Ranbaxy's anti-malaria molecule enters Phase III clinical trial

Ranbaxy Laboratories Ltd, one of India's largest pharmaceutical companies, on Tuesday announced the commencement of Phase-III clinical trials for its new anti-malaria combination drug, arterolane maleate + piperaquine phosphate in India, Bangladesh and Thailand.

The trial is expected to be completed by the end of 2010. Ranbaxy aims to market the drug in malaria endemic regions of India, Africa, Latin America and the Asia Pacific.

Most of the currently available drugs for malaria are either expensive or ineffective,  the company said, adding that its new drug is targeted at patients in developing countries.

The Phase III trial was launched at an investors' meet in New Delhi.

Speaking on the occasion, chief guest V M Katoch, secretary, department of health research and director general of Indian Council of Medical Research, lauded the efforts of Ranbaxy in developing a new anti-malaria drug.

On the occasion, Sudershan Arora, president-R&D (generics, novel drug delivery systems, clinical & drug development), Ranbaxy, said that the company will apply for marketing authorisation by late 2010.

Malvinder Mohan Singh, chairman, CEO and MD, Ranbaxy, said, he was very much delighted of the development.

''Our new anti-malaria drug, likely the first NCE from India, will benefit patients immensely and provide a more potent solution to developing nations where Malaria is endemic,'' he said.

Arterolane maleate + piperaquine phosphate is a synthetic drug and hence easier to manufacture with better predictability and reliability of supplies. The drug is being developed as a once-a-day therapy for three days and will improve patient compliance, besides being safe and efficacious.

The available therapy requires an adult to consume 24 tablets over three days whereas arterolane maleate + piperaquine phosphate dosage is one tablet per day for three days, thereby resulting in lesser pill burden for the patients and reduced cost.

According to the World Health Organisation, about 250-300 million cases of malaria occur every year, causing approximately one million deaths.

Ranbaxy is an integrated, research-oriented, international pharmaceutical company producing a wide range of generic medicines.

The company  has presence in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, and ground operations in 49 countries and manufacturing operations in 11 countries.