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KENYA: WHO approves Africa’s first locally-made malaria drug for pregnant women and children

By Uwagbale Edward-Ekpu with Quartz Africa

Vaccine nationalism during the covid-19 pandemic resulted in advocacy for local vaccine manufacturing in Africa. Malaria—one of the leading causes of death among young children in Africais one disease that stands to benefit from advocacy efforts.

Yesterday, Kenyan drugmaker, Universal Corporation Ltd (UCL) became the first African manufacturer to be awarded World Health Organization (WHO) quality assurance certification (pre-qualification) for an antimalarial drug used to prevent infection in pregnant women and children. UCL will begin to manufacture sulfadoxine-pyrimethamine, a medicine it markets as Wiwal.

“UCL is committed to supplying the African continent with quality medicines that are most needed by the people who live here. We are not only the first pharmaceutical company to receive pre-qualification of sulfadoxine-pyrimethamine in Africa, but one of only five manufacturers in Africa to have received this quality certification for any product. We’re filling a much-needed gap,” said Perviz ‘Palu’ Dhanani, Founder and Managing Director of UCL.

Africa’s disproportionate malaria burden

For decades, Africa has disproportionately been burdened with malaria. Of the estimated 241 million malaria cases and 627,000 deaths reported globally in 2020, the WHO African region accounted for 95% and 96% of all the cases and deaths respectively, with children under the age of five years accounting for about 80% of all deaths in the region.

UCL achieved the pre-qualification with funding from Unitaid, a global health agency that has invested about $160 million to deliver sulfadoxine-pyrimethamine as a preventive malaria treatment in pregnant women and infants, according to Medicines for Malaria Venture (MMV), a Geneva-based product development partnership for antimalarial drug research and development, which supported the process with funds from Unitaid.

Sulfadoxine-pyrimethamine, a combination drug, was first tested in the US and approved by the Food and Drug Administration in 1981. It has since been manufactured and marketed by Swiss drug maker Hoffmann-LaRoche as Fansidar. However, sales in the US were discontinued, and its use is limited in some countries due to adverse reactions.

UCL is based on the outskirts of Nairobi and began as a family business in 1996, headed by Palu and his brother Rajan—none of whom have a university degree. They received early funding from a Finnish investor in 2000 for the construction of a factory. In 2005, UCL received a €400,000 investment for a 10% stake and a loan of $1.5 million from Finnfund, a Finnish development finance company, which enabled it to produce its first batch of drugs from the new factory.

Finnfund invested an additional $10 million for a 39% stake in 2008. it enabled UCL to achieve WHO pre-qualification in 2011 for its zidovudine/lamivudine antiretroviral drug marketed as Lamozid—the first company to achieve this in Kenya. Lamozid is among about 255 medicines approved for Global Fund financing for combating malaria, Aids, and other diseases.

Finnfund exited the company in 2015, and the Indian Pharmaceutical company, Strides Shasun, a company listed on the Bombay Stock Exchange, bought a 51% stake at $11 million a year after. UCL currently manufactures over 100 formulations of medicinal products exported to more than 22 countries.

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