The Hindu Business Line : Ranbaxy to file new application for anti-malarial drug

RANBAXY Laboratories Ltd plans to file, in early 2009, a New Drug Application (NDA) for its anti-malarial drug, which is a combination of the short acting molecule called RBx 11160 and the long-acting piperaquine phosphate (PQP).

RBx 11160 is being jointly developed with Medicines for Malaria Venture (MMV), and will soon enter Phase IIb dose range studies in India, Thailand and Africa. The Phase IIa Proof of Concept study was completed in October 2005 in Bangkok on 72 patients,

In a statement, the company said that this product was intended for the treatment of acute uncomplicated P. falciparum malaria, and a safety and tolerability date of a wide range of PQP doseswill be generated in a Phase I clinical trial expected to begin in Switzerland in 2006.

Dr Brian Tempest, CEO and Managing Director, Ranbaxy, said: "Ranbaxy is committed to help save lives from the worldwide scourge of malaria, and we, therefore, are doing everything we can to expedite the progress of RBx 11160 through all necessary clinical trials and regulatory reviews. Our goal is to bring this drug to market as quickly as possible at affordable prices to developing countries, and exchanging information on our progress at symposia like these helps to facilitate the process and encourage our efforts."

RBx 11160 is the first synthetic peroxide antimalarial that could be produced inexpensively and quickly. This molecule could replace Artemisinin, a natural chemical derived from a scarce and expensive plant, because bulk production of RBx 11160 is expected to be faster and more economical. Being a drug with short half-life, RBx 11160 will be combined with piperaquine phosphate, to comply with the current World Health Organisation (WHO) guidelines for development of new anti-malarial compounds.

The company feels that this drug holds great promise for the millions of people in 90 countries who are afflicted with the disease.