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DNDi and sanofi-aventis: an innovative partnership
Since December 2004, DNDi and sanofi-aventis have been collaborating closely on industrial, preclinical and clinical product development to optimise the quality of the drug and to expedite its availability.
Product development
Following the agreement signed in 2004, DNDi exchanged product data with sanofi-aventis who in turn shared their development programme. From the formulation developed by DNDi, sanofi-aventis carried out the industrial development programme, which takes into account available findings and comprises ongoing work as well as new studies.
DNDi has pursued the pharmaceutical and clinical investigations of the FACT programme, and sanofi-aventis has carried out numerous studies as well as the industrial scale-up and development (for further information, please see the individual ASAQ contributions of each partner).
Drug registration
The development studies have been used to compile the marketing authorisation application. Sanofi-aventis has registered the drug with the regulatory authorities in Morocco where the product is manufactured and then in the other countries concerned. Sanofi-aventis submitted a full dossier for WHO prequalification in February 2007.
Price
The drug will be available at cost in the public sector, i.e. national health services of the countries concerned, NGOs, and international organisations.
DNDi and sanofi-aventis commit to a reduced cost price in the public sector. In return for the use of information and findings provided by DNDi, sanofi-aventis agreed to pay DNDi 3% of the net private sector turnover over a period of seven years. DNDi has decided to use this payment to lower the drug’s public sector sale price.
Non-exclusivity of the product
DNDi and sanofi-aventis have agreed not to take any patent covering this artesunate + amodiaquine fixed-dose combination.
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