An agreement between sanofi-aventis and the Medicines for Malaria Venture (MMV) has lead to the initiation of the largest safety and efficacy study of an antimalarial drug. In a sanofi-aventis press statement, the company explained that drug development studies, which are conducted under very controlled conditions, can differ enormously from the real-life situation.

"Data collected in clinical trials do not always provide the full picture of a new drug's efficacy and safety," Chris Hentschel, President and CEO of the MMV, said in the press statement.

The study, which has already begun in Cote D'Ivoire (Africa), will assess the safety and efficacy of ASAQ, which was developed as the result of a partnership between sanofi-aventis and the Drugs for Neglected Diseases initiative and launched in 2007. The field monitoring programme involves several studies throughout Africa and will involve the treatment of more than 20000 malaria episodes. All of the collected data will be merged into a single database for detailed analyses.

Under the terms of the agreement, the MMV will provide $1.5 million towards the implementation of the study. Hentschel said: "This large Cote d'Ivoire study will use innovative methods to monitor antimalarial drugs' efficacy and safety, and generate critical data. The experience gained with ASAQ in the field will help us design pharmacovigilance programmes for new antimalarials in our own pipeline."

www.sanofi-aventis.com