Ranbaxy Laboratories Ltd, Medicines for Malaria Venture's (MMV) pharmaceutical partner for the development of anti-malarial drug, has obtained authorisation from Medicines and Healthcare Products Regulatory Agency (MHPRA) to conduct clinical trials in the United Kingdom. This is the first regulatory step in new drug development after safety and drug activity is established in the pre-clinical phase, release from Ranbaxy said.
The drug, OZ277/RBx11160, is currently being evaluated in a Phase I study for its safety, tolerability and pharmacokinetics (PK) in humans in the United Kingdom.
"The need to develop a low-cost, potent synthetic anti-malarial drug is more urgent than ever," MMV CEO Dr. Christopher Hentschel said adding, "This project has surpassed our expectations as it moved so successfully and rapidly through candidate selection and scale-up."
"Ranbaxy is privileged to carry on the baton from this team of talented researchers. Our scientists are excited to be able to work on a drug that could save millions of lives," said Dr. Brian Tempest, CEO & managing director of Ranbaxy.
In May 2003, Ranbaxy entered into an agreement with MMV, Geneva, for the development of Synthetic Peroxide anti-malarial drug.
Findings in the discovery of this new anti-malarial drug will be published on 19 August in Nature, a premier international scientific journal.