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Ranbaxy to start human trials for anti-malarial drug



Mr Malvinder Mohan Singh

Our Bureau

New Delhi, Oct. 16 Ranbaxy Laboratories Ltd has announced that it has obtained approval from the Drug Controller General of India to initiate Phase III human clinical trials in India for its new anti-malaria combination molecule.

The clinical trial will be conducted on patients from India, Africa and South and South-East Asian countries.

Ranbaxy also plans to seek regulatory approval in other countries to do the Phase-III clinical trial at the earliest. The company had recently submitted an Investigational New Drug (IND) application to the drug controller seeking permission to initiate Phase-I human clinical trials for a respiratory inflammation drug.

Mr 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 many deaths in 2006.

With no vaccine for malaria currently available, a variety of antimalarial drugs is available for the treatment of malaria, including quinoline and related anti-malarials.

The new drug from Ranbaxy is an inexpensive, quick and long acting, high activity anti-malarial.

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.

Related Stories:
Ranbaxy: Authorised generic boost
Ranbaxy plans to hire 400 scientists

More Stories on : Research & Development | Pharmaceuticals | Ranbaxy Laboratories Ltd

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