Gilead to let 7 Indian firms make Hep-C drug generic

Pharmaceutical major Gilead on Monday inked agreements with seven Indian drug companies for generic manufacture of its proprietary medicine against Hepatitis-C, for sale in 91 low and middle-income countries at a fraction of the medicine's cost in the US.

Even the relatively low cost of the medicine—Rs 90,000 for an Indian patient if the treatment continues for six months—is too high for most people in the country, claim patient groups and activists, who challenged Gilead's pricing at the patent offices in Kolkata and Delhi.

As many as four petitions against the medicine—costing $84,000 in the US—are being heard by Indian patent examiners.

The US company now offers the same medicine at $900 for 91 nations, including India and Pakistan but excluding China.

The Indian manufacturers who can make the medicine, called sofosbuvir, and a single tablet combining two medicines called ledipasvir and sofosbuvir, are Cadila, Cipla, Hetero, Mylan, Ranbaxy, Sequent and Strides Arcolab.

“At the earliest, we can launch the Indian generics by the third quarter of 2015,” said Bhavesh Shah, one of the vice-presidents of Hetero.

Prior to the Indian launch, Gilead will have to complete clinical trials in India and each of the seven drug companies have to register themselves with the Drugs Controller General of India.

The World Health Organisation estimates that viral hepatitis kills approximately five  lakh people every year in the South-East Asian region, and poses a serious public health problem. Most of the deaths are caused by Hepatitis B and C infections, which lead to hepatic cirrhosis and cancer.

“The licences with the seven Indian companies will cover 10 crore people living with Hepatitis C, representing 54 per cent of the total global infected population,” said Gregg Alton, Executive Vice-President (corporate and medical affairs) at Gilead.

Under the licensing agreements, Indian companies receive a complete technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible.

Asked about the medicine's price in the Indian market, the Indian manufacturers said it would be premature to calculate the cost. But the ceiling could be $300 for a bottle of 28 tablets—the price in which Gilead plans to launch sofosbuvir in the Indian market later.

“Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, which are home to over 70 per cent of people with Hepatitis C,” said Rohit Malpani from Médecins Sans Frontières.

The deal excludes many middle-income countries considered by the industry to be emerging markets, though people living with chronic Hepatitis C in these countries often come from poor and marginalised communities with little ability to pay for expensive medicines.