After successful clinical trials and approvals by the Drug Controller General of India, the new anti-malaria drug Synriam, developed by Ranbaxy, was finally launched on April 25. It was a historic step, being the first new chemical entity (NCE) ever developed indigenously. Its launch is also a pointer to how much can be achieved if government and industry work together. The project's R&D cost was around Rs 15 crore, of which Rs 5 crore came from the Department of Science and Technology, in the form of a grant to conduct the Phase III clinical trials. The department also provided a soft loan for the Phase IIB clinical trials. For earlier reports, go to www.businesstoday.in/malaria-drug
Work on the drug was actually started under a project called Medicine for Malaria Venture, led by global pharma major Roche, and was handed over to Ranbaxy in May 2003. But even if Ranbaxy did not initiate work on the drug, its achievement in developing it is a landmark. Around 80 per cent of new drugs are brought to market by the big global majors, even though only 35 per cent of these have been developed by them from the earliest stage. Smaller companies engaged in research often find going the full course up to the market beyond their means and end up out-licensing their NCEs to the big pharmas.
Of the four major types of malarial parasites, it is plasmodium falciparum, carried by the female anopheles mosquito, which causes about 90 per cent of the malaria deaths. Synriam, intended to combat falciparum malaria, has two major advantages over other drugs like chloroquine. Its dosage regimen is just one tablet for three days, while other drugs have to be taken twice or four times a day for three or more days. It is also prepared synthetically, using two chemical substances, arterolane maleate with piperaquine phosphate, unlike current drugs which are made from a plant-based substance called artemisinin. "Since the drug has a synthetic source and is not plant-based, supplies will not be a problem," says Neena Valecha, a scientist and Director at National Institute of Malaria Research, Delhi.
Again, plasmodium falciparum is becoming increasingly resistant to existing antimalaria drugs. "Traditional drugs are proving ineffective in cases of falciparum malaria because of drug resistance," Valecha adds. The new one will be a potent new weapon against the disease.
Synriam has only been cleared for India, where some 1.9 million people come down with malaria every year. Estimates of people who die of it every year vary around 200,000. The drug will cost Rs 130 for three tablets, though it may also be delivered free - like other anti-malaria drugs - under the national health programme.