Malaria drugs currently on the market contain artemisinin which is derived from extracts from sweet wormwood, a plant long used in traditional Chinese medicines and known since the 1970s to be effective against the parasite Plasmodium falciparum.
But while artemisinin-based combination therapies (ACTs) are effective – and indeed they are the only malaria treatment recommended by the World Health Organisation (WHO) – problems with the quality and consistency of botanical artemisinin over the last decade prompted scientists to try and develop alternative production processes.
And it is one of these methods – a photochemical transformation developed by University of California, Berkeley in the US – which Sanofi has adopted.
The process begins with Bulgarina drugmaker Huvepharma which makes the starting material – artemisinic acid – in cultures of a genetically modified strain of the yeast Saccharomyces cerevisiae at its plant in Sofia.
The raw material is converted into the artemisinin by Sanofi at its plant in Garessio, Italy. The French drugmaker plans to make 35 tons of the API in 2013 and 50 to 60 tons a year from then on, which it says is sufficient for up to 150 million treatments.
The other unique aspect of the manufacturing project – which is conducted in collaboration with Path and non-profit drug development organisation OneWorld Health, is that Sanofi is making the API at cost in a so called “no profit, no loss” production model as spokesman Frederic Lemond told in-Pharmatechnologist.com.
"We are not doing this for profit but to play of role of key partner to the anti-malaria community," he said explaining that while installation of a new production line at Garessio had been necessary no additional staff had been hired to operate the technology.
The idea is that this business model – coupled with the new production method – will stabilize the price of ATCs which has fluctuated wildly in recent years, thereby enabling the drugs to be provided to people in developing countries who are at greatest risk of malaria.