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As Ranbaxy readies to launch novel synthetic antimalarial, Cipla-DNDi unveil artesunate FDC

This article was originally published in Scrip

Even as Ranbaxy is expected to unveil what is expected to be India's first new chemical entity (NCE) for malaria on 25 April, competitor Cipla said it was ready to introduce a fixed-dose combination of artesunate and mefloquine in collaboration with Drugs for Neglected Diseases Initiative (DNDi) for the treatment of uncomplicated Plasmodium falciparum malaria.

The fixed does combination, which is expected improve patient compliance, will be launched in India (to be marketed as Mefliam Plus) and Malaysia soon, a statement from Cipla said. It will be made in Cipla's facility in Patalganga.

Ranbaxy is expected to unveil details of its antimalarial combination, arterolane maleate plus piperaquine phosphate against P falciparum malaria, potentially India's first NCE to make it to the market, though the project itself was originally part of a collaboration with the Medicines for Malaria Venture (MMV). Arterolane maleate plus piperaquine phosphate is a synthetic drug which is easier to manufacture, with better predictability and reliability of supplies, than products sourced from natural ingredients.

Cipla's arrangement

Cipla said that it had entered into an agreement with the Brazilian government-owned firm, Farmanguinhos/Fiocruz, to introduce the new fixed-dose combination in Asian and African countries, under a partnership supported and facilitated by DNDi in 2008.

Cipla's chair and managing director, Dr Yusuf Hamied, told Scrip that the new combination was for specialised forms of malaria and no 'run-of-the-mill' antimalarial, but added it was no 'block-buster'.

A company statement added that the new combination simplifies the patient’s treatment with a single dose of one or two tablets for three days, ensuring that the drugs are taken together and in correct proportions. No details on how the alliance hopes to tackle the vagaries of supplies of artemisinin were immediately available.

The combination of artesunate and mefloquine is proven to be an effective treatment for uncomplicated P. falciparum malaria and recommended by the World Health Organisation. The clinical efficacy of the fixed-dose combination had been established in various countries including India, a company statement added. There were an estimated 216 million cases of malaria globally in 2010.

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