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Chapter- 1: INTRODUCTION
STUDY GOALS AND OBJECTIVES
REASONS FOR DOING THIS STUDY
INTENDED AUDIENCE
SCOPE OF REPORT
METHODOLOGY
INFORMATION SOURCES
AUTHOR’S CREDENTIALS
RELATED BCC WORK CREDENTIALS
BCC ONLINE SERVICES
DISCLAIMER

Chapter-2: SUMMARY
SUMMARY
SUMMARY TABLE THE WORLDWIDE MARKET FOR ANTIPSYCHOTIC DRUGS, THROUGH 2014 ($, MILLIONS)
SUMMARY FIGURE THE WORLDWIDE MARKET FOR ANTIPSYCHOTIC DRUGS, 2010--2014 ($, MILLIONS)

Chapter-3: OVERVIEW
DEFINITION OF AN ANTIPSYCHOTIC DRUG
HISTORY OF ANTIPSYCHOTIC DRUGS
TYPES OF ANTIPSYCHOTICS ON THE MARKET
TYPICAL ANTIPSYCHOTICS
TABLE 1 CLASSES OF TYPICAL ANTIPSYCHOTICS ON THE MARKET AND THEIR SIDE EFFECTS
ATYPICAL ANTIPSYCHOTICS
TABLE 2 CURRENTLY APPROVED ATYPICAL ANTIPSYCHOTICS ON THE MARKET
TABLE 3 FEATURES OF TYPICAL VERSUS ATYPICAL ANTIPSYCHOTICS
TABLE 4 COST OF SELECTED ATYPICAL AND TYPICAL ANTIPSYCHOTIC DRUGS ($)
RECEPTOR TARGETS OF ANTIPSYCHOTIC DRUGS
DOPAMINE
SEROTONIN
GLUTAMATE
TACHYKININ
GLUCOCORTICOID
SIDE EFFECTS OF ANTIPSYCHOTICS
NEUROLOGIC SIDE EFFECTS (EXTRAPYRAMIDAL SYMPTOMS)
ANTICHOLINERGIC SIDE EFFECTS
CARDIOVASCULAR SIDE EFFECTS
METABOLIC SIDE EFFECTS
OTHER SIDE EFFECTS
TABLE 5 COMPARISON OF SIDE EFFECT PROFILES OF ANTIPSYCHOTICS ON THE MARKET
ANTIPSYCHOTICS IN CLINICAL DEVELOPMENT
TABLE 6 ANTIPSYCHOTICS IN CLINICAL TRIALS, ORDERED BY PHASE
TABLE 7 NUMBER OF ANTIPSYCHOTICS IN CLINICAL TRIALS, BY PHASE (NUMBER/%)
FIGURE 1 ANTIPSYCHOTICS IN CLINICAL TRIALS BY PRIMARY RECEPTOR TARGET
TABLE 8 COMPANIES WITH MORE THAN ONE ANTIPSYCHOTICS IN CLINICAL TRIALS OR ON THE MARKET*

Chapter-4: TECHNOLOGY OVERVIEW
TECHNOLOGY OVERVIEW
TABLE 9 SALES OF ATYPICAL ANTIPSYCHOTICS BY FORMULATION, THROUGH 2014 ($, MILLIONS)
TABLE 10 ADMINISTRATION PROFILES OF LONG-ACTING ATYPICAL ANTIPSYCHOTICS

Chapter-5: PATENT EVALUATION
PATENT LENGTHS AND MARKET EXCLUSIVITY
TABLE 11 PATENT EXPIRATION DATES FOR ANTIPSYCHOTICS ON THE MARKET OR IN PHASE III DEVELOPMENT
TABLE 12 SALES OF ANTIPSYCHOTICS POTENTIALLY FACING GENERIC COMPETITION BY THE END OF 2014 ($ MILLIONS)

Chapter-6: ANTIPSYCHOTICS ON THE MARKET AND IN DEVELOPMENT
TABLE 13 GLOBAL MARKET FOR ANTIPSYCHOTICS BY INDIVIDUAL DRUG, THROUGH 2014 ($ MILLIONS)
TABLE 14 GLOBAL MARKET FOR ANTIPSYCHOTIC DRUGS BY MECHANISM OF ACTION, THROUGH 2014 ($ MILLIONS)
DOPAMINERGIC ANTIPSYCHOTICS IN DEVELOPMENT
DOPAMINE D2/SEROTONIN 5-HT2A RECEPTOR ANTAGONISTS
TABLE 15 MARKET FOR D2/5-HT2A ANTAGONISTS BY REGION, THROUGH 2014 ($ MILLIONS)
Serdolect (Sertindole)
Solian (Amisulpride)
Lonasen (Blonanserin)
Lullan (Perospirone)
Saphris/Sycrest (Asenapine, ORG 5222, SCH 900274)
Risperdal (Risperidone)
Risperdal Consta (Risperidone)
Clozaril/Leponex (Clozapine)
Seroquel IR and XR (Quetiapine)
Zyprexa (Olanzapine)
Zyprexa Relprevv/Zypadhera (Olanzapine Pamoate)
Fanapt (Iloperidone)
Iloperidone Depot
AZ-004 (Staccato Loxapine)
TABLE 16 PROFILE OF AZ-004 VERSUS OTHER ANTIPSYCHOTICS FOR TREATING AGITATION
TABLE 17 AZ-004/STACCATO LOXAPINE STUDIES
Lurasidone (SM-13496)
TABLE 18 LURASIDONE STUDY RESULTS
Geodon/Zeldox (Ziprasidone)
Invega (Paliperidone)
TABLE 19 INVEGA COMPARED TO RISPERDAL
Invega Sustenna (Paliperidone Palmitate)
TGOF02N
Zicronapine (Lu 31-130)
ATI-9242
YKP1447
DOPAMINE D2 RECEPTOR PARTIAL AGONISTS
TABLE 20 MARKET FOR D2 PARTIAL AGONISTS BY REGION, THROUGH 2014 ($ MILLIONS)
Abilify (Aripiprazole, OPC-14597)
Aripiprazole Depot
Cariprazine (RGH-188, MP-214)
OPC-34712
ACR343
PNB02
ALKS 9070 (Long-acting Aripiprazole)
Bifeprunox (DU-127,090)
SEROTONERGIC ANTIPSYCHOTICS IN DEVELOPMENT
TABLE 21 SELECTED SEROTONIN RECEPTOR SUBTYPES AND ANTIPSYCHOTIC DRUGS BINDING TO THESE SITES
Pimavanserin (ACP-103)
TABLE 22 PIMAVANSERIN PHASE II ADJUNCTIVE SCHIZOPHRENIA EFFICACY RESULTS
CYR-101 (MT-210)
5-HT6 RECEPTOR AGONISTS AND ANTAGONISTS
AVN-211
PF-5212365 (SAM-531)
Eplivanserin (SR46349B)
GLUTAMATERGIC ANTIPSYCHOTICS IN DEVELOPMENT
LY2140023
ADX71149
AZD8529
AZD8418
Glutamatergic Modulators in Preclinical Testing
GLYCINE TRANSPORT INHIBITORS
SCH 900435 (Org 25935)
RG1678
GSK1018921
OTHER ANTIPSYCHOTICS IN DEVELOPMENT
BL-1020
GSK1144814
Talnetant (SB-223412)
Osanetant (SR-142801)
Lu AA39959
Licarbazepine (LIC477D)
Corlux (Mifepristone, RU-486, C-1073)
SCH 900636 (ORG 34517)
PDE10 Inhibitors

Chapter-7: DISEASE APPLICATIONS
SCHIZOPHRENIA
OVERVIEW
SYMPTOMS OF SCHIZOPHRENIA
TREATMENT OF SCHIZOPHRENIA
TESTS OF SCHIZOPHRENIA DRUG EFFECTIVENESS
Positive and Negative Syndrome Scale (PANSS)
Brief Psychiatric Rating Scale (BPRS)
Clinical Global Impression scale (CGI)
Scale for the Assessment of Positive Symptoms/Negative Symptoms (SAPS/SANS)
CATIE
CATIE Phase 1 Results
TABLE 23 CATIE PHASE 1 ALL-CAUSE STUDY DISCONTINUATIONS
CATIE Phase 2 Results
CATIE Phase 3 Results
CUtLASS
The Lancet Second-generation vs First-Generation Antipsychotics Meta-analysis
BIPOLAR DISORDER
OVERVIEW
Young Mania Rating Scale
Montgomery-Asberg Depression Rating Scale
Hamilton Depression Rating Scale
MAJOR STUDIES USING ANTIPSYCHOTICS IN BIPOLAR DISORDER
STEP-BD
MARKET OPPORTUNITY
TABLE 24 LIST OF APPROVED BIPOLAR I DISORDER USES FOR ATYPICAL ANTIPSYCHOTICS
MAJOR DEPRESSIVE DISORDER
MARKET OPPORTUNITY
OTHER ON- AND OFF-LABEL USES OF ANTIPSYCHOTICS
ANXIETY SPECTRUM DISORDERS
ALZHEIMER’S AND PARKINSON’S DISEASES
MARKET OPPORTUNITY

Chapter-8: MAJOR COMPANIES AND MARKET SHARE
MARKET SHARE
TABLE 25 FORECASTED SALES AND MARKET SHARE OF COMPANIES WITH ANTIPYSCHOTICS ON THE MARKET, 2014 ($ MILLIONS/%)
COMPANY PROFILES
ACADIA PHARMACEUTICALS
ADDEX PHARMACEUTICALS
ALEXZA PHARMACEUTICALS
ALKERMES
ASTRAZENECA
AstraZeneca -- U.S. Headquarters
BIOLINERX
BIOTIE THERAPIES
BIOVAIL
BRISTOL-MYERS SQUIBB
CYRENAIC PHARMACEUTICALS
DAINIPPON SUMITOMO PHARMA
ELI LILLY
FABRE-KRAMER PHARMACEUTICALS
GEDEON RICHTER
GLAXOSMITHKLINE
JOHNSON AND JOHNSON
LIPOCINE
LUNDBECK
MITSUBISHI TANABE PHARMA
MERCK & CO.
NEUROSEARCH
NOVARTIS
NPS PHARMACEUTICALS
OMEROS
OTSUKA PHARMACEUTICAL CO.
PFIZER
SK GROUP
TITAN PHARMACEUTICALS
VANDA PHARMACEUTICALS

Chapter-9: INTERNATIONAL ASPECTS AND REGULATORY ISSUES
MARKET BY REGION
TABLE 26 GLOBAL FORECAST FOR ANTIPSYCHOTICS MARKET BY REGION, THROUGH 2014 ($ MILLIONS)
UNITED STATES
The FDA Modernization Act of 1997
Fast-track Status
Special Protocol Assessments
New Surveillance and Safety Requirements
Approvable Letters
Consumer Confidence
Medicare
Other Health Care Changes
EUROPEAN UNION
New Drug Approvals and Innovation
Drug Reimbursement and Reference Pricing
Relocation of R&D
JAPAN
New Drug Approvals
Regulatory Climate
Relationship Between Academia and Industry

Chapter-10: FUTURE DIRECTIONS
THE ROLE OF BIOMARKERS AND PHARMACOGENOMICS
COMBINATION THERAPIES
THE EFFECT OF GENERIC ANTIPSYCHOTICS ON PRICE