Sanofi-aventis and Medicines for Malaria Venture (MMV) announced that they have entered an agreement to launch the largest safety and efficacy study of an antimalarial drug. This field-monitoring programme on ASAQ, a fixed-dose combination of artesunate and amodiaquine, started in Côte d’Ivoire in October 2009. MMV is a not-for-profit drug research and development organization dedicated to reducing the burden of malaria.
ASAQ is the only fixed-dose combination of artesunate and amodiaquine prequalified by WHO in the treatment of Plasmodium falciparum uncomplicated malaria. ASAQ is the result of a partnership between sanofi-aventis and Drugs for Neglected Diseases initiative (DNDi) and was launched in 2007.
“We have designed an innovative field-monitoring programme to assess the effectiveness and safety of ASAQ in real life conditions”, said Robert Sebbag, vice president, Access to Medicines at sanofi-aventis. “Thanks to MMV’s support, we are now able to launch in Côte d’Ivoire this large study that completes the most ambitious drug monitoring programme ever launched in Africa”, he added.
Under the terms of the agreement, MMV will provide $1.5 million towards the implementation of this large field-monitoring study developed by sanofi-aventis and the National Malaria Control Program of Côte d’Ivoire. Over a two-year period, approximately 15,000 patients afflicted by malaria are expected to be enrolled. All patients diagnosed with uncomplicated malaria at public health clinics in selected parts of the Agboville district (approximately 100km north of Abidjan) will receive a prescription of ASAQ. Within a week, patients will be visited at home by specially trained community health workers to assess treatment tolerability and compliance.
“Data collected in clinical trials do not always provide the full picture of a new drug’s efficacy and safety. This large Côte d’Ivoire study will use innovative methods to monitor antimalarial drugs’ efficacy and safety and generate critical data,” said Dr. Chris Hentschel, president and CEO of MMV. “MMV is pleased to support this important study. The experience gained with ASAQ in the field will help us design pharmacovigilance programmes for the new antimalarials in our own pipeline.”
Malaria is a fatal infectious disease that causes almost a million deaths a year of which over 90% are in Africa and 85% are children under the age of five. Most of these deaths are due to lack of access to effective antimalarials and erratic patient compliance.
ASAQ, the first fixed-dose combination of artesunate (AS) and amodiaquine (AQ) was developed by sanofi-aventis and the FACT (Fixed-dose, Artemisinin-based Combination Therapy) partners, managed by DNDi. First registered in Morocco, where it is manufactured, in 2007, it was pre-qualified by the WHO in 2008. ASAQ is available under the name Artesunate-Amodiaquine Winthrop (ASAQ) for public markets, and under the brand name Coarsucam in private markets.
Drug development studies are conducted under very controlled circumstances that differ enormously from the situation on the ground. Once a new drug is widely distributed, it is important to monitor its rational use. Due to the wide distribution of antimalarials and the shortcomings of pharmacovigilance systems in many endemic countries, post registration studies to assess the safety and efficacy of the product are necessary. Following the launch of ASAQ in 2007, sanofi-aventis and DNDi decided to set-up a proactive monitoring plan of the drug’s efficacy and safety in real life conditions: the “ASAQ field-monitoring programme”. The Côte d’Ivoire study is a key component, and the largest study, of this programme.
The ASAQ field-monitoring programme includes several studies throughout Africa. Each will provide specific sets of data on ASAQ safety and efficacy using a variety of study designs. These studies have been set up by sanofi-aventis, by DNDi, or by academic or government institutions, in close collaboration with each country’s National Malaria Control Program. All the data collected will be aggregated into a single data base to enable detailed analyses. With over 20,000 malaria episodes to be treated with ASAQ, this is the most ambitious proactive drug monitoring programme ever launched in Africa, for any drug. The WHO Department of Medicines Policy and Standards has expressed interest in seeing this programme formalized as a Risk Management Plan (RMP) for ASAQ, the first programme of this kind to be submitted to the WHO. The experience gained through this RMP will be useful for future antimalarials that will be launched in developing countries with relatively limited sets of safety and efficacy data.
Medicines for Malaria Venture (MMV) was established in 1999 as a not-for-profit organization created to discover, develop and deliver safe, effective and affordable antimalarial drugs through effective public-private partnerships. MMV’s vision is a world in which affordable and effective medicines will cure and protect the millions at risk of malaria and help to ultimately eradicate this terrible disease.
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