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AstraZeneca launches cholesterol drug Crestor (rosuvastatin) in India, statins market hots up

Tagged with: astrazeneca, cholesterol Thursday, April 16, 2009, 15:27 This news item was posted in Industry, Pharma category and has 3 Comments so far.

AstraZeneca launched its block-buster anti-cholesterol medication Crestor (rosuvastatin) in India, fuelling more competition in the countrys fast-emerging statins market. AstraZeneca India introduced rosuvastatin pills in 5, 10, 20 and 40 mg strengths in India, on Wednesday. Crestor is indicated for use in the treatment of dyslipidemia, atherosclerosis and primary hypercholesterolaemia. Dyslipidemia is a clinical condition characterized by an elevation of cholesterol and/or triglycerides in the bloodstream. Over 69% of patients with coronary heart disease, even those currently on medications, remain above the targeted levels for cholesterol. AstraZenecas launch of Crestor in India achieves greater significance at this point of time because the cardiovascular disease occurrence in the sub-continent is peaking to an all time high with the increasing population of rich urban middle-class. Estimates suggest that by the year 2020 India will have the largest cardiovascular disease burden in the world and account for one third of all deaths, with one fifth of the deaths in India resulting from coronary heart disease. Heart disease in India occurs 8 to 10 years earlier than in the West. Even women are prone to the risk as one in four women in urban India and every eighth woman in rural India is suffering from high cholesterol. We are delighted to introduce Crestor, the original rosuvastatin in India, said Anandh Balasundaram, managing director, AstraZeneca Pharma India Ltd. We believe that Crestor offers an important treatment option for the large patient pool who are either untreated or not at target cholesterol levels. The launch of Crestor is in line with our India strategy to bring global brands to India at prices affordable for Indian patients. Crestor (rosuvastatin) is a new member of the cholesterol-lowering statin (HMG-CoA reductase inhibitors) class of drug therapy. In addition to its LDL (low-density lipoprotein) or bad cholesterol lowering effects, Crestor, has been shown to provide a significant increase in HDL (high-density lipoprotein) or good cholesterol. For the first time a statin could slow down and reverse the progression of atherosclerosis, the leading cause of heart attack and stroke. Atherosclerosis is the term used to describe the process when plaque, composed of cholesterol, fatty substances, builds up on the inside walls of the arteries. As plaque builds, it hardens and narrows the arteries, which can eventually lead to cardiovascular disease often causing chest pain (angina) heart attack, heart failure and stroke.

Statin market in India

Statins are cholesterol-lowering agents used to treat and prevent coronary diseases and are amongst the largest selling drugs worldwide. Pfizers Lipitor (atorvastatin calcium) is the largest selling pharma product in the world. Lipitor was generating revenues to the tune of $13.2 billion last year. Mercks Mevacor (Lovastatin), Bristol-Myers Squibbs Pravachol (Pravastatin Sodium), Mercks Zocor (Simvastatin), Novartis Lescol (Fluvastatin Sodium), AstraZenecas Crestor (Rosuvastatin Calcium), Merck/Schering-Plough Vytorin (Ezetimibe/Simvastatin) are the leading statin brands in the world market. Statins are mainly used to treat dyslipidemia, hyperlipidemia, hypercholesterolaemia and to prevent cardiovascular diseases including atherosclerosis. Statins are also used in postmenopausal women for oteoporosis treatment. Indian statins in India, presently estimated over Rs 1000 crore, is controlled by domestic players. Biocon, Indias largest and USFDA qualified producer and exporter of statins, is the market leader. Other prominent players 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. Among them only a few companies manufacture statins such as lovastatin, simvastatin, atorvastatin, pravastatin and rosuvastatin. Biocon, Ranbaxy, Themis Medicare and Zydus Cadila focus more on exports. India exports statins at more than half of the price compared with that of in regulated markets. However, statin prices in India are not that low. Biocon, which identified statins as the major focus area has successfully developed lovastatin, simvastatin, atorvastatin and pravastatin and has been exporting them to Europe, Japan, Canada, the US markets. A big chunk of Biocons revenue come from these statins. Ranbaxy has been marketing Storvas (atorvastatin), Simvotin (simvastatin), Pravator (pravastatin) and Rovacor (lovastatin). In 2005, Ranbaxy received USFDA approval to manufacture and market Simvastatin Tablets in the US. The Hyderabad based Matrix Laboratories, which acquired a 45 percent stake in Concord Biotech, has USFDA approved facilities for producing lovastatin, pravastatin and simvastatin. During first half of 2005, Zydus Cadila launched a generation statin, pitavastatin under the brand Pitava, which is the latest addition to its family of statins. Zydus Cadila has received approval from the USFDA to market Pravastatin Sodium Tablets in the US market. Themis Medicare signed an agreement with Darou Pakhsh Pharma Chem, (DPPC) of Iran, a government company manufacturing pharmaceutical preparations. Following the agreement, the company supplies statins to DPPC with the technology for producing various biotechnological products. Artemis Biotech, a division of Themis Medicare, is a

producer of lovastatin and some its major customers in India include Alembic Chemicals, Dr Reddys Laboratories, RPG Life Sciences, Sun Pharma, Unichem Laboratories, and Wockhardt. AstraZeneca claims the clinical development program for Crestor as the largest program ever submitted to evaluate a statin initially. In multiple clinical studies, Crestor has been shown to be more effective in lowering LDL-cholesterol than currently prescribed statins, these studies have been published in leading international medical journals. Evidence collected from over 30,000 patients who have taken Crestor demonstrates that it is well tolerated with a safety profile comparable to that of other statins. AstraZeneca is one of the worlds leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. AstraZeneca Pharma India Limited (AZPIL), has products in seven major therapeutic areas Oncology, Cardiovascular, Maternal Healthcare, Gastrointerstinal, Infection, Respiratory & Neuroscience and a world-class manufacturing unit conforming to WHO current Good Manufacturing Practices (cGMP). AstraZeneca India Pvt. Ltd. (AZIPL) also has the centre of excellence established in 1996, an integrated part of the AstraZeneca R&D network, focused on discovering novel drugs or therapies for tuberculosis. In addition, a recently constructed state-of-the-art Process R&D facility, built adjacent to the R&D facility, commenced operations to help AstraZeneca maximize the scientific interactions and enable shared use of the R&D infrastructure.