South Africa’s Council for Scientific and Industrial Research (CSIR) has developed a low-cost method of manufacturing the antiretrovirals used to treat HIV/Aids, paving the way for more extensive HIV treatment across Africa.
The CSIR’s new technique will reduce the production costs of thymidine, a valuable ingredient in the antiretroviral (ARV) drugs AZT and stavudine. The two generic drugs are used in combination therapy treatment of HIV/Aids.
By using two drugs of different classes, combination therapy minimises both HIV virus resistance to ARVs and the development of serious side-effects. Because of this, it is the preferred method of ARV administration.
Until now, Indian drug manufacturers supported by state subsidies have offered the most competitively priced active pharmaceutical ingredients, and so dominated the global market.
The CSIR’s breakthrough will now allow for the production of thymidine at a fraction lower than the Indian market.
According to Dr Moira Bode, who led the CSIR project probing the low-cost production of ARVs, this research could stimulate establishment of an industry for local production of active pharmaceutical ingredients.
“This will empower African governments to supply more people with the life-saving drugs,” Bode said.
The CSIR-developed technology relies on a biocatalytic step to produce thymidine. The research included total development of the biocatalysis reaction to produce 5-methyluridine as well as the chemistry to convert 5-methyluridine to thymidine.
“This involved, among other things, initial screening work to identify useful enzymes, the fermentations to produce enzymes and the process development for scale-up of the biocatalytic reaction, as well as the chemistry,” said Bode.
“The entire process was scaled at the CSIR to produce thymidine at kilogram scale.”
The CSIR has filed a patent application on the technology and a new market player in antiretroviral manufacturing, Arvir Technologies, has been granted the commercial rights.
The company will explore various options, including granting licences to existing ARV active pharmaceutical ingredient producers, and establishing a new ARV pharmaceutical ingredients facility for South Africa.
“We need to ensure that South Africa has an economically sustainable and well-secured supply of high quality ARVs,” ,” said Dr David Walwyn, CEO of Arvir. “Negotiations are presently underway with government.”
Dr Gatsha Mazithulela, executive director of the CSIR Biosciences research unit, said South Africa’s high HIV prevalence rate made low-cost ARVs essential.
“In South Africa, with the number of people requiring ARV drugs estimated at approaching 1 million [where the CD4 count of the individual is less than 200], the local manufacturing of these drugs is an imperative,” he said.
“Ironically, now that the science has been done, the challenge is to find commercial partners willing to invest in manufacturing. We look forward to interesting conversations with our government and other stakeholders in making local production of ARVs a reality.”
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