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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

Summary

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.


Chronic Obstructive Pulmonary Disease Treatment Pipeline Lacks Robust Innovation, says GBI Research

Despite an influx of new therapies over recent years, the Chronic Obstructive Pulmonary Disease (COPD) treatment market has a number of unmet needs, and the innovation in its product development pipeline is lagging in comparison to other indications, says business intelligence provider GBI Research.

According to the company’s latest report*, while currently-available drugs aim to manage the symptoms associated with COPD by reducing the frequency and severity of exacerbations and improving lung function, none have been shown to modify long-term disease progression.

Yasser Mushtaq, Senior Analyst for GBI Research, states that in addition to the need for disease-modifying drugs, much of the unmet need associated with COPD has been linked to poor adherence to medication.

Mushtaq says: “Tedious drug delivery processes and the need for frequent daily doses ultimately lead to poor compliance and management of COPD symptoms. As a consequence, drug development programs are focusing on long-acting medication.
0“There is also a need for alternative anti-inflammatory agents. Traditionally reliant on Inhaled Corticosteroids (ICS), analysis of the COPD product development pipeline has confirmed greater interest into novel anti-inflammatory agents.”

The analyst adds that beyond ICS therapy, the current market offers very limited anti-inflammatory treatment, which is a notable unmet need in COPD.

GBI Research’s report also states that first-in-class product development in COPD treatment constitutes only 16.5% of the pipeline, which is relatively small compared to other respiratory indications. For example, asthma therapeutics exhibit greater innovation, with first-in-class products making up 23% of the pipeline.

Mushtaq continues: “There are suggestions that such innovation is filtering through into the COPD therapeutics pipeline, as asthma and COPD share mechanisms of pathophysiology, making it likely that products will be applicable to both diseases.

“In this way, innovations in the asthma treatment pipeline will significantly aid that of COPD. However, there is no clear indication that disease-modifying drugs will be released onto the COPD market any time soon, making it an attractive proposition for major pharma players.”

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

This report provides analysis of the Chronic Obstructive Pulmonary Disease (COPD) treatment pipeline, stratified by stage of development, molecule type and molecular target. It includes information on the current clinical and commercial landscape, and the composition of the COPD therapeutics market in terms of dominant molecule types and targets, as well as highlighting current unmet needs.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 Unmet Needs Remain in COPD Market
2.2 First-in-Class Innovation Beginning to Emerge in COPD
2.3 COPD Lags Behind Asthma in First-in-Class Innovation
3 The Case for Innovation in COPD
3.1 Growing Number of Opportunities for Biologic Products
3.2 Diversification of Molecular Targets
3.3 Innovative First-in-Class Product Developments Remain Attractive
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation
3.5 Sustained Innovation
3.6 GBI Research Report Guidance
4 Clinical and Commercial Landscape
4.1 Disease Overview
4.1.1 Epidemiology
4.1.2 Symptoms
4.1.3 Etiology
4.1.4 Pathophysiology
4.1.5 Diagnosis
4.1.6 Assessment of Disease Severity
4.1.7 Treatment
4.1.8 Treatment Algorithm
4.2 Overview of Marketed Products
4.2.1 Molecule Type and Target Analysis
4.2.2 Quick Relief Medication
4.2.3 Bronchodilator and Inhaled Corticosteroid Combination Therapy
4.2.4 Bronchodilator Monotherapy
4.2.5 Bronchodilator Combination Therapy
4.2.6 Alternative Therapy
4.2.7 Conclusion
4.2.8 Unmet Needs
5 Assessment of Pipeline Product Innovation
5.1 Molecular Target Analysis
5.2 Comparative Distribution of Programs between COPD Market and Pipeline by Therapeutic Target Family
5.3 First-In-Class Pipeline Programs Targeting Novel Molecular Targets
6 Signaling Pathways, Disease Causation and Innovation Alignment
6.1 The Complexity of Signaling Networks in COPD
6.2 Signaling Pathways and First-in-Class Molecular Target Integration
6.3 First-in-Class Target Matrix Assessment
7 First-in-Class Target Evaluation
7.1 Pipeline Programs Targeting Toll-Like Receptor 3
7.2 Pipeline Programs Targeting Adenosine A(2B) Receptor
7.3 Pipeline Programs Targeting Prostaglandin D2 Receptor 2
7.4 Pipeline Programs Targeting P-selectin
7.5 Pipeline Programs Targeting Macrophage Metalloelastase
7.6 Pipeline Programs Targeting Rho Associated Protein Kinase 1
7.7 Pipeline Programs Targeting Soluble Epoxide Hydrolase
7.8 Pipeline Programs Targeting Vasoactive Intestinal Peptide Receptor Family
7.9 Conclusion
8 Deals and Strategic Consolidations
8.1 Industry-Wide First-in-Class Deals
8.2 Licensing Deals
8.3 Co-development Deals
8.4 First-in-Class Programs not Involved in Licensing or Co-Development Deals
9 Appendix
9.1 References
9.2 Abbreviations
9.3 Research Methodology
9.4 Secondary Research
9.4.1 Marketed Product Heatmaps and Treatment Algorithm
9.4.2 Pipeline Analysis
9.4.3 First-in-Class Matrix Assessment
9.4.4 First-in-Class Target Profiles
9.4.5 Licensing and Co-Development Deals
9.5 Contact Us
9.6 Disclaimer
1.1 List of Tables
Table 1: COPD, Introduction, Disease Severity, 2015
Table 2: COPD, Introduction, Patient Risk Categories, 2015
Table 3: COPD, Introduction, Treatment Algorithm, 2015
1.2 List of Figures
Figure 1: Innovation Trends in Product Approvals
Figure 2: Sales Performance of First-in-Class and Non-First-in-Class Product Post Marketing Approval
Figure 3: COPD Market,Molecular Targets of Marketed Products, 2015
Figure 4: COPD Market, Global, Pipeline, 2015
Figure 5: COPD Market, Global, Pipeline, Molecular Target, 2015
Figure 6: COPD Market, Global, Pipeline, Molecular Target Tier 2, 2015
Figure 7: COPD, Molecular Target Category Comparison, Pipeline and Marketed Products, 2015
Figure 8: COPD, Molecular Target Category Comparison, Pipeline First-in-Class and Established Molecular Targets, 2015
Figure 9: COPD, First-in-Class Pipeline Products, 2015
Figure 10: COPD, First-in-Class Molecular Target Analysis Matrix, 2015
Figure 11: COPD, Toll-Like Receptor 3 Profile
Figure 12: COPD, Products Targeting Toll-Like Receptor 3
Figure 13: COPD, Adenosine Receptor Profile
Figure 14: COPD, Products Targeting Adenosine Receptor
Figure 15: COPD, Prostaglandin d2 Receptor 2 Profile
Figure 16: COPD, Products Targeting Prostaglandin d2 Receptor 2
Figure 17: COPD, P-selectin Profile
Figure 18: COPD, Products Targeting P-selectin
Figure 19: COPD, Macrophage Metalloelastase Profile
Figure 20: COPD, Products Targeting Macrophage Metalloelastase
Figure 21: COPD, Rho Associated Protein Kinase 1 Profile
Figure 22: COPD, Products Targeting Rho Associated Protein Kinase 1 Profile
Figure 23: COPD, Soluble Epoxide Hydrolase Profile
Figure 24: COPD, Products Targeting Soluble Epoxide Hydrolase
Figure 25: COPD, Vasoactive Intestinal Peptide Receptor Family Profile
Figure 26: COPD, Products Targeting Vasoactive Intestinal Peptide Receptor Family
Figure 27: Industry-Wide Deals by Stage of Development, 2006–2015
Figure 28: Industry-wide Deals by Stage of Development, 2006–2015
Figure 29: COPD, Global, Licensing Deals by Region, 2006–2015
Figure 30: COPD Market, Global, Licensing Deals by Value, 2006–2015
Figure 31: COPD, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006–2015
Figure 32: COPD, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006–2015
Figure 33: COPD, Global, Licensing Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006–2015
Figure 34: COPD, Global, Licensing Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006–2015
Figure 35: COPD, Global, Co-development Deals by Region, 2006–2015
Figure 36: COPD, Global, Co-development Deals by Value, 2006–2015
Figure 37: COPD, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Value ($m), 2006–2015
Figure 38: COPD, Global, Co-development Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006–2015
Figure 39: COPD, Global, Co-development Deals by Molecule Type, Stage of Development and Aggregate Deal Value ($m), 2006–2015
Figure 40: COPD, Global, Co-development Deals by Mechanism of Action and Aggregate Deal Value ($m), 2006–2015
Figure 41: COPD, Global, First-in-class Programs with no Recorded Prior Deal Involvement, 2006–2015

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