A cheaper, easy to comply, anti-malarial drug artesunate amodiaquine (ASAQ) that costs less than $1 for adults and $0.5 for children could hit the Indian market in the first half of 2009.

The fixed-dose formulation has been developed by Drugs for Neglected Diseases initiative (DNDi), an international non-profit drug development organisation and Sanofi-aventis, a leading global pharmaceutical company listed in Paris and New York stock exchange.

Currently a course of artesunate-based pills cost Rs 100 upwards in the country, while a course of mefloquine based tablets cost around Rs 104.

?We are working towards bringing ASAQ to India by next year? said Bhavna Sharma, head, and regional support office of DNDi in India. DNDi?s agreement with Sanofi-aventis is non-exclusive. However, DNDi guaranteed exclusivity to Sanofi-aventis for the duration of the product development programme till the first registration. ?This co-formulation drug will help in improving treatment compliance as it?s simple once-a-day regimen is easy to manage, both for the prescriber and the patient. Consequently it will reduce the probability of drug-resistant strains development,? said Sharma.

DNDi developed the co-formulation by combining the two active ingredients in a single pill and carried out the initial pharma and clinical development before chosing Sanofi-aventis as its industrial partner for further development.

Using DNDi?s studies as the base, Sanofi-aventis helped develop the product at the industrial level, conducted the requisite additional clinical studies, prepared the dossier for regulatory authorities and obtained World Health Organisation (WHO) pre-qualification for the drug.

The combination of artesunate (AS) and amodiaquine (AQ) is one of the anti-malarial drug combinations now recommended by the WHO for Africa. Of the 41 sub-Saharan countries that have adopted Artemisinin-based combination therapies (ACTs) in their malaria treatment protocols, over 20 have chosen the ASAQ for their public programs.

Sanofi has marketed the co-formulation drugs under two brand names?Artesunate-Amodiaquine Winthrop (ASAQ) for public markets and Coarsucam for private markets internationally.

ASAQ is available at a ?no profit-no loss? price to public organisations of endemic countries, international institutions, NGOs and pharmacists promoting ?access to medicine? (Sanofi?sponsored social responsibility scehme ).

Coarsucam will be three to four times expensive than theprice of other version. Sanofi will offer pharmacists? organizations incentives to sell a full course of Coarsucam for either $1 to poorer customers or $3 to $4 to customers who can afford the higher price.

Sanofi will allow pharmacists to decide which of their customers cannot afford to pay the higher price.

The cut-off income is about $40 monthly, according to international reports. The company also plans to package Coarsucam differently to ensure lower-cost drugs are not sold at the higher price.The drug could result in slashing the price of ACT drugs internationally.

Easy remedy

•Currently, a course of artesunate-based pills cost Rs 100 upwards in the country, while a course of mefloquine-based tablets cost around Rs 104

•The fixed-dose formulation has been developed by Drugs for Neglected Diseases initiative, an international non-profit drug development organisation and Sanofi-aventis, a leading global pharmaceutical company listed in Paris and New York stock exchanges

•DNDi developed the co-formulation by combining the two active ingredients in a single pill and carried out the initial pharma and clinical development before chosing Sanofi-aventis as its industrial partner for further development

•Using DNDi?s studies as the base, Sanofi-aventis helped develop the product at the industrial level, conducted the requisite additional clinical studies, prepared the dossier for regulatory authorities and obtained World Health Organisation pre-qualification for the drug