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Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD)-Identifying and Commercializing First-in-Class Innovation

Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD)-Identifying and Commercializing First-in-Class Innovation


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Executive Summary

Frontier Pharma: Chronic Obstructive Pulmonary Disease (COPD)-Identifying and Commercializing First-in-Class Innovation

Chronic Obstructive Pulmonary Disease (COPD) is a progressive disorder associated with chronic inflammation of the airways and lungs. Persistent breathing difficulties and repeated exacerbations of COPD symptoms make the disease one of the leading causes of morbidity and the fifth-leading cause of death in the world. COPD is linked to cumulative exposure to risk factors, primarily tobacco smoke, but also environmental pollutants. The COPD marketed products landscape consists of pharmacological therapies aimed at managing the symptoms associated with COPD, although none of the available therapies have been shown to modify long-term disease progression.

The current COPD pipeline consists of 212 active products in development. Initial analysis revealed a small presence of first-in-class products, constituting 16.5% of the pipeline. In comparison to other indications, this is relatively low; however, there are some promising trends within COPD product development. The Preclinical Phase of development is the most active in terms of first-in-class products. This diminishes throughout clinical development, with only two such products being present in Phase III. However, if either of these products is approved, they would represent the first, first-in-class products to be approved for COPD since roflumilast, which was approved in 2011 by the FDA and in 2010 in the EU. Roflumilast was the first novel therapy for COPD in almost 20 years, which demonstrates the infrequency at which first-in-class products enter the COPD market. So to have two first-in-class products in Phase III and six in Phase II is a promising sign.

Scope

The COPD market has benefited from notable additions in recent years.

-Which classes of drug dominate the market?

-What additional benefits have newly approved therapies brought to market?

-How do the leading marketed therapies compare clinically?

The pipeline contains a range of molecule types and molecular targets, including those that are well established in COPD and novel, first-in-class therapies.

-Which molecular targets appear most frequently in the pipeline?

-To what degree is the pipeline penetrated by first-in-class innovation?

-Which target families consist of the most first-in-class products?

First-in-class products differ substantially in their clinical potential, based on their alignment to disease causing pathways.

-How well are first-in-class targets aligned to known disease causing pathways?

-Which targets are specifically found in early-stage development?

-What is the industry-wide interest in these targets?

-Which are the most promising first-in-class targets in early-stage development?

There have been 59 licensing deals and 41 co-development deals pertaining to COPD products since 2006.

-Which territories show the most deal activity?

-What were the trends in deal completion by product stage of development?

-How many deals involved first-in-class products?

-Which of the first-in-class products in development are not currently involved in a licensing or co-development deal, and therefore represent investment opportunities?

Reasons To Buy

This report will allow you to

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

Visualize the composition of the COPD 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 COPD pipeline and stratify by stage of development, molecule type and molecular target. There are promising signs in the pipeline that the industry is seeking novel approaches to treating COPD.

Assess the therapeutic potential of first-in-class targets. Using a proprietary matrix, first-in-class products have been assessed and ranked according to clinical potential. Promising early-stage targets have been reviewed in greater detail.

Identify commercial opportunities in the COPD deals landscape by analyzing trends in licensing and co-development deals and producing a curated list of COPD therapies that are not yet involved in deals and may be potential investment opportunities.

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 Unmet Needs Remain in COPD Market 4

2.2 First-in-Class Innovation Beginning to Emerge in COPD 4

2.3 COPD Lags Behind Asthma in First-in-Class Innovation 4

3 The Case for Innovation in COPD 5

3.1 Growing Number of Opportunities for Biologic 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 GBI Research Report Guidance 8

4 Clinical and Commercial Landscape 9

4.1 Disease Overview 9

4.1.1 Epidemiology 9

4.1.2 Symptoms 9

4.1.3 Etiology 9

4.1.4 Pathophysiology 9

4.1.5 Diagnosis 11

4.1.6 Assessment of Disease Severity 11

4.1.7 Treatment 12

4.1.8 Treatment Algorithm 14

4.2 Overview of Marketed Products 14

4.2.1 Molecule Type and Target Analysis 15

4.2.2 Quick Relief Medication 15

4.2.3 Bronchodilator and Inhaled Corticosteroid Combination Therapy 15

4.2.4 Bronchodilator Monotherapy 16

4.2.5 Bronchodilator Combination Therapy 17

4.2.6 Alternative Therapy 17

4.2.7 Conclusion 17

4.2.8 Unmet Needs 18

5 Assessment of Pipeline Product Innovation 19

5.1 Molecular Target Analysis 21

5.2 Comparative Distribution of Programs between COPD Market and Pipeline by Therapeutic Target Family 26

5.3 First-In-Class Pipeline Programs Targeting Novel Molecular Targets 26

6 Signaling Pathways, Disease Causation and Innovation Alignment 30

6.1 The Complexity of Signaling Networks in COPD 30

6.2 Signaling Pathways and First-in-Class Molecular Target Integration 30

6.3 First-in-Class Target Matrix Assessment 31

7 First-in-Class Target Evaluation 33

7.1 Pipeline Programs Targeting Toll-Like Receptor 3 33

7.2 Pipeline Programs Targeting Adenosine A(2B) Receptor 34

7.3 Pipeline Programs Targeting Prostaglandin D2 Receptor 2 34

7.4 Pipeline Programs Targeting P-selectin 35

7.5 Pipeline Programs Targeting Macrophage Metalloelastase 35

7.6 Pipeline Programs Targeting Rho Associated Protein Kinase 1 36

7.7 Pipeline Programs Targeting Soluble Epoxide Hydrolase 37

7.8 Pipeline Programs Targeting Vasoactive Intestinal Peptide Receptor Family 37

7.9 Conclusion 38

8 Deals and Strategic Consolidations 39

8.1 Industry-Wide First-in-Class Deals 39

8.2 Licensing Deals 40

8.3 Co-development Deals 43

8.4 First-in-Class Programs not Involved in Licensing or Co-Development Deals 45

9 Appendix 48

9.1 References 48

9.2 Abbreviations 51

9.3 Research Methodology 51

9.4 Secondary Research 52

9.4.1 Marketed Product Heatmaps and Treatment Algorithm 52

9.4.2 Pipeline Analysis 52

9.4.3 First-in-Class Matrix Assessment 52

9.4.4 First-in-Class Target Profiles 53

9.4.5 Licensing and Co-Development Deals 53

9.5 Contact Us 53

9.6 Disclaimer 53

1.1 List of Tables

Table 1: COPD, Introduction, Disease Severity, 2015 11

Table 2: COPD, Introduction, Patient Risk Categories, 2015 12

Table 3: COPD, Introduction, Treatment Algorithm, 2015 14

1.2 List of Figures

Figure 1: Innovation Trends in Product Approvals 5

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

Figure 3: COPD Market,Molecular Targets of Marketed Products, 2015 15

Figure 4: COPD Market, Global, Pipeline, 2015 20

Figure 5: COPD Market, Global, Pipeline, Molecular Target, 2015 22

Figure 6: COPD Market, Global, Pipeline, Molecular Target Tier 2, 2015 25

Figure 7: COPD, Molecular Target Category Comparison, Pipeline and Marketed Products, 2015 26

Figure 8: COPD, Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets, 2015 27

Figure 9: COPD, First-in-Class Pipeline Products, 2015 28

Figure 10: COPD, First-in-Class Molecular Target Analysis Matrix, 2015 32

Figure 11: COPD, Toll-Like Receptor 3 Profile 33

Figure 12: COPD, Products Targeting Toll-Like Receptor 3 33

Figure 13: COPD, Adenosine Receptor Profile 34

Figure 14: COPD, Products Targeting Adenosine Receptor 34

Figure 15: COPD, Prostaglandin d2 Receptor 2 Profile 35

Figure 16: COPD, Products Targeting Prostaglandin d2 Receptor 2 35

Figure 17: COPD, P-selectin Profile 35

Figure 18: COPD, Products Targeting P-selectin 35

Figure 19: COPD, Macrophage Metalloelastase Profile 36

Figure 20: COPD, Products Targeting Macrophage Metalloelastase 36

Figure 21: COPD, Rho Associated Protein Kinase 1 Profile 36

Figure 22: COPD, Products Targeting Rho Associated Protein Kinase 1 Profile 37

Figure 23: COPD, Soluble Epoxide Hydrolase Profile 37

Figure 24: COPD, Products Targeting Soluble Epoxide Hydrolase 37

Figure 25: COPD, Vasoactive Intestinal Peptide Receptor Family Profile 37

Figure 26: COPD, Products Targeting Vasoactive Intestinal Peptide Receptor Family 38

Figure 27: Industry-Wide Deals by Stage of Development, 2006-2015 39

Figure 28: Industry-wide Deals by Stage of Development, 2006-2015 40

Figure 29: COPD, Global, Licensing Deals by Region, 2006-2015 41

Figure 30: COPD Market, Global, Licensing Deals by Value, 2006-2015 41

Figure 31: COPD, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2015 41

Figure 32: COPD, Global, Licensing Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2015 42

Figure 33: COPD, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2015 42

Figure 34: COPD, Global, Licensing Deals by Mechanism of Action and Aggregate Deal Value (USD m), 2006-2015 43

Figure 35: COPD, Global, Co-development Deals by Region, 2006-2015 43

Figure 36: COPD, Global, Co-development Deals by Value, 2006-2015 43

Figure 37: COPD, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value (USD m) and Aggregate Upfront Value (USD m), 2006-2015 44

Figure 38: COPD, Global, Co-development Deals by Stage of Development, Deal Value (USD m) and Upfront Payment Value (USD m), 2006-2015 44

Figure 39: COPD, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value (USD m), 2006-2015 45

Figure 40: COPD, Global, Co-development Deals by Mechanism of Action and Aggregate Deal Value (USD m), 2006-2015 45

Figure 41: COPD, Global, First-in-class Programs with no Recorded Prior Deal Involvement, 2006-2015 46

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COPD, Chronic Obstructive Pulmonary Disease, Respiratory disorders, Obstructive Pulmonary Disease


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