Ranbaxy expects to complete the trial on the anti-malaria combination medicine (Arterolane maleate + Piperaquine phosphate) in India, Bangladesh and Thailand and apply for marketing authorisation by late 2010.
Ranbaxy became the “pharma partner” of MMV in May 2003 to develop a more effective medicine for malaria. Two years earlier, MMV stopped funding the project and handed over development rights of the drug to Ranbaxy. The ministry of science and technology also funded the research through its Drugs and Pharmaceuticals Research Programme.
Rashmi Barbhaiya, former research head of Ranbaxy, who was instrumental in making the alliance with MMV happen, said it should be the first research-based new drug developed and marketed by an Indian pharma company.
The drug is targeted at patients in developing countries with the aim of replacing the conventional options available for the treatment of P-falciprum malaria. The drugs available at present are either those to which the malarial parasite has developed resistance or newer alternatives that are expensive and derived from agricultural sources, thus having limitations on scalability.
Malvinder Mohan Singh, chairman, CEO and MD, Ranbaxy, said, “Our new anti-malaria drug, likely the first NCE (New Chemical Entity) from India, will benefit patients immensely and provide a more potent solution to developing nations where malaria is endemic.”
Arterolane maleate + Piperaquine phosphate is a synthetic drug and so, is easier to manufacture.
Patient compliance will also be much easier; available therapy requires an adult to consume 24 tablets over three days. Whereas, the Arterolane maleate + Piperaquine phosphate dosage is only tablet per day for three days. Ranbaxy aims to market the drug in the malaria-endemic geographies of India, Africa, Latin America and the Asia Pacific.
According to the World Health Organization, an estimated 250-300 million cases of malaria occur every year, mainly in developing countries, causing approximately a million deaths. Anti-malarial research is one of the neglected areas.