Chemical strucure of simvastatinSales, 2002-2004, as percentage of total during period.Sales, 2002-2004.
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Simvastatin is a hypolipidemic drug belonging to the class of pharmaceuticals called "statins". It is used to control hypercholesterolemia (elevated cholesterol levels) and to prevent cardiovascular disease. more...

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Simvastatin is a synthetic derivate of a fermentation product of Aspergillus terreus.

Uses

Simvastatin is a powerful lipid-lowering drug that can decrease low density lipoprotein (LDL) levels by up to 50%. It is used in doses of 10 mg up to 80 mg. Higher doses (160 mg) have been found to be too toxic, while giving only minimal benefit in terms of lipid lowering. There is no real effect on HDL and triglyceride levels.

From recent research it has become apparent that simvastatin and other statins inhibit the progression of atherosclerosis beyond their effects on LDL. A large number of explanations has been proposed, for example its inhibitory effect on macrophages in the atherosclerotic plaque lesions.

Rationing

Since its introduction, there has been a large debate surrounding the price for lipid-lowering treatment and its benefits on atherosclerosis. Although this has affected the other statins as well, simvastatin was the first statin drug to be used extensively in clinical practice.

A number of large epidemiological studies were conducted to discover which patients would benefit most from statin drugs; most studies involve simvastatin as the study drug. The most influential studies were the Scandinavian Simvastatin Survival Study (4S) and the Heart protection study (HPS).

It has now become apparent that patients with one or more risk factors for cardiovascular disease (such as diabetes mellitus, hypertension or a positive family history) can benefit from statins—even if they do not have substantially elevated cholesterol levels.

Simvastatin was introduced in the late 1980s, and in many countries it is now available as a generic preparation. This has led to a decrease of the price of most statin drugs, and a reappraisal of the health economics of preventive statin treatment.

In the UK, simvastatin (in a dose of 10mg) has recently become available to purchase from pharmacies without prescription.

Pharmacology

All statins act by inhibiting HMG-CoA reductase, the rate-limiting enzyme of the HMG-CoA reductase pathway, the metabolic pathway responsible for the endogenous production of cholesterol.

The drug is the form of an inactive lactone that is hydrolized after ingestion to produce the active agent. It is a white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol.

Marketing

Reference: Drug Discovery Today editorial, 2005

Brand names: Zocor®, Zocor Heart Pro®, marketed by the pharmaceutical company Merck & Co. and Denan (Germany), Liponorm, Sinvacor, Sivastin (Italy), Lipovas (Japan), Lodales (France), Zocord (Austria and Sweden) and other.

Read more at Wikipedia.org


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'Broken' branded pipeline opens new generics pathways
From Drug Store News, 9/26/05 by James Frederick

SAN DIEGO -- A slowdown in sales growth continues to plague the branded pharmaceutical industry, according to an industry expert from IMS Health, leaving the field open for new inroads by generic drug competitors.

Describing pharmaceuticals as a "cyclical business," IMS vice president of industry relations Doug Long noted that a general weakening in sales tot branded drugs had opened the door wider for generic competition.

"When it was very strong, you had a lot of innovation," he said. "And now that it's weak on a dollar basis, what you see is many patent expirations, and that gives generics companies an opportunity to compete."

That competition, he added, is based on price discounting. "The way they compete is on price, and since there are many more generics companies in the game today, the price is going lower and lower and lower.

"That necessitates the branded companies that lost the patent to go back and replace those lost products with new ones," Long noted. "That's the part that's broken right now: They can't replace what they lost with new products in this environment. It's getting tougher, and the FDA is getting more cautious at the same time.

"That means it will be even more expensive to bring drugs to market--and longer. And there will be more burdens after the product is launched until the marketing is available. So it's going to be difficult, and it will be less likely to see as many new products entering the market."

Last year, on the other hand, "was a pretty good year" for branded drug makers, said Long, with 31 new molecular entities approved by the Food and Drug Administration. "Right now, we have 10 [this year]," he noted.

Several trends have put the brakes on growth momentum for branded pharmaceuticals, according to the IMS official. Among them: moderating prices for drugs as cost pressures continue to mount for government and private health plan payers; a delay in new product approvals from the FDA; a general, if temporary, slowdown in prescription utilization; and a weak flu season. Also slowing sales growth is the continued shift of prescription drugs to OTC status and the highly publicized and controversial withdrawals of blockbuster medications like Vioxx over safety concerns.

Ironically, more aggressive efforts by payers and pharmacies to shift patients to generics also have stymied branded pharmaceutical sales growth, said Long.

JAMES FREDERICK

CATEGORY SPECIALIST

COPYRIGHT 2005 Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
COPYRIGHT 2005 Gale Group

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