Natco Pharma has gained 5% to Rs 1267 also its 52-week high on the BSE after the pharmaceutical company announced that its marketing partner in the USA, Mylan Inc. has filed an Abbreviated New Drug Application (ANDA) for a three-times-aweek generic Copaxone and has been accepted by the US Food and Drug Administration (USFDA).
According to the company’s press release, Copaxone is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS).
Natco’s partner Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval.
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Copaxone 40 mg/mL had U.S. sales of approximately $411.5 million for the 12 months ending June 30, 2014, according to IMS Health.
The stock opened at Rs 1255 and touched a low of Rs 1233 on National Stock Exchange (NSE). A combined 50,800 shares changed hands on the counter during noon trades on NSE and BSE.