The Natco Pharma scrip tumbled 14.10 per cent on the BSE on Tuesday after the US Supreme Court agreed to hear a patent case on Copaxone. The stock, which opened for trading at ₹775, closed at ₹684.65.
Copaxone (Glatiramer Acetate) of Teva Pharmaceuticals is used in the treatment of relapsing-remitting multiple sclerosis and had registered a revenue of $4.2 billion in the US during 2013.
Teva’s Copaxone patents expiring in September 2015 were held invalid by a US court in July 2013, making generic entry possible in May this year, when the remaining patents expire. This cleared the road for Hyderabad-based Natco in partnership with Mylan Inc and Momenta Pharmaceuticals and its partners, to move in. But Teva’s appeal has injected uncertainty into the future scenario.
The outcome of the US apex court’s hearing would be crucial since Natco-Maylan were expected to launch the drug in or after the current financial year. Analysts earlier gave 80 per cent probability for the speedy launch of the drug by Natco and said the opportunity could be “huge” for Natco due to low competition in the market as a result of product complexity and delayed entry of new players.
Besides Copzxone, Natco has also lined up some other filings in the US market such as the Abbreviated New Drug Applications for Revlimid, Tamiflu, Fosrenol and Tykerb.
Nod for capsules Last week, it received a tentative approval for Oseltamivir Phosphate capsules from the United States Food and Drug Administration (USFDA). Natco may have first to file approval status for this. Tamiflu, Roche’s trade name for Oseltamivir Phosphate, had US sales of approximately $495 million for the 12 months ending September 2013.
However, as observed in a Spark Capital report, monetisation of most of these opportunities depends on litigation outcomes.