Lonasen (Blonanserin) Lullan (Perospirone) Saphris/Sycrest (Asenapine, ORG 5222, SCH ) Saphris/Sycrest (Continued)...

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1 CHAPTER ONE: INTRODUCTION... 1 STUDY GOALS AND OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 2 INTENDED AUDIENCE... 2 SCOPE OF REPORT... 3 METHODOLOGY... 3 INFORMATION SOURCES... 4 AUTHOR S CREDENTIALS... 4 RELATED BCC WORK CREDENTIALS... 4 BCC ONLINE SERVICES... 4 DISCLAIMER... 5 CHAPTER TWO: SUMMARY... 6 SUMMARY... 6 SUMMARY TABLE THE WORLDWIDE MARKET FOR ANTIPSYCHOTIC DRUGS, THROUGH 2014 ($, MILLIONS)... 7 SUMMARY FIGURE THE WORLDWIDE MARKET FOR ANTIPSYCHOTIC DRUGS, ($, MILLIONS)... 7 CHAPTER THREE: OVERVIEW... 8 DEFINITION OF AN ANTIPSYCHOTIC DRUG... 8 HISTORY OF ANTIPSYCHOTIC DRUGS... 9 TYPES OF ANTIPSYCHOTICS ON THE MARKET TYPICAL ANTIPSYCHOTICS Typical Antipsychotics (Continued) 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 2 (CONTINUED) 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... 22

2 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 6 (CONTINUED) 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 FOUR: TECHNOLOGY OVERVIEW TECHNOLOGY OVERVIEW TABLE 9 SALES OF ATYPICAL ANTIPSYCHOTICS BY FORMULATION, THROUGH 2014 ($, MILLIONS) TABLE 10 ADMINISTRATION PROFILES OF LONG-ACTING ATYPICAL ANTIPSYCHOTICS CHAPTER FIVE: PATENT EVALUATION PATENT LENGTHS AND MARKET EXCLUSIVITY TABLE 11 PATENT EXPIRATION DATES FOR ANTIPSYCHOTICS ON THE MARKET OR IN PHASE III DEVELOPMENT TABLE 12 SALES OF ANTIPSYCHOTICS POTENTIALLY FACING GENERIC COMPETITION BY THE END OF 2014 ($ MILLIONS) CHAPTER SIX: ANTIPSYCHOTICS ON THE MARKET AND IN DEVELOPMENT TABLE 13 GLOBAL MARKET FOR ANTIPSYCHOTICS BY INDIVIDUAL DRUG, THROUGH 2014 ($ MILLIONS) TABLE 13 (CONTINUED) 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) Serdolect (Continued) Solian (Amisulpride)... 40

3 Lonasen (Blonanserin) Lullan (Perospirone) Saphris/Sycrest (Asenapine, ORG 5222, SCH ) Saphris/Sycrest (Continued) Risperdal (Risperidone) Risperdal Consta (Risperidone) Risperdal Consta... (Continued) Clozaril/Leponex (Clozapine) Seroquel IR and XR (Quetiapine) Seroquel IR and XR (Continued) Zyprexa (Olanzapine) Zyprexa (Continued) Zyprexa Relprevv/Zypadhera (Olanzapine Pamoate) Fanapt (Iloperidone) Fanapt (Continued) 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 ) ATI YKP 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) Cariprazine (Continued) OPC ACR PNB ALKS 9070 (Long-acting Aripiprazole) Bifeprunox (DU-127,090) SEROTONERGIC ANTIPSYCHOTICS IN DEVELOPMENT... 72

4 TABLE 21 SELECTED SEROTONIN RECEPTOR SUBTYPES AND ANTIPSYCHOTIC DRUGS BINDING TO THESE SITES Pimavanserin (ACP-103) Pimavanserin (Continued) TABLE 22 PIMAVANSERIN PHASE II ADJUNCTIVE SCHIZOPHRENIA EFFICACY RESULTS CYR-101 (MT-210) HT6 RECEPTOR AGONISTS AND ANTAGONISTS AVN PF (SAM-531) Eplivanserin (SR46349B) GLUTAMATERGIC ANTIPSYCHOTICS IN DEVELOPMENT LY LY (Continued) ADX AZD AZD Glutamatergic Modulators in Preclinical Testing GLYCINE TRANSPORT INHIBITORS SCH (Org 25935) RG GSK OTHER ANTIPSYCHOTICS IN DEVELOPMENT BL GSK Talnetant (SB ) Osanetant (SR ) Lu AA Licarbazepine (LIC477D) Corlux (Mifepristone, RU-486, C-1073) Corlux (Continued) SCH (ORG 34517) PDE10 Inhibitors CHAPTER SEVEN: DISEASE APPLICATIONS SCHIZOPHRENIA OVERVIEW SYMPTOMS OF SCHIZOPHRENIA TREATMENT OF SCHIZOPHRENIA Treatment of Schizophrenia (Continued) TESTS OF SCHIZOPHRENIA DRUG EFFECTIVENESS Positive and Negative Syndrome Scale (PANSS) Brief Psychiatric Rating Scale (BPRS) Clinical Global Impression scale (CGI)... 97

5 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 Market Opportunity (Continued) CHAPTER EIGHT: 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

6 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 Pfizer (Continued) SK GROUP TITAN PHARMACEUTICALS VANDA PHARMACEUTICALS CHAPTER NINE: INTERNATIONAL ASPECTS AND REGULATORY ISSUES MARKET BY REGION TABLE 26 GLOBAL FORECAST FOR ANTIPSYCHOTICS MARKET BY REGION, THROUGH 2014 ($ MILLIONS) MARKET BY REGION (CONTINUED) UNITED STATES The FDA Modernization Act of 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

7 Relationship Between Academia and Industry CHAPTER TEN: FUTURE DIRECTIONS THE ROLE OF BIOMARKERS AND PHARMACOGENOMICS COMBINATION THERAPIES THE EFFECT OF GENERIC ANTIPSYCHOTICS ON PRICE THE EFFECT OF GENERIC (CONTINUED)