The Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Materiel Development Activity (USAMMDA) initiated a new partnership with Sigma-Tau Pharmaceuticals to help finalize the R&D of a treatment for severe malaria.
The collaborative R&D agreement between WRAIR, USAMMDA, and Sigma-Tau is focused on IV Artesunate. The company plans to submit an application for FDA review in 2008. It will be responsible for the commercial development and manufacturing of IV Artesunate should the FDA approve it.
WRAIR and USAMMDA initially developed IV Artesunate in response to concerns over the risks of malaria exposure to deployed forces. Additionally, IV Quinidine, the current standard therapy for severe malaria in the U.S., has potentially harmful side effects, according to the collaborating companies.
IV Artesunate is a semisynthetic derivative of the natural product, Artemisinin, from qing hao, the sweet wormwood plant. It was developed with the goals of rapid parasite reduction, prevention of death, and reduction of mortality. In March 2006, an Orphan Drug designation was granted for IV Artesunate for the immediate treatment of malaria.