Gilead is negotiating voluntary licenses with `seven or eight` Indian manufacturers to make the anti-HIV drug tenofovir within the next year, after obtaining a patent on tenofovir in India. The company hopes that by granting voluntary licenses it will be able to increase production capacity.
The company also revealed that global marketing of the new triple combination pill containing tenofovir, emtricitabine and efavirenz is likely to be handled by Merck & Co, the distributor of efavirenz in middle-income and resource-limited countries. The pill, called Atripla, received approval in the United States last week. Atripla will be distributed by Merck wherever Gilead or Bristol Myers Squibb do not have sales forces or distribution networks.
Merck is also likely to handle distribution of tenofovir and Truvada (Gilead’s two drug pill combining tenofovir and emtricitabine) in middle-income countries, but is waiting to see the outcome of voluntary license negotiations with Indian companies before deciding whether it will cover any of the 97 countries currently eligible for a reduced tenofovir price through the company's access programme.
Gilead unveiled its plans at a meeting with treatment advocates from all continents in London on July 6th, following months of criticism over its developing country access programme.
The company had been criticised by Médecins sans Frontieres for its slow progress in registering tenofovir and Truvada in Africa, where tenofovir is chiefly viewed as a second-line drug.
Defending the company's progress, Gilead's access programme director Joe Steele told aidsmap: "We have no infrastructure or people in any of those countries. The approvals are coming in very slowly. So, we wanetd to enlist the support of partners."
After two years struggling to get tenofovir registered more widely, Gilead decided in May to assign voluntary licenses for the drug – but only after it has obtained patent protection in India. The company says this step is necessary so that it can control where Indian companies sell the drug. While Gilead is happy to see Indian manufacturers undercut each other and drive the price down for the poorest countries, the company wants to retain control over pricing the drug for middle-income markets.
Two versions of tenofovir not licensed by Gilead are already on sale in India. One version manufactured by Cipla is selling at $103 a month.
"We think this is an inappropriately high price," Joe Steele said today.
Gilead will charge a royalty of 5% on the access price of $200 a year, and will require any company that signs a manufacturing agreement to make active ingredients of tenofovir to sell them only to generic manufacturers that have voluntary license agreements with Gilead.
In sub-Saharan Africa the South African company Aspen Pharmacare holds the rights to make tenofovir and the two drug combination pill Truvada. Aspen is expected to receive FDA tentative approval for its versions of these drugs by early 2007, allowing them to be supplied to PEPFAR programmes. This approval will automatically guarantee WHO prequalification for the products.
The company is effectively sub-contracting its access programme to generic manufacturers in India and South Africa. How will Gilead ensure the quality of the products supplied by its licensees?
"Licensees will have to seek FDA or WHO prequalification and undergo manufacturing inspections by those authorities," said Joe Steele.
Tenofovir’s price as a single drug remains higher than the prices charged for several three drug combination pills containing nevirapine that are manufactured by Indian companies.
According to the Clinton HIV/AIDS Initiative, potential may exist for a 10-20% reduction in the price of tenofovir manufactured in India if manufacturing processes can be streamlined and improved.