Local ARV manufacture on the cards

2 December 2008

South Africa’s Council for Scientific and Industrial Research (CSIR) has stepped up its battle against HIV/Aids by developing a cost-effective method of producing two active pharmaceutical ingredients used in the manufacture of anti-retroviral drugs.

The CSIR has filed a patent for its technology, which is expected to reduce production costs of thymidine, a valuable ingredient in the pharmaceutical preparation of AZT and stavudine, two generic drugs used in first- and second-line combination therapy treatment regimens.

The technology will enable the CSIR to produce active pharmaceutical ingredients at a fraction of the price of those imported from India, which currently dominates the global market with help from state subsidies.

CSIR project leader Moira Bode said the research could stimulate the establishment of an industry for the local production of active pharmaceutical ingredients.

“This will empower African governments to supply more people with the life-saving drugs,” Bode said in a statement this week.

New market player

Arvir Technologies, a new antiretroviral manufacturer, has been granted commercial rights, and will explore various options, including the granting of licences to existing active pharmaceutical ingredient producers and the establishment of a new active pharmaceutical ingredient manufacturing facility in the country.

“The latter will manufacture AZT and other ARV products,” explained Arvir CEO David Walwyn. “We need to ensure that South Africa has an economically sustainable and well-secured supply of high-quality ARVs, [and] negotiations are presently under way with government.”

Commercial partners

CSIR Biosciences executive director Gatsha Mazithulela pointed out that with the number of people in South Africa needing ARV treatment estimated to be approaching one million, the local manufacturing of such drugs was an imperative.

“Ironically, now that the science has been done, the challenge is to find commercial partners willing to invest in manufacturing,” he said. “We look forward to interesting conversations with our government and other stakeholders in making the local production of ARVs a reality.”

SAinfo reporter