July 17, 2008

Examine the Opportunities With Dyslipidemia in Cardiovascular Risk Reduction

Research and Markets (http://www.researchandmarkets.com/research/8bcf80/dyslipidemia_oppo) has announced the addition of the "Dyslipidemia: Opportunities in Cardiovascular Risk Reduction" report to their offering.

This report deals with the market for drugs used to control blood lipid levels (mainly LDL cholesterol, HDL cholesterol, and triglycerides) in individuals at risk of developing new or worsening cardiovascular disease, i.e. in primary and secondary prevention respectively. These drugs include statins, ezetimibe, fibrates, niacin products, bile acid sequestrants, and prescription omega-3 products. Many clinical trials over the past 30 years or so have shown that treatment with these drugs substantially reduces cardiovascular risk. The report reviews current approaches to treatment, drugs on the market, marketing strategies, lessons learnt from landmark clinical trials, biomarkers, surrogates of atherosclerosis for drug development, and pipeline agents. It also derives market forecasts (2008-2012) and assesses market potential.

Why buy this report?

Buy this report to gain an insight into the performance of statins and other lipid-modulating drugs and commercial implications of post-marketing clinical trials such as ASTEROID and ENHANCE:

1. identify biomarkers and surrogates of atherosclerosis, their potential and limitations in drug development

2. obtain market forecasts for the dyslipidemia market to 2012 by major market segments and geographic areas

3. discover why much of the growth in the dyslipidemia market is forecast to come from non-statin segments, in particular niacins and fibrates

4. be alerted to opportunities presented by the growing challenges of mixed dyslipidemias and undertreated patient subpopulations

5. identify companies developing novel lipid-modulating drugs and the most promising classes of drugs under development

The term "dyslipidemia" refers to abnormal blood lipid values which, individually or in combination, elevate the risk of atherosclerotic vascular disease. Most lipid-related abnormalities can be corrected or at least improved by drug therapy, and many clinical trials over the past 30 years or so have shown that such treatment substantially reduces the risk of developing new or worsening disease of the cardiovascular system. Treatment of dyslipidemia is therefore currently indicated for all patients with cardiovascular disease (secondary prevention) and for some higher-risk individuals without it (primary prevention). This report reviews current approaches to treatment, drugs on the market, marketing strategies, lessons learnt from landmark clinical trials, biomarkers, surrogates of atherosclerosis for drug development, and pipeline agents. It also derives market forecasts and assesses market potential.

We forecast that, if present trends continue, the dyslipidemia market, dominated by statins, will grow slowly from $36 billion in 2007 to $42 billion in 2012. As a proportion of the market, statins will fall from 67% to 44%: most of this decline will occur at the end of the forecast period as Pfizer's Lipitor (atorvastatin), still the world's top-selling medicine, loses patent protection. Generic statins are currently worth less than 20% of the audited statin market by sales volume, but their share is increasing. Much of the growth in the market will come from non-statin segments: niacin, fibrates, and even prescription omega-3 esters. Important new drug types (e.g. CETP inhibitors, Lp-PLA2 inhibitors, HDL mimetics) are in development, but for a variety of reasons are unlikely to be introduced during the forecast period. However, we believe that there are many opportunities for market players to maintain or increase sales in the meantime, e.g. by means of new drug combinations and improved targeting of particular patient subgroups.

Current guidelines focus primarily on treating elevated "bad" LDL cholesterol and secondarily on treating reduced "good" HDL cholesterol and elevated triglycerides. Increasing attention is being paid to aggressive LDL-C management in high-risk patients. Recent trials such as REVERSAL and ASTEROID have suggested that atherosclerosis can be halted, or even reversed, in many patients by such methods. However, the fact remains that therapy focused mainly on LDL-C fails to prevent most cardiovascular events. There are other lipid parameters that could (and arguably should) be targeted as well. Emerging lipid and protein biomarkers enable more accurate diagnosis of dyslipidemia and risk stratification, while vascular imaging technologies enable measurement of atherosclerotic progression and are potentially useful as surrogate endpoints in clinical trials.

Statins are well established as the primary LDL-lowering intervention. Merck & Co/Schering-Plough's ezetimibe also primarily lowers LDL-C and is generally used in combination with statins. We assess the prospects for ezetimibe in the light of the disappointing ENHANCE study, published early in 2008. Although they are less well tolerated, bile acid sequestrants are another alternative or adjunct to statins. Niacin is the most effective drug for raising HDL-C, and also produces some additional degree of LDL lowering when used with statins, but side effects are common. Fibrates are first choice for lowering triglycerides, despite gastrointestinal side-effects.

There is growing interest in combination therapies, because they can address multiple aspects of the lipid profile in mixed dyslipidemias, and there are indications that they produce a synergistic reduction in cardiovascular events. In this situation, fixed-dose combination pills have advantages and disadvantages. For example they are easier for patients to take, but they make dose adjustments more difficult. Several such products are on the market, with increasing numbers in development.

Low HDL-C levels are prevalent and constitute an independent risk factor for CHD. It is increasingly appreciated that raising HDL-C should not be the only objective, but producing HDL particles with better functionality is also an important goal. Of the new small molecule drug categories still in the pipeline, CETP inhibitors appear to have the most potential despite the recent well-publicised withdrawal of torcetrapib following the so-called ILLUMINATE clinical trial. This, however, means that niacin will remain the most potent HDL-raising agent for some time to come, and has led to a renewed interest in more tolerable niacin formulations and niacin/statin combinations.

Promising biopharmaceuticals in the pipeline are injectable HDL mimetics which have produced remarkable effects on the progression and regression of atherosclerosis in preclinical studies. Other lipid modulators in development include therapies which show promise for the treatment of hypertriglyceridemia and mixed dyslipidemias and therapies that may attenuate inflammation associated with atherosclerosis. Since obesity is often associated with lipid abnormalities, particularly hypertriglyceridemia, treatments for obesity that modulate blood lipids are also of interest and are reviewed.

 Key Topics Covered:  - Introduction - Biomarkers and surrogates of atherosclerosis - Improving mainstay therapies - Focus on HDL - Other lipid modulators in development - Market outlook - Market potential  Companies Mentioned:  - 7TM Pharma - Abbott - AbGenomics - Aegerion - Affiris - Alnylam - Amarin - Amgen - Angelini - Arena - Ark Therapeutics - Astellas - AstraZeneca - AtheroGenics - Avanir - Bayer - Bebaas - BioInvent - BioLineRx - Biovitrum - Bristol-Myers Squibb - Celera Genomics - Cerenis - Chipscreen Biosciences - CombinatoRx - Critical Therapeutics - CV Therapeutics - Cytos Biotechnology - CytRx - Daiichi Sankyo - Dainippon Sumitomo Pharma - Dara Biosciences - deCODE genetics - Dr Reddy's Laboratories - Eisai - Elan - Eli Lilly - Exelixis - Ferrer - Forbes Medi-Tech - GalMed Medical Research - Genentech - Genfit - Genzyme - Giaconda - GlaxoSmithKline - GlycoMimetics - Hillcrest Therapeutics - Hollis-Eden Pharmaceuticals - Isis Pharmaceuticals - Japan Tobacco - Johnson & Johnson - Kalypsys - Karo Bio - Kemia - KineMed - Kowa - Kyorin - Lexicon Pharmaceuticals - LifeCycle Pharma - Ligand - Lipid Sciences - Liponex - Martek Biosciences - Merck & Co - Merck KGaA - Metabasis Therapeutics - Metabolex - Metabolic Solutions - Microbia - Millennium - Mitsubishi Tanabe Pharma - Mochida - Napo Pharmaceuticals - NicOx - Nippon Chemiphar - Nippon Shinyaku - Nissan Chemical - Novartis - Numerate - Ono - Orion Pharma - Paladin Labs - Perlecan Pharma - Pfizer - PheneX - Phosphagenics - Pierre Fabre - Plexxikon - Poli - Pronova BioPharma - Protemix - QuatRx - Ranbaxy - ratiopharm - Recordati - Resverlogix - Sanofi-Aventis - Santaris Pharma - Schering-Plough - Sciele Pharma - Scotia Pharmaceuticals - Servier - Shionogi - Solvay - SPA - Surface Logix - Takeda - Targeted Genetics - Teijin - Teva - Theracos - Titan Pharmaceuticals - TransTech Pharma - Vascular Biogenics - VIA Pharmaceuticals - Watson - Wyeth - Yeda - Zydus Cadila 

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