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BANGALORE May 20

BIOCON India Ltd, the Bangalore-based pharma-biotech company, is planning to try out application of mycophenolate mofetil popularly known as CellCept, an immunosuppressive drug, to treat diabetic nephropathy, a stage wherein diabetic patients end up with renal malfunctions.

The company expects to start limited clinical trials soon to try out the extended usage of the molecule in collaboration with the Bangalore-based MS Ramaiah Hospital, said Ms Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon. "We have received the necessary approvals from the Drugs Controller of India and the ethics committee to go ahead with the trials," she said.

Inventor of the molecule, Dr Anthony Allison, who is also on the board of Biocon, said mycophenolate mofetil is widely used in organ transplantation to prevent the allograft rejection. It is gaining rapid acceptance on account of its low cytotoxic profile compared with conventional immunosuppressants. Recent studies have indicated that mycophenolate, which has a good safety profile, could retard the progression of diabetic nephropathy, he said.

Pharmaceutical giant Roche, which holds the marketing rights for the molecule at present, does not have the interest to try out extended usage, Dr Allison said. However, Biocon has proactively been trying various applications by carrying out small trials. The drug, if found effective, could immensely benefit a large number of diabetic patients in India who fear dreaded progression into renal malfunction, he said. It is estimated that diabetic nephropathy affects nearly 30 per cent of the diabetics and India has a diabetic population of nearly 32 million.

Biocon India, which has developed a novel process for mycophenolate mofetil, is the only manufacturer of this fermentation derived drug in the country. The trials planned by Biocon will be the first such trial to be conducted and will be carried out by a group of the Bangalore-based Medical Investigators. Trial results are expected to be generated over a period of approximately 9-12 months, based on which further extensive trials will be planned, Ms Shaw said.

Biocon is keenly focused on Diabetes both in terms of research and products. Biocon expects to launch its Recombinant Human Insulin by the year-end. The current trial is expected to add an additional product to this Diabetic portfolio.

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