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Frontier Pharma: Innovative Licensing Opportunities in Non-Hodgkin Lymphoma

Frontier Pharma: Innovative Licensing Opportunities in Non-Hodgkin Lymphoma

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Executive Summary

Frontier Pharma: Innovative Licensing Opportunities in Non-Hodgkin Lymphoma

Non-Hodgkin Lymphoma (NHL) can be seen as a collection of up to 60 smaller subtypes of malignant lymphoid disease, defined by distinct morphological, cytogenetic and immunophenotypic characteristics that can be broadly classified as either indolent or aggressive disease. The slow growing nature of the former means that first-line treatment for diagnosed patients can be delayed, an option not commonly recommended for aggressive disease. Across both indolent and aggressive disease, first-line chemotherapy in combination with the blockbuster drug rituxumab can induce high rates of response, and prolonged durations of remission. Despite this, indolent disease is typically incurable, with the most aggressive lymphoma subtype-diffuse large B-cell lymphoma having 5-year survival rates of ~50%. Re-treatment with chemotherapy can induce second and subsequent remissions, but most NHL patients develop chemotherapy resistant disease, for whom there are limited treatment options. Overall, in terms of numbers small molecule chemotherapeutic agents dominate the current market, with a clear need for novel targeted therapies to prolong durations of remission, and provide options for patients with chemo resistant, heavily pretreated disease.

The current developmental pipeline addresses these gaps in the market, dominated by cancer immunotherapies and inhibitors of cancer-associated signal transduction. Pathways of significant interest include B-cell receptor signaling, the PI3K/Akt/mTOR pathway, and Wnt/'-catenin signaling, as well as oncogenes such as BCL-6 and BCL-2. Characteristic cell surface molecules that represent targets for cancer immunotherapies include CD19, LMP-1/2 and CD20, with several pipeline drugs already approved for CD20. First-in-class drug development in NHL corresponds strongly to these known somatic mutations and affected pathways. Clinical results of drugs against profiled targets in this report show many are being investigated in relapsed disease.


There are 666 marketed products for NHL, 95% of which are small molecules

-What are the dominant mechanisms of action across marketed products?

The treatment of lymphoma is dominated by the use of combination cyclophosphamide based chemotherapy in combination with rituximab

-What are these chemotherapy regimens?

-How did they perform in key clinical trials?

The variation in molecule type has shifted away from small molecules, whose dominance has decreased to 46% across the pipeline

-What are the dynamics of the remaining 54% of the pipeline?

-How does this reflect the need for novel targeted therapies?

There is a significant shift away from cytotoxic agents, with the current pipeline dominated by cancer immunotherapies and signal transduction inhibitors

-What is the scientific rationale behind these mechanisms of action?

-How successful have approved targeted therapies been?

Profiled first-in-class therapies include: PIK3CA, EZH2, CD40 and MDM2

-What is the scientific rationale behind these targets?

-What preclinical and clinical results are available for drugs against these targets?

-What is the overall opinion on these targets for drug development across NHL?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape. This includes a comprehensive study of disease pathogenesis, diagnosis, prognosis and the available treatment options available at each stage of diagnosis.

Visualize the composition of the NHL market in terms of dominant molecule types and targets, highlighting what the current unmet needs are and how they can be addressed. This knowledge allows a competitive understanding of gaps in the current market.

Analyze the NHL pipeline, and stratify by stage of development, molecule type and molecular target. There are promising signs in focussed on the development of targeted therapies for this disease.

Visualize the clinical safety and efficacy of drugs against first-in-class targets via a detailed heat map, outlining the results across major clinical trial endpoints.

Identify commercial opportunities in the NHL deals landscape by analyzing trends in licensing and co-development deals, and those first-in-class drugs which are yet to be involved in a strategic alliance.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 3

1.2 List of Figures 3

2 Executive Summary 4

2.1 Development of Targeted Therapies Remains a Focus across NHL Drug Development 4

2.2 NHL Shows a Moderate Level of First-in-Class Innovation 4

2.3 High Number of First-in-Class Pipeline Drugs with No Associated Deal 4

3 The Case for Innovation in NHL Development 5

3.1 Growing Opportunities for Biological Products 6

3.2 Diversification of Molecular Targets 6

3.3 Innovative First-in-Class Product Developments Remain Attractive 6

3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 7

3.5 Sustained Innovation 7

3.6 Report Guidance 8

4 Clinical Landscape 9

4.1 Disease Overview 9

4.2 Epidemiology and Risk Factors 9

4.3 Symptoms 10

4.4 Diagnosis 10

4.4.1 Biopsy 10

4.4.2 Flow-Cytometry and Immunophenotyping 10

4.5 Normal B-Cell Development and NHL Classification 10

4.6 Pathophysiology 17

4.6.1 BCL2 18

4.6.2 BCL6 18

4.6.3 Wnt/?-catenin Pathway 18

4.6.4 BCR Pathway 19

4.6.5 PI3K/Akt/mTOR Pathway 19

4.7 Patient Prognosis 20

5 Overview of Marketed Products and Treatment Algorithm for NHL 22

5.1 Marketed Products by Molecule Type and Mechanism of Action 22

5.2 Treatment Algorithm 23

5.2.1 Clinical Trial Response Criteria in NHL 26

5.2.2 Indolent NHL-Follicular Lymphoma 27

5.2.3 Aggressive NHL 33

5.3 Unmet Needs 45

6 Assessment of Pipeline Product Innovation 47

6.1 Non-Hodgkin Lymphoma Pipeline by Phase and Molecule Type 47

6.2 Non-Hodgkin Lymphoma Pipeline by Mechanism of Action 48

6.3 First-in-Class Pipeline Programs Targeting Novel Molecular Targets 51

7 Signaling Network, Disease Causation and Innovation Alignment 58

7.1 The Complexity of Signaling Networks in Oncology 59

7.2 Signaling Pathways, Disease-Causing Mutations and First-in-Class Molecular Target Integration 59

7.3 First-in-Class Target Matrix Assessment 63

8 First-in-Class Target Evaluation 66

8.1 Pipeline Programs Targeting Spleen Tyrosine Kinase 66

8.2 Pipeline Programs Targeting PIK3CA and PIK3CB 69

8.3 Pipeline Programs Targeting PDPK1 71

8.4 Pipeline Programs Targeting EZH2 72

8.5 Pipeline Programs Targeting MDM2 74

8.6 Pipeline Programs Targeting PTPRC 76

8.7 Pipeline Programs Targeting CD40 78

8.8 Pipeline Programs Targeting IRAK4 81

8.9 Pipeline Programs Targeting CD22 82

8.10 Pipeline Programs Targeting BCL6 86

9 Deals and Strategic Consolidations 88

9.1 Industry-Wide First-in-Class Deals 88

9.2 Licensing Deals 90

9.2.1 Licensing Deals by Molecule Type 92

9.3 Co-development Deals 95

9.3.1 Molecule Type and Mechanism of Action 97

9.4 First-in-Class Programs not Involved in Licensing of Co-development Deals 100

10 Appendix 102

10.1 Abbreviations 102

10.2 Bibliography 103

10.3 Methodology 114

10.4 Secondary Research 114

10.5 Contact Us 115

10.6 Disclaimer 115

1.1 List of Tables

Table 1: WHO Classification of Lymphoid Neoplasms, 2008 13

Table 2: Key Lymphoma Subtypes, Associated Morphological Features, and Cytogenetic and Immunohistochemical Profiles 15

Table 3: Approximate One- and Five-Year Survival Rates of Major NHL Subtypes 20

Table 4: International Working Formulation (IWF) Classification System 20

Table 5: Ann Arbor Staging of Lymphoma and Associated Criteria 20

Table 6: ECOG Performance Status Grade and Criteria 21

Table 7: Follicular Lymphoma International Prognostic Index and International Prognostic Index, Prognostic Risk Criteria for Follicular Lymphomas and All Other Lymphomas Respectively 21

Table 8: Combination Therapies Used in the Treatment of FL, DLBCL and MCL, Part 1 25

Table 9: Combination Therapies Used in the Treatment of FL, DLBCL and MCL, Part 2 26

Table 10: Non-Hodgkin Lymphoma Therapeutics, Clinical Trial Endpoints and Response Criteria 27

Table 11: Clinical Results, R-CHOP21 versus R-CHOP14, 2004 35

Table 12: Effects of Selected Prognostic Factors on the Survival of Patients Treated with R-ICE and R-DHAP for Relapsed DLBCL 36

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals, 1987-2013 5

Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval 7

Figure 3: Non-Hodgkin Lymphoma, Marketed Products 23

Figure 4: Treatment Algorithm, Follicular Lymphoma 33

Figure 5: Treatment Algorithm, Diffuse Large B-Cell Lymphoma 38

Figure 6: Clinical Trials of Intensive Chemotherapy for Newly Diagnosed Mantle Cell Lymphoma in Eligible Patients 40

Figure 7: Treatment Algorithm, Mantle Cell Lymphoma 45

Figure 8: Pipeline Overview by Stage and Molecule Type 47

Figure 9: Comparative Analysis of Mechanisms of Action between Pipeline and Marketed Products 49

Figure 10: Developmental Pipeline by Mechanism of Action 50

Figure 11: Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets 52

Figure 12: Non-Hodgkin Lymphoma, Pipeline Drugs Acting Against First-in-Class Targets, Part 1 53

Figure 13: Non-Hodgkin Lymphoma, Pipeline Drugs acting Against First-in-Class Targets, Part 2 54

Figure 14: Non-Hodgkin Lymphoma, Pipeline Drugs Acting Against First-in-Class Targets, Part 3 55

Figure 15: Non-Hodgkin Lymphoma, Pipeline Drugs acting Against First-in-Class Targets, Part 4 56

Figure 16: Non-Hodgkin Lymphoma, Pipeline Drugs acting Against First-in-Class Targets, Part 5 57

Figure 17: Signaling Networks of Functional Families in Non-Hodgkin Lymphoma 61

Figure 18: Location of Key First-in-Class Targets within the Signaling Matrix 62

Figure 19: Target Matrix Assessment (Part 1) 64

Figure 20: Target Matrix Assessment (Part 2) 65

Figure 21: Clinical Trial Results, Drugs Targeting Spleen Tyrosine Kinase 68

Figure 22: Pipeline Programs Targeting Spleen Tyrosine Kinase 69

Figure 23: Clinical Trial Results, Drugs Targeting PIK3CA/PIK3CB 71

Figure 24: Pipeline Programs Targeting PIK3CA/PIK3CB 71

Figure 25: Pipeline Programs Targeting PDPK1 72

Figure 26: Clinical Trial Results, Drugs Targeting EZH2 74

Figure 27: Pipeline Programs Targeting EZH2 74

Figure 28: Clinical Trial Results, Drugs Targeting MDM2 76

Figure 29: Pipeline Programs Targeting MDM2 76

Figure 30: Clinical Trial Results, Drugs Targeting PTPRC 78

Figure 31: Pipeline Programs Targeting PTPRC 78

Figure 32: Clinical Trial Results, Drugs Targeting CD40 80

Figure 33: Clinical Trial Results, Drugs Targeting IRAK4 82

Figure 34: Pipeline Programs Targeting IRAK4 82

Figure 35: Clinical Trial Results, Drugs Targeting CD22 85

Figure 36: Pipeline Programs Targeting CD22 86

Figure 37: Clinical Trial Results, Drugs Targeting BCL6 87

Figure 38: Pipeline Programs Targeting BCL6 87

Figure 39: Industry-Wide Deals by Stage of Development, 2006-2014 88

Figure 40: Industry Licensing Deal Values by Stage of Development, 2006-2014 89

Figure 41: Licensing Deals, Geographic Distribution, 2006-2014 91

Figure 42: Licensing Deals by Year and Value (USD ), 2006-2014 92

Figure 43: Licensing Deals Analysis by Value, Stage of Development and Molecule Type, 2006-2014 93

Figure 44: Non-Hodgkin Lymphoma, Completed Licensing Deals, 2006-2014 94

Figure 45: Co-development Deals, Geographic Distribution, 2006-2014 96

Figure 46: Co-development Deal Value Analysis, 2006-2014 97

Figure 47: Co-development Deals Analysis by Value, Stage of Development and Molecule Type, 2006-2014 98

Figure 48: Non-Hodgkin Lymphoma Market, Completed Co-development Deals, 2006-2014 99

Figure 49: Non-Hodgkin Market, First-in-Class Programs with no Recorded Prior Deal Involvement, 2006-2014 101

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