Statins are a class of drugs that lowers the level of cholesterol in the blood by reducing the production of cholesterol by the liver. These are hypolipidemic agents, used as pharmaceutical ingredients to lower cholesterol levels in people with risk of cardiovascular diseases. Statins block the enzyme in the liver that is responsible for making cholesterol.
Scientifically, statins are referred to as HMG-CoA reductase inhibitors. The statins approved for use in the US include lovastatin (Mevacor), simvastatin (Zocor), pravastatin (Pravachol), atorvastatin (Lipitor), fluvastatin (Lescol), and rosuvastatin (Crestor).
Indian companies which manufacture statins as an active pharmaceutical ingredient (API) or as formulations are Biocon, AstraZeneca, Micro Labs, Dr. Reddy's, Ranbaxy, Intas, Emcure, Cipla, US Vitamins, Sun Pharma, Bal Pharma to name a few.
Biocon is one of three companies globally to obtain USFDA approval for lovastatin, which went off patent in June 2001. The company expects the statin opportunity to be further augmented by simvastatin going over-the-counter and with the expiry of patents pravastatin and simvastatin " said Kiran Mazumdar Shaw, CMD, Biocon.
Presently, Biocon is the only large API player with a non-infringing process for simvastatin and pravastatin, besides Teva. Currently, Merck holds the patent on simvastatin, which is marketed as Zocor and Bristol-Myers Squibb holds the patent on pravastatin, which is marketed as Pravachol. The other big statin, Pfizer's Lipitor (atorvastatin) is the world's largest pharma brand with sales of $ 14 billion.
Biocon statin portfolio comprises lovastatin, simvastatin pravastatin and atrovastatin besides other statins under development.It exports simvastatin to the US, Europe, Japan and Canada. Lovastatin is marketed to US and Pravastatin to the US and European markets. The company has over the years been facing severe pricing pressure in this segment due to increased competition and changing industry price dynamics. The US patent expired during the fiscal 2007 and the company has commenced exports to US in the second half of 2007. It also received the received USFDA certification this fiscal for its new facilities at the Biocon Park thereby substantially increasing the production capacity to address the growing demand for statins globally.
Lipitor and Pravachol are statins, the world's most widely prescribed class of drugs. At around $20 billion, they sell more than any single class of drugs. These blockbusters are going off patent in key western markets, leaving the field open to Indian generic manufacturers. Indian firms already make statin copies here as the country does not award product patents.
The Indian statin market valued at $16 million which is less than .001 percent of the $17 billion global market of $20 billion regulated and $17 billion unregulated markets. The domestic market growth is estimated at 40 per cent annually. The crucial cardio-vascular statin segment is growing at 14 per cent per annum. Similarly, while the global market is growing at 30 per cent annually, the cardiovascular segment is rising at 9 per cent per annum, stated VR Kannan, pharma consultant.
Statins is used for preventing and treating atherosclerosis that causes chest pain, heart attacks, strokes, in individuals who have or are at risk for atherosclerosis. Risk factors for atherosclerosis include abnormally elevated cholesterol levels.
According to cardiologists, since it is not clear which effect of statins is responsible for their benefits, the purpose of treatment with it should not be only the reduction of cholesterol to normal levels, but rather the prevention of the complications of atherosclerosis-angina, heart attacks and stroke.
Experts state that though statins differ in several ways. The most noticeable variation is in their ability to reduce cholesterol. Presently atorvastatin (Lipitor) and rosuvastatin (Crestor) are the most potent, and fluvastatin (Lescol) is the least potent. It also differs in how powerfully they interact with other drugs. For instance, pravastatin and rosuvastatin levels in the body are less likely to be elevated by other drugs that may be taken at the same time as the statins. Statins differ in the frequency with which they cause a severe type of myopathy called rhabdomyolysis, in which muscles are severely damaged. Cerivastatin (Baycol) was withdrawn from pharmacies worldwide because it caused rhabdomyolysis 10 to 100 times more often than other statins. Rhabdomyolysis may occur more often in patients taking lovastatin, simvastatin or atorvastatin than patients taking pravastatin or fluvastatin, stated sources.