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The collaboration between
sanofi-aventis and DNDi |
Combination therapy in global strategy for treatment of malaria |
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DNDi and sanofi-aventis are collaborating closely on industrial, preclinical and clinical product development to optimise the quality of the drug and to expedite its availability.
Product development by sanofi-aventis
Following the signing of the agreement, sanofi-aventis and DNDi exchanged product data in their possession. Sanofi-aventis will carry out the agreed development programme, which takes into account available findings and comprises ongoing work as well as new studies. The formulation chosen is that developed by DNDi.
In the months to come, DNDi will pursue the pharmaceutical and clinical investigations and sanofi-aventis will carry out the preclinical, clinical and industrial studies.
Drug registration
The development studies will be used to compile the marketing authorisation application. Sanofi-aventis will be responsible for applying for WHO prequalification and registering the drug with the regulatory authorities of the countries concerned. The aim is to submit the first marketing authorisation applications by late 2005/early 2006.
Sanofi-aventis will make the drug available at cost price in the public sector
Sanofi-aventis has agreed to make the product available at cost price to the national health services of the countries concerned, NGOs, and international organisations.
This new co-formulation will be less expensive than existing combinations containing artemisinin derivatives since it combines two well-known active ingredients that are already widely used in monotherapy and in two-tablet blister packs.
A target price of less than one dollar for adults and 50 cents for children is envisaged on the basis of WHO market projections and within the framework of the cost price strategy1 of sanofi-aventis. This goal will only be achieved if international organisations provide financial aid to the countries concerned to enable them to implement the changes required for malaria treatment, thereby stabilising the raw materials market. This price will therefore greatly reduce the budgetary impact of malaria treatment worldwide.
DNDi commits to a reduced cost price in the public sector
Sanofi-aventis will fix the price of the new drug in the private sector. As stipulated in the contract, and in return for the use of information and findings provided, sanofi-aventis has agreed to pay DNDi 3% of the net private sector turnover over a period of seven years.
DNDi's Board of Directors has decided to use this payment to lower the drug's public sector sale price.
Non-exclusivity of the product
As there is no patent covering this artesunate + amodiaquine combination, a reference marketing authorisation will enable third parties to submit a simplified application for a generic version of this product.
1 * The cost price must enable sanofi-aventis to cover all production and direct distribution costs. It does not cover any research and development costs or commercial expenses other than direct distribution costs, with no profit margin.
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