New, Once-a-Day Fixed-Dose Combination Against Malaria Now Available

01 Mar 2024
Paris, March 1, 2024 - Sanofi-aventis and the non-profit Drugs for Neglected Diseases initiative (DNDi) announced today that ASAQ, the new fixed-dose combination of artesunate (AS) and amodiaquine (AQ), will soon be available throughout sub-Saharan Africa. ASAQ is the first drug developed by the FACT (Fixed-dose, Artemisinin-based Combination Therapy) partners, managed by DNDi in partnership with sanofi-aventis.

One of 4 artemisinin-based combination therapies (ACTs) that have been recommended by WHO since 2001 to thwart the emergence of resistances, the association of AS and AQ is now available in an innovative ASAQ fixed-dose formulation. It will be available in all markets, including public ones at a preferential price. To date, of the 41 sub-Saharan countries that have adopted ACTs in their malaria treatment protocols, 20 have chosen the combination of artesunate and amodiaquine.

ASAQ is an innovative product to treat malaria that is:
- Adapted to patient needs of all ages, a fixed combination of two well-known drugs, and following WHO recommendations,
- Simple as a once-a-day regimen easy to manage for the prescriber and the patient,
- Accessible as a non-patented drug, at an affordable price,
- Quality in terms of galenical development, manufacturing and storage.

"Sanofi-aventis is very proud to be involved in this innovative partnership" said Jean-François Dehecq, Chairman of sanofi-aventis. "In manufacturing the drug in Morocco for use in sub-Saharan Africa and in applying for WHO prequalification we aim to ensure that ASAQ is made available to patients as soon as possible, while, at the same time, demonstrating adherence to international quality standards."

For a full treatment cost of less than US $ 0.50 for children less than 5 years old, and a cost of less than US $ 1 for older children and adults, ASAQ will be available at a "no profit-no loss" price to public organizations of endemic countries, international institutions, NGOs, and programs promoting access to drugs in pharmacies.

"This new fixed-dose combination has been adapted to patients' needs by being simple to use, more affordable and a quality product," said Dr. Bernard Pecoul, Executive Director of DNDi. "The fact that ASAQ is made so affordable right from the start and is not under patent removes a significant barrier to its availability and should serve as a model for future drug development for neglected diseases."

In Africa, where malaria consumes 25% of household incomes and kills approximately 3,000 children every day, ASAQ offers a state-of-the-art galenical formulation with 4 presentations, 3 for children and one for adults. Patients with uncomplicated P. falciparum malaria are treated in a simple, once-a-day dosing regimen over the course of three days.

"The world urgently needs more, affordable and easy-to-use fixed-dose treatment for malaria, especially for children," remarked Dr Awa Marie Coll-Seck, Executive Director - Roll Back Malaria Partnership. "We welcome this new product developed in a public-private partnership."

ASAQ is available under the name Artesunate-Amodiaquine Winthrop® (ASAQ) for public markets, and under the brand name Coarsucam® in private markets.

Background information on the drug
ASAQ is one of two fixed-dose ACTs developed through the innovative FACT Project (Fixed-dose, Artemisininbased Combination Therapy) managed by the non-profit product development organization, Drugs for Neglected Diseases initiative (DNDi). Since 2004, sanofi-aventis has been responsible for co-development, industrial production, registration and worldwide implementation of the product.

- Easier to use
To improve patient compliance and to reduce the risks of resistance, the use of antimalarial drugs should be as simple as possible. The fixed-dose combination avoids the risk for patients to take one active ingredient only. The new formulation is so designed that adult treatment is limited to 2 tablets per day for three days, instead of 8 tablets per day. The paediatric dosing for infants and children is also simplified: one tablet a day for three days.
The paediatric formulations can be easily crushed and mixed with liquids or semi-liquid food, which considerably facilitates drug administration. Compared with the presently available co-blisters or loose combinations the fixed-dose combination is a real step forward.

- More affordable
This new drug is less expensive than all other fixed-dose combinations containing artemisinin derivatives. Sanofiaventis and DNDi made a commitment to provide it at a "no profit-no loss" price to the poorest patients. This price level will apply, right from the start, to public markets. Furthermore, this new formulation is not covered by any patent.
Malaria in Figures
- Malaria, is, with HIV/AIDS and tuberculosis, one of the three most important diseases in Africa according to WHO. It is a major cause of morbidity and mortality worldwide, and consumes 25% of household incomes in Africa.
- The disease is present in over 100 countries and threatens half of the world's population.
- Every year, 350 to 500 million cases of malaria occur worldwide, with over 1 million deaths, affecting mostly children in sub-Saharan Africa.
- Malaria remains the single largest cause of death for children under five in Africa, where it kills one child every 30 seconds - this translates to the deaths of approximately 3,000 children every day.
- To date, twenty national protocols in Africa as well as in Indonesia have recommended combining artesunate and amodiaquine in a first-line treatment.
• It is estimated that tens of millions of people could benefit from this treatment each year.

About DNDi
The Drugs for Neglected Diseases Initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 by five public-sector research organisations - Oswaldo Cruz Foundation Brazil, IMCR (Indian Council of Medical Research), KEMRI (Kenya Medical Research Institute), Malaysian Ministry of Health, and France's Institut Pasteur and Médecins Sans Frontières. The UNICEF/UNDP/World Bank/WHO's Special Programme for Research and Training in Tropical Diseases (TDR) is a permanent observer to the initiative.

ASAQ is the first drug developed by DNDi. With a current portfolio of 22 projects, DNDi aims to develop new, improved, and field-relevant drugs for neglected diseases, such as malaria, leishmaniasis, human African trypanosomiasis, and Chagas disease. DNDi also raises awareness about the need for greater R&D; for neglected diseases and strengthens existing research capacity in disease-endemic countries.

The Fixed-dose Artesunate-based Combination Therapies (FACT) project, initiated in 2002, demonstrates the efficacy of partnerships in the field of drug R&D; for neglected diseases. Fast-track development, testing, and registration of the two FDCs, artesunate-amodiaquine (AS/AQ) and artesunate-mefloquine (AS/MQ), were the primary objectives of the project and are being achieved by the multi-partner FACT Project Consortium: DNDi; Tropival of the Bordeaux II University, France; Oxford University, UK; Universiti Sains Malaysia; Mahidol University, Thailand; Farmanguinhos, Brazil; TDR in Switzerland; and the Centre National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso. Consistent with DNDi's mission of collaboration based on relative strengths, the FACT project capitalizes on the skills and know-how of a broad range of partners in both developing and developed countries. Thus far, the FACT project has received financial support from the European Union, Agence Française de Développement (AFD), the Swiss Development Cooperation, the Dutch and the UK governments, and MSF.

About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical industry, ranking number one in Europe. Backed by a world-class R&D; organisation, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

"Sanofi-aventis Impact Malaria Programme"
Sanofi-aventis reiterates its historic involvement in the fight against malaria, through its Impact Malaria programme and its medicines. Initially, with the derivatives of quinine and chloroquine, then with the first derivative of artemisinin, Arsumax, made available in Africa in 1996, and more recently with Arsucam, co-blister of artesunate and amodiaquine (separate tablets put together in the same package).
The Impact Malaria programme was created in 2001 and is sanofi-aventis contribution to the fight against malaria. Its four major axes are:
1. to discover new antimalarial drugs,
2. to develop new combinations or formulations from existing drugs, particularly ACTs,
3. to inform, educate and communicate about malaria, especially remote healthcare facilities, communities and families,
4. to distribute antimalarial drugs which are vital to the poorest populations, with a differential pricing approach, including a "no profit-no loss" policy.
These actions are carried out with public and private healthcare organisations and the health authorities in the countries concerned, notably through national malaria control programmes in liaison with the WHO, Roll Back Malaria Partnership and leading international institutions.

Forward Looking Statements
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