Natco Pharma shares soar

Marketing partner Mylan’s multiple sclerosis drug gets USFDA nod

A private security guard looks out from a window of the head office of Natco in the southern Indian city of Hyderabad March 13, 2012. India's move to strip German drugmaker Bayer of its exclusive rights to a cancer drug has set a precedent that could extend to other treatments, including modern HIV/AIDS drugs, in a major blow to global pharmaceutical firms, experts say. On Monday, the Indian Patent Office effectively ended Bayer's monopoly for its Nexavar drug and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India. REUTERS/Krishnendu Halder (INDIA - Tags: HEALTH BUSINESS)

Natco Pharma shares on Wednesday gained Rs.159.05 apiece to hit the upper circuit limit of 20% on the back of USFDA approving marketing partner Mylan’s application for generic version of Teva’s Copaxone, that is used in the treatment of multiple sclerosis (MS).

The regulator has approved Mylan’s abbreviated new drug applications for Glatiramer Acetate injection 40 mg/ml (three-times-a-week injection) as well as Glatiramer Acetate Injection 20 mg/mL (once-daily injection), the Hyderabad-headquartered firm said.

The FDA has approved the products as therapeutic AP-rated equivalents to Copaxone, meaning if they are substituted for their branded counterpart they can be expected to have the same clinical effect and safety profile, Mylan N.V. said in its announcement late on Tuesday evening.

Copaxone is used for the treatment of patients with relapsing forms of multiple sclerosis, a chronic inflammatory disease of the central nervous system. It is the “most prescribed” MS treatment for relapsing forms of MS in the U.S with brand sales for the 20 mg/mL dose of approximately $700 million and for the 40 mg/mL dose of about $3.64 billion for the 12 months ended July 31,2017, Natco said citing Quintiles IMS.

Around 400,000 individuals in the US have MS and relapsing MS accounts for 85% of initial MS diagnoses.

Natco Pharma, whose share touched the upper limit of Rs.954.35, said launch plans for both the products will be communicated shortly after concurring with Mylan.

Announcing that it would “begin shipping imminently”, Mylan said according to the regulator’s approval letter it was one of the first to submit a substantially complete ANDA for Glatiramer Acetate Injection, 40 mg/mL, containing a Paragraph IV certification. Thus, Mylan and other first filers may be eligible for 180 days of generic drug exclusivity. The regulator, however, has not made a formal determination on exclusivity at this time.

“Mylan has invested tens of millions of dollars over many years to bring this important medicine to market,” CEO Heather Bresch said. The FDA approvals, she said, reinforce “our proven capabilities in bringing complex and difficult-to-manufacture products to market.”