Ranbaxy Laboratories Limited (Ranbaxy) announced today that the company has obtained approval from the Drug Controller General of India (DCGI) to initiate phase-III human clinical trials in India for its new Anti-Malaria combination molecule, RBx 11160 (Arterolane maleate and piperaquine phosphate). The clinical trial will be conducted on patients from India, Africa and South and South-East Asian countries.
Ranbaxy has successfully completed all the required regulatory safety and toxicity studies apart from a phase-II clinical trial in India and Thailand with the drug candidate and also plans to seek regulatory approval in other countries outside India to the phase-III clinical trial at the earliest.
Malvinder Mohan Singh, CEO and managing director, Ranbaxy, said, "This is a landmark achievement for Ranbaxy's R&D team. Ranbaxy's synthetic molecule will be safer and more effective than the existing artemisinin based drugs and will also have a clear cost advantage. We remain committed to the development and launch of this new synthetic drug for the needy patients in India, Africa and other disease endemic nations."
Commenting on the progress of the anti-malarial project, Dr Sudershan Arora, president-Clinical & Drug Development, Ranbaxy, said, "We are looking forward to complete the development phase of the anti-malarial combination which is expected to culminate in obtaining marketing approvals. This achievement also reflects the new drug development capabilities of Ranbaxy's R&D team."
Half of the world's population is at risk of malaria and an estimated 247 million cases led to nearly 881 000 deaths in 2006. In humans, one or more of four species of the intracellular protozoan parasite causes malaria infection. These are Plasmodium falciparum, Plasmodium vivax, Plasmodium malariae, and Plasmodium ovale. Plasmodium falciparum, however, remains the main species that results in disease and mortality from malaria. In the recent years, the number of clinical cases and number of deaths in India is on the rise.
With no vaccine for malaria currently available, a variety of antimalarial drugs are available for the treatment of malaria, including quinoline and related antimalarials.(quinine, mefloquine), antifolates (sulfadoxine-pyrimethamine), artemisinins (artesunate), antibiotics (clindamycin, tetracycline), and other drugs such as atovaquone-proguanil and primaquine. These medications may be used alone; however, a combination drug therapy remains the most efficacious therapeutic approach for the treatment of P falciparum malaria.
The development of P falciparum drug resistance, coupled with the widening geographic distribution of P falciparum to non-endemic regions of the world, has directed awareness towards the urgent need for the development of novel antimalarial agents. The development of this new synthetic peroxide antimalarial combination drug, RBx 11160 (Arterolane maleate and piperaquine phosphate) an inexpensive, quick and long acting, high activity antimalarial, is a signifcant step in this direction.
Ranbaxy has a strong R&D pipeline consisting of 8-10 molecules in various stages of development. The anti-malaria drug is in the most advanced stage. The company's R&D focus includes Asthma, Anti-infectives, Urology and Diabetes.