Launch of the new antimalarial therapy ASAQ by DNDi and sanofi-aventis

Cardinal Systems is proud to have participated in the development and launch of the new antimalarial therapy ASAQ

In 2005, DNDi entrusted Cardinal Systems with the methodology and analysis review, clinical data management, statistics and ICH E3 report production for the Field-based Phase III Clinical Trial to examine efficacy and tolerability of ASAQ vs non-fixed AS+AQ in children < 5 years of age.

The contribution of DNDi and the FACT Partners table is given below with more information at actwithasaq.

ASAQ: Contribution of DNDi and FACT Partners

Rationale for AS+AQ in Africa
In 1998, the UNICEF-UNDP-World Bank-WHO’s Special Programme for Research and Training in Tropical Diseases (TDR) was charged by the US Agency for International Development and the Wellcome Trust with the task of identifying suitable combinations of existing antimalarial drugs to control malaria resistance. From their data analyses, it emerged that AS+AQ could be a good clinical option in many parts of Africa.

In 2001 the World Health Organization recommended, in particular, the use of four artemisinin-based combination therapies (ACTs), including the combination of AS+AQ. However, in the case of AS+AQ, there was neither a co-formulation nor any development partners.

FACT Project: ASAQ, 2002-2009
FACT 2002-2006 : ASAQ Development through Registration
The FACT (Fixed-Dose Artesunate Combination Therapy) project began in 2002, under the umbrella of MSF (and then DNDi) in coordination with TDR.
- Objective: to develop a fixed-dose combination of AS+AQ for international registration that would improve compliance and would be available to all countries where resistance to amodiaquine was low (mainly African countries, but also some Asian countries like India and Indonesia)
- Key partners (who signed onto the original EU INCO-DEV grant): Instituto de Tecnologia em Farmacos of Farmanguinhos, Mahidol University, Université Victor Segalen Bordeaux 2 (TROPIVAL), University of Oxford, University Sains Malaysia, Centre National de Recherche et de Formation sur le Paludisme (CNRFP).

Development Step		Institutions Involved
Pharmaceutical and Preclinical Development
Vital to the efforts of the FACT Project throughout the entire period of development has been the contribution and expert advice of academics		University of Oxford (UK) Mahidol University (Thailand)
Preformulation, coordination and local support with partners in Bordeaux region		Tropival of Univ Bordeaux II (France)
Formulation of combination product adapted with appropriate stability and biopharmaceutical characteristics and with a viable manufacturing process Development and validation of analytical methods First scale up coordinated with Rottendorf Pharma		Ellipse Pharma (France)
Set of GLP toxicology studies on single drugs and combinations		Unitox and Genotox (Brazil)
Development and utilization of toxico-kinetic protocols, bioanalytical methods		University Sains Malaysia (USM) (Malaysia)
First industrial scale up and GMP production of the FDC for clinical and stability studies		Rottendorf Pharma (Germany) Creapharm (France)
Innovative partnership signed with industrial partner		sanofi-aventis: Contract signed, Dec 2004
Clinical Development
Phase I for PK data, biopharmaceutical quality, and bioavailability		University Sains Malaysia (Malaysia)
Field-based Phase III to examine efficacy and tolerability of ASAQ vs non-fixed AS+AQ in children <5 years of age		Cardinal Systems (France) CNRFP (Burkina Faso)
Support of 10-year survey of efficacy, tolerability, and pharmacovigilance in Senegal		Institut de Recherche pour le Développement (IRD) (Senegal) Ministère français des Affaires Etrangères (FAC 2000 programme) Ministère français de la Recherche (PAL+), TDR. As of 2007: Ongoing in year 7
Support of meta-analysis of 31 clinical studies examining AS+AQ vs other antimalarials		TDR with FACT partners, MSF/Epicentre
FACT 2007-2009: Post-Registration Activities Through 2009, DNDi intends to play an active role in facilitating FACT implementation by engaging partners that include pharmaceutical companies, national malaria programs, research institutes, contract research organisations, WHO, TDR, and NGOs. DNDi has convened an independent panel of experts, the FACT Implementation Advisory Group, to provide independent advice and critical guidance about issues related to AS/AQ implementation and to advise on issues related to the rational use and towards ensuring equitable access.
Illustrations of the Next Steps	Institutions Involved
Clinical study that will serve to facilitate the adoption of a new antimalarial policy	ICMR (India); sanofi-aventis (drug supply)
Workshop meeting to engage national malaria control program managers and international & regional organizations	KEMRI (Kenya) 30 (including NMCPMs, WHO, MMV, etc) attended meeting in Nairobi, Sept 2006.
Tolerability study	Epicentre / MSF, sanofi-aventis

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Launch of the new antimalarial therapy ASAQ by DNDi and sanofi-aventis

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