[Ip-health] Reuters: Merck Grants South Africa License for Generic Efavirenz

[Mike Palmedo]

 From the Health GAP list...

http://www.hivandhepatitis.com/recent/developing/040904e.html

Merck Grants South Africa License for Generic Efavirenz

Andrew Quinn, Reuters
04/09/04

US drug maker Merck & Co Inc. plans to license a South African firm to
make and sell a generic version of efavirenz (Sustiva), a key
antiretroviral AIDS drug, the company said on Wednesday.

Under terms of a preliminary offer, Thembalami Pharmaceuticals Ltd, a
joint venture between Adcock Ingram and India's Ranbaxy Laboratories,
will provide generic efavirenz in the Southern African Development
Community, which includes some of the countries worst hit by the
worldwide AIDS epidemic.

MSD Ltd., Merck's South African subsidiary, said in a statement that the
royalty-free deal was intended to complement South Africa's recent moves
to roll out public antiretroviral drug treatment.

"We...believe strongly in working with different stake holders to
accelerate access to our breakthrough products," said Per Wold-Olsen,
president of Merck's human health division for Europe, the Middle East
and Africa.

Efavirenz, licensed to Merck by developer BristolMeyersSquibb in Europe,
Middle East and Africa, was named by U.S. researchers in December as one
part of the "best" regimen of antiretroviral drugs along with
GlaxoSmithKline's AZT and lamivudine.

High AIDS Caseload

AIDS activists have accused a number of pharmaceutical companies of
keeping drug prices unfairly high in South Africa, which has an
estimated 5.3 million people infected with HIV, the world's highest
caseload.

In an out-of-court settlement in December, British-based Glaxo and
Germany's Boehringer Ingelheim said they planned to grant more licences
to South African generic firms to produce and import antiretroviral drugs.

Glaxo, which has already licensed South Africa's Aspen Pharmacare for
generic antiretrovirals, said it was in advanced talks with Thembalami
and was looking at further possible licences for copies of its drugs AZT
and lamivudine.

Thembalami spokeswoman Maureen Stewart said the company was in
"advanced-stage" negotiations with both GSK and Boehringer Ingelheim,
although no licenses had actually yet been awarded to the company.

Generic deals with Aspen and other South African firms are viewed as
increasingly important as the country ramps up its public antiretroviral
programme, which began officially this month.

Officials say the programme could cover as many as 1.4 million people by
2009, forcing the government to search out the cheapest possible sources
for the drugs while increasing South Africa's own domestic production.