Company Watch

Ranbaxy-GSK molecule awaits DCGI nod for phase I trial

Our News Bureau - Mumbai

Ranbaxy Laboratories (Ranbaxy) has obtained Drug Controller General (India) (DCGI) approval for initiating Phase III clinical trials in India for an anti-malaria combination molecule, RBx 11160. It has also submitted an Investigational New Drug (IND) application to the DCGI for permission to initiate Phase-I human clinical trials for a respiratory inflammation candidate, identified by the GSK-Ranbaxy steering committee earlier last year.

The RBx 11160 (arterolane maleate and piperaquine phosphate) clinical trial will be conducted on patients from India, Africa and South and South-East Asian countries. It 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. Ranbaxy also plans to seek regulatory approval in other countries outside India for Phase-III clinical trials at the earliest.

Malvinder Mohan Singh, CEO, Managing Director, Ranbaxy, said, "This is a landmark achievement for Ranbaxy's Research and Development (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 needy patients in India, Africa and other disease endemic nations."

Today, half of the world's population is at risk of malaria and an estimated 247 million cases led to nearly 881000 deaths in 2006. In humans, one or more of four species of the intracellular protozoan parasite causes malaria infection. These are Plasmodium falciparum, P vivax, P malariae, and P ovale. P falciparum however, remains the main species that results in disease and mortality from malaria. In recent years, the number of clinical cases and deaths in India is on the rise. With no vaccine for malaria currently available, a variety of anti-malarial drugs are available for the treatment of malaria, including quinoline and related anti-malarial (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 this parasite to non-endemic regions of the world, has directed awareness towards the urgent need for the development of novel anti-malarial agents. The development of this new synthetic peroxide anti-malarial combination drug, RBx 11160 (arterolane maleate and piperaquine phosphate) an inexpensive, quick and long acting, high activity anti-malarial, is a significant step in this direction.

Commenting on the progress of the anti-malarial project, Dr Sudershan Arora, President-Clinical and 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.'

Speaking on the IND submission, Dr Pradip Bhatnagar, Senior Vice President, New Drug Discovery Research (NDDR), Ranbaxy, said, "The long-standing vibrant collaboration between GSK's Center of Excellence for External Drug Discovery (CEEDD) and Ranbaxy has been the key for this success. This achievement also reflects the discovery and development capabilities of Ranbaxy's R&D team."

This is a major landmark in the GSK-Ranbaxy R&D collaboration, which was initiated in 2003, and further expanded in February 2007. As per the multi-year R&D collaboration agreement, Ranbaxy will be responsible for conducting Phase I and Phase II clinical studies through proof of concept. GSK will then have the option to conduct further development through final registration and commercialisation. The Ranbaxy-GSK alliance envisages strong research workflow to emanate from a wide range of therapeutic areas of interest to Ranbaxy and GSK, including anti-infective, respiratory, and oncology. Ranbaxy could receive over $100 million in potential milestone payments for a product developed by Ranbaxy and subsequently launched by GSK in multiple indications and up to double digit royalties on worldwide net sales.