd has also filed application for its generic of copaxone injection and is likely to get a response from the USFDA for its 20 mg product in November. The stock had hit a high of Rs 954.35 and a low of Rs 927.65 so far during the day. In exchange for manufacturing formulations of the drug, the Indian pharmaceutical company is set to receive one-third of its revenues, according to Bloomberg.

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 USA, with sales in the billions of dollars.

The drug is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system.

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