[Ip-health] Bloomberg: Gilead's Viread Unavailable in Developing Countries

[Sheila.SHETTLE@geneva.msf.org]

Gilead's Viread Unavailable in Developing Countries

By Carey Sargent
Feb. 7 (Bloomberg) -- Gilead Sciences Inc.'s Viread HIV drug is ``largely
unavailable'' in developing countries more than three years after the
company announced plans to introduce the medicine at lower prices, Doctors
Without Borders said.  Gilead said it would make Viread, known generically
as tenofovir, available at no profit in every country in Africa and in 15
additional countries in December 2002.

``Over three years later, tenofovir is registered for use in only six of
these countries,'' Doctors Without Borders said today in an e-mailed
statement. ``The company has failed to request marketing clearance or
otherwise make their drugs available in most developing countries.''

AIDS killed more than 3.1 million in 2005, about 18 percent children under
age 15, said UNAIDS, an alliance of six United Nations agencies fighting
the disease. About 77 percent of deaths and 65 percent of new infections in
2005 were in sub- Saharan Africa, UNAIDS said. AIDS drug makers have been
under pressure to lower prices to help control spread of the disease.

Gilead spokeswoman Amy Flood said Viread is approved for use in 10 of 97
countries in a company program that provides the drug to developing
nations. Gilead has submitted applications for Viread in about 48
countries, she said.

``The process for regulatory approval has proven to be more time-consuming
that we anticipated,'' Flood said in an e-mail today. ``In some countries,
our application has been pending for more than two years.''

Doctors Without Borders

Doctors Without Borders, a humanitarian group, said Viread is now available
only in the Bahamas, Gambia, Kenya, Rwanda, Uganda and Zambia. The drug is
also approved in Botswana, the Democratic Republic of Congo, Namibia and
Ghana, Flood said.

In South Africa, Gilead completed its registration application in November
2005, three years after it announced the price reduction, Doctors Without
Borders said. This means the drug is unlikely to reach South African
patients before 2007, the group said.

``We had a lot of discussion with them face to face before putting out this
kind communication,'' Doctors Without Borders spokesman Daniel Berman said.

Gilead plans to make Viread available at a discount in all 97 countries
covered by the program, Flood said.

``That means that should the drug be registered in that country then they
would sell it at that price,'' Berman said.

``But how does a drug get registered? The company has to do it. And they
haven't.''

Gilead shares rose 44 cents, or less than a percent, to $60.46 at 3:33 p.m.
New York time in Nasdaq Stock Market trading.

+++++++++++++++++++++
Sheila Shettle
Communications Officer
M=E9decins Sans Fronti=E8res
Campaign for Access to Essential Medicines
Rue de Lausanne 78
1211 Geneva
Switzerland
+ 41.22.849.8403
sheila.shettle@geneva.msf.org
www.accessmed-msf.org