Natco Pharma up 20% as Mylan gets USFDA nod for generic Glatiramer Acetate

The stock up 20% to Rs 954 on BSE after the company said its marketing partner Mylan receives final approval of generic Glatiramer Acetate, for both 20 mg/mL and 40 mg/mL versions.

Natco Pharma is locked in maximum upper limit of day, up 20% to Rs 954 on BSE after the company said its marketing partner Mylan has received final approval of generic Glatiramer Acetate, for both 20 mg/mL and 40 mg/mL versions.

The trading volumes on the counter jumped more than four-fold with a combined 548,773 shares exchanging hands on BSE and NSE till 09:28 AM. There were pending buy orders for 610,513 shares on both the exchanges.

“The U.S. Food and Drug Administration (FDA) has approved its marketing partner Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic version of Teva's Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, an AP-rated, substitutable generic version of Teva's Copaxone 20 mg/mL, which are indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system,” Natco Pharma said in a press release.

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

According to Quintiles IMS, 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 July 31, 2017.

Approximately 400,000 individuals in the U.S. have MS and relapsing MS accounts for 85% of initial MS diagnoses.