The Hindu Business Line : Human trials for Ranbaxy-MMV malaria drug soon

HUMAN clinical trials of the anti-malarial drug developed by Ranbaxy Laboratories Ltd in collaboration with Medicines for Malaria Venture (MMV), Geneva is expected to commence shortly.

The pharmaceutical company has already obtained authorisation from Medicines and Healthcare Products Regulatory Agency (MHPRA) to conduct clinical trials in the UK. This is the first regulatory step in new drug development after safety and drug activity is established in the pre-clinical phase.

The drug, OZ277/RBx11160, is currently being evaluated in a Phase I study for its safety, tolerability and pharmacokinetics (PK) in humans in the UK.

OZ, a synthetic peroxide, is believed to have similar mode-of-action as the most effective anti-malarial drug currently available - artemisinin - a herbal remedy based on the Artemisia annua plant. However, because of the costly and lengthy extraction process from the plant, artemisinins are at least 10 times more expensive than the cheap standard anti-malarials.

According to Dr Christopher Hentschel, CEO, MMV, "The need to develop a low-cost, potent synthetic anti-malarial drug is more urgent than ever. This could be the biggest breakthrough in malaria treatment of our generation."

Dr Brian Tempest, CEO and Managing Director of Ranbaxy, added in a statement, "Ranbaxy is committed to developing a drug that is not only safe and effective, but also affordable to people in India and hundreds of millions others who have to live with this terrible disease everyday."

Top level changes

THERE seems to be a churning of sorts among the top management of pharma major, Ranbaxy Laboratories Ltd. Mr Sanjiv D. Kaul, Vice-President, Global Licensing and Corporate Affairs, is set to move on later this year after spending close to two decades in the company.

Industry sources said that Mr Kaul is currently also an advisor to investment company ChrysCapital. Mr Kaul was responsible for the various licensing deals Ranbaxy had entered into such as the one with Schwarz Pharma AG of Germany.

"Mr Kaul has informed the company about his intention to move out and is preparing to do so," said a company spokesperson.

The recent months have seen the departure of several senior management personnel of the company. Dr Kiran Marthak, Vice-President, Medical Affairs and Clinical Research has put in his papers citing "personal reasons."

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