The results presented in New Orleans come from a development program for worldwide drug approval. The most important trials in the program were two large phase III comparative clinical trials conducted in Africa (Burkina Faso, Zambia, Kenya, Mozambique and Uganda) and Asia (Thailand, India and Laos) respectively, which involved a total of about 2,700 patients, of whom 1,600 children under 5, all with uncomplicated malaria caused by Plasmodium falciparum, the most widespread and dangerous parasite and the cause of the highest mortality in infected individuals.
"The new data," said Claudio Cavazza, sigma-tau Chairman. "Confirm the huge potential of this new combination which may become the gold standard in malaria treatment in all those countries where fatal drug-resistance has been observed with conventional antimalarials. Our hope is that the joint efforts made to develop this new drug and make it available to the greatest possible number of patients will substantially contribute to the achievement of the ambitious goal of the Gates Foundation to eliminate and ultimately fully eradicate malaria. The extremely positive results of the clinical trials make us hope the drug will rapidly receive marketing approval. The NDA is expected to be filed with the EMEA and the FDA around mid-2009, so that the drug can be made available as soon as possible not only in Europe and the United States, but also in all those countries where malaria is endemic."
sigma-tau's commitment began to become tangible in 2004 when the company
entered into a partnership with Medicines for Malaria Venture, the
Geneva-based non-profit organization created to discover, develop and deliver
effective and affordable antimalarial drugs through public-private
partnerships, supported primarily by the Bill & Melinda Gates Foundation and
sigma-tau is a leading
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