The World Health Organisation estimates there are 185 million people infected with Hepatitis C
New Delhi (AFP) - US biotechnology giant Gilead Sciences announced on Monday licensing deals with seven Indian drug firms to produce cheaper copies of a $1,000-a-pill to treat Hepatitis C in over 90 developing countries.
Gilead has come under fire from patient rights' groups, US legislators and insurers over the high price tag for its Hepatitis C drug, Sovaldi, which in the United States costs $84,000 for a total 12-week course of treatment.
"This announcement is a game-changer," Gregg Alton, Gilead medical affairs executive vice-president, told AFP in New Delhi where the announcement was made.
"The great thing is we are making this medicine available to millions of people around the world" who might not otherwise have access, Alton said.
Bhavesh Shah, international marketing director at Hetero Drugs, one of the Gilead licensees, told reporters the medicine could "be on the market (in India) by the second or third quarter of 2015".
Some 185 million people worldwide are affected by Hepatitis C, according to World Health Organisation figures. The licensing deals will cover 91 countries where more than 100 million people are living with Hepatitis C.
The virus, which can be transmitted by needle-sharing, contaminated blood transfusions or having sex with an infected person, claims some 350,000 lives annually.
Treatment with Sovaldi is effective in nine out of 10 cases of Hepatitis C, US clinical trials suggest. Gilead says the drug's cost is justified as it may avert liver failure and liver cancer.
Patient rights' groups said Gilead's announcement was aimed at deflecting public criticism of its pricing of Sovaldi, which has become one of the top-selling medicines globally since its launch in late 2013.
Gilead was dubbed the "poster child of drug industry greed" for Sovaldi's $1,000-a-pill price by US-based AIDS Healthcare Foundation, a fierce critic of skyrocketing pharmaceutical prices.
Among the countries covered by the licensing deals are Indonesia, Kenya, South Africa, Uganda and Vietnam.
But patients' groups said the licensing deals exclude millions of patients, many of them marginalised and poor, who live in middle-income countries such as Brazil, Thailand and Mexico, and in wealthy nations like the United States.
More than three million Americans are living with Hepatitis C.
- 'Pharmacy' to the world -
The problem of poorer patients in wealthier nations "is a big problem -- there's no denying it", said Gilead's Alton.
But "Gilead is working to make its chronic Hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible", he said.
Gilead chose Indian firms to make the generic versions as the country is known as the "pharmacy" to the developing world and to wealthy nations, supplying inexpensive copies of many medicines.
Among the other firms licensed to make copies are Indian companies Cipla, Ranbaxy Laboratories, Cadila Healthcare and Strides Arcolab -- and Mylan Laboratories, based in Pennsylvania.
California-based Gilead, one of the biggest producers of HIV-AIDS drugs, said it would make Sovaldi available separately in India for $300 for a month's supply.
This, Alton said, could serve as a "benchmark" for pricing of generic versions in developing countries.
Patients with Hepatitis C require three or six months of treatment with the drug depending on the virus strain.
In the United States, the Hepatitis C strain is usually treated with a 12-week course, while in India and some other countries strains are different, often requiring a 24-week therapy regimen.
The companies said it was too early to say what they would charge.
"Nobody will be seeking to make a huge profit, this is a lifesaving drug," Strides Arcolab chief executive Mohan Kumar told AFP.
Gilead will get a seven percent royalty on sales.
"We welcome the interest of generic companies to scale up production of new direct-acting anti-virals," said Rohit Malpani, access campaign policy director at medical charity Medecins Sans Frontieres.
But the existence of licensing agreements which "block millions of people with Hepatitis C from affordable prices is not acceptable", Malpani said.
Eight years ago, Gilead worked out a deal similar to the Hepatitis C licensing pacts under which it allowed generic firms to sell cheaper versions of its anti-HIV/AIDS medicines in developing countries.