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Innovative public-private partnerships to maximize the delivery of anti-malarial medicines: lessons learned from the ASAQ Winthrop experience.

Bompart F, Kiechel JR, Sebbag R, Pecoul B - Malar. J. (2011)

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Sanofi-Aventis, Access to Medicines Department, 74- 82 Avenue Raspail 94255 Gentilly Cedex, France. francois.bompart@sanofi-aventis.com

ABSTRACT

Background: 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.

Case description: 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.

Discussion and evaluation: The partnership between DNDi and Sanofi-Aventis has enabled the development and pre-qualification of ASAQ Winthrop in a short timeframe. 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.

Conclusions: 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.

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Related in: MedlinePlus

ASAQ Winthrop and non-fixed combination dosing regimens. Simplified dosing regimen with fixed-dose ASAQ. The bi-layer formulation allows for AS and AQ to be taken together, in correct proportions, with fewer tablets as compared with the co-blistered non-fixed dose options.
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Figure 1: ASAQ Winthrop and non-fixed combination dosing regimens. Simplified dosing regimen with fixed-dose ASAQ. The bi-layer formulation allows for AS and AQ to be taken together, in correct proportions, with fewer tablets as compared with the co-blistered non-fixed dose options.

Mentions: These conventions led to selecting 4 dosage forms based on age and weight ranges, for infants (4.5 to 8 kg, 2 to 11 months), toddlers (9-17 kg, 1 to 5 years), children (18-35 kg, 6 to 13 years) and adults (> 36 kg, 14 years and above). Figure 1 shows the dosing regimen of ASAQ Winthrop, compared with that of the non-fixed combination.


Innovative public-private partnerships to maximize the delivery of anti-malarial medicines: lessons learned from the ASAQ Winthrop experience.

Bompart F, Kiechel JR, Sebbag R, Pecoul B - Malar. J. (2011)

ASAQ Winthrop and non-fixed combination dosing regimens. Simplified dosing regimen with fixed-dose ASAQ. The bi-layer formulation allows for AS and AQ to be taken together, in correct proportions, with fewer tablets as compared with the co-blistered non-fixed dose options.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3117751&req=5

Figure 1: ASAQ Winthrop and non-fixed combination dosing regimens. Simplified dosing regimen with fixed-dose ASAQ. The bi-layer formulation allows for AS and AQ to be taken together, in correct proportions, with fewer tablets as compared with the co-blistered non-fixed dose options.
Mentions: These conventions led to selecting 4 dosage forms based on age and weight ranges, for infants (4.5 to 8 kg, 2 to 11 months), toddlers (9-17 kg, 1 to 5 years), children (18-35 kg, 6 to 13 years) and adults (> 36 kg, 14 years and above). Figure 1 shows the dosing regimen of ASAQ Winthrop, compared with that of the non-fixed combination.

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: Sanofi-Aventis, Access to Medicines Department, 74- 82 Avenue Raspail 94255 Gentilly Cedex, France. francois.bompart@sanofi-aventis.com

ABSTRACT

Background: 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.

Case description: 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.

Discussion and evaluation: The partnership between DNDi and Sanofi-Aventis has enabled the development and pre-qualification of ASAQ Winthrop in a short timeframe. 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.

Conclusions: 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.

Show MeSH
Related in: MedlinePlus