read registration update
read DNDi/sanofi-aventis position paper on Financial Times article

registration status and how to get access at a ‘no profit-no loss price’

21 October 2008

A lot has happened since we last updated you on the status of ASAQ, the artesunate-amodiaquine fixed-dose combination (Coarscucam™/ Artesunate Amodiaquine Winthrop®) developed together by DNDi and sanofi-aventis; and we want to make sure that you are aware of the most recent news!

What is status of ASAQ?
This month, ASAQ has been granted 'prequalified' status by the WHO Prequalification Program.

• ASAQ is the first fixed-dose combination (FDC) of the antimalarials, artesunate and amodiaquine, to be granted "prequalified" status by the WHO
• ASAQ is the first antimalarial FDC with a soluble formulation specifically designed for young children, to be granted "prequalified" status This status makes
• ASAQ eligible for procurement of medicines by a larger number of countries and international agencies
• ASAQ joins Coartem as the only two FDC antimalarials on the "prequalified list"
• View the list on the WHO Prequalification website: http://healthtech.who.int/pq

Packaging for ASAQ has been improved for field use Earlier this year, and based on discussions with NGOs and the public sector, the blister packaging has been improved for ease of use by healthcare personnel and patients.

	Previous Blister Packaging	New Blister Packaging
Infants
Young children
Children
Adolescents/Adults

What is the profile of ASAQ?
a very simple, age-based dosing regimen

• 1 tablet per day for 3 days for infants, children, and adolescents
• 2 tablets once a day for 3 days for adults
• Optimised dose ratio to avoid over- and –under-dosage

soluble tablets specifically designed for young children
a commitment to make it available to all patients, right from the start

<US$1 for adults and <US$0.50 for children in public markets

Not patented

1st concrete result of an innovative partnership between a product development partnership (PDP) and a pharmaceutical firm

highest standards of quality enforced throughout the entire manufacturing process

Where is ASAQ?
The artesunate-amodiaquine fixed-dose combination has now been approved in 21 African countries.

Over 3 million treatments of ‘no-profit, no-loss’ ASAQ have been distributed into the field.

In 2008, ASAQ is reaching more and more patients, including at this MSF treatment programme in Guinea (pictured to the right).




Is there any recent clinical evidence on ASAQ?
Additional clinical data supporting the use of ASAQ has been presented at recent scientific meetings, including the XVIIth International Congress on Tropical Medicine and Malaria at Jeju, Korea, earlier this month:
In a multi-center, non-inferiority trial comparing ASAQ with Coartem® (fixed-dose artemether-lumefantrine) in Cameroon, Madagascar, Mali, and Senegal, ASAQ was shown to be as efficacious and well-tolerated as Coartem® (primary objective: 28-Day PCR-corrected parasitological and clinical cure rates was ≥95% in all arms) in a total of 941 patients including in 112 paediatric patients less than 5 years old.1
The Phase III study carried out in Burkina Faso, comparing the fixed-dose ASAQ combination with the non-fixed AS+AQ association in 750 children less than 5 years old, with uncomplicated P. falciparum malaria, 28-Day PCR-corrected parasitological and clinical cure rate was ≥95% in both arms.1
A clinical trial studying the drug’s tolerability and effectiveness in real-life conditions for its eventual registration in India has recently been concluded. The promising study results are consistent with previous studies with ASAQ in Africa, and support the consideration of ASAQ as first-line therapy in India where appropriate.2

What are the plans for further study of ASAQ’s appropriate use?
DNDi, sanofi-aventis and additional partners are in the process of developing a comprehensive “ASAQ Deployment Monitoring Plan” that aims at collecting good quality data on ASAQ effectiveness and safety profile in “the field”. This program will be presented at the upcoming American Society of Tropical Medicine and Hygiene 57th Annual Meeting in New Orleans (December 7 – 11, 2008).