Sanofi-aventis press release
Philadelphia, November 7, 2007
CoarsucamTM/”ASAQ” is as Effective
as Coartem® in Treating Uncomplicated Malaria
The findings of a non-inferiority, multicentric, blinded, comparative study called ATAQ EASY (ArTesunate
AmodiaQuine EfficAcy and SafetY) that enrolled 941 patients divided up into three treatment groups, including
433 children aged less than 5 years, are being presented today at the ASTMH Congress in Philadelphia. They
confirm that Coarsucam™ / « ASAQ » is as effective as Coartem ® in the African countries where the 2
combinations are recommended by the WHO. Tolerance proved satisfactory in all three treatment groups.
This study compared the new fixed-dose combination of artesunate + amodiaquine jointly developed by sanofiaventis and DNDi (Coarsucam™/ « ASAQ ») with the fixed-dose combination of artemether + lumefantrine
(Coartem®). It was conducted in 5 centres in Africa, two of which are in Senegal, 1 in Mali, 1 in Cameroon and
1 in Madagascar, from March 2006 to January 2007. 3 groups of patients were enrolled – two of these groups
were treated using artesunate + amodiaquine taken once or twice a day and one was treated with artemether +
lumefantrine administered twice daily in accordance with recommended dosage.
The primary objective was to demonstrate, 28 days after treatment initiation (D28), the non-inferiority of
artesunate + amodiaquine in terms of clinical and parasitological efficacy compared with artemether +
lumefantrine.
The two secondary objectives were to compare the clinical and parasitological efficacy of the two treatments on
D28 in the sub-group made up of the children aged less than 5 years, which is the WHO’s main target
population, as well as to evaluate the treatment regimens of artesunate + amodiaquine administered once or
twice daily. Clinical and biological tolerability was also evaluated for all 3 groups.
Overall, 941 patients were included in the study, with the following results:
• On D28, clinical and parasitological cure was achieved in 95.2% of the patients treated with artesunate +
amodiaquine once daily, and in 95.5% of the patients in the artemether + lumefantrine group.
• Non-inferiority was established for all treatment groups, including children aged less than 5 years.
• Clinical and biological tolerability was good with a comparable profile between the treatment groups; no
unexpected side effects were observed.
This new study confirms the value of treating patients suffering from uncomplicated P. falciparum malaria with
Coarsucam™ / « ASAQ » whose once-a-day for three days dosing regimen promotes treatment compliance by
patients, a crucial element in ensuring the long-term efficacy of antimalarial treatments.
This new fixed dose combination drug is available in pharmacies under the trade name Coarsucam™ and is
offered in adjudication procedures under the name Artesunate Amodiaquine Winthrop ® (« ASAQ »). The
business model that makes the same drug available to the private market (Coarsucam™) and to the public
procurement market (« ASAQ ») but at a preferential price ensures that it is affordable for as many people as
possible.
Sanofi-aventis www.sanofi-aventis.com
Media Relations: Tél. : (+) 33 1 53 77 44 50
E-mail : [email protected]
Investor Relations : Tél. : (+) 33 1 53 77 45 45
E-mail : [email protected]
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Information about the drug
Coarsucam™ / « ASAQ » is an innovative dosage form developed jointly by Sanofi-aventis and DNDi, that
combines two active ingredients - artesunate (AS) and amodiaquine (AQ) – in a “bi-layer” tablet.
To improve treatment compliance by patients and diminish risks of resistance, the use of a drug should be as
simple as possible. This new formulation allows neonates and children up to the age of 13 years to be treated
using just one tablet a day for three days. For teenagers aged 14 years and above and for adults, the dosage
regimen is also simplified: one administration of 2 tablets per day for 3 days, rather than 8 tablets a day when
the two ingredients are combined either as loose drugs or in a co-blister. The tablets can be dissolved or crushed
and given in liquid or semi-liquid food making them much easier to administer to children.
Malaria in just a few figures
•Malaria is rated by the WHO as one of the three major diseases in Africa alongside HIV/Aids and tuberculosis.
Malaria absorbs 25% of household income in Africa.
• Malaria is found in 100 countries and poses a threat to nearly half the world population.
• Every year, between 350 and 500 million cases of malaria occur worldwide, causing more than one million
deaths, mainly among children in sub-Saharan Africa.
• Malaria is the main cause of mortality among children aged under 5 years in Africa where it is estimated that
3000 children die every day as a result of a malaria attack, i.e., one child every 30 seconds.
• So far twenty national programmes in Africa and in Indonesia have recommended combination artesunateamodiaquine as first line treatment against malaria.
The sanofi-aventis Impact Malaria programme
The sanofi-aventis group continues its long-standing involvement in fighting malaria through its « Impact
Malaria » programme and its drugs, initially quinine- and chloroquine-derivatives, followed by the release in
1996 of the first artemisinin derivative in Africa - Arsumax.
The Impact Malaria programme is the sanofi-aventis contribution to the fight against malaria.
Established in 2001, Impact Malaria is part of sanofi-aventis’s « Access to Drugs » department, and is organised
in four areas:
1. Discovering new anti-malarial compounds,
2. Developing new combinations or formulations using existing drugs, particularly artemisinin-based
combination therapies as recommended by the WHO,
3. Providing information, education and communication relating to malaria targeted at healthcare facilities and
at communities and families,
4. Distributing antimalarial drugs which are vital to the poorest populations with a differential price approach.
These activities are conducted in cooperation with public and private healthcare organisations and national
health authorities, in particular National Malaria Control Programmes.
About DNDi
DNDi (Drugs for Neglected Diseases Initiative) is an independent, not-for-profit drug development initiative
established in 2003 by four public-sector research organisations in endemic countries – Oswaldo Cruz
Foundation Brazil, ICMR (Indian Council of Medical Research), KEMRI (Kenya Medical Research Institute),
Malaysian Ministry of Health, in association with France’s Institut Pasteur; and Médecins Sans Frontières. The
Special Programme for Research and Training in Tropical Diseases (WHO/TDR) is a permanent observer to the
initiative.
Under its FACT (Fixed-Dose Artesunate Combination Therapy) project, the new fixed-dose combination
artesunate +amodiaquine « ASAQ » is the first drug developed by DNDi in partnership with Sanofi-aventis. In
2008, DNDi will be releasing a second fixed-dose combination artesunate +mefloquine (ASMQ) in partnership
with Farmanguinhos in Brazil intended for Latin America and Southeast Asia.
With a current portfolio of 18 projects, by 2014, DNDi aims to develop 6 – 8 new treatments for neglected
diseases such as malaria, human African trypanosomiasis (« sleeping sickness »), leishmaniasis and Chagas
disease.
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About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic
solutions to improve the lives of everyone.
Sanofi-aventis is listed in Paris (EURONEXT : SAN) and in New York (NYSE : SNY).
Forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995,
as amended. Forward-looking statements are statements that are not historical facts. These statements include product
development, product potential projections and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events, operations, products and services, and statements
regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,”
“believes,” “intends,” “estimates,” “plans” and similar expressions. Although sanofi-aventis’ management believes that
the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking
information and statements are subject to various risks and uncertainties, many of which are difficult to predict and
generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether
and when to approve any drug, device or biological application that may be filed for any such product candidates as well
as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such
products candidates, the absence of guarantee that the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public
filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary
Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended
December 31, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update
or revise any forward-looking information or statements.
Contacts
Mireille Cayreyre
Tel: +33 (0)1 41 24 57 94
Mob: +33(0)6 08 18 88 18
[email protected]
Geoffroy Bessaud
Tel: +33(0)1 53 77 45 07
Mob: +33 (0)6 71 62 85 54
[email protected]
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