Table of Contents
1 Table of Contents
1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 9
2 Top Partnership Deal Terminations – Introduction 10
2.1 Licensing Agreement – An Authorization 10
2.2 Termination of Licensing Agreements 10
2.3 GBI Research Report Guidance 11
3 Top Partnership Deal Terminations – Trends 12
3.1 Reasons for Deal Terminations 12
3.2 Therapeutic Areas – Terminated Deals 13
3.3 Deal Values – Terminated Deals 14
4 Top Partnership Deal Terminations - Deals 16
4.1 GlaxoSmithKline Terminates Licensing Agreement with Actelion for Almorexant 16
4.1.1 Companies Overview 16
4.1.2 Product Overview 17
4.1.3 Deal Overview 19
4.1.4 Reason for Termination 20
4.2 GlaxoSmithKline Terminates Co-Development Agreement with Targacept for Development of Neuronal Nicotinic Receptor Therapeutics 20
4.2.1 Companies Overview 21
4.2.2 Product Overview 21
4.2.3 Deal Overview 23
4.2.4 Reason for Termination 23
4.3 Shire Terminates Licensing Agreement with Renovo Group for Juvista 24
4.3.1 Companies Overview 24
4.3.2 Product Overview 26
4.3.3 Deal Overview 28
4.3.4 Reason for Termination 28
4.4 Anacor Pharmaceuticals Terminates Licensing Agreement with Merck for AN2690 29
4.4.1 Companies Overview 29
4.4.2 Product Overview 31
4.4.3 Deal Overview 34
4.4.4 Reason for Termination 34
4.5 Novartis Terminates Licensing Agreement with Human Genome Sciences for Albuferon 35
4.5.1 Companies Overview 35
4.5.2 Product Overview 37
4.5.3 Deal Overview 38
4.5.4 Reason for Termination 39
4.6 InterMune Terminates Licensing Agreement with F. Hoffmann-La Roche for ITMN-191 39
4.6.1 Companies Overview 40
4.6.2 Product Overview 42
4.6.3 Deal Overview 43
4.6.4 Reason for Termination 44
4.7 GTx Terminates Worldwide Licensing Agreement with Merck for Ostarine 45
4.7.1 Companies Overview 45
4.7.2 Product Overview 46
4.7.3 Deal Overview 48
4.7.4 Reason for Termination 48
4.8 Aveo Pharmaceuticals Terminates Licensing Agreement with Merck for AV-299 49
4.8.1 Companies Overview 49
4.8.2 Product Overview 50
4.8.3 Deal Overview 53
4.8.4 Reason for Termination 53
4.9 Merck KGaA Terminates Worldwide Licensing Agreement with Lpath for Asonep 54
4.9.1 Companies Overview 54
4.9.2 Product Overview 56
4.9.3 Deal Overview 57
4.9.4 Reason for Termination 57
4.10 Portola Pharmaceuticals Terminates Licensing Agreement with Merck for Betrixaban 58
4.10.1 Companies Overview 58
4.10.2 Product Overview 59
4.10.3 Deal Overview 61
4.10.4 Reason for Termination 61
4.11 Celldex Therapeutics Terminates Licensing Agreement with Pfizer for Rindopepimut 62
4.11.1 Companies Overview 62
4.11.2 Product Overview 63
4.11.3 Deal Overview 66
4.11.4 Reason for Termination 66
4.12 Depomed Terminates Licensing Agreement with Abbott Laboratories for DM-1796 67
4.12.1 Companies Overview 67
4.12.2 Product Overview 70
4.12.3 Deal Overview 73
4.12.4 Reason for Termination 73
4.13 Sanofi Terminates Licensing Agreement with Metabolex for MBX-2982 74
4.13.1 Companies Overview 74
4.13.2 Product Overview 75
4.13.3 Deal Overview 76
4.13.4 Reason for Termination 76
4.14 BioLineRx Terminates Licensing Agreement with Cypress Bioscience for BL-1020 77
4.14.1 Companies Overview 78
4.14.2 Product Overview 79
4.14.3 Deal Overview 82
4.14.4 Reason for Termination 83
4.15 Cilag Terminates Licensing Agreement with Basilea Pharmaceutica for Ceftobiprole 83
4.15.1 Companies Overview 84
4.15.2 Product Overview 85
4.15.3 Deal Overview 86
4.15.4 Reason for Termination 87
4.16 Roche Terminates Licensing Agreement with Ipsen for Taspoglutide 87
4.16.1 Companies Overview 88
4.16.2 Product Overview 88
4.16.3 Deal Overview 95
4.16.4 Reason for Termination 95
4.17 Roche Terminates Licensing Agreement with Transgene for Papilloma Vaccine TG4001 96
4.17.1 Companies Overview 96
4.17.2 Product Overview 97
4.17.3 Deal Overview 97
4.17.4 Reason for Termination 98
4.18 Rigel Pharmaceuticals Terminates Licensing Agreement with Pfizer for R343 98
4.18.1 Companies Overview 99
4.18.2 Product Overview 100
4.18.3 Deal Overview 100
4.18.4 Reason for Termination 100
4.19 Abbott Laboratories Terminates Licensing Agreement with SkyePharma for Flutiform 101
4.19.1 Companies Overview 102
4.19.2 Product Overview 103
4.19.3 Deal Overview 108
4.19.4 Reason for Termination 108
4.20 Merck Terminates Strategic Alliance with Intercell for V710 109
4.20.1 Companies Overview 109
4.20.2 Product Overview 110
4.20.3 Deal Overview 114
4.20.4 Reason for Termination 114
5 Top Partnership Deal Terminations - Appendix 115
5.1 Market Definitions 115
5.2 Abbreviations 115
5.3 Research Methodology 117
5.3.1 Coverage 117
5.3.2 Secondary Research 118
5.3.3 Primary Research 118
5.3.4 Section-wise Research Methodology 118
5.3.5 Expert Panel Validation 119
5.4 Contact Us 119
5.5 Disclaimer 119
5.6 Sources 119
1.1 List of Tables
Table 1: Top Partnership Deal Terminations, Reasons for Deal Terminations, 2010-2011 12
Table 2: Top Partnership Deal Terminations, Therapeutic Areas, 2010-2011 13
Table 3: Top Partnership Deal Terminations, Comparative Analysis of Reasons for Deal Terminations for Various Therapeutic Areas, 2010-2011 14
Table 4: Top Partnership Deal Terminations, Comparative Analysis of Deal Values of the Top Terminated Deals, 2010-2011 15
Table 5: Top Partnership Deal Terminations, Clinical Trial Details, Almorexant in Primary Insomnia, 2006-2007 18
Table 6: Top Partnership Deal Terminations, Clinical Trial Details, Almorexant in Elderly Subjects With Chronic Primary Insomnia, 2007-2008 18
Table 7: Top Partnership Deal Terminations, Clinical Trial Details, Almorexant in Adult Subjects With Chronic Primary Insomnia, 2008-2009 19
Table 8: Top Partnership Deal Terminations, GSK-Actelion Licensing Agreement, Deal Value ($m), 2008 19
Table 9: Top Partnership Deal Terminations, GSK-Targacept Licensing Agreement, Deal Value ($m), 2007 23
Table 10: Top Partnership Deal Terminations, Clinical Trial Details, Juvista in Scars Following Varicose Vein Removal, 2006-2009 27
Table 11: Top Partnership Deal Terminations, Clinical Trial Details, Juvista in the Non-Surgical Improvement of Existing Scars, 2009-2010 27
Table 12: Top Partnership Deal Terminations, Shire-Renovo Licensing Agreement, Deal Value ($m), 2007 28
Table 13: Top Partnership Deal Terminations, Clinical Trial Details, Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail, 2005-2007 31
Table 14: Top Partnership Deal Terminations, Clinical Trial Details, Absorption and Systemic Study of AN2690 in Patients With Moderate to Severe Onychomycosis, 2006-2007 32
Table 15: Top Partnership Deal Terminations, Clinical Trial Details, Safety and Efficacy Evaluation of Topically Applied AN2690 Solutions for Subjects With Onychomycosis, 2006-2007 32
Table 16: Top Partnership Deal Terminations, Clinical Trial Details, Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail, 2010-2012 33
Table 17: Top Partnership Deal Terminations, Clinical Trial Details, Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail, 2011–2012 33
Table 18: Top Partnership Deal Terminations, Merck-Anacor Licensing Agreement, Deal Value ($m), 2007 34
Table 19: Top Partnership Deal Terminations, Novartis-HGS Licensing Agreement, Deal Value ($m), 2006 38
Table 20: Top Partnership Deal Terminations, Roche-InterMune Licensing Agreement, Deal Value ($m), 2006 44
Table 21: Top Partnership Deal Terminations, Clinical Trial Details, Study of GTx-024 on Muscle Wasting Cancer, 2007-2008 47
Table 22: Top Partnership Deal Terminations, Merck-GTx Licensing Agreement, Deal Value ($m), 2007 48
Table 23: Top Partnership Deal Terminations, Clinical Trial Details, A Phase I Dose-Escalation Study in Advanced Solid Tumors, Lymphomas or Multiple Myeloma, 2008-2012 51
Table 24: Top Partnership Deal Terminations, Clinical Trial Details, A Pharmacodynamic Study of AV-299 (Formerly SCH 900105) in Subjects With Advanced Solid Tumors Who Have Liver Metastases, 2009-2011 52
Table 25: Top Partnership Deal Terminations, Clinical Trial Details, Study to Evaluate AV-299 (Formerly SCH 900105) in Combination With Gefitinib in Subjects With Non-Small Cell Lung Cancer (NSCLC), 2009-2012 52
Table 26: Top Partnership Deal Terminations, Merck-Aveo Licensing Agreement, Deal Value ($m), 2007 53
Table 27: Top Partnership Deal Terminations, Clinical Trial Details, Safety Study of Asonep to Treat Advanced Solid Tumors, 2008-2010 56
Table 28: Top Partnership Deal Terminations, Merck KGaA-Lpath Licensing Agreement, Deal Value ($m), 2008 57
Table 29: Top Partnership Deal Terminations, Clinical Trial Details, Phase II Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin, 2008-2009 60
Table 30: Top Partnership Deal Terminations, Clinical Trial Details, A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerability of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment, 2009-2010 60
Table 31: Top Partnership Deal Terminations, Clinical Trial Details, Evaluate the Pharmacokinetics and Safety of Betrixaban in Participants With Nonvalvular Atrial Fibrillation, 2010–2011 61
Table 32: Top Partnership Deal Terminations, Merck-Portola Licensing Agreement, Deal Value ($m), 2009 61
Table 33: Top Partnership Deal Terminations, Clinical Trial Details, Phase II Study of CDX-110 in Patients With Glioblastoma Multiforme, 2007-2011 65
Table 34: Top Partnership Deal Terminations, Clinical Trial Details, Chemotherapy, Radiation Therapy, and Vaccine Therapy With Basiliximab in Treating Patients With Glioblastoma Multiforme That Has Been Removed by Surgery, 2007-2013 65
Table 35: Top Partnership Deal Terminations, Clinical Trial Details, Phase I Rindopepimut After Conventional Radiation in Children w/ Diffuse Intrinsic Pontine Gliomas, 2011-2012 66
Table 36: Top Partnership Deal Terminations, Pfizer-Celldex Licensing Agreement, Deal Value ($m), 2008 66
Table 37: Top Partnership Deal Terminations, Clinical Trial Details, Safety and Efficacy of Gabapentin in Diabetic Peripheral Neuropathy, 2006 70
Table 38: Top Partnership Deal Terminations, Clinical Trial Details, Safety and Efficacy of Gabapentin in Postherpetic Neuralgia, 2006-2007 71
Table 39: Top Partnership Deal Terminations, Clinical Trial Details, Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women, 2007-2008 71
Table 40: Top Partnership Deal Terminations, Clinical Trial Details, Safety and Efficacy of Gabapentin in Postherpetic Neuralgia, 2008-2009 72
Table 41: Top Partnership Deal Terminations, Clinical Trial Details, Study of Gabapentin Extended Release (G-ER) in the Treatment of Vasomotor (Hot Flashes/Hot Flushes) Symptoms in Postmenopausal Women, 2008-2009 72
Table 42: Top Partnership Deal Terminations, Abbott-Depomed Licensing Agreement, Deal Value ($m), 2009 73
Table 43: Top Partnership Deal Terminations, Clinical Trial Details, Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of MBX-2982 in Patients With Type 2 Diabetes, 2009-2010 76
Table 44: Top Partnership Deal Terminations, Clinical Trial Details, A Positron Emission Tomography (PET) Study to Assess the Degree of Dopamine-2 (D2) Receptor Occupancy in the Human Brain After Single Doses of BL-1020 or Perphenazine in Healthy Male Subjects Using [11C] Raclopride as PET Tracer, 2007 80
Table 45: Top Partnership Deal Terminations, Clinical Trial Details, Safety and Tolerability of BL-1020 in Hospitalized Subjects With Chronic Schizophrenia or Schizo-Affective Disorder, 2007 80
Table 46: Top Partnership Deal Terminations, Clinical Trial Details, A Six-week, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-centre, Phase II Study, 2008-2009 81
Table 47: Top Partnership Deal Terminations, Clinical Trial Details, Phase IIb-III Study of BL-1020 Small Molecule for Schizophrenia, 2011 81
Table 48: Top Partnership Deal Terminations, Clinical Trial Details, Safety, Tolerability and Efficacy Study of BL-1020 in Patients with Schizophrenia, 2011 82
Table 49: Top Partnership Deal Terminations, BioLineRx-Cypress Licensing Agreement, Deal Value ($m), 2010 82
Table 50: Top Partnership Deal Terminations, Clinical Trial Details, Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections, 2005 85
Table 51: Top Partnership Deal Terminations, Clinical Trial Details, Ceftobiprole in the Treatment of Resistant Staphylococcus Aureus Skin and Skin Structure Infections, 2005-2006 86
Table 52: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both, 2008-2011 89
Table 53: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise, 2008-2010 90
Table 54: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone, 2008-2010 90
Table 55: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, 2008-2011 91
Table 56: Top Partnership Deal Terminations, Clinical Trial Details, A Study of the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Insulin Glargine in Insulin Naive Type 2 Diabetic Patients Inadequately Controlled With Metformin Plus Sulphonylurea, 2008-2011 91
Table 57: Top Partnership Deal Terminations, Clinical Trial Details, A Study of the Effect of Taspoglutide on Gastric Emptying in Patients With Type 2 Diabetes, 2008 92
Table 58: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide in Type 2 Diabetic Patients, 2008-2009 92
Table 59: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy 93
Table 60: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes, 2009-2011 93
Table 61: Top Partnership Deal Terminations, Clinical Trial Details, A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy, 2010-2011 94
Table 62: Top Partnership Deal Terminations, Clinical Trial Details, A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease, 2010-2011 94
Table 63: Top Partnership Deal Terminations, Roche-Ipsen Licensing Agreement, Deal Value ($m), 2006 95
Table 64: Top Partnership Deal Terminations, Roche-Transgene Licensing Agreement, Deal Value ($m), 2007 97
Table 65: Top Partnership Deal Terminations, Pfizer-Rigel Licensing Agreement, Deal Value ($m), 2005 100
Table 66: Top Partnership Deal Terminations, Clinical Trial Details, Single-Dose Crossover Study to Compare the Safety and Efficacy of Flutiform With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients, 2004-2005 104
Table 67: Top Partnership Deal Terminations, Clinical Trial Details, New Combination Inhaler in Patients With Asthma, 2006-2007 105
Table 68: Top Partnership Deal Terminations, Clinical Trial Details, New Combination Inhaler Versus Fluticasone and Formoterol Administered Alone, and Placebo in Patients With Moderate to Severe Asthma, 2006-2008 105
Table 69: Top Partnership Deal Terminations, Clinical Trial Details, Comparison of New Combination Inhaler (Flutiform HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone in Patients With Asthma, 2006-2008 106
Table 70: Top Partnership Deal Terminations, Clinical Trial Details, A Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (Flutiform) With Fluticasone or Flovent to Treat Moderate to Severe Asthma in Adolescents and Adults, 2008 106
Table 71: Top Partnership Deal Terminations, Clinical Trial Details, A Phase I Study in Asthma Patients Evaluating the Effect of Doses of Flutiform on the Amount of Cortisol Produced by the Adrenal Glands, 2008 107
Table 72: Top Partnership Deal Terminations, Clinical Trial Details, A Phase III, Multicenter, Open-Label Continuation Study in Moderate to Severe Asthmatic Subjects Who Completed Flutiform HFA pMDI Study SKY2028-3-005 107
Table 73: Top Partnership Deal Terminations, Clinical Trial Details, Merck Vaccine Study in Healthy Adults, 2006 111
Table 74: Top Partnership Deal Terminations, Clinical Trial Details, Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant, 2006-2007 112
Table 75: Top Partnership Deal Terminations, Clinical Trial Details, Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery, 2007-2014 112
Table 76: Top Partnership Deal Terminations, Clinical Trial Details, V710 Clinical Study in Healthy Male Japanese Subjects, 2008 113
Table 77: Top Partnership Deal Terminations, Clinical Trial Details, A Study to Evaluate the Safety and Immunogenicity of V710 in Adults With Kidney Disease on Hemodialysis, 2008-2010 113
Table 78: Top Partnership Deal Terminations, Merck-Intercell Licensing Agreement, Deal Value ($m), 2004 114
1.2 List of Figures
Figure 1: Top Partnership Deal Terminations, Licensing Strategies in Large Pharmaceutical Companies, Pharmaceutical Licensing Life Cycle, 2011 10
Figure 2: Top Partnership Deal Terminations, Reasons for Deal Terminations, 2010-2011 12
Figure 3: Top Partnership Deal Terminations, Therapeutic Areas, 2010-2011 13
Figure 4: Top Partnership Deal Terminations, Comparative Analysis of Deal Values of the Top Terminated Deals, 2010-2011 14
Figure 5: Top Partnership Deal Terminations, GlaxoSmithKline Terminates Licensing Agreement with Actelion for Almorexant, 2011 16
Figure 6: Top Partnership Deal Terminations, GlaxoSmithKline Terminates Co-Development Agreement with Targacept for Development of Neuronal Nicotinic Receptor Therapeutics, 2011 20
Figure 7: Top Partnership Deal Terminations, Shire Terminates Licensing Agreement with Renovo Group for Juvista, 2011 24
Figure 8: Top Partnership Deal Terminations, Anacor Pharmaceuticals Terminates Licensing Agreement with Merck for AN2690, 2010 29
Figure 9: Top Partnership Deal Terminations, Novartis Terminates Licensing Agreement with Human Genome Sciences for Albuferon, 2010 35
Figure 10: Top Partnership Deal Terminations, InterMune Terminates Licensing Agreement with F. Hoffmann-La Roche for ITMN-191, 2010 39
Figure 11: Top Partnership Deal Terminations, GTx Terminates Worldwide Licensing Agreement with Merck for Ostarine, 2010 45
Figure 12: Top Partnership Deal Terminations, Aveo Pharmaceuticals Terminates Licensing Agreement with Merck for AV-299, 2010 49
Figure 13: Top Partnership Deal Terminations, Merck KGaA Terminates Worldwide Licensing Agreement with Lpath for Asonep, 2010 54
Figure 14: Top Partnership Deal Terminations, Portola Pharmaceuticals Terminates Licensing Agreement with Merck for Betrixaban, 2011 58
Figure 15: Top Partnership Deal Terminations, Celldex Therapeutics Terminates Licensing Agreement with Pfizer for Rindopepimut, 2010 62
Figure 16: Top Partnership Deal Terminations, Depomed Terminates Licensing Agreement with Abbott Laboratories for DM-1796, 2011 67
Figure 17: Top Partnership Deal Terminations, Sanofi Terminates Licensing Agreement with Metabolex for MBX-2982, 2011 74
Figure 18: Top Partnership Deal Terminations, BioLineRx Terminates Licensing Agreement with Cypress Bioscience for BL-1020, 2011 77
Figure 19: Top Partnership Deal Terminations, Cilag Terminates Licensing Agreement with Basilea Pharmaceutica for Ceftobiprole, 2010 83
Figure 20: Top Partnership Deal Terminations, Roche Terminates Licensing Agreement with Ipsen for Taspoglutide, 2011 87
Figure 21: Top Partnership Deal Terminations, Roche Terminates Licensing Agreement with Transgene for Papilloma Vaccine TG4001, 2011 96
Figure 22: Top Partnership Deal Terminations, Rigel Pharmaceuticals Terminates Licensing Agreement with Pfizer for R343, 2011 98
Figure 23: Top Partnership Deal Terminations, Abbott Laboratories Terminates Licensing Agreement with SkyePharma for Flutiform, 2010 101
Figure 24: Top Partnership Deal Terminations, Merck Terminated Strategic Alliance with Intercell for V710, 2011 109