Will Metabolic Syndrome Emerge as a Commercial Market?DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c61103) has announced the addition of new Decision Resources report Will Metabolic Syndrome metabolic syndrome n. See syndrome X. Metabolic syndrome A group of risk factors for heart disease, diabetes, and stroke. Emerge as a Commercial Market? to their offering. Is metabolic syndrome a disease itself, or merely a grouping of diagnoses that identify a person as being at increased risk for cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease ? Current medical practice, regulatory guidance, and drug development appear to be shifting away from the concept of metabolic syndrome as a discrete condition; rather, aspects of metabolic syndrome -- including diabetes, hypertension, dyslipidemia, and obesity--are beginning to be included as part of an assessment of patients' overall global cardiovascular risk. Drug makers are thus likely to have greater success developing agents for the individual components of metabolic syndrome rather than trying to treat multiple aspects concurrently. Get the Answers Needed to Shape Your Strategy: - The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. recently increased the challenges associated with obtaining approval for an agent for metabolic syndrome, stating that the only way an agent will be approved is if it addresses multiple aspects of the disease. What approaches are drug companies taking to finding agents that effectively treat multiple components of metabolic syndrome? Which companies already have such agents in Phase II and Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials? - DiObex is developing an agent to inhibit cortisol cortisol (kôr`tĭsôl') or hydrocortisone, steroid hormone that in humans is the major circulating hormone of the cortex, or outer layer, of the adrenal gland. production -- the primary glucocorticoid glucocorticoid /glu·co·cor·ti·coid/ (-kor´ti-koid) 1. any of the group of corticosteroids predominantly involved in carbohydrate metabolism, and also in fat and protein metabolism and many other activities (e.g. in humans. Inhibiting cortisol production provides a potential approach to treating both diabetes and metabolic syndrome. What aspect of DiObex's agent should help facilitate the agent's clinical development? - Despite being the only available agent that treats multiple components of metabolic syndrome, Pfizer's Caduet has seen limited uptake. Why aren't physicians prescribing Caduet more frequently? - Currently, type 2 diabetes type 2 diabetes n. See diabetes mellitus. appears to be the indication of focus for most companies developing drugs for metabolic syndrome. Why do companies find type 2 diabetes to be a particularly attractive indication? - 11beta-HSD1, one of the two 11beta-hydroxysteroid dehydrogenase dehydrogenase /de·hy·dro·gen·ase/ (de-hi´dro-jen-as?) an enzyme that catalyzes the transfer of hydrogen or electrons from a donor, oxidizing it, to an acceptor, reducing it. de·hy·dro·gen·ase n. enzymes that regulate the production of cortisol from cortisone cortisone (kôr`tĭsōn'), steroid hormone whose main physiological effect is on carbohydrate metabolism. It is synthesized from cholesterol in the outer layer, or cortex, of the adrenal gland under the stimulation of adrenocorticotropic , is attracting a great deal of attention from pharmaceutical companies. Three 11beta-HSD1 inhibitors are currently confirmed to be in clinical development. Which companies are developing these agents? Which company has reported preliminary results of a Phase II trial that indicated a compound's complete inhibition of 11beta-HSD1? Scope: - The metabolic syndrome controversy: disease definitions, FDA perspective, payer reimbursement issues. - Current treatment options: lifestyle modifications; treatments for obesity, dyslipidemia, hypertension, and insulin resistance Insulin Resistance Definition Insulin resistance is not a disease as such but rather a state or condition in which a person's body tissues have a lowered level of response to insulin, a hormone secreted by the pancreas that helps to regulate the level ; Pfizer's Caduet. - Strategies for drug development: multimodal Two or more modes of operation. The term is used to refer to a myriad of functions and conditions in which two or more different methods, processes or forms of delivery are used. On the Web, it refers to asking for something one way and receiving the answer another; for example requesting approaches and fixed-dose combinations. - The future for metabolic syndrome treatment: FDA requirements for new agents, the shift to a focus on reducing overall cardiovascular risk, the likelihood of new agents being approved, reimbursement challenges, antiobesity agents currently in development, and will metabolic syndrome emerge as a discrete indication? Executive Summary Strategic Considerations Stakeholder Implications Introduction An Overview of Metabolic Syndrome Disease Definition Prevalence Is Metabolic Syndrome a Discrete Disease? Perspective of Regulatory Agencies Perspective of Payers Current Treatment Options FDCs to Treat Dyslipidemia/Hypertension (Pfizer's Caduet) Agents to Treat Obesity Agents to Treat Diabetes Strategies for Developing Agents for Metabolic Syndrome Multimodal Approaches Peroxisome Proliferator-Activated Receptor In cell biology, peroxisome proliferator-activated receptors (PPARs) are a group of nuclear receptor isoforms that exist across biology. They are intimately connected to cellular metabolism (carbohydrate, lipid and protein) and cell differentiation. Agonists Cortisol Modulators Fixed-Dose Combinations What Is the Future for Metabolic Syndrome Treatment? Tables 1. Definitions for Metabolic Syndrome 2. Prevalent Cases of Metabolic Syndrome, 2006 3. Metabolic Syndrome: Current Therapies and 2006 Worldwide Sales 4. Agents in Development to Treat Multiple Components of Metabolic Syndrome 5. Agents in Development to Treat Single Components of Metabolic Syndrome Figures 1. Prevalent Cases of Metabolic Syndrome and Component Diseases in the Seven Major Markets, 2006 2. Prescriptions Attributed to Metabolic Syndrome in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , 2000-2006 3. Disease Targets of Multimodal and Fixed-Dose Combination Agents for Metabolic Syndrome Components Companies Mentioned: - Abbott - Alizyme - Amgen - Amylin - Arena - AstraZeneca - Biovail - Boehringer Ingelheim - Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were - Chenzhen Chipscience - Daiichi-Sankyo - Depomed - Diamedica - DiObex - Eli Lilly - Fournier - GlaxoSmithKline - Glenmark - Incyte - Innodia - Japan Tobacco - King Pharmaceuticals - Kissei - Kyorin - Merck - Merck KGaA - Metabasis - Microbia - Neurosearch - Obecure - Ono - Orexigen - (OSI (1) (Open System Interconnection) An ISO standard for worldwide communications that defines a framework for implementing protocols in seven layers. Control is passed from one layer to the next, starting at the application layer in one station, proceeding to the ) Prosidian - Par Pharmaceuticals - Pfizer - Phenomix - Roche - Sanofi -Aventis - Schering-Plough - Shionogi - Solvay - Speedel - Takeda - Vivus - Wyeth For more information visit http://www.researchandmarkets.com/reports/c61103 |
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