Lupin Ltd's biotechnology division hopes to hit the market with its first biotechnology-based cancer drug in India this year, if it gets regulatory approval for clinical trials on time .
“We have conducted two sets of clinical trials for the drug and are awaiting approval for the third trial which should be completed within six months of getting the approval. It will take us another six months for the commercial launch,” Mr Cyrus Karkaria, president of Lupin's biotechnology division, told media persons on the sidelines of the Bio-Asia meet here.
The company is conducting the clinical trials at different centres across the country.
New biotech drugs
It has in the pipeline six more bio-technology based drugs, three of which are undergoing clinical trials; one will undergo clinical trials this year and the remaining two are in the pre-clinical stage. These mainly deal with oncology and inflammation therapeutic areas.
Mr Karkaria pointed out that bio-technology based drug research was more complicated than small molecules and needed significantly more investments. He also felt that the regulatory mechanism could be made simpler , which would help companies launch products at a faster pace.
The company, which has a research-cum-manufacturing facility near Pune, will consider setting up a new manufacturing facility once the products hit the market and gains critical mass in terms of demand. ‘We may initially set up a single train facility at a cost of about $20 million. We are on the look-out for land near our existing facility. Till then, our existing facility will cater to market,” Mr Karkaria said.
The current biotechnology drugs market globally is estimated at between $120 billion and $140 billion. Emerging markets account for a one-fifth share. The domestic market for this category of drugs is expected to touch $2 billion by 2015.