Indian company starts Phase III trials of synthetic artemisinin

from Ranbaxy.com:

Gurgaon (India)

Ranbaxy Laboratories Limited (Ranbaxy) today 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 drug is targeted at patients in developing countries with the aim of significantly improving upon the conventional options available for the treatment of P. falciparum malaria. Currently available alternatives in the market are either those to which the malarial parasite has developed widespread resistance, making the drug in-effective or newer alternatives that are comparatively expensive and derived from an agricultural source, having limitations on scalability.

The Phase III trial was kicked off by holding an Investigators' Meeting in New Delhi, last month. Speaking on the occasion, chief guest Dr VM Katoch, Secretary, Department of Health Research and Director General, ICMR (Indian Council of Medical Research), lauded the efforts of Ranbaxy in developing a new anti-malaria drug. On the occasion, Dr. Sudershan Arora, President-R&D (Generics, NDDS, Clinical & Drug Development), Ranbaxy, mentioned that Ranbaxy will strive to successfully complete the trial and apply for marketing authorization by late 2010.

Commenting on the development, Mr. Malvinder Mohan Singh, Chairman, CEO and MD, Ranbaxy, said, "I am delighted that our Anti-malaria drug is entering Phase-III trials. Ranbaxy has always been at the forefront of research for drugs that are both relevant and affordable. 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."

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 1 tablet per day for three days, thereby resulting in lesser pill burden for the patients and reduced cost.

Ranbaxy aims to market the drug in malaria endemic geographies of India, Africa, Latin America and the Asia Pacific.

According to the World Health Organization, estimated 250-300 million cases of malaria occur every year, mainly in developing countries causing approximately 1 million deaths. Anti Malarial research is one of the neglected research areas with very few organizations actively working in this field.

Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

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