FDAnews Drug Daily Bulletin


Dec. 21, 2005

Ranbaxy Laboratories announced positive clinical study results for its experimental malaria drug, RBx 11160, which it is touting as an affordable alternative to current therapies. Ranbaxy said it would file a new drug application (NDA) in early 2009 for a combination malaria drug containing RBx 11160.

Malaria deaths are on the rise because malaria parasites have become increasingly resistant to older, cheaper malaria drugs, and most malaria cases occur in countries too poor to pay for newer, more effective drugs made with artemisinin, an expensive Chinese plant extract. Ranbaxy and its drug development partner, the Geneva-based Medicines for Malaria Venture (MMV), said RBx 11160, a synthetic drug, could be produced cheaper and faster than artemisinin-based drugs. Ranbaxy and MMV partnered in May 2003 to develop the drug, which was also engineered to cure malaria in just three days.

"RBx 11160 is more predictable to produce [than artemisinin], and you can produce it in the quantities you need," Ranbaxy spokesman Charles Caprariello told FDAnews. With artemisinin "if it's a good season you get high yields -- if it's not you don't."

In a study conducted in Thailand and completed in October, RBx 11160 effectively reduced malaria parasites in afflicted patients, Ranbaxy said. Another study, conducted in the UK, showed the drug was well tolerated in healthy young and elderly patients. Ranbaxy is presenting more data on RBx 11160 today at a meeting of the American Society of Tropical Medicine and Hygiene in Washington, D.C.

Because Ranbaxy's product is a short-acting drug, it will be combined with a long-acting malaria drug, piperaquine phosphate, in concordance with World Health Organization (WHO) guidelines for development of new anti-malarial compounds. Ranbaxy will file its NDA for a combination of RBx 11160 and PQP.

Malaria is a health problem in 90 countries, home to 40 percent of the world's population, according to MMV. Between 1 and 3 million people die of malaria every year, most of them pregnant women and children younger than five, MMV said.