Mumbai: After dragging leading multinational drug makers Pfizer Inc. and F Hoffman-La Roche Ltd into a licensing spat over their cancer drugs Sutent and Tarceva, Hyderabad-based Natco Pharma Ltd, a cancer drugs specialist, is planning another patent fight against Pfizer’s new anti-HIV/AIDS drug Celzentry.
While Natco’s earlier licensing pleas, which await final decisions of the Indian patent controller, were intended for exporting the two cancer drugs to Nepal, the new move is to launch a copycat version in India of Celzentry, a second-line HIV/AIDS drug used in patients who develop resistance to medication given in the early stages of infection.
Sales of HIV/AIDS drugs in India currently is about Rs65 crore with up to 130,000 patients under preliminary treatment, also referred to as first-line treatment, for the virus according to industry estimate at the price level of Rs5,048 per patient a year, fixed for government drug supply.
However, experts estimate the potential market in the world’s second largest HIV/AIDS-infected country to be up to Rs1,200 crore annually if all of the country’s estimated 2.5 million people infected with the virus are treated.
In June last year, Pfizer was granted a patent for Celzentry, known as maraviroc in generic terms, in India. It is a new class of oral medicine prescribed for follow-up treatment for HIV patients. However, Pfizer is yet to launch the drug in the local market.
“We are currently working with Indian regulators to obtain the necessary approval. We will launch the life-saving drug as soon as this process is complete,” a spokesperson for Pfizer Ltd, the Indian unit of the world’s biggest drug firm by sales, said.
“In the interim, we have a licence that allows us to provide limited access in line with a clinical trial we are conducting for patients with this class of HIV infection, who have limited or no approved treatment options due to resistance or intolerance to existing drugs,” the spokesperson added.
The spokesperson declined to comment on Natco’s plan.
A senior executive from Natco, who did not want to be identified, said the “company will soon approach the patent controller seeking a compulsory licence for manufacturing this drug in India for the local market as well as exporting it to other least developed countries.” A compulsory licence essentially sets aside a patent in the larger interest of the public, to tackle a national emergency, or in a few other situations.
Among doctors, maraviroc is considered a salvage therapy for patients not responding to preliminary HIV/AIDS medication, also known as anti-retroviral, or ARV, drugs. The drug costs around $32 (about Rs1,280) for a day’s treatment in the US.