Bangalore-based Biocon India has managed to garner a 10 per cent market share of the cholesterol lowering drug lovastatin in the United States in less than six months of its launch.
The company is making rapid inroads into the United States' statins market and is aiming at a 25 per cent market share of lovastatin by the end of next year.
The market size of lovastatin in US is in excess of $1 billion. "Lovastatin is doing extemely well in US and we are already short of capacity," Kiran Mazumdar Shaw, chairman and managing director of Biocon India said.
"We are now increasing our capacity to meet the growing demand and will comfortably be able to achieve a 25 per cent marklet share by 2004 end," she said.
Biocon India's lovastatin facility received approval from the US Food and Drug Administration in January 2001 and became one of the three companies in the world to have obtained USFDA approval. The drug went off patent in June 2001.
Biocon India's most successful commercialisation has been in the area of statins and the company is now gearing up to launch other statins in the US market including simvastatin, pravastatin and atorvastatin.
Collectively, these statins account for a market size of $18 billion worldwide, growing at the rate of 30 per cent.
Biocon also uses some of its lovastatin for converting it into simvastatin through chemical reactions.
The company is ramping up the production for all its statins in order to become a global player in statin production.
"We have unveiled a major expansion plan for all the statins and are looking at entering the regulated markets," said Shaw.
Lovastatin is a cholesterol lowering agent isolated from a strain of Aspergillus terreus. It prevents the formation of LDL-cholesterol (low-density lipoprotein).
High levels of LDL-cholesterol causes atherosclerosis or hardening of the arteries that can lead to heart attacks.
The company is targeting US and Europe for lovastatin and simvastatin, and markets like South America and Europe for atorvastatin and paravstatin.
Biocon's lovastatin process is based on a proprietary solid state fermentation technology, the only company in the world to have adopted this route for manufacturing the statin.
The Indian statin market is close to $16 million and is growing at a rate of 40 per cent.
"Statins are low-volume but high-value products as they are extremely difficult to manufacture," said Shaw.
Statins form 30 per cent of the company's pharmaceutical revenues. The patent for pravastatin will expire in 2004, simvastatin in 2007 and that of atorvastatin in 2010.