Gilead reduces price of anti-HIV medication

Gilead Sciences, from Foster City, CA, has reduced the price of Viread (tenofovir disoproxil fumarate) in the developing world.

Gilead provides Viread, a once-a-day antiretroviral medication for HIV to be used in combination therapy, through the Gilead Access Program at a no-profit price in every country in Africa and in 15 additional countries in other parts of the world classified as 'least developed' by the United Nations(UN).

As a result of continued improvements in the manufacturing process for Viread and increased economies of scale, Gilead will now be able to make Viread available to any private or public programme treating people with HIV/AIDS in the 68 nations for US$24.71 for a 30-day supply, or $0.82 per day. This is nearly a 37% reduction in the original no-profit price of Viread. The price for supplying Viread represents Gilead's cost of manufacturing the drug and administering the no-profit programme.

'Since the launch of this program Gilead has continued to invest in process improvements that could reduce our manufacturing costs. Now that we have identified improvements, we are able to lower our manufacturing cost and consequently our not-for-profit price,' said Dr John Martin, president and ceo, Gilead Sciences. 'We created the Gilead Access Program to make Viread available in resource-limited settings, and this price reduction will allow us to make it even more widely available. In addition to this initiative, Gilead is also participating in and providing drug for several studies designed to identify the best treatments and methods for delivering treatment in the developing world, as well as studies that will evaluate Viread as a potential chemoprophylaxis to prevent infection.'

Gilead also announced that the company intends to make the fixed-dose combination of Viread and Emtriva (emtricitabine) available through the programme as soon as that product receives US regulatory approval.

The company submitted its NDA for the fixed-dose combination product in March 2004. The application received six month priority review status from the FDA in May and was assigned an action date, under the Prescription Drug User Fee Act (PDUFA), of September 12, 2004. Priority designation is granted to drugs that address unmet medical needs, offering a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious or life-threatening disease, according to FDA policies and procedures.

'We are looking forward to adding the fixed-dose combination of Viread and Emtriva to the Gilead Access Program,' Dr Martin said. 'We believe this combination may be a particularly useful treatment option for resource-limited settings, given its convenient once-daily dosing and side-effect profile.'