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WHO approves Africa's first locally made malaria drug for pregnant women and children

Vaccine nationalism during the covid-19 pandemic leads to advocacy for local vaccine production in Africa. Malaria – one of the leading causes of death among young children in Africa is a disease that could benefit from advocacy efforts.

Yesterday, Kenyan drugmaker Universal Corporation Ltd (UCL) became the first African manufacturer to receive World Health Organization (WHO) Quality Assurance Certification (Prequalification) for antimalarial drugs for Prevention of infection in pregnant women and children. UCL will start manufacturing sulfadoxine-pyrimethamine, a drug marketed under the name Wiwal.

“UCL is committed to providing the African continent with the quality medicines that the people who live here need most. We are not only the first in Africa to be prequalified for sulfadoxine-pyrimethamine pharmaceutical company and is one of only five manufacturers in Africa to receive any product quality certification. We are filling a much-needed void,” said Perviz ‘Palu’ Dhanani, founder and managing director of UCL.

Africa’s disproportionate burden of malaria

For decades, the burden of malaria in Africa has been disproportionate. Of the estimated 241 million malaria cases and 627,000 deaths reported globally in 2020, the WHO African Region accounted for 95% and 96%, respectively, of all cases and deaths, with children under five accounting for approximately 80% of all deaths

UCL prequalified with funding from Unitaid based in Geneva Medicines for Malaria Venture (MMV), a product development partner in antimalarial drug development, said the global health agency has invested approximately $160 million to provide pregnant women and infants with sulfadoxine-pyrimethamine as a preventive malaria treatment. , which supports the process with funding from Unitaid.

Sulfadoxine-pyrimethamine, 1981 US Food and Drug Administration First FDA trial in the US since manufacture and sale by free Swiss drugmaker Hoffmann – La Roche as Fansidar. However, sales have been discontinued in the United States, and use has been limited in some countries due to adverse reactions.

UCL is located on the outskirts of Nairobi and started as a family business in 1996 by Palu and his brother Rajan lead – none of them have college degrees. In 2000, they received early funding from Finnish investors to build the factory. In 2005, UCL received a 10% equity investment of EUR 400,000 and a loan of USD 1.5 million from Finnfund, a Finnish development finance company, enabling it to manufacture its first batch of drugs from the new facility.

Finnfund invested an additional $10 million in 2008 to acquire a 39% stake. It enabled UCL’s zidovudine/lamivudine antiretroviral drug to be prequalified by the WHO in 2011, marketed under the name Lamozid – the first in Kenya. Lamozid is one of about 255 medicines funded by the Global Fund to fight malaria, AIDS and other illnesses.

Finnfund exited the company in 2015 and a year later Indian pharma company Strides Shasun, listed on the Bombay Stock Exchange, bought a 51% stake for $11 million. UCL currently manufactures more than 100 pharmaceutical formulations, which are exported to more than 22 countries.



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