DNDi-Sanofi Aventis sign agreement on AS/AQ

DNDi has developed a fixed-dose formulation of artesunate amodiaquine (AS/AQ) for the treatment of malaria. This combination has the two drugs, artesunate and amodiaquine, in one tablet. The adult dosage has been simplified to 2 tablets once a day for 3 days (6 tablets in all) which compares favourably with the current regimen of 4 tablets twice a day for 3 days (24 tablets in total) of co-blister artesunate amodiaquine. DNDi has also developed a paediatric AS/AQ co-formulation – small, easy to swallow, water-soluble tablets for children.

DNDi has recently signed an agreement with Sanofi-Aventis to complete the development of the AS/AQ fixed-dose formulation and prepare the dossier mandatory for registration as well as for WHO pre-qualification.

The price1 targeted is less than one US dollar per adult treatment.

Sanofi-Aventis will be in charge of the first registration, production and distribution of AS/AQ and has agreed to do this at cost for the public sector, international organisations, and NGOs. The new drug should be available in mid 2006.

• DNDi’s agreement with Sanofi-Aventis is non-exclusive. However, DNDi has guaranteed exclusivity to Sanofi Aventis for the duration of the product development programme and until the first registration is obtained.
• It will be available at a target price of less than $1 for an adult treatment and for $0.5 for children to the public sector, international organisations, and NGOs
• Sanofi Aventis has agreed to give 3% of private sector sales revenue to DNDi which DNDi will use to reduce the price of treatment to the public sector.

1. Due to the production shortage of artemisinin plants the price is high today but, with an increase in plant production, we are expecting the price to stabilise to the previous level of $500 per kilo in 2006 enabling a target price of around one dollar.