Hyderabad-based Shantha Biotech will be the only company in the country after Dr. Reddy's Labs to manufacture indigenous Granulocyte- Colony Stimulating Factor (G-CSF) or Filgrastim. According to the company officials, Shantha has already begun to manufacture the product on a pilot scale. "On the clinical level we have finished Phase II clinical trials of G-CSF. We should be filing for a Phase III application in August," said a senior official in Shantha Biotech.
Grastim is the recombinant protein used in chemotherapy-induced neutropenia and in bone marrow transplantation. It is also useful in the treatment of leukopenia associated with myelosuppressive therapies, and in patients with AIDS-related cytomegalovirus retinitis.
Shantha Biotech has planned to construct a multi product facility near its plant in Hyderabad. The company will be manufacturing its G-CSF in this plant. The plant will also be expanding its interferon alpha production and other protein therapeutic products in this plant, said the official. Shantha Biotech is developing filgrastim on the yeast Pichia Pastoris.
Currently the major companies who market G-CSF in the country are Dr. Reddy's Labs, Nicholas Piramal, Ranbaxy and Cadila Healthcare. Dr. Reddy's is the first company from India to develop this molecule all the way from the molecular biology stage to production, and also to obtain approval to launch the product in India. The remaining companies import the product from overseas and market domestically.
According to a report published in the biotech journal Biospectrum in May 2003, the Filgrastim market in the country in 2001 was Rs. 11.6 crore, which is expected to increase to Rs. 200 crore by 2005 and Rs. 294.8 crore by 2007. According to some pharma analysts, the current market size of filgrastim in the country is about Rs. 25-30 crore.