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Natco Pharma hits roof after USFDA approval for generic

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Capital Market
Last Updated : Oct 04 2017 | 10:01 AM IST

Natco Pharma hit an upper circuit limit of 20% at Rs 954.35 at 9:42 IST on BSE after the company's marketing partner Mylan received US drug regulator's approval for generic version of Copaxone.

The announcement was made during trading hours today, 4 October 2017.

Meanwhile, the S&P BSE Sensex was up 47.99 points, or 0.15% to 31,545.37.

On the BSE, 1.75 lakh shares were traded in the counter so far, compared with average daily volumes of 37,000 shares in the past two weeks. The stock had hit a high of Rs 954.35 and a low of Rs 927.65 so far during the day.

Natco Pharma announced that the US Food and Drug Administration (USFDA) approved its marketing partner Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate 40 mg/mL and 20 mg/mL injection, an AP-rated, substitutable generic version of Teva's Copaxone.

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. The launch plans for both products will be communicated shortly after concurring with its partner Mylan.

Copaxone is the most prescribed MS treatment for relapsing forms of MS in the United States with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of approximately $3.64 billion for the 12 months ending 31 July 2017, according to Quintiles IMS. Approximately 400,000 individuals in the US have MS and relapsing MS accounts for 85% of initial MS diagnoses.

Natco Pharma's consolidated net profit spurted 97.1% to Rs 94 crore on 31.6% increase in net sales to Rs 428.10 crore in Q1 June 2017 over Q1 June 2016.

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Natco Pharma manufactures generic dosage forms, bulk actives and intermediates for the Indian and international markets.

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First Published: Oct 04 2017 | 9:43 AM IST

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