For DNDi, the transfer of technology consists of transferring the industrial development know-how to partners in disease endemic regions to ensure a wide-spread distribution of treatments. It involves providing the required regulatory files and information needed to maintain competitive prices and reinforce the technological and scientific capacities of disease-endemic countries.
Technology Transfer for ASAQ Malaria
ASAQ, the artesunate-amodiaquine fixed-dose combination, was the first treatment developed by DNDi in partnership with Sanofi, and is produced in Morocco. Developed as a non-patented product, the technology transfer for ASAQ to a second partner in Africa is a vital part of DNDi’s strategy to increase patient access to this treatment, according to the market demand forecast of 100 million treatments.
In 2010, DNDi, with support from a group of experts, assessed various potential partners in Africa in order to ensure that all criteria for a successful technology transfer were met. In 2011, an agreement was signed with a partner in Tanzania – Zenufa.
In 2016, technology transfer to the Tanzanian company Zenufa as a second source of production for the antimalarial ASAQ was finalized. This is in addition to the one produced by Sanofi. Zenufa’s production site in Tanzania is now ‘Good Manufacturing Practice’ certified by the Tanzanian authorities and its prequalification dossier is being finalized for submission to the WHO.
South-South Technology Transfer for ASMQ Malaria
Successful transfer of technology necessitates true partnership, as it is more than just a question of offering acquired information. The Farmanguinhos- Cipla technology transfer required the alignment of procedures to Good Manufacturing Practices (GMP) to achieve similar and comparable products that meet international requirements in order to benefit patients in all endemic countries.In order to facilitate access of ASMQ in Southeast Asia, a South-South technology transfer between Farmanginhos/Fiocruz in Brazil and Cipla Ltd in India, the agreement for which was signed in 2008, came to completion in 2010 with support and facilitation by DNDi.
This technology transfer for the artesunate-mefloquine fixed-dose combination was the first of its kind between a company in Brazil and one in India, and was even more unique in that it involved a transfer from a public entity, Farmanguinhos, to a private company, Cipla Ltd.
Thanks to this transfer, ASMQ was registered in India in 2011 and in Malaysia in 2012.