Natco Pharma hits upper circuit on USFDA approval for Glatiramer Acetate injection

Natco Pharma, a leading pharma company engaged in developing, manufacturing and marketing finished dosage formulations (FDF) has informed in its filing that its marketing partner Mylan has received USFDA (US Food and Drug Administration) approval for Glatiramer Acetate injection in strengths of 40 mg/mL and 20 mg/mL.

Glatiramer Acetate is a generic version of Teva’s Copaxone 40mg/mL which is used in treatment of multiple sclerosis (MS), a chronic inflammatory disease of the central nervous system (CNS).

Copaxone is majorly prescribed MS treatment for relapsing forms of MS in the United States. In the United States, ~4 lac individuals have MS and relapsing MS accounts for 85% of initial diagnosis.

As per Quintiles IMS, brand sales for the twelve months ending July 31, 2017 for Copaxone  40 mg/mL dose were  ~USD 3.64 billion and for 20 mg/mL dose, the sales were ~USD 700 million.

After this announcement, the stock breached its upper circuit limit by reaching to its intra-day high of Rs 534.35.