Statins

Statins are cholesterol-lowering agents used to treat and prevent coronary diseases and are amongst the largest selling drugs worldwide. The statins market in India is presently estimated at about Rs 300 crore (it doesn't include export figures) against last year's sales of Rs 227 crore. Biocon, India's largest and USFDA qualified producer and exporter of statins, is the market leader. Besides Biocon the other names in this market include Ranbaxy, Lupin, Themis Medicare, RPG Life Sciences, Claris Lifesciences, Intas Pharma, Medley, Sun Pharma, USV, Concord Biotech, Emcure, Zydus Cadila, Torrent, Cadila Pharma, Carsyon, a division of Micro Labs, Cipla etc. But only few companies are into manufacturing of statins such as Lovastatin, Simvastatin, Atorvastatin, Pravastatin and Rosuvastatin. The Indian statin manufacturers like Biocon, Ranbaxy, Themis Medicare and Zydus Cadila have strong exports focus.

In regulated market the statins are priced at over $950 per kg while in non- regulated it is priced at $450-500 per kg. On the contrary statins are priced in the range of Rs 1,650-1,700 per kg in India. In spite of the pricing pressure in Europe and rise in material costs, the Indian companies have been looking at exports for better price realizations.

Matrix Laboratories, one of the leading pharma companies, has acquired a 45 percent stake in Concord Biotech that has received USFDA approval for its Lovastatin facilities and also for manufacturing Pravastatin and Simvastatin.

Biocon has seen the successful in development and commercialization of Lovastatin, Simvastatin, Atorvastatin and Pravastatin. Biocon is currently exporting Simvastatin to Europe, Japan and Canada, Lovastatin to the US and Pravastatin to the European markets.

Over 60 percent of its biopharmaceutical sales of Rs 603 crore comes on account of sale of statins, largely through exports. The statin sales were affected during 2005-06 despite sharp volume growth and increased market share, due to significant pricing pressure in European markets. Sales were also affected due to delayed launch of Pravastatin and Simvastatin in the US consequent to the grant of six months exclusivity to the generic players. However, the opening up of the US market in the later half of FY 2007 is likely to see a surge in sale of statins.

During first half of 2005, Zydus Cadila launched a novel statin, Pitavastatin under the brand Pitava, which is the latest addition to its family of statins. Zydus Cadila has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market.

Ranbaxy, another leading name in statin business has been marketing all four statins-Storvas (Atorvastatins), Simvotin (Simvastatin), Pravator (Pravastatin) and Rovacor (Lovastatin). In 2005, Ranbaxy received USFDA approval to manufacture and market Simvastatin Tablets in the US.

Themis Medicare last year signed an agreement with Darou Pakhsh Pharma Chem, (DPPC) of Iran, a government company manufacturing pharmaceutical preparations. As per the agreement, the company will supply DPPC with the technology for producing various biotechnological products, mainly statins and DPPC will make milestone payments to the company. Artemis Biotech, a division of Themis Medicare, is a major producer of Lovastatin and some its major customers in India include Alembic Chemicals, Dr Reddy's Laboratories, RPG Life Sciences, Sun Pharma, Unichem Laboratories, and Wockhardt.