Gilead's Tenofovir 'Access Program' For Developing Countries: A Case of False Promises ?

[Guest guest]

Gilead's Tenofovir 'Access Program' For Developing Countries:

A Case of False Promises ?

Denver, CO-February 7, 2006 - As AIDS experts gather this week in Denver to

discuss advances in treatment at the 13th Conference on Retroviruses and

Opportunistic Infections (CROI), Doctors Without Borders/Médecins Sans

Frontières (MSF) is concerned that innovations from years ago are still not

reaching people in developing countries. More than three years after Gilead

Sciences first announced its " Access Program " for tenofovir, this key

antiretroviral medicine remains largely unavailable in developing countries.

Marketed as Viread® (tenofovir disoproxil fumarate) in the United States,

tenofovir was approved by the US Food and Drug Administration more than four

years ago and is now an important option for antiretroviral treatment for both

AIDS patients starting therapy for the first time, and those that require access

to newer drugs a few years down the line, particularly because it has fewer side

effects than older antiretrovirals.

As Gilead is the sole producer of tenofovir (no generic versions have been

internationally validated), MSF and others are dependent on the willingness of

the company to make this urgently needed drug widely available. In December

2002, Gilead announced that tenofovir would be available at a reduced price

initially to 68, and then to 97 developing countries through its Viread Access

Program. Over three years later, tenofovir is registered for use in only six of

these countries - the Bahamas, Gambia, Kenya, Rwanda, Uganda, and Zambia. The

company has failed to request marketing clearance or otherwise make their drugs

available in most developing countries.

" Gilead is proud to show physicians and shareholders how effective tenofovir is

in treating AIDS, but other than issuing press releases and empty promises, the

company has done little to ensure that the medicine is available to those who

need it most in developing countries, " said Dr. andra Calmy, AIDS specialist

with MSF's Campaign for Access to Essential Medicines, attending CROI in Denver

this week.

In South Africa, Gilead only completed its registration application in November

2005, three years after it announced the price reduction for selected developing

countries. Considering the average time between filing and approval of a drug

registration application in South Africa, this means the drug is unlikely to

reach patients before 2007. That's a five-year gap between Gilead's announcement

and availability in the country.

To obtain the drug for patients in South Africa today, MSF physicians running

AIDS treatment programs are forced to go through a series of burdensome

procedures, like providing the name of each patient needing the drug, in order

to import tenofovir directly from Gilead in California under a special

authorization of South African law.

" The complicated application process and in particular the difficulties and

added expense of shipping from California means that the vast majority of

physicians in South Africa will not have access to tenofovir. And if shipments

get delayed, we will also be faced with the painful reality of needing to ration

the drug. " said Dr. Goemaere, head of mission for MSF's HIV/AIDS treatment

project in Khayelitsha, outside of Cape Town.

Gilead does not consider Thailand as an " Access Country " and has, to date, not

marketed the drug there. " When MSF met with the Gilead representatives at the

International AIDS Conference here in Bangkok back in July of 2004, they assured

us they would register the drug right away, " said Dr. , medical

coordinator for MSF's AIDS treatment programs in Thailand. " 18 months later, we

are still waiting. "

" If Gilead waits to register tenofovir in Thailand until after the US-Thailand

Free Trade Agreement is signed, the company could have five years of exclusivity

on the drug. One can't help but wonder if this is motivating the delay, "

concluded.

MSF is urging Gilead to turn its promises on paper into pills for patients and

make good on its promises.

MSF and HIV/AIDS Treatment:

MSF began providing HIV/AIDS prevention and care services in the 1990s. In

2000, MSF introduced antiretroviral therapy in its projects in Thailand, South

Africa, and Cameroon. Currently, MSF provides antiretroviral therapy to nearly

60,000 patients in 50 projects in 29 countries.

***

For further Information contact: Leena Menghaney

Project Manager-India

Campaign for Access to Essential Medicines

Medecins Sans Frontieres - Holland (in India)

Tel: +91 11 24337225, + 91 1151552413

Fax: +91 11 24336834

E-mail: msfh-india-medco-assist@...