'CNS Drug Discoveries: What the Future Holds 2008' Identifies 60 Drugs or Therapeutic Agents That Have the Potential to Reach the Market by 2014.DUBLIN Dublin, city, Republic of Ireland Dublin, Irish Baile Átha Cliath, county borough (1991 pop. 915,516), Leinster, capital of the Republic of Ireland, on Dublin Bay at the mouth of the Liffey River. , Ireland Ireland, Irish Eire (âr`ə) [to it are related the poetic Erin and perhaps the Latin Hibernia], island, 32,598 sq mi (84,429 sq km), second largest of the British Isles. -- Research and Markets (http://www.researchandmarkets.com/research/706fd4/cns_drug_discoveri) has announced the addition of the "CNS See Continuous net settlement. CNS See continuous net settlement (CNS). Drug Discoveries: What the Future Holds 2008" report to their offering. A comprehensive examination of 5 CNS therapy areas: multiple sclerosis multiple sclerosis (MS), chronic, slowly progressive autoimmune disease in which the body's immune system attacks the protective myelin sheaths that surround the nerve cells of the brain and spinal cord (a process called demyelination), resulting in damaged areas , Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. , Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. , schizophrenia schizophrenia (skĭt'səfrē`nēə), group of severe mental disorders characterized by reality distortions resulting in unusual thought patterns and behaviors. and depression. The report includes unique market share and sales forecasts Sales forecast A key input to a firm's financial planning process. External sales forecasts are based on historical experience, statistical analysis, and consideration of various macroeconomic factors. by product to 2014, as well as detailed competitor analysis Competitor analysis in marketing and strategic management is an assessment of the strengths and weaknesses of current and potential competitors. Created by Michael Porter competitor analysis focuses on four key aspects: competitor's objectives, competitor's assumptions, of current and upcoming products. With this new 4000+ page analysis you can: -- Easily evaluate and understand the prospects for 60 leading and upcoming products -- Assess the impact on companies of new product introduction -- Understand the impact of generic Generic Describes the characteristics and/or experience of the total universe of a coupon of MBS sector type; that is, in contrast to a specific pool or collateral group, as in a specific CMO issue. competition in key sectors -- Appreciate the drivers and dampeners which will help or hinder hin·der 1 v. hin·dered, hin·der·ing, hin·ders v.tr. 1. To be or get in the way of. 2. To obstruct or delay the progress of. v.intr. market growth -- Review the Phase II product pipeline For each therapy area the report provides: -- Comprehensive Overview -- Patient statistics: -- Prevalence prevalence /prev·a·lence/ (prev´ah-lins) the number of cases of a specific disease present in a given population at a certain time. prev·a·lence n. , diagnosed and treatment rates -- Patient populations in the US, Europe Europe (y  r`əp), 6th largest continent, c.4,000,000 sq mi (10,360,000 sq km) including adjacent islands (1992 est. pop. 512,000,000). and Japan
Growth drivers: -- Risk factors (genetics genetics, scientific study of the mechanism of heredity. While Gregor Mendel first presented his findings on the statistical laws governing the transmission of certain traits from generation to generation in 1856, it was not until the discovery and detailed study of , age, sex), medical guidelines A medical guideline (also called a clinical guideline, clinical protocol or clinical practice guideline) is a document with the aim of guiding decisions and criteria in specific areas of healthcare, as defined by an authoritative examination of current evidence , unmet un·met adj. Not satisfied or fulfilled: unmet demands. clinical need and off-label use Off-label use A drug that is prescribed for uses, periods of time, or at dosages that are not FDA-approved. Mentioned in: Antidepressant Drugs, SSRI off-label use in other CNS disorders A
Growth dampeners: -- Safety issues, label changes, impact of generics, reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. and ethical eth·i·cal adj. 1. Of, relating to, or dealing with ethics. 2. Being in accordance with the accepted principles of right and wrong that govern the conduct of a profession. issues An overview of the value of the CNS market: -- Global sales -- Sales growth to 2014 -- Major players and market share 2007 and 2014 -- Current treatments -- Competitor analysis of leading brands and companies -- Patent exposure -- Sales forecasts by product 2007-2014 Drugs in Phase II/III development: -- Focus on new classes of drugs and companies involved -- Sales forecasts by year of product launch to 2014 Unique competitor ratio analysis: -- Drugs within each sector are analysed in the report using 5 point criteria criteria (krītēr´ē  ),n. for success evaluation Who will be the winners & losers? -- Identify the winners and losers within each sector based on competitor analysis, current pipeline products and market conditions Understand the prospects for this US$92 billion market! The global market for CNS disorders is now one of the largest therapeutic sectors with sales estimated at almost US$92 billion in 2007. In the new edition of this best-selling best·sell·er also best seller n. A product, such as a book, that is among those sold in the largest numbers. best report we have identified 60 drugs or therapeutic agents which we believe have the potential to reach the market by 2014, and could offer significant advancement A gift of money or property made by a person while alive to his or her child or other legally recognized heir, the value of which the person intends to be deducted from the child's or heir's eventual share in the estate after the giver's death. in treatment and address areas of large unmet clinical need. All CNS categories have attracted, and continue to attract, significant investment from the pharmaceutical industry in the development of safer, more efficacious ef·fi·ca·cious adj. Producing or capable of producing a desired effect. See Synonyms at effective. [From Latin effic medicines. In some areas such as depression and schizophrenia, many of the new agents are based on similar chemical classes to existing treatments ("me too"), but may be better tolerated and/or and/or conj. Used to indicate that either or both of the items connected by it are involved. Usage Note: And/or is widely used in legal and business writing. more efficacious. In contrast, other areas such as Parkinson's disease (PD), Alzheimer's disease (AD) and multiple sclerosis (MS) have seen a plethora plethora /pleth·o·ra/ (pleth´ah-rah) 1. an excess of blood. 2. by extension, a red florid complexion.pletho´ric pleth·o·ra n. 1. of innovative medicines emerging that have novel mechanisms of actions. These may lend themselves for use as both monotherapies and in combination with existing therapies in the symptomatic treatment Symptomatic treatment is any medical therapy of a disease that only affects its symptoms, not its cause, i.e., its etiology. It is usually aimed at reducing the signs and symptoms for the comfort and well-being of the patient, but it also may be useful in reducing organic of disease or in some cases in modifying the course of the disease. Several drugs are being developed for multiple indications and this is particularly apparent in depression and schizophrenia where cognitive cog·ni·tive adj. 1. Of, characterized by, involving, or relating to cognition. 2. Having a basis in or reducible to empirical factual knowledge. symptoms are addressed. The majority of companies focus on a diverse range of CNS disorders attempting to address unmet clinical need and large patient populations. However, in some markets such as MS, a handful of companies dominate the market, whilst in AD and PD there are many players, including biotechnology biotechnology, the use of biological processes, as through the exploitation and manipulation of living organisms or biological systems, in the development or manufacture of a product or in the technological solution to a problem. and biopharmaceutical companies, where large specialist sales forces may not be necessary to promote novel medicines. Thorough research, hard-hitting opinion and year-by-year forecasts This report provides a complete review of the markets, products and pipeline prospects for 5 key CNS areas. Firstly, the individual markets, the major players, treatment drivers, market resistors, potential patient populations and unmet clinical needs have been analysed, in addition to which, many therapies and pipeline products currently in Phase II and III development have been evaluated. Secondly, we have reviewed each of the leading brands and potential new brands and identified their key attributes, based on a number of criteria including: -- Novelty/rationale for mechanism of action. -- Proof of concept/clinical data. -- Management/clinical expertise. -- Competition within the marketplace/gaining share of voice through marketing, advertising and sales force ability. -- Risks associated with developing a drug within a therapeutic class. Thirdly, we have established a competitor ratio analysis based on each of the criteria mentioned above. Each criterion attracts an award of up to 10 points, with a maximum score of 50, thus enabling the establishment of an Espicom "ranking table" in each segment of the market, dependent on the drug/company's relative attributes and enabling comparison across therapy areas. Fourthly Fourth´ly adv. 1. In the fourth place. Adv. 1. fourthly - in the fourth place; "fourthly, you must pay the rent on the first of the month" fourth , based on the competitor ratio analysis of each therapeutic section, we have been able to draw conclusions as to which CNS therapy areas receive R&D focus from the leading pharmaceutical companies and which therapy areas are most likely to result in product launches by 2014. Multiple sclerosis With the launch of up to 12 new disease-modifying agents, three vaccines and one novel drug designed to treat the symptoms of multiple sclerosis (MS) and improve quality of life, the MS market is in an exciting phase of evolution. Alzheimer's disease By 2014, there will be considerable change in the Alzheimer's disease (AD) market due to generic competition, better utilisation of acetylcholinesterase inhibitors acetylcholinesterase inhibitor n. See cholinesterase inhibitor. and new product launches which, for the first time, will treat the condition and not the symptoms. Parkinson's disease In 2007, approximately ap·prox·i·mate adj. 1. Almost exact or correct: the approximate time of the accident. 2. US$3.6 billion was spent on the symptomatic treatment of Parkinson's disease (PD). Although this neurodegenerative disease Neurodegenerative disease A disease in which the nervous system progressively and irreversibly deteriorates. Mentioned in: Amnesia affects approximately 1% of the population its prevalence increases with age, thus it is likely to become more commonplace due to patient demographics The attributes of people in a particular geographic area. Used for marketing purposes, population, ethnic origins, religion, spoken language, income and age range are examples of demographic data. and become a greater burden to healthcare payers. Schizophrenia The antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic market generated global sales of US$19.6 billion, accounting for 21% of global CNS sales in 2007. While atypical antipsychotics The atypical anti-psychotics (also known as second generation anti-psychotics) are a class of prescription medications used to treat psychiatric conditions. Some atypical anti-psychotics are FDA approved for use in the treatment of schizophrenia. now account for over 80% of global sales, concerns over safety are leading to a slow down in growth. Depression Antidepressants Antidepressants Medications prescribed to relieve major depression. Classes of antidepressants include selective serotonin reuptake inhibitors (fluoxetine/Prozac, sertraline/Zoloft), tricyclics (amitriptyline/ Elavil), MAOIs (phenelzine/Nardil), and heterocyclics accounted for around 21% of the total CNS drug sales in 2007, with sales of US$19.4 billion. However, we anticipate that within our forecast period to 2014, the market will show negative growth as the emergence of new products is offset by the impact of generics on leading brands. Key Topics Covered: EXECUTIVE SUMMARY 1 Global CNS Market 2007 (US$91.9 billion) 1 Competitor Ratio Analysis Summary 3 Competitor Ratio Analysis - Drugs 4 CNS Drugs Analysed for Launch by 2014 - Therapeutic Category 5 Competitor Ratio Analysis - Companies 6 CNS Drugs Analysed for Launch by 2014 - by Company 6 Pharmaceutical Companies and Products Analysed in this Report 8 Key: 9 ALZHEIMER'S DISEASE 11 EXECUTIVE SUMMARY 11 THE FACTS 12 What is Alzheimer's disease and why are we interested in it? 12 PATIENT STATISTICS 13 Incidence, diagnosis rates and treatment; now and in the future 13 PATIENT MODEL 14 The treatable AD patient population will grow by 2.7 per cent per annum Per annum Yearly. 14 Summary of AD Patient Population Forecasts 2007A-2014E 14 Model Assumptions 14 DRUG GROWTH DRIVERS 15 Potential Diagnostic Biomarkers for AD 15 DRUG GROWTH RISKS/DAMPENERS 16 THE AD MARKET 17 Global CNS Market (US$91.9 billion) 17 AD Global Sales Split (2006) 18 THE MAJOR PLAYERS 19 Market Share of AD Players by Sales (Dec 2007A) 19 PLAYERS AND PRODUCTS IN 2014 20 Market Share of AD Players by Sales (Dec 2014E) 20 CURRENT AD TREATMENTS 21 Leading Brands 22 Comparison of Leading AD Drugs 22 Current Products' Patent Exposure 22 Patent Exposure of Leading AD Brands 23 ANALYSIS OF LEADING BRANDS 24 Acetylcholinesterase acetylcholinesterase /ac·e·tyl·cho·lin·es·ter·ase/ (AChE) (-ko?li-nes´ter-as) an enzyme present in the central nervous system, particularly in nervous tissue, muscle, and red cells, that catalyzes the hydrolysis of acetylcholine to (AChE) Inhibitors 25 Aricept Ar·i·cept A trademark for the drug donepezil hydrochloride. donepezil hydrochloride Aricept Pharmacologic class: Acetylcholinesterase inhibitor Therapeutic class: 25 Novelty/rationale for mechanism of action 25 Proof of concept/clinical data 25 Management/clinical expertise 26 Competition within the marketplace/gaining share of voice 26 Risks associated with developing a drug within a therapeutic class 27 Filings and approvals 27 Sales forecasts and assumptions 28 Competitor ratio analysis 28 Exelon This article is about the Exelon Corporation. See Exelon (drug) for the Alzheimer's medication. Exelon Corporation (NYSE: EXC) is an electricity generating and distributing company headquartered in Chicago. 29 Novelty/rationale for mechanism of action 29 Proof of concept/clinical data 29 Management/clinical expertise 29 Competition within the marketplace/gaining share of voice 29 Risks associated with developing a drug within a therapeutic class 30 Filings and approval 30 Sales forecasts and assumptions 30 Competitor ratio analysis 31 Razadyne 32 Novelty/rationale for mechanism of action 32 Proof of concept/clinical data 32 Management/clinical expertise 33 Competition within the marketplace/gaining share of voice 33 Risks associated with developing a drug within a therapeutic class 33 Filings and approval 34 Sales forecasts and assumptions 34 Competitor ratio analysis 35 NMDA Antagonist NMDA antagonist Neurology Any of a number of agents that protect against brain damage in neurologic disorders–eg, stroke; PCP–phencyclidine and ketamine are effective, but have psychotomimetic effects or damage neurons in the cerebral cortex; diazepam 36 Namenda/Ebixa 36 Novelty/rationale for mechanism of action 36 Proof of concept/clinical data 36 Management/clinical expertise 37 Competition within the marketplace/gaining share of voice 37 Risks associated with developing a drug within a therapeutic class 38 Filings and approval 38 Sales forecasts and assumptions 38 Competitor ratio analysis 39 GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A - 2014E 40 Sales Forecasts of Current Leading AD Drugs 40 Model Assumptions 40 NEW DRUGS IN R&D 42 Drugs in Development to Treat AD 42 ANALYSIS OF 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 DRUGS 45 New Drugs in Phase III Development to Treat AD 45 Bapineuzumab Bapineuzumab is a humanized monoclonal antibody which acts on the nervous system and has potential therapeutic value for the treatment of Alzheimer's disease and quite possibly Glaucoma [1]. 45 Novelty/rationale for mechanism of action 45 Proof of concept/clinical data 45 Management/clinical expertise 46 Competition within the marketplace/gaining share of voice 46 Risks associated with developing a drug within a therapeutic class 47 Filings and approval 47 Sales forecasts and assumptions 47 Competitor ratio analysis 47 Flurizan 48 Novelty/rationale for mechanism of action 48 Proof of concept/clinical data 48 Management/clinical expertise 48 Competition within the marketplace/gaining share of voice 49 Risks associated with developing a drug within a therapeutic class 49 Filings and approval 49 Sales forecasts and assumptions 49 Competitor ratio analysis 49 LY450139 50 GLOBAL SALES FORECASTS OF PHASE III AD DRUGS 20011E - 2014E 51 Sales Forecasts of Phase III Developmental AD Drugs 51 Model Assumptions 51 ANALYSIS OF PHASE II DRUGS 52 Drugs in Phase II Development to Treat AD 52 CX717 53 EVT EVT Eventueel (Danish: Maybe) EVT Extreme Value Theory (prediction tool for extrapolation of trend graphs) EVT Embedded Visual Tools EVT Emergency Vehicle Technician EVT Erstverkaufstag 101 53 Ketasyn 54 MEM (MicroElectroMechanical) See MEMS. 1003 55 MEM 3454 55 PBT PBT Provider Backbone Transport (networking technology adding determinism to ethernet) PBT Polybutylene Terephthalate PBT Profit Before Tax PBT Paper Based Test (education) 2 56 COMPETITOR RATIO ANALYSIS 57 COMPETITOR RATIO ANALYSIS - PRODUCTS 58 CR Analysis of AD Agents Approved by 2014 - Based on Drug Class 58 COMPETITOR RATIO ANALYSIS - COMPANIES 59 CR Analysis of AD and PD Agents Approved by 2014 - Based on Company 59 WINNERS & LOSERS 60 Summary of Key Companies and Drugs in the AD Market by 2014 60 DISCONTINUATION dis·con·tin·u·a·tion n. A cessation; a discontinuance. Noun 1. discontinuation - the act of discontinuing or breaking off; an interruption (temporary or permanent) discontinuance OF DRUGS 61 AD Drugs Discontinued dis·con·tin·ue v. dis·con·tin·ued, dis·con·tin·u·ing, dis·con·tin·ues v.tr. 1. To stop doing or providing (something); end or abandon: from Clinical Development 61 AD APPENDIX appendix, small, worm-shaped blind tube, about 3 in. (7.6 cm) long and 1-4 in. to 1 in. (.64–2.54 cm) thick, projecting from the cecum (part of the large intestine) on the right side of the lower abdominal cavity. 1 62 Phase Transition Probability probability, in mathematics, assignment of a number as a measure of the "chance" that a given event will occur. There are certain important restrictions on such a probability measure. 62 Probability of Launch 62 AD APPENDIX 2 63 AD Patient Model 63 Summary of AD Patient Population Forecasts 63 AD APPENDIX 3 64 Global AD Drugs Sales 2007A-2014E 64 Global AD Drug Sales 2007A-2014E 64 AD APPENDIX 4 65 Competitor Ratio Analysis Criteria 65 Key AD Drugs on the Market by 2014 65 ALZHEIMER'S DISEASE GLOSSARY A term used by Microsoft Word and adopted by other word processors for the list of shorthand, keyboard macros created by a particular user. See glossaries in this publication and The Computer Glossary. 66 ALZHEIMER'S DISEASE REFERENCES 70 ACRONYMS ACRONYMS A Crazy Roundup of Nonsense You Must See (website) ACRONYMS A Common Representation Of Names You Must Shorten ACRONYMS A Cryptic Rendition Of Names You Might See :-) 72 Multiple Sclerosis 73 EXECUTIVE SUMMARY 73 THE FACTS 74 What is multiple sclerosis and why are we interested in it? 74 PATIENT STATISTICS 76 Incidence, diagnosis rates and treatment; now and in the future 76 MS Categories 77 Types of MS 78 PATIENT MODEL 79 The treatable MS patient population will have a CAGR CAGR See: Compound Annual Growth Rate 2007E-2014E - 2.5 per cent 79 Summary of Patient Population Forecasts (2007A-2014E) 79 Model Assumptions 79 DRUG GROWTH DRIVERS 80 DRUG GROWTH RISKS/DAMPENERS 82 THE MS MARKET 83 Global CNS Market (US$91.9 billion) 83 The Major Players 84 Market Share of Major MS Players by Sales (Dec 2007A) 84 Players and Products in 2007 85 Players and Products in 2014 86 CURRENT MS TREATMENTS 88 Leading Brands 89 Comparison of Leading MS Agents 89 Current Products' Patent Exposure 90 Patent Exposure of Leading MS Brands 91 ANALYSIS OF LEADING BRANDS 92 Disease-modifying Agents 93 Avonex 93 Novelty/rationale for mechanism of action 93 Proof of concept/clinical data 93 Management/clinical expertise 94 Competition within the market-place/gaining share of voice 94 Risks associated with developing a drug within a therapeutic class 95 Filings and approval 95 Sales forecasts and assumptions 95 Competitor ratio analysis 96 Betaferon/Betaseron 97 Novelty/rationale for mechanism of action 97 Proof of concept/clinical data 97 Management/clinical expertise 98 Competition within the market-place/gaining share of voice 99 Risks associated with developing a drug within a therapeutic class 99 Filings and approval 100 Sales forecasts and assumptions 100 Competitor ratio analysis 101 Copaxone Copaxone® Glatiramer acetate, copolymer-1 Therapeutics A noninterferon, nonsteroidal agent that ↓ relapses in Pts with multiple sclerosis. See Multiple sclerosis. 102 Novelty/rationale for mechanism of action 102 Proof of concept/clinical data 102 Management/clinical expertise 103 Competition within the market-place/gaining share of voice 103 Risks associated with developing a drug within a therapeutic class 104 Filings and approval 105 Sales forecasts and assumptions 105 Competitor ratio analysis 106 Rebif 107 Novelty/rationale for mechanism of action 107 Proof of concept/clinical data 107 Management/clinical expertise 108 Competition within the market-place/gaining share of voice 108 Risks associated with developing a drug within a therapeutic class 109 Filings and approval 109 Competitor ratio analysis 110 Tysabri 111 Novelty/rationale for mechanism of action 111 Proof of concept/clinical data 111 Management/clinical expertise 112 Competition within the market-place/gaining share of voice 113 Risks associated with developing a drug within a therapeutic class 113 Filings and approval 114 Sales forecasts and assumptions 114 Competitor ratio analysis 115 Novantrone Novantrone® Mitoxantrone, see there 116 Novelty/rationale for mechanism of action 116 Proof of concept/clinical data 116 Management/clinical expertise 116 Competition within the market-place/gaining share of voice 117 Risks associated with developing a drug within a therapeutic class 117 Filings and approval 117 Sales forecasts and assumptions 118 Competitor ratio analysis 118 GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A-2014E 119 Sales Forecasts of Current Leading MS Drugs 119 Model Assumptions 119 NEW DRUGS IN R&D 121 Drugs in Development to Treat MS 121 ANALYSIS OF PHASE III DRUGS 123 New Drugs in Phase III Development to Treat MS 123 Disease-modifying Agents 124 BG-12 124 Novelty/rationale for mechanism of action 124 Proof of concept/clinical data 124 Management/clinical expertise 124 Competition within the market-place/gaining share of voice 124 Risks associated with developing a drug within a therapeutic class 125 Filings and approval 125 Sales forecasts and assumptions 125 Competitor ratio analysis 126 Campath Campath® Oncology A humanized monoclonal antibody to leukocyte antigen CD52, used to manage CLL refractory to standard therapies; it is expressed on lymphocytes and monocytes, but not hematopoietic stem cells 127 Novelty/rationale for mechanism of action 127 Proof of concept/clinical data 127 Management/clinical expertise 127 Competition within the market-place/gaining share of voice 128 Risks associated with developing a drug within a therapeutic class 128 Filings and approval 129 Sales forecasts and assumptions 129 Competitor ratio analysis 129 Fingolimod 130 Novelty/rationale for mechanism of action 130 Proof of concept/clinical data 130 Management/clinical expertise 130 Competition within the market-place/gaining share of voice 131 Risks associated with developing a drug within a therapeutic class 131 Filings and approval 131 Sales forecasts and assumptions 132 Competitor ratio analysis 132 Laquinimod Laquinimod is an immunomodulator developed by Active Biotech and produced by Teva Pharmaceutical Industries. It is currently under development in phase III trials for treatment of multiple sclerosis as an oral therapy, like fingolimod. 133 Novelty/rationale for mechanism of action 133 Proof of concept/clinical data 133 Management/clinical expertise 133 Competition within the market-place/gaining share of voice 134 Risks associated with developing a drug within a therapeutic class 134 Filings and approval 135 Sales forecasts and assumptions 135 Competitor ratio analysis 135 MBP (Manchester Bus Powered) A synchronous transmission standard used in industrial networks. It provides 31.25 Kbps over a two-wire connection that delivers power in the bus and intrinsic safety. 8298 136 Novelty/rationale for mechanism of action 136 Proof of concept/clinical data 136 Management/clinical expertise 136 Competition within the market-place/gaining share of voice 137 Risks associated with developing a drug within a therapeutic class 137 Filings and approval 137 Sales forecasts and assumptions 138 Competitor ratio analysis 138 Mylinax 139 Novelty/rationale for mechanism of action 139 Proof of concept/clinical data 139 Management/clinical expertise 139 Competition within the market-place/gaining share of voice 140 Risks associated with developing a drug within a therapeutic class 140 Filings and approval 141 Sales forecasts and assumptions 141 Competitor ratio analysis 141 Teriflunomide 142 Novelty/rationale for mechanism of action 142 Proof of concept/clinical data 142 Management/clinical expertise 142 Competition within the market-place/gaining share of voice 142 Risks associated with developing a drug within a therapeutic class 143 Filings and approval 143 Sales forecasts and assumptions 143 Competitor ratio analysis 144 MS Symptoms 145 Neurelan 145 Novelty/rationale for mechanism of action 145 Proof of concept/clinical data 145 Trial MS-F202: Timed 25-foot Walk Response Rate of MS Patients Treated with Fampridine SR 146 Management/clinical expertise 146 Competition within the market-place/gaining share of voice 147 Risks associated with developing a drug within a therapeutic class 147 Filings and approval 147 Sales forecasts and assumptions 147 Competitor ratio analysis 148 GLOBAL SALES FORECASTS OF PHASE III MS DRUGS 2009E-2014E 149 Sales Forecasts of Phase III Developmental MS Drugs 149 Model Assumptions 149 ANALYSIS OF PHASE II DRUGS 150 New Drugs in Early Clinical Development to Treat MS 150 Disease-modifying Agents 152 ATL (Active Template Library) A set of software routines from Microsoft that provide the basic framework for creating ActiveX and COM objects. Stemming from the standard template library (STL) that comes with C++ compilers, ATL includes an object wizard that sets up 1102/TV1102 152 Novelty/rationale for mechanism of action 152 Proof of concept/clinical data 152 Management/clinical expertise 152 Competition within the market-place/gaining share of voice 153 Risks associated with developing a drug within a therapeutic class 153 Filings and approval 153 Sales forecasts and assumptions 153 Competitor ratio analysis 154 CDP CDP (cytidine diphosphate): see cytosine. (1) (Certificate in Data Processing) An earlier award for the successful completion of an examination in hardware, software, systems analysis, programming, management and accounting, 323 155 Novelty/rationale for mechanism of action 155 Proof of concept/clinical data 155 Management/clinical expertise 155 Competition within the market-place/gaining share of voice 155 Risks associated with developing a drug within a therapeutic class 156 Filings and approval 156 Sales forecasts and assumptions 156 Competitor ratio analysis 157 Daclizumab daclizumab /da·cliz·u·mab/ (dah-kliz´u-mab) an immunosuppressant used to prevent acute organ rejection in renal transplant patients. 158 Novelty/rationale for mechanism of action 158 Proof of concept/clinical data 158 Management/clinical expertise 158 Competition within the market-place/gaining share of voice 159 Risks associated with developing a drug within a therapeutic class 159 Filings and approval 160 Sales forecasts and assumptions 160 Competitor ratio analysis 160 Firategrast 161 Novelty/rationale for mechanism of action 161 Proof of concept/clinical data 161 Management/clinical expertise 161 Competition within the market-place/gaining share of voice 162 Risks associated with developing a drug within a therapeutic class 162 Filings and approval 162 Sales forecasts and assumptions 162 Competitor ratio analysis 163 Ibudilast 164 Novelty/rationale for mechanism of action 164 Proof of concept/clinical data 164 Management/clinical expertise 164 Competition within the market-place/gaining share of voice 164 Risks associated with developing a drug within a therapeutic class 165 Filings and approval 165 Sales forecasts and assumptions 165 Competitor ratio analysis 165 Vaccines 166 BHT-3009 166 Novelty/rationale for mechanism of action 166 Proof of concept/clinical data 166 Management/clinical expertise 166 Competition within the market-place/gaining share of voice 167 Risks associated with developing a drug within a therapeutic class 167 Filings and approval 167 Sales forecast and assumptions 167 Competitor ratio analysis 167 NeuroVax Neurovax is a vaccine designed to treat patients with Multiple Sclerosis (M.S.). Developed by Orchestra Therapeutics, it is currently in phase II clinical trials. Neurovax is designed to stimulate FOXP3+ regulatory T-cells that can then suppress the autoreactive T-cells in some 168 Novelty/rationale for mechanism of action 168 Proof of concept/clinical data 168 Management/clinical expertise 168 Competition within the market-place/gaining share of voice 169 Risks associated with developing a drug within a therapeutic class 169 Filings and approval 169 Sales forecasts and assumptions 169 Competitor ratio analysis 169 Tovaxin Tovaxin is a novel anti-T-cell therapeutic vaccine that parallels the concept of autologous cancer vaccines. Instead of modifying cancerous cells, TovaxinTM consists of attenuated autoreactive T cells. 170 Novelty/rationale for mechanism of action 170 Proof of concept/clinical data 170 Management/clinical expertise 171 Competition within the market-place/gaining share of voice 171 Risks associated with developing a drug within a therapeutic class 171 Filings and approval 171 Sales forecasts and assumptions 171 Competitor ratio analysis 172 GLOBAL SALES FORECASTS OF PHASE II MS DRUGS 2011E - 2014E 173 Sales Forecasts of Phase II Developmental MS Drugs 173 Model Assumptions 173 COMPETITOR RATIO ANALYSIS 174 COMPETITOR RATIO ANALYSIS - PRODUCTS 175 CR Analysis of MS Agents Approved by 2014 - Based on Drug Class 176 COMPETITOR RATIO ANALYSIS - COMPANIES 177 CR Analysis of MS Agents Approved by 2014 - Based on Company 178 WINNERS & LOSERS 179 Summary of Key Companies and Drugs in the MS Market by 2014 179 DISCONTINUATION OF DRUGS 182 MS Drugs Discontinued from Clinical Development 182 MS APPENDIX 1 184 Clinical Diagnostic Test for MS 184 MS APPENDIX 2 186 Expanded Disability Status Scale The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.[1] The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. (EDSS EDSS Expanded Disability Status Scale EDSS Equine Digit Support System EDSS Executive Decision Support System EDSS Equipment Deployment and Storage System EDSS Electronic Document Storage System EDSS Electronic Data Storage System EDSS Electronic Document Submission System ) 186 MS APPENDIX 3 188 Phase Transition Probability 188 Probability of Launch 188 MS APPENDIX 4 189 MS Patient Model 189 Summary of US MS Patient Population Forecasts 189 Summary of Europe (Top 5) MS Patient Population Forecasts 190 Summary of Japan MS Patient Population Forecasts 190 MS APPENDIX 5 191 Global MS Drugs Sales 2007A-2014E 191 Global MS Drug Sales 2007A-2014E 191 MS APPENDIX 6 193 Competitor Ratio Analysis Criteria 193 Key MS Drugs on the Market by 2014 193 MS GLOSSARY 194 MS REFERENCES 199 ACRONYMNS 200 DEPRESSION 201 EXECUTIVE SUMMARY 201 THE FACTS 202 What is depression and why are we interested in it? 202 PATIENT STATISTICS 203 Incidence, diagnosis rates and treatment; now and in the future 203 PATIENT MODEL 204 Summary of Depression Patient Population Forecasts in Seven Major Markets (2007E-2014E) 204 Model Assumptions 205 DRUG GROWTH DRIVERS 206 DRUG GROWTH RISKS/DAMPENERS 208 THE ANTIDEPRESSANT antidepressant, any of a wide range of drugs used to treat psychic depression. They are given to elevate mood, counter suicidal thoughts, and increase the effectiveness of psychotherapy. MARKET 209 Global CNS Market 2007 (US$91.9 billion) 209 Global Sales Split by Drug Class (2007A) 210 Global Sales Split by Region (2006) 210 The Major Players Products in 2007 211 Market Share of Antidepressant Players by Sales (Dec 2007A) 212 The Major Players and Products in 2014 213 Market Share of Antidepressant Players by Sales (Dec 2014E) 214 CURRENT TREATMENTS 215 Leading Brands 215 Comparison of Leading Antidepressant Drugs Antidepressant Drugs Definition Antidepressant drugs are medicines that relieve symptoms of depressive disorders. Purpose Depressive disorders may either be unipolar (depression alone) or bipolar (depression alternating with periods of 216 Current Products' Patent Exposure 217 Patent Exposure of Leading Antidepressant Brands 217 ANALYSIS OF LEADING BRANDS 218 Selective Serotonin Reuptake Inhibitors Selective Serotonin Reuptake Inhibitors Definition Selective serotonin reuptake inhibitors are medicines that relieve symptoms of depression. Purpose (SSRIs SSRIs Selective serotonin reuptake inhibitors, a class of medication used to treat depression. Mentioned in: Erectile Dysfunction ) 219 Lexapro/Cipralex 219 Novelty/rationale for mechanism of action 219 Proof of concept/clinical data 219 Management/clinical expertise 220 Competition within the market-place/gaining share of voice 220 Risks associated with developing a drug within a therapeutic class 221 Filings and approval 221 Sales forecasts and assumptions 222 Competitor ratio analysis 222 Prozac Prozac, trade name for fluoxetine hydrochloride. See antidepressant. Prozac First of the class of antidepressant drugs called selective serotonin reuptake inhibitors (SSRIs), generic name fluoxetine hydrochloride. 223 Novelty/rationale for mechanism of action 223 Proof of concept/clinical data 223 Management/clinical expertise 223 Competition within the market-place/gaining share of voice 223 Risks associated with developing a drug within a therapeutic class 224 Filings and approval 224 Sales forecasts and assumptions 225 Competitor ratio analysis 225 Seroxat/Paxil 226 Novelty/rationale for mechanism of action 226 Proof of concept/clinical data 226 Management/clinical expertise 226 Competition within the market-place/gaining share of voice 227 Risks associated with developing a drug within a therapeutic class 227 Filings and approval 228 Sales forecasts and assumptions 228 Competitor ratio analysis 229 Zoloft Zo·loft A trademark for the serotonin-inhibiting antidepressant sertraline hydrochloride. sertraline hydrochloride Lustral (UK), Zoloft Pharmacologic class: 230 Novelty/rationale for mechanism of action 230 Proof of concept/clinical data 230 Management/clinical expertise 230 Competition within the market-place/gaining share of voice 231 Risks associated with developing a drug within a therapeutic class 231 Filings and approval 231 Sales forecasts and assumptions 232 Competitor ratio analysis 232 Serotonin serotonin (sĕr'ətō`nĭn), organic compound that was first recognized as a powerful vasoconstrictor occurring in blood serum. It was partially purified, crystallized, and named in 1948, and its structure was deduced a year later. and Noradrenaline noradrenaline /nor·adren·a·line/ (nor?ah-dren´ah-lin) norepinephrine. noradrenaline (nōrˈ· Reuptake reuptake /re·up·take/ (re-up´tak) reabsorption of a previously secreted substance. re·up·take n. Inhibitors (SNRIs) 233 Cymbalta 233 Novelty/rationale for mechanism of action 233 Proof of concept/clinical data 233 Management/clinical expertise 234 Competition within the market-place/gaining share of voice 234 Risks associated with developing a drug within a therapeutic class 235 Filings and approval 235 Sales forecasts and assumptions 235 Competitor ratio analysis 236 Effexor Ef·fex·or A trademark for the drug venlafaxine hydrochloride. venlafaxine hydrochloride Efexor (UK), Effexor, Effexor XR Pharmacologic class: Phenethylamine derivative 237 Novelty/rationale for mechanism of action 237 Proof of concept/clinical data 237 Management/clinical expertise 237 Competition within the market-place/gaining share of voice 238 Risks associated with developing a drug within a therapeutic class 238 Filings and approval 239 Sales forecasts and assumptions 239 Competitor ratio analysis 240 Pristiq 241 Novelty/rationale for mechanism of action 241 Proof of concept/clinical data 241 Management/clinical expertise 241 Competition within the market-place/gaining share of voice 241 Risks associated with developing a drug within a therapeutic class 242 Filings and approval 242 Sales forecasts and assumptions 242 Competitor ratio analysis 243 Noradrenaline and Dopamine Reuptake Inhibitors Dopamine Reuptake Inhibitors (DARI), Dopamine Uptake Inhibitors, Dopamine Transporter Inhibitors are compounds that inhibit the reuptake of extracellular dopamine back into the presynaptic cell by blocking the cell membrane-spanning dopamine transporter. (NDRIs) 244 Wellbutrin Well·bu·trin A trademark for the drug bupropion hydrochloride, used to treat depression. bupropion hydrochloride Budeprion SR, Budeprion XL, Wellbutrin, Wellbutrin SR, Wellbutrin XL, Zyban 244 Novelty/rationale for mechanism of action 244 Proof of concept/clinical data 244 Management/clinical expertise 245 Competition within the market-place/gaining share of voice 245 Risks associated with developing a drug within a therapeutic class 245 Filings and approval 246 Sales forecasts and assumptions 246 Competitor ratio analysis 246 GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A - 2014E 247 Sales Forecasts of Current Leading Antidepressant Drugs 247 Model Assumptions 248 NEW DRUGS IN R&D 249 Drugs in Development to Treat Depression and Anxiety Related Disorders 249 ANALYSIS OF PHASE III DRUGS 251 New Drugs in Phase III Development to Treat Depression and Anxiety 251 Neurokinin neurokinin (A) (n  Receptor Antagonist A receptor antagonist is a drug that does not provoke a biological response itself upon binding to a receptor, but blocks or attenuates agonist-mediated responses. It may be competitive (or surmountable), i.e. 251
Saredutant Saredutant, or SR 48968, is a neurokinin-2 antagonist drug being developed as an antidepressant and anxiolytic by sanofi-aventis. Its mechanism of action is different from antidepressants currently available on the market. 251 Novelty/rationale for mechanism of action 251 Proof of concept/clinical data 252 Management/clinical expertise 252 Competition within the market-place/gaining share of voice 252 Risks associated with developing a drug within a therapeutic class 252 Filings and approval 253 Sales forecasts and assumptions 253 Competitor ratio analysis 253 Melatonergic Receptor receptor /re·cep·tor/ (-ter) 1. a molecule on the surface or within a cell that recognizes and binds with specific molecules, producing a specific effect in the cell; e.g. Agonist agonist /ag·o·nist/ (ag´ah-nist) 1. one involved in a struggle or competition. 2. agonistic muscle. 3. 254 Valdoxan 254 Novelty/rationale for mechanism of action 254 Proof of concept/clinical data 254 Management/clinical experience 254 Competition within the market-place/gaining share of voice 254 Risks associated with developing a drug within a therapeutic class 255 Filings and approval 255 Sales forecasts and assumptions 255 Competitor ratio analysis 255 Other Late-Phase Drugs 256 Amibegron 256 Seroquel Ser·o·quel A trademark for the drug quetiapine fumarate. quetiapine fumarate Seroquel Pharmacologic class: Dibenzothiazepine derivative Therapeutic class: 256 Vilazodone 256 GLOBAL SALES FORECASTS OF PHASE III ANTIDEPRESSANT AND ANTI-ANXIETY DRUGS 2009E - 2014E 258 Sales Forecasts of Phase III Developmental Drugs for Depression and Anxiety 258 Model Assumptions 258 ANALYSIS OF PHASE II DRUGS 259 New Drugs in Early Clinical Development to Treat Depression and Anxiety 259 Triple Uptake uptake /up·take/ (up´tak) absorption and incorporation of a substance by living tissue. up·take n. Inhibitor inhibitor /in·hib·i·tor/ (in-hib´i-tor) 1. any substance that interferes with a chemical reaction, growth, or other biologic activity. 2. 260 NS2359 260 Novelty/rationale for mechanism of action 260 Proof of concept/clinical data 260 Management/clinical expertise 261 Competition within the market-place/gaining share of voice 262 Risks associated with developing a drug within a therapeutic class 262 Filings and approval 262 Sales forecasts and assumptions 262 Competitor ratio analysis 263 Other Phase II Drugs of Interest 264 DOV DOV Data-Over-Voice DOV Degree of Variation DOV Defenders of Valor (gaming group) DOV Disbursing Officer Voucher DOV Director of Orbital Verification (Hubble Telescope) DOV Diaphragm-Operated Valve 21,947 264 MN-305 264 GLOBAL SALES FORECASTS OF PHASE II ANTIDEPRESSANT DRUGS 2010E - 2014E 265 Sales Forecasts of Phase II Developmental Antidepressant Drugs 265 Model Assumptions 265 COMPETITOR RATIO ANALYSIS 266 COMPETITOR RATIO ANALYSIS - PRODUCTS 267 CR Analysis of Antidepressant Agents Approved by 2014 - Based on Drug Class 268 COMPETITOR RATIO ANALYSIS - COMPANIES 269 CR Analysis of Antidepressant Agents Approved by 2014 - Based on Company 269 WINNERS & LOSERS 270 Summary of Key Companies and Drugs in the Antidepressant Market by 2014 270 Winners 270 Losers 271 DISCONTINUATION OF DRUGS 272 Antidepressants/Anxiolytics Discontinued from Clinical Development 272 DEPRESSION APPENDIX 1 274 Assessment of Depression Criteria 274 DEPRESSION APPENDIX 2 275 Phase Transition Probability 275 Probability of Launch 275 DEPRESSION APPENDIX 3 276 Patient Model 276 Summary of US Depression and Anxiety Patient Population Forecasts 276 Summary of Europe (Top 5) Depression and Anxiety Patient Population Forecasts 277 Summary of Japanese Japanese (jăp'ənēz`), language of uncertain origin that is spoken by more than 125 million people, most of whom live in Japan. There are also many speakers of Japanese in the Ryukyu Islands, Korea, Taiwan, parts of the United States, and Depression and Anxiety Patient Population Forecasts 278 DEPRESSION APPENDIX 4 279 Global Antidepressant Drugs Sales 2007A-20014E 279 DEPRESSION APPENDIX 5 280 Competitor Ratio Analysis Criteria 280 Key Antidepressant/Anxiolytic Drugs on the Market by 2014 280 DEPRESSION GLOSSARY 281 DEPRESSION REFERENCES 286 ACRONYMS 287 Parkinson's Disease 289 EXECUTIVE SUMMARY 289 THE FACTS 290 What is Parkinson's disease and why are we interested in it? 290 PATIENT STATISTICS 291 Incidence, diagnosis rates and treatment; now and in the future 291 PATIENT MODEL 292 The treated PD patient population will grow by 3.6 per cent per annum 292 Summary of PD Patient Population Forecasts 2007A-2014E 292 Model Assumptions 292 DRUG GROWTH DRIVERS 293 Potential Diagnostic Biomarkers for PD 293 DRUG GROWTH RISKS/DAMPENERS 294 THE PD MARKET 295 Global CNS Market 2007 (US$91.9 billion) 295 PD Global Sales Split (2006) 296 The Major Players 296 Market Share of PD Players by Sales (Dec 2007A) 297 Players and Products in 2014 297 Market Share of PD Players by Sales (Dec 2014E) 298 CURRENT PD TREATMENTS 299 Leading Brands 300 Comparison of Leading PD Drug Classes 301 Current Products' Patent Exposure 302 Patent Exposure of Leading PD Brands 302 ANALYSIS OF LEADING BRANDS 303 Dopamine Agonists A dopamine agonist is a compound that activates dopamine receptors, mimicking the effect of the neurotransmitter dopamine. Uses Some medical drugs act as dopamine agonists; they are typically used for treating Parkinson's disease, and may be useful for restless legs 304 Apokyn 304 Novelty/rationale for mechanism of action 304 Proof of concept/clinical data 304 Management/clinical expertise 304 Competition within the market-place/gaining share of voice 305 Risks associated with developing a drug within a therapeutic class 305 Filings and approval 305 Sales forecasts and assumptions 305 Competitor ratio analysis 306 Neupro 307 Novelty/rationale for mechanism of action 307 Proof of concept/clinical data 307 Clinical Endpoint In a research trial, a clinical endpoint refers to a disease, symptom, or sign that constitutes one of the target outcomes of the trial. The results of a clinical trial generally indicate the number of people enrolled who reached the pre-determined clinical endpoint during the of Phase III trials with Neupro 1) Europe 2) the US 307 Management/clinical expertise 308 Competition within the market-place/gaining share of voice 308 Risks associated with developing a drug within a therapeutic class 308 Filings and approval 309 Sales forecasts and assumptions 309 Competitor ratio analysis 310 Sifrol/Mirapex/Mirapexin 311 Novelty/rationale for mechanism of action 311 Proof of concept/clinical data 311 Management/clinical expertise 311 Competition within the market-place/gaining share of voice 311 Risks associated with developing a drug within a therapeutic class 312 Filings and approval 312 Sales forecasts and assumptions 313 Competitor ratio analysis 313 Requip Requip® Ropinirole Pharmacology A 2nd-generation dopamine agonist for treating Parkinson's disease. See Parkinson's disease. 314 Novelty/rationale for mechanism of action 314 Proof of concept/clinical data 314 Management/clinical expertise 314 Competition within the market-place/gaining share of voice 314 Risks associated with developing a drug within a therapeutic class 315 Filings and approval 315 Sales forecasts and assumptions 315 Competitor ratio analysis 316 Monoamine Oxidase Inhibitors Monoamine Oxidase Inhibitors Definition Monoamine oxidase inhibitors (MAO inhibitors) are medicines that relieve certain types of mental depression. 317 Azilect 317 Novelty/rationale for mechanism of action 317 Proof of concept/clinical data 317 Management/clinical expertise 318 Competition within the market-place/gaining share of voice 318 Risks associated with developing a drug within a therapeutic class 318 Filings and approval 319 Sales forecasts and assumptions 319 Competitor ratio analysis 319 Catechol-O-Methyltransferase Inhibitors 320 Comtan/Comtess/Stalevo 320 Novelty/rationale for mechanism of action 320 Proof of concept/clinical data 320 Management/clinical expertise 320 Competition within the market-place/gaining share of voice 321 Risks associated with developing a drug within a therapeutic class 321 Filings and approval 321 Sales forecasts and assumptions 321 Competitor ratio analysis 322 GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A - 2014E 323 Sales Forecasts of Current Leading PD Drugs 323 Model Assumptions 324 NEW DRUGS IN R&D 325 Drugs in Development to Treat PD 325 ANALYSIS OF LATE-PHASE DRUGS 327 New Drugs in Phase III Development to Treat PD 327 Istradefylline 328 Novelty/rationale for mechanism of action 328 Proof of concept/clinical data 328 Management/clinical expertise 328 Competition within the market-place/gaining share of voice 328 Risks associated with developing a drug within a therapeutic class 329 Filings and approval 329 Sales forecasts and assumptions 330 Competitor ratio analysis 330 Pardoprunox 331 Novelty/rationale for mechanism of action 331 Proof of concept/clinical data 331 Management/clinical expertise 332 Competition within the market-place/gaining share of voice 332 Risks associated with developing a drug within a therapeutic class 332 Filings and approval 332 Sales forecasts and assumptions 332 Competitor ratio analysis 333 Safinamide 334 Novelty/rationale for mechanism of action 334 Proof of concept/clinical data 334 Management/clinical expertise 335 Competition within the market-place/gaining share of voice 335 Risks associated with developing a drug within a therapeutic class 336 Filings and approval 336 Sales forecasts and assumptions 336 Competitor ratio analysis 337 GLOBAL SALES FORECASTS OF LATE-PHASE PD DRUGS 2009E - 2014E 338 Sales Forecasts of Late-Phase Developmental PD Drugs 338 Model Assumptions 338 ANALYSIS OF PHASE II DRUGS 339 New Drugs in Early Clinical Development to Treat PD 339 Spheramine 341 Novelty/rationale for mechanism of action 341 Proof of concept/clinical data 341 Management/clinical expertise 341 Competition within the market-place/gaining share of voice 342 Risks associated with developing a drug within a therapeutic class 342 Filings and approval 342 Sales forecasts and assumptions 342 Competitor ratio analysis 343 VR040 344 COMPETITOR RATIO ANALYSIS 345 COMPETITOR RATIO ANALYSIS - PRODUCTS 346 CR Analysis of PD Agents Approved by 2014 - Based on Drug Class 346 COMPETITOR RATIO ANALYSIS - COMPANIES 347 CR Analysis of PD Agents Approved by 2014 - Based on Company 347 WINNERS & LOSERS 348 Summary of Key Companies and Drugs in the PD Market by 2014 348 DISCONTINUATION OF DRUGS 349 PD Drugs Discontinued from Clinical Development 349 PD APPENDIX 1 350 Phase Transition Probability 350 Probability of Launch 350 PD APPENDIX 2 351 PD Patient Model 351 Summary of PD Patient Population Forecasts 351 PD APPENDIX 3 352 Global PD Drugs Sales 2007A-2014E 352 Global PD Drug Sales 2007A-2014E 352 PD APPENDIX 4 354 Competitor Ratio Analysis Criteria 354 Key PD Drugs on the Market by 2014 354 PARKINSON'S DISEASE GLOSSARY 355 PARKINSON'S DISEASE REFERENCES 361 ACRONYMS 362 SCHIZOPHRENIA 363 EXECUTIVE SUMMARY 363 THE FACTS 364 What is schizophrenia and why are we interested in it? 364 Symptoms Associated with Schizophrenia 364 Schematic A graphical representation of a system. It often refers to electronic circuits on a printed circuit board or in an integrated circuit (chip). See logic gate and HDL. Depicting Mood Swings in Bipolar Disorder bipolar disorder, formerly manic-depressive disorder or manic-depression, severe mental disorder involving manic episodes that are usually accompanied by episodes of depression. 365 PATIENT STATISTICS 366 Incidence, diagnosis rates and treatment; now and in the future 366 PATIENT MODEL 367 Summary of Patient Population Forecasts 2007A-2014E 367 Model Assumptions 367 DRUG GROWTH DRIVERS 368 DRUG GROWTH RISKS/DAMPENERS 369 THE SCHIZOPHRENIA MARKET 370 Global CNS Market 2007 (US$91.9 billion) 370 Global Sales Split (2006) 371 The Major Players 372 Market Share of Antipsychotic Players by Sales (Dec 2007A) 372 Players and Products in 2007 372 Players and Products in 2014 373 Market Share of Antipsychotic Players by Sales (Dec 2014E) 374 CURRENT TREATMENTS 375 Leading Brands 376 Comparison of Leading Antipsychotic Drugs Antipsychotic Drugs Definition Antipsychotic drugs are a class of medicines used to treat psychosis and other mental and emotional conditions. Purpose 376 Current Products' Patent Exposure 378 Patent Exposure of Leading Antipsychotic Brands 378 ANALYSIS OF LEADING BRANDS 379 Atypical Antipsychotics 380 Abilify A·bil·i·fy A trademark for the drug aripiprazole. aripiprazole Abilify Pharmacologic class: Quinolone-derived atypical antipsychotic agent Therapeutic class: 380 Novelty/rationale for mechanism of action 380 Proof of concept/clinical data 380 Management/clinical expertise 380 Competition within the market-place/gaining share of voice 380 Risks associated with developing a drug within a therapeutic class 381 Filings and approval 381 Sales forecasts and assumptions 382 Competitor ratio analysis 382 Geodon/Zeldox 383 Novelty/rationale for mechanism of action 383 Proof of concept/clinical data 383 Management/clinical expertise 383 Competition within the market-place/gaining share of voice 383 Risks associated with developing a drug within a therapeutic class 384 Filings and approval 384 Sales forecasts and assumptions 385 Competitor ratio analysis 385 Invega 386 Novelty/rationale for mechanism of action 386 Proof of concept/clinical data 386 Management/clinical expertise 386 Competition within the market-place/gaining share of voice 386 Risks associated with developing a drug within a therapeutic class 387 Filings and approval 387 Sales forecasts and assumptions 387 Competitor ratio analysis 388 Lonasen 389 Novelty/rationale for mechanism of action 389 Proof of concept/clinical data 389 Clinical Efficacy efficacy /ef·fi·ca·cy/ (ef´i-kah-se) 1. the ability of an intervention to produce the desired beneficial effect in expert hands and under ideal circumstances. 2. of Blonanserin 389 Management/clinical expertise 389 Competition within the market-place/gaining share of voice 390 Risks associated with developing a drug within a therapeutic class 390 Filings and approval 390 Sales forecasts and assumptions 390 Competitor ratio analysis 391 Risperdal Ris·per·dal A trademark for the drug risperidone. risperidone Risperdal, Risperdal Consta, Risperdal M-Tab Pharmacologic class: Benzisoxazole derivative Therapeutic class: 392 Novelty/rationale for mechanism of action 392 Proof of concept/clinical data 392 Management/clinical expertise 393 Competition within the market-place/gaining share of voice 393 Risks associated with developing a drug within a therapeutic class 394 Filings and approval 394 Sales forecasts and assumptions 395 Competitor ratio analysis 395 Seroquel 396 Novelty/rationale for mechanism of action 396 Proof of concept/clinical data 396 Management/clinical expertise 397 Competition within the market-place/gaining share of voice 397 Risks associated with developing a drug within a therapeutic class 398 Filings and approval 398 Sales forecasts and assumptions 399 Competitor ratio analysis 399 Zyprexa Zy·prex·a A trademark for the drug olanzapine. olanzapine Zyprexa, Zyprexa IntraMuscular, Zyprexa Zydis Pharmacologic class: Thienobenzodiazepine Therapeutic class: 400 Novelty/rationale for mechanism of action 400 Proof of concept/clinical data 400 Management/clinical expertise 400 Competition within the market-place/gaining share of voice 401 Risks associated with developing a drug within a therapeutic class 401 Filings and approval 402 Sales forecasts and assumptions 403 Competitor ratio analysis 403 Other Atypical Antipsychotics 404 Serdolect 404 Lullan 404 Clozaril/Leponex 404 Solian 405 GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2007A - 2014E 406 Sales Forecasts of Current Leading Antipsychotics Antipsychotics A class of drugs used to control psychotic symptoms in patients with psychotic disorders such as schizophrenia and delusional disorder. Antipsychotics include risperidone (Risperdal), haloperidol (Haldol), and chlorpromazine (Thorazine). 406 Model Assumptions 406 NEW DRUGS IN R&D 408 Drugs in Development to Treat Schizophrenia and Bipolar Disorder 409 ANALYSIS OF LATE-PHASE DRUGS 411 Drugs in Late-Phase Development to Treat Schizophrenia and Bipolar Disorder 411 D/5-HT Receptor Antagonists 412 Asenapine Asenapine is a new 5-HT2A- and D2-receptor antagonist that is being developed by Organon International for the treatment of schizophrenia and acute mania associated with bipolar disorder. 412 Novelty/rationale for mechanism of action 412 Proof of concept/clinical data 412 Management/clinical expertise 412 Competition within the market-place/gaining share of voice 412 Risks associated with developing a drug within a therapeutic class 413 Filings and approval 413 Sales forecasts and assumptions 413 Competitor ratio analysis 413 Bifeprunox Bifeprunox is a novel atypical antipsychotic agent which, along with SLV313, aripiprazole and SSR-181507 combines minimal D2 receptor agonism with 5-HT receptor agonism. [1] Bifeprunox has a novel mechanism of action. 414 Novelty/rationale for mechanism of action 414 Proof of concept/clinical data 414 Management/clinical expertise 414 Competition within the market-place/gaining share of voice 415 Risks associated with developing a drug within a therapeutic class 415 Filings and approval 415 Sales forecasts and assumptions 415 Competitor ratio analysis 416 Lurasidone 417 Novelty/rationale for mechanism of action 417 Proof of concept/clinical data 417 Management/clinical expertise 417 Competition within the market-place/gaining share of voice 417 Risks associated with developing a drug within a therapeutic class 417 Filings and approval 417 Sales forecasts and assumptions 418 Competitor ratio analysis 418 Fanapta 419 Novelty/rationale for mechanism of action 419 Proof of concept/clinical data 419 Management/clinical expertise 419 Competition within the market-place/gaining share of voice 420 Risks associated with developing a drug within a therapeutic class 420 Safety Profile of Iloperidone iloperidone Zomaril™ An antipsychotic for treating schizophrenia and related disorders vs Approved Antipsychotics 420 Filings and approval 420 Sales forecasts and assumptions 421 Competitor ratio analysis 421 GLOBAL SALES FORECASTS OF LATE-PHASE SCHIZOPHRENIA DRUGS 2008E - 2014E 422 Sales Forecasts of Late-Phase Developmental Antipsychotic Drugs 422 Model Assumptions 422 ANALYSIS OF PHASE II DRUGS 423 BL-1020 423 Cariprazine 423 EVP-6124 423 MEM 3454 424 LY2140023 424 Vabicaserin 424 COMPETITOR RATIO ANALYSIS 425 COMPETITOR RATIO ANALYSIS - PRODUCTS 426 CR Analysis of Antipsychotic Agents antipsychotic agent Major tranquilizer, neuroleptic Neuropharmacology Any drug that attenuates psychotic episodes Agents Phenothiazines, thioxanthenes, butyrophenones, dibenzoxazepines, dibenzodiazepines, diphenylbutylpiperidines Indications Management of Approved by 2014 - Based on Drug Class 427 COMPETITOR RATIO ANALYSIS - COMPANIES 428 CR Analysis of Antipsychotics Approved by 2014 - Based on Company 428 WINNERS & LOSERS 429 Summary of Key Companies and Drugs in the Antipsychotic Market by 2014 429 Winners 429 Losers 430 DISCONTINUATION OF DRUGS 432 Antipsychotic Drugs Discontinued from Clinical Development 432 SCHIZOPHRENIA APPENDIX 1 433 ASSESSMENT OF ANTIPSYCHOTIC EFFICACY IN SCHIZOPHRENIA 433 ASSESSMENT OF ANTIPSYCHOTIC EFFICACY IN BIPOLAR DISORDER 433 SCHIZOPHRENIA APPENDIX 2 434 Phase Transition Probability 434 Probability of Launch 434 SCHIZOPHRENIA APPENDIX 3 435 Patient Model 435 Summary of US Schizophrenia Patient Population Forecasts 435 Summary of European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. (Top 5) Schizophrenia Patient Population Forecasts 436 Summary of Japanese Schizophrenia Patient Population Forecasts 437 SCHIZOPHRENIA APPENDIX 4 438 Global Antipsychotic Drug Sales 2007A-2014E 438 SCHIZOPHRENIA APPENDIX 5 439 Competitor Ratio Analysis Criteria 439 Key Antipsychotic Drugs on the Market by 2014 439 SCHIZOPHRENIA GLOSSARY 440 SCHIZOPHRENIA REFERENCES 445 ACRONYMS 446 For more information visit http://www.researchandmarkets.com/research/706fd4/cns_drug_discoveri. Source: Espicom Business Intelligence Introduction Espicom Business Intelligence is a publisher of independent and impartial information and analysis services focusing on the pharmaceutical and medical device markets. Ltd |
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