Middle east Fast tracker coming for trials

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Shantha Bio readies for a blockbuster

C Chitti Pantulu

HYDERABAD: Shantha Biotechnics Ltd has filed a pre-IND (investigational new drug) application with US regulators for permission to carry out Phase-I clinical trials on human monoclonal antibodies to treat lung cancer. If cleared, it will be the first trial by an Indian company in the US.

Human monoclonal antibodies are the fastest growing segment of therapeutic proteins and it is forecast to account for 48% of the total sales in the US, with a market potential of $45 billion by 2009.

“We expect to kick off the trails in January 2008 and are preparing the materials at our plant in Hyderabad,” K I Varaprasad Reddy, founder and managing director of India’s first biopharmaceuticals company, said. Shantha is owned 60% by France-based biotechnology major Merieux Allinace.

According to experts, the antibody for lung cancer has the potential to be a $1 billion opportunity for Shantha.

Called RM1 internally, the monoclonal antibody, on which the company has spent $15 million so far, will need a further investment of $7 million, though it is some way before it can become a commercial reality. Three other monoclonal antibodies for treating melanoma, pancreatic cancer and breast cancer are also under development.

Antibodies are proteins that seek out infection causing antigens and destroy them. They are specific to one particular antigen and, once activated by the occurrence of a disease, continue to confer resistance against the ailment — for instance chickenpox and measles.

It is because of this characteristic that monoclonal antibodies can be used therapeutically against a wide variety of diseases.

The trials could be completed much earlier than for conventional drugs as there is a possibility of it being put on the fast track after the Phase-II trials. Shantha is also looking at a cocktail approach to develop new monoclonal antibody-based drugs by combining the lung cancer and pancreatic cancer antibodies.