Health GAP
www.healthgap.org

For Immediate Release: August 3, 2004
Contact: Robert Dabney +1 267-467-4683

NEWLY APPROVED HIV DRUGS HIGLIGHT FLAWS IN U.S. GLOBAL HIV/AIDS FIGHT

Fast track approval of Gilead Sciences and GlaxoSmithKline drugs by the FDA falls short of expanding HIV/AIDS treatment to the world's poor

(Philadelphia) Ð The announcement of approval by the Food and Drug Administration of two drugs designed to be distributed as part of the President's Emergency Plan for AIDS Relief will not significantly alter the landscape for treatment of millions of people living with HIV/AIDS in the world's poor nations. That analysis was released today by Health GAP (Global Access Project) following the announcement that fast track approval has been granted to Truvada, to be manufactured by Gilead Sciences, and the GlaxoSmithKline product Epzicom. Both products are fixed-dose combination antiretroviral drugs, joining two existing drugs in one dose. Health GAP's Asia Russell says that there are several potential issues with the approval that require a closer examination.

'Health GAP is extremely concerned about the fast track approval of Truvada and Epzicom," said Russell. 'We have consistently urged the administration to make life-sustaining medicines available at low cost to people living with HIV in the developing world. Our information at this time is that while Gilead has agreed to make its product available for less than a dollar per day, Glaxo will charge more than $600 per month for their drug. This is not an affordable price."

Russell went on to say that the pharmacological makeup of the new drugs makes it impossible for less expensive drugs to be made using their formulation.

'What would make these drugs more affordable is the presence of generic competition in overseas markets," Russell continued. 'There are intellectual property issues with one of the components of both of these drugs that means that no generic manufacturer can recreate the product. It is unconscionable that Glaxo, the world's largest maker of HIV drugs should find it necessary once again to maintain its position on the backs of people living with HIV/AIDS."

In addition to the pricing issue, Russell pointed out that one of the benefits being touted of these two combination drugs is that they will address the multiple-dosing issue for many countries where it is difficult to get patients to adhere to a multiple pill regime.

'The problem with this is that each of the new drugs only combines two HIV medicines," said Russell. 'The normal dosing regimen for HIV patients is a three-pill combination. So anyone using these products would still have to add another antiretroviral drug negating the true impact of the drugs."

#30#