UK-based GeneMedix Plc is awaiting clearance from the Department of Biotechnology (DBT) for the launch of its anti-cancer product granulocyte macrophage colony-stimulating factor (GM-CSF) in the country. After approval the company will be tying up with the Hyderabad-based Gland Pharma for the launch of the product in India, said the company's director, Regulatory Affairs, John Greenwood, who was there in India recently.
Speaking to Chronicle Pharmabiz, Greenwood said the company has already secured approval from the Genetic Engineering Approval Committee (GEAC) and is waiting for further clearances from DBT for the launch.
"GM-CSF, a biotech product, finds application in cancer therapy. Its use stimulates the production of white blood cells, essential for increasing body's immunity," he added. If approved, GeneMedix would be the first company to launch GM-CSF in India, said sources.
The role of the product is to render tumour cells immunogenic, that is, recognisable for attack by the immune system. This would in turn stimulate a general attack by the immune system on cancer cells wherever they are in the body. Hence, the product has the potential to destroy not only the cells in the primary tumour, but also those of potentially dangerous metastases that may have migrated elsewhere in the body. It may also provide the body with immunological 'memory' that could protect against subsequently recurring tumours.
GM-CSF finds application in almost all cases of cancer and therefore market for the product is huge. The company launched GM-CSF, under the trademark Neustim, into the Chinese market in December 2001.
GeneMedix is a UK based-biopharmaceutical company, specialising in the development and manufacture of cost effective treatments for some of the world's most serious diseases. The company has manufacturing facilities in China, Malaysia and Ireland.