What have been the strategies for the registration, positioning and control of medical information for intramuscular artemether?
At the beginning of the 1990s the Chinese Authorities and Rhone-Poulenc Rorer signed an agreement to develop intramuscular (i.m.) artemether (Paluther) and to market the product in the malaria endemic countries. This accord ushered in an exemplary period of co-operation between an international pharmaceutical group and its Chinese partners, the WHO (especially TDR), the Wellcome Trust, and several university research departments. The challenge was to complement the Asian development (to Western standards of Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices) of a molecule which was already used on an everyday basis in East Asia and by Chinese medical missions in Africa. The implementation of Good Manufacturing Practice was the priority for Rhone-Poulenc Rorer in order to ensure the pharmaceutical quality of Paluther. New preclinical and clinical studies confirmed the importance of the drug in the curative treatment of severe malaria due to Plasmodium falciparum, or when resistance to other antimalarial drugs is suspected. The outcome of these new trials was the recognition that i.m. artemether is at least as efficient as quinine. The results of the current development of Paluther have been presented at several international congresses and the latest clinical trials were published in the New England Journal of Medicine in July 1996. The neurotoxicity observed in animals after long term administration of high and repeated dosages has never been reported in human subjects. I.m. artemether was listed in the WHO List of Essential Drugs in December 1995, and the product has now been registered in more than 40 malaria endemic countries. Authorization for use of Paluther in hospitals in France and in several other European countries was granted in 1996.
Helenport
J P
JP
Rhône-Poulenc Rorer International, Antony, France.
Roche
G
G
D000962:Antimalarials / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins; D002681:China; D004345:Drug Industry / Q000458:organization & administration*; D004346:Drug Information Services / Q000458:organization & administration*; D004335:Drug and Narcotic Control / Q000458:organization & administration*; D018954:Drugs, Essential / Q000627:therapeutic use; D005602:France; D006801:Humans; D007273:Injections, Intramuscular; D007391:International Cooperation; D016778:Malaria, Falciparum / Q000188:drug therapy; D012042:Registries; D012717:Sesquiterpenes / Q000627:therapeutic use*; D014944:World Health Organization
D000962:Antimalarials; D037621:Artemisinins; D018954:Drugs, Essential; D012717:Sesquiterpenes; D000077549:Artemether