REGULATORY UPDATES: APPROVAL, DENIALS AND AGREEMENTS REGULATORY UPDATES: APPROVAL, (CONTINUED)... 38

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1 CHAPTER ONE: INTRODUCTION... 1 STUDY OBJECTIVES... 1 REASONS FOR DOING THIS STUDY... 1 INTENDED AUDIENCE... 2 SCOPE OF THE STUDY... 2 METHODOLOGY... 2 INFORMATION SOURCES... 2 ABOUT THE AUTHOR... 3 RELATED BCC RESEARCH REPORTS... 3 BCC ONLINE SERVICES... 3 DISCLAIMER... 4 CHAPTER TWO: EXECUTIVE SUMMARY... 5 EXECUTIVE SUMMARY... 5 SUMMARY TABLE WORLDWIDE REVENUE OF ANTIEMETICS, THROUGH 2015 ($ MILLIONS)... 6 SUMMARY FIGURE WORLDWIDE REVENUE OF ANTIEMETICS, ($ MILLION)... 6 CHAPTER THREE: OVERVIEW... 7 STAGES IN NAUSEA AND VOMITING... 7 TYPES OF EMESIS... 8 RELATIONSHIP BETWEEN RECEPTORS AND NAUSEA... 8 THE GI TRACT... 9 THE CHEMORECEPTOR TRIGGER ZONE (CTZ)... 9 THE VESTIBULAR APPARATUS... 9 THE CEREBRAL CORTEX HISTORY HISTORY OF PATHOPHYSIOLOGY HISTORY OF ANTIEMETIC THERAPY TABLE 1 HISTORY OF ANTIEMETIC THERAPY TABLE 1 (CONTINUED) TABLE 2 HISTORY OF SEROTONIN AND 5-HT RECEPTORS TABLE 3 HISTORY OF TACHYKININS AND NEUROKININ RECEPTORS TABLE 4 HISTORY OF CORTICOSTEROIDS TABLE 5 HISTORY OF DOPAMINE AND DOPAMINE RECEPTORS CAUSES OF EMESIS AND ITS THERAPY VESTIBULAR INVOLVEMENT OBSTRUCTION MIND INFECTION, IRRITATION, AND INFLAMMATION TOXINS TABLE 6 CAUSES OF EMESIS AND THE THERAPY INVOLVED... 16

2 CHAPTER FOUR: TYPE OF ANTIEMETIC DRUGS TYPES OF ANTIEMETIC DRUGS HTЗ RECEPTOR ANTAGONISTS TABLE 7 5-HTЗ RECEPTOR ANTAGONISTS DRUG PRODUCTS AS ANTIEMETICS NK1 RECEPTOR ANTAGONISTS TABLE 8 5NK1 RECEPTOR ANTAGONISTS DRUG PRODUCTS AS ANTIEMETICS ANTIHISTAMINES (HI ANTIHISTAMINE RECEPTOR ANTAGONISTS): TABLE 9 ANTIHISTAMINES DRUG PRODUCTS AS ANTIEMETICS TABLE 9 (CONTINUED) DOPAMINE ANTAGONISTS TABLE 10 DOPAMINE ANATAGONISTS, DRUG PRODUCTS AS ANTIEMETICS STEROID-CORTICOSTEROIDS TABLE 11 STEROIDS-CORTICOSTEROIDS, DRUG PRODUCTS AS ANTIEMETICS CANNABINOIDS TABLE 12 CANNABINOIDS, DRUG PRODUCTS AS ANTIEMETICS BENZODIAZEPINES TABLE 13 BENZODIAZEPINES, DRUG PRODUCTS AS ANTIEMETICS ANTICHOLINERGICS TABLE 14 ANTICHOLENERGIC DRUG PRODUCTS AS ANTIEMETICS OTHERS TABLE 15 OTHER PRODUCTS AS ANTIEMETICS TABLE 16 NON-PHARMACEUTICAL THERAPIES TABLE 16 (CONTINUED) CHAPTER FIVE: REGULATORY ASPECTS TABLE 17 APPROVALS OF ANTIEMETICS, 2007 TO APRIL TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 17 (CONTINUED) TABLE 18 REGULATORY CHANGES OF ANTIEMETICS, 2007 TO APRIL 2010, BY ACTIVE INGREDIENT TABLE 18 (CONTINUED) TABLE 18 (CONTINUED) TABLE 19 SAFETY ALERTS FOR ANTIEMETICS, 2007 TO APRIL 2010, BY ACTIVE INGREDIENT TABLE 19 (CONTINUED)... 37

3 REGULATORY UPDATES: APPROVAL, DENIALS AND AGREEMENTS REGULATORY UPDATES: APPROVAL, (CONTINUED) CHAPTER SIX: INDUSTRY STRUCTURE MANUFACTURERS/PRODUCTS FOR ANTIEMETICS TABLE 20 LEADING MANUFACTURERS OF 5-HT3 RECEPTOR ANTAGONISTS TABLE 20 (CONTINUED) TABLE 21 LEADING MANUFACTURERS OF NK-1 RECEPTOR ANTAGONISTS TABLE 22 LEADING MANUFACTURERS OF H1 RECEPTOR ANTAGONISTS TABLE 22 (CONTINUED) TABLE 23 LEADING MANUFACTURERS OF DOPAMINE ANTAGONISTS TABLE 23 (CONTINUED) TABLE 24 LEADING MANUFACTURERS/ SUPPLIERS OF STEROIDS-CORTICOSTEROIDS TABLE 25 LEADING MANUFACTURERS/ SUPPLIERS OF CANNABINOIDS TABLE 26 LEADING MANUFACTURERS/ SUPPLIERS OF BENZODIAZEPINES TABLE 27 LEADING MANUFACTURERS/ SUPPLIERS OF ANTICHOLINERGICS MARKET SHARES OF INDUSTRY LEADERS HT3 RECEPTOR ANATAGONISTS TABLE 28 WORLDWIDE MARKET SHARES OF 5-HT3 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) FIGURE 1 WORLDWIDE MARKET SHARES OF 5-HT3 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) NK-1 RECEPTOR ANATAGONISTS TABLE 29 WORLDWIDE MARKET SHARES OF NK-1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) H1 RECEPTOR ANATAGONISTS TABLE 30 WORLDWIDE MARKET SHARES OF H1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) FIGURE 2 WORLDWIDE MARKET SHARES OF H1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) DOPAMINE ANATAGONISTS TABLE 31 WORLDWIDE MARKET SHARES OF DOPAMINE ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) FIGURE 3 WORLDWIDE MARKET SHARES OF DOPAMINE ANTAGONISTS USED AS ANTIEMETICS, 2009 (%) STEROIDS-CORTICOSTEROIDS... 48

4 TABLE 32 WORLDWIDE MARKET SHARES OF STEROIDS- CORTICOSTEROIDS USED AS ANTIEMETICS, 2009 (%) FIGURE 4 WORLDWIDE MARKET SHARES OF STEROIDS- CORTICOSTEROIDS USED AS ANTIEMETICS, 2009 (%) CANNABINOIDS TABLE 33 WORLDWIDE MARKET SHARES OF CANNABINOIDS USED AS ANTIEMETICS, 2009 (%) FIGURE 5 WORLDWIDE MARKET SHARES OF CANNABINOIDS USED AS ANTIEMETICS, 2009 (%) BENZODIAZEPINES TABLE 34 WORLDWIDE MARKET SHARES OF BENZODIAZEPINES USED AS ANTIEMETICS, 2009 (%) FIGURE 6 WORLDWIDE MARKET SHARES OF BENZODIAZEPINES USED AS ANTIEMETICS, 2009 (%) ANTICHOLINERGICS TABLE 35 WORLDWIDE MARKET SHARES OF ANTICHOLINERGICS USED AS ANTIEMETICS, 2009 (%) FIGURE 7 WORLDWIDE MARKET SHARES OF ANTICHOLINERGICS USED AS ANTIEMETICS, 2009 (%) CHAPTER SEVEN: NEW DEVELOPMENTS NEW DEVELOPMENTS TABLE 36 WORLDWIDE NEW DEVELOPED DRUGS SINCE TABLE 37 PIPELINE ANTIEMETICS TABLE 37 (CONTINUED) RECENT UPDATES FROM THE ANTIEMETIC WORLD RECENT UPDATES FROM THE (CONTIUED) RECENT UPDATES FROM THE (CONTIUED) CHAPTER EIGHT: MARKET ANALYSIS HT3 RECEPTOR ANTAGONISTS MARKET OVERVIEW Market Overview (Continued) MARKET REVENUE TABLE 38 WORLDWIDE MARKET FOR 5-HT3 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 8 WORLDWIDE MARKET FOR 5-HT3 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS BY REGION, ($ MILLIONS) NK1 RECEPTOR ANTAGONISTS MARKET OVERVIEW MARKET REVENUE... 64

5 TABLE 39 WORLDWIDE MARKET FOR NK-1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 9 WORLDWIDE MARKET FOR NK-1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS BY REGION, ($ MILLIONS) H1 RECEPTOR ANTAGONISTS MARKET OVERVIEW MARKET REVENUE TABLE 40 WORLDWIDE MARKET FOR H1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 10 WORLDWIDE MARKET FOR H1 RECEPTOR ANTAGONISTS USED AS ANTIEMETICS BY REGION, ($ MILLIONS) DOPAMINE ANTAGONISTS MARKET OVERVIEW MARKET REVENUE TABLE 41 WORLDWIDE MARKET FOR DOPAMINE ANTAGONISTS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 11 WORLDWIDE MARKET FOR DOPAMINE ANTAGONISTS USED AS ANTIEMETICS BY REGION, ($ MILLIONS) STEROIDS -CORTICOSTEROIDS MARKET OVERVIEW MARKET REVENUE TABLE 42 WORLDWIDE MARKET FOR STEROIDS- CORTICOSTEROIDS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 12 WORLDWIDE MARKET FOR STEROIDS- CORTICOSTEROIDS USED AS ANTIEMETICS BY REGION, ($ MILLIONS) CANNABINOIDS MARKET OVERVIEW MARKET REVENUE TABLE 43 WORLDWIDE MARKET FOR CANNABINOIDS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 13 WORLDWIDE MARKET FOR CANNABINOIDS USED AS ANTIEMETICS BY REGION, ($ MILLIONS) BENZODIAZEPINES MARKET OVERVIEW MARKET REVENUE TABLE 44 WORLDWIDE MARKET FOR BENZODIAZEPINES USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS)... 76

6 FIGURE 14 WORLDWIDE MARKET FOR BENZODIAZEPINES USED AS ANTIEMETICS BY REGION, ($ MILLIONS) ANTICHOLINERGICS MARKET OVERVIEW MARKET REVENUE TABLE 45 WORLDWIDE MARKET FOR ANTICHOLINERGICS USED AS ANTIEMETICS BY REGION, THROUGH 2015 ($ MILLIONS) FIGURE 15 WORLDWIDE MARKET FOR ANTICHOLINERGIC USED AS ANTIEMETICS BY REGION, ($ MILLIONS) MARKET SHARES TABLE 46 WORLDWIDE ANTIEMETICS AGENTS MARKET SHARES BY REGION, 2009 (%) FIGURE 16 WORLDWIDE ANTIEMETICS AGENTS MARKET SHARES BY REGION, 2009 (%) CHAPTER NINE: MARKET BY APPLICATIONS MARKET SHARE OF APPLICATIONS TABLE 47 WORLDWIDE ANTIEMETIC MARKET SHARES, BY APPLICATION, 2009 (%) FIGURE 17 WORLDWIDE ANTIEMETICS MARKET SHARES, BY APPLICATION, 2009 (%) CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) CHEMOTHERAPY-INDUCED NAUSEA (CONTINUED) TABLE 48 ANTIMETIC THERAPIES FOR CHEMOTHERAPY- INDUCED NAUSEA AND VOMITING MARKET REVENUE TABLE 49 GLOBAL SALES OF ANTIEMETIC DRUGS IN CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, THROUGH 2015 ($ MILLIONS) FIGURE 18 GLOBAL SALES OF ANTIEMETIC DRUGS IN CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING, ($ MILLIONS) NAUSEA AND VOMITING DUE TO MOTION SICKNESS TABLE 50 ANTIEMETIC THERAPIES FOR NAUSEA AND VOMITING DUE TO MOTION SICKNESS MARKET REVENUE TABLE 51 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN MOTION SICKNESS, THROUGH 2015 ($ MILLIONS) FIGURE 19 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN MOTION SICKNESS, ($ MILLIONS) POSTOPERATIVE NAUSEA AND VOMITING TABLE 52 ANTIEMETIC THERAPIES FOR POSTOPERATIVE NAUSEA AND VOMITING MARKET REVENUE... 87

7 TABLE 53 GLOBAL SALES OF ANTIEMETIC DRUGS IN POSTOPERATIVE NAUSEA AND VOMITING, THROUGH 2015 ($ MILLIONS) FIGURE 20 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN POSTOPERATIVE NAUSEA AND VOMITING, THROUGH 2015 ($ MILLIONS) POST-RADIATION NAUSEA AND VOMITING TABLE 54 ANTIEMETIC THERAPIES FOR RADIOTHERAPY INDUCED NAUSEA AND VOMITING MARKET REVENUE TABLE 55 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN RADIOTHERAPY-INDUCED NAUSEA AND VOMITING, THROUGH 2015 ($ MILLIONS) FIGURE 21 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN RADIOTHERAPY INDUCED NAUSEA AND VOMITING, ($ MILLIONS) ACUTE GASTROENTERITIS TABLE 56 ANTIEMETIC THERAPIES FOR ACUTE GASTROENTRITIES VOMITING MARKET REVENUE TABLE 57 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN ACUTE GASTROENTRITIS, THROUGH 2015 ($ MILLIONS) FIGURE 22 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN ACUTE GASTROENTRITIS, ($ MILLIONS) OTHER CONDITIONS TABLE 58 ANTIEMETIC THERAPIES FOR OTHER CONDITIONS MARKET REVENUE TABLE 59 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN OTHER CONDITIONS, THROUGH 2015 ($ MILLIONS) FIGURE 23 GLOBAL SALES OF ANTIEMETIC DRUGS USED IN OTHER CONDITIONS, THROUGH 2015 ($ MILLIONS) CHAPTER TEN: PATENT ANALYSIS PATENTS BY YEAR TABLE 60 NUMBER OF SIGNIFICANT ANTIEMETIC PATENTS BY YEAR, FIGURE 24 NUMBER OF ANTIEMETIC PATENTS BY YEAR, FIGURE 25 NUMBER OF ANTIEMETIC PATENTS BY YEAR, (%) PATENTS BY MODE OF ADMINISTRATION TABLE 61 PATENTS BY MODE/ ROUTE OF ADMINISTRATION, FIGURE 26 PATENTS BY MODE/ OUTE OF ADMINISTRATION,

8 PATENTS BY TYPE/CATEGORY TABLE 62 PATENTS BY TYPE/ CATEGORY FOR ANTIEMETICS, FIGURE 27 PATENTS BY TYPE/CATEGORY FOR ANTIEMETICS, PATENTS BY COMPANY TABLE 63 NUMBER OF U.S. PATENTS BY COMPANY FOR ANTIEMETICS, FIGURE 28 NUMBER OF U.S. PATENTS BY COMPANY FOR ANTIEMETICS, PATENTS BY COUNTRY TABLE 64 NUMBER OF U.S. PATENTS BY COUNTRY FOR ANTIEMETICS, FIGURE 29 NUMBER OF U.S. PATENTS BY COUNTRY FOR CONTRAST AGENTS, TABLE 65 PATENT SHARES BY COUNTRY FOR ANTIEMETICS, (%) FIGURE 30 PATENT SHARES BY COUNTRY FOR ANTIEMETICS, (%) ANTIEMETICS PATENTS WORLDWIDE TABLE 66 NUMBER OF ANTIEMETIC PATENTS ISSUED BY DIFFERENT PATENT ORGANIZATIONS WORLDWIDE, FIGURE 31 ANTIEMETIC PATENTS ISSUED BY DIFFERENT PATENT ORGANIZATIONS WORLDWIDE, PATENTS BY ASSIGNEE (WORLDWIDE) TABLE 67 PATENTS BY ASSIGNEE (WORLDWIDE) FOR ANTIEMETICS, FIGURE 32 PATENTS BY ASSGINEE (WORLDWIDE) FOR ANTIEMETICS, CHAPTER ELEVEN: CURRENT SITUATION OF ANTIEMETICS MARKET MARKET RESTRAINTS COMPETITION COST OF THE DRUGS PATENTS EXPIRATIONS TABLE 68 PATENT EXPIRATIONS GROWTH FACTORS LIFE EXPECTANCY PATENT PROTECTION DRUGS PORTFOLIO MANAGEMENT FUTURE OF ANTIEMETICS MARKET TABLE 69 COMPARISON OF I AND II GENERATION 5-HT3 RECEPTOR ANTAGONISTS

9 CHAPTER TWELVE: COMPANY PROFILES ABBOTT LABS ACTAVIS AKORN, INC. AND AKORN STRIDES APOTEX INC APP PHARMACEUTICALS ASTELLAS PHARMA GMBH AUROBINDO PHARMA BAXTER HEALTHCARE CORPORATION BEDFORD LABORATORIES BIOVAIL PHARMACEUTICALS, INC CADILA PHARMACEUTICALS LTD CIPLA LTD CLARIS LIFESCIENCES CORE PHARMA LLC CYPRESS PHARMACEUTICAL, INC DR. REDDY S LABORATORIES LTD EISAI INC GLAND PHARMA LTD GLAXO SMITHKLINE GLENMARK GENERICS LIMITED GROUP TECHNICALE-FARMOZ S.A G & W LABS HAMELN PHARMACEUTICALS LTD HAWTHORN PHARMACEUTICALS, INC HELSINN HEALTHCARE SA/EISAI HETERO DRUGS LIMITED HIKMA FARMACEUTICA PLC HOSPIRA IMPAX LABS INSIGHT PHARMACEUTICALS CORP IPCA LABS LTD JANSSEN (A DIVISION OF ORTHO MCNEIL JANSSEN, J & J) KING PHARMACEUTICALS INC KVK-TECH, INC LUITPOLD PHARMACEUTICALS, INC MANX PHARMA LTD MEDA PHARMACEUTICALS MERCK & CO., INC MYLAN NOVARTIS PHARMACEUTICALS AUSTRALIA PTY LTD NOVELL PHARMACEUTICAL LABORATORIES PAR PHARMACEUTICALS PFIZER INC

10 PIRAMAL HEALTHCARE LIMITED PLIVA HRVATSKA DOO (TEVA GROUP COMPANY) PROSTRAKAN GROUP PLC ROCHE LABORATORIES (F. HOFFMANN-LA ROCHE AG) ROSEMONT PHARMACEUTICALS LTD SALIX PHARMACEUTICALS INC SANOFI AVENTIS US SATO PHARMACEUTICALS SCHWARZ PHARMA (UCB SUBSIDIARY) SOLVAY PHARMACEUTICALS (UNIMED/ABBOTT) STRATIVA PHARMACEUTICALS SUN PHARMACEUTICAL INDUSTRIES LTD TARO PHARMACEUTICAL INDUSTRIES LTD TEVA PHARMACEUTICAL INDUSTRIES LTD TORRENT PHARMACEUTICALS WALLACE PHARMACEUTICALS LTD WATSON PHARMACEUTICALS, INC WOCKHARDT USA LLC ZYDUS CADILA ZYDUS PHARMS USA CHAPTER THIRTEEN: ABBREVIATIONS TABLE 70 ABBREVIATIONS TABLE 70 (CONTINUED) TABLE 70 (CONTINUED)