This case study describes how a public-private partnership initiated to
develop a new anti-malarial combination, ASAQ Winthrop, has evolved over
time to address issues posed by its effective deployment in the field.
In 2002, DNDi created the FACT project to develop two fixed-dose
combinations, artesunate-amodiaquine and artesunate-mefloquine, to meet
the WHO anti-malarial treatment recommendations and international
regulatory agencies approval standards. In 2002, Sanofi-aventis had
started a development programme for a fixed-dose combination of
artesunate and amodiaquine, to replace its co-blister combination. DNDi
and sanofi-aventis joined forces in 2004, with the objective of
developing within the shortest possible time frame a non-patented,
affordable and easy to use fixed-dose combination of artesunate and
amodiaquine adapted to the needs of patients, in particular, those of
children. The partners developed Coarsucam®/Artesunate Amodiaquine
Winthrop® (\"ASAQ Winthrop\") which was prequalified by the WHO in 2008.
Additional partnerships have since been established by DNDi and
sanofi-aventis to ensure: 1- the adoption of this new medicine by
malaria-endemic countries, 2- its appropriate usage through a broad
range of information tools, and 3- the monitoring of its safety and
efficacy in the field through an innovative Risk Management Plan.
The partnership between DNDi and sanofi-aventis has enabled the
development and pre-qualification of ASAQ Winthrop in a short time
frame. As a result of the multiple collaborations established by the two
partners, as of late 2010, ASAQ Winthrop was registered in 30
sub-Saharan African countries and in India, with over 80 million
treatments distributed in 21 countries. To date, 10 clinical studies,
involving 3432 patients with ASAQ Winthrop were completed to document
efficacy and safety issues identified in the Risk Management Plan.
The speed at which ASAQ Winthrop was adopted in the field shows that
this drug fits the needs of patients and health authorities. It also
demonstrates the power of partnerships that combine different sets of
strengths and skills, and that evolve to include additional actors to
meet new global health challenges for poverty-related diseases.
Bompart, F.; Kiechel, J.-R.; Sebbag, R.; Pecoul, B. Innovative public-private partnerships to maximize the delivery of anti-malarial medicines: lessons learned from the ASAQ Winthrop experience. Malaria Journal (2011) 10 (1) 143. [DOI: 10.1186/1475-2875-10-143]
Innovative public-private partnerships to maximize the delivery of anti-malarial medicines: lessons learned from the ASAQ Winthrop experience