COPD: Market, Treatment and Development Overview - ISR ...

COPD: Market, Treatment and Development Overview 1

[email protected] © 2012 Industry Standard Research www.ISRreports.com

Scope of the Research - COPD Disease Overview

- Epidemiology of COPD

- Current COPD Therapies

- COPD Market Size

- Leading COPD Companies and Products

- Clinical Development Analysis and Pipeline for COPD Drug Therapies

Decision-making Focused - Opportunity assessment, COPD market size

- Market dynamics, how products currently in the pipeline could unseat current therapies and shake-up the market

- Identify strategic development opportunities

- Enhance commercialization strategic planning

- Competitive assessment, provides a full analysis and summary of major COPD companies, including: Current products, financial summary, and R&D efforts

COPD: Market, Treatment and Development Overview

This report offers a unique therapeutic assessment and in-depth market and pipeline analysis, providing a combined view of the COPD pipeline not available elsewhere. The purpose of this report is to give an extensive overview of the current and future COPD market and discuss the activities of the key players and some of the issues surrounding COPD drug development.

In this summary… Introduction 2 Major Sections 2 Companies/Therapies/ Pipelines 3 Table of Contents 4 List of Tables 6 List of Figures 7 Samples Pages 8 Ordering 11

Q2, 2012

Length: 146 Pages, including 68 Charts and Graphs

Publisher: Industry Standard Research (ISR)

Valuable for: Pharma / Biotech Marketing Sales Sales Training R&D Contract Sales Organizations Contract Research Organizations

mailto:[email protected]

http://www.isrreports.com/



Introduction

It is widely recognized that the global social and economic burden of COPD is high; affecting an estimated 64 million people worldwide. However, the availability of accurate data for COPD prevalence is hampered by variability in study methodology and both under-diagnosis and misdiagnosis of the disease. While 12 million Americans are diagnosed with COPD, it is estimated that an additional 12 million remain undiagnosed. The economic burden of COPD is tremendous. This creates a tremendous opportunity for substantial economic gains by pharmaceutical companies that can bring novel products to market. In Europe the annual economic burden of respiratory diseases is estimated to be approximately €102 billion, with COPD responsible for over half of the burden. The COPD market is currently dominated by a few therapies in a very limited number of classes which are used to manage the symptoms of COPD, but have little effect on the underlying, poorly understood disease process. The substantial unmet need associated with the disease creates significant market potential for players in the field. Indeed the COPD market is set to undergo significant change, with the recent launch of a new product class and new highly anticipated combination therapies with block-buster potential set to reach market in the near and mid-term. The patent expiration and arrival of generics of some of the fields’ key drugs will also herald change in the market.

Major Report Sections

1. Chronic Obstructive Lung Disease (COPD) 2. Epidemiology of COPD

a) COPD prevalence b) Future prevalence

3. Current COPD Therapies a) Current treatment options b) Unmet patient needs

4. COPD Market Size 5. Leading COPD Companies and Products

a) Key players in the respiratory and COPD market 6. Clinical Development Issues for COPD Drug Therapies

a) Clinical trial design requirements and selection of endpoints b) COPD development plans c) Competition in COPD arena

7. Clinical Development Pipeline a) R&D trends in the treatment of COPD b) Upcoming companies in COPD Research

A full table of contents is available on page 4





Companies, Treatment Therapies, and Pipelines

Leading COPD Companies The leading COPD companies were included in this analysis. Depending on information available, ISR’s report provides financial summaries, key COPD products, and COPD R&D activities for: - GlaxoSmithKline - Merck & Co - Boehringer Ingelheim - AstraZeneca - Novartis - Sunovion - Almirall - Nycomed - Forest Labs

Currently Available Treatment Options

Bronchodilators Therapies - Beta2-Adrenergic Agonists - Short-Acting Beta2-Adrenergic Agonists

(SABA) - Long-Acting Beta2-Adrenergic Agonists

(LABA) - Ultra-LABAs - Antimuscarinics - Inhaled Corticosteroids (ICS) - Oral Corticosteroids - LABA and ICS Combinations - SABA and SAMA Combinations - Xanthine Derivatives - Selective Phosphodiesterase Type 4 (PDE-4)

Inhibitors

Non-bronchodilator Therapies - Antibiotics - Oral Mucolytic Therapy - Alpha-1 Antitrypsin Augmentation

Therapy (AAAT) - Oxygen Therapy - Surgical Treatments

Upcoming Companies in COPD Treatment- Vectura - Theravance - Pearl Therapeutics - Elevation Pharmaceuitcals - Rottapharm Madaus - Sandoz





Table of Contents

Copyright and Usage Guidelines 11 Table of Abbreviations 12 Chapter 1: Chronic Obstructive Lung Disease (COPD) 14 Disease Overview 14 Pathogenesis 14 Pathophysiology 15 Risk Factors 16 Diagnosis of COPD 18 Chapter 2: Epidemiology of COPD 20 COPD Prevalence 20 Global 20 United States 21 Europe 21 Asia 24 Africa 25 Latin America 25

Future Prevalence 26 Mortality 27 The Economic Cost of COPD 30

CHAPTER 3: Current COPD Therapies 32 Current Treatment Options 32 Bronchodilators 35

Beta2-Adrenergic Agonists 35 Short-Acting Beta2-Adrenergic Agonists (SABA) 35 Long-Acting Beta2-Adrenergic Agonists (LABA) 36 Ultra-LABAs 37 Antimuscarinics 37 Inhaled Corticosteroids (ICS) 38 Oral Corticosteroids 38 LABA and ICS Combinations 39 SABA and SAMA Combinations 40 Xanthine Derivatives 40 Selective Phosphodiesterase Type 4 (PDE-4) Inhibitors 40

Non-bronchodilator Therapies for COPD 42 Antibiotics 42 Oral mucolytic therapy 42

Alpha-1 Antitrypsin Augmentation Therapy (AAAT) 42 Oxygen Therapy 42 Surgical Treatments 43

Unmet Patient Needs 43 Morbidity 43 Medical Needs 44

Chapter 4: Respiratory Market 47 The COPD Market Size 47

Chapter 5: Leading COPD Companies and Products 53

Key Players in the Respiratory and COPD Market 53 GlaxoSmithKline (GSK) 56

Financial Summary 57 Key COPD Products 59 COPD Research and Development 65

Merck & Co. 66 Financial Summary 67 Key COPD Products 68

Boehringer Ingelheim 69 Financial Summary 70 Key COPD Products 71 COPD Research and Development 74

AstraZeneca 75 Financial Summary 76 Key COPD Products 78 COPD Research and Development 80

Novartis 81 Financial Summary 82 Key COPD Products 83 COPD Research and Development 86

Sunovion 87 Financial Summary 87 Key COPD Products 88 COPD Research and Development 88

Almirall 88 Financial Summary 89 Key COPD Products 89 COPD Research and Development 90





Table of Contents (Continued)

Nycomed (Takeda) 91 Financial Summary 92 Key COPD Products 92 COPD Research and Development 93

Forest Labs 94 Financial Summary 94 COPD Research and Development 95

Chapter 6: Clinical Development Issues for COPD Drug Therapies 96 Clinical Trial Design Requirements and

Selection of Endpoints 96 Physiologic Assessments 97 Patient- or Evaluator- Reported Outcome Measures 98 Biomarkers and Surrogate Endpoints 99 Occurrence of Exacerbations 100 Secondary Efficacy Endpoints 100 Study Duration 101 Number of Studies 101 Demonstration of Safety 101 Combination Drug Products 102

COPD Development Plans 102 Development of Generics 108 Inhalation Devices 109 Competition in the COPD Arena 111

Location of COPD Clinical Trials 112 Industry Interest in COPD 113

Chapter 7: Clinical Development Pipeline 115 R&D Trends in the Treatment of COPD 115

Fixed Dose Combination Therapies 115 Novel Anti-inflammatory Therapies 115

Late Stage Development Products 117 Early Phase Development Pipeline 127 Upcoming Companies in COPD Research 129

Vectura 129 Theravance 130 Pearl Therapeutics 131 Elevation Pharmaceuticals 133 Rottapharm Madaus 134 Sandoz 135

Bibliography 136





List of Tables

Table 1: Lifetime Risk of Physician Diagnosed COPD Table 2: Estimated Prevalence of COPD in England, 2011 Table 3: The Prevalence of COPD by Disease Stage Table 4: The Prevalence Range of COPD in Latin America Table 5: Estimated Future Diagnosed Population (age 40+ years) Table 6: Top Ten Causes of Death 2008 Table 7: 5-Year Survival by COPD Stage Table 8: Mortality Rates Following COPD Exacerbations Table 9: GOLD Guidelines for the Treatment of COPD Table 10: Major COPD Drug Classes and Products Table 11: COPD Market Size 2012 - 2017 Table 12: Drivers and Constraints on the COPD Market Table 13: Summary of the Key Players in the Respiratory / COPD Market Table 14: Analysis of GSK’s Position in Respiratory Table 15: GSK Respiratory Products Table 16: GSK Respiratory Revenues Table 17: Ventolin SWOT Analysis Table 18: Seretide/Advair SWOT Analysis for COPD Table 19: GSK COPD Development Pipeline Table 20: Merck Respiratory and Inflammation Revenues Table 21: Summary of Dulera Phase III Trial Results Table 22: BI’s Respiratory Portfolio Table 23: Summary of BI Respiratory Revenues Table 24: SWOT Analysis for Spiriva in COPD Table 25: BI COPD Development Pipeline Table 26: Summary of AZ’s Respiratory Products Table 27: Summary of AZ Respiratory Revenues Table 28: SWOT Analysis for Symbicort Table 29: AZ COPD Development Pipeline Table 30: Novartis Respiratory Products Table 31: Novartis Respiratory Revenues Table 32: SWOT Analysis of Arcapta Table 33: Novartis COPD Development Pipeline Table 34: Key Respiratory Drugs Table 35: Sunovion Respiratory Revenues Table 36: Almirall Key Respiratory Products Table 37: Almirall Respiratory Financials Table 38: Almirall COPD Development Pipeline Table 39: Nycomed Respiratory Portfolio Table 40: SWOT Analysis for Daliresp Table 41: Forest Labs COPD Development Pipeline





List of Tables (Continued)

Table 42: LABA/ICS: Advair (fluticasone and salmeterol), GSK Table 43: LABA/ICS: Symbicort (budesonide/fomoterol), AZ Table 44: Ultra-LABA: Arcapta (indacaterol), Novartis: Table 45: Ultra-LABA/ICS: Relovair (vilanterol/fluticasone), GSK Table 46: LAMA: Spiriva (tiotropium), BI Table 47: LAMA: Aclidinium Bromide, Almirall Table 48: LAMA: Seebri Breezhaler (NVA237), Novartis Table 49: LABA/LAMA: Aclidinium Bromide/Formoterol, Almirall Table 50: LABA/LAMA: Vilanterol/GSK573719, GSK Table 51: LABA/LAMA: olodaterol/tiotropium, BI Table 52: LABA/LAMA: QVA149 (indacaterol/NVA237), Novartis Table 53: PDE4 Inhibitor: Daliresp/Daxas (Roflumilast), Nycomed/Forest Table 54: The Late Stage COPD Pipeline Table 55: Aclidinium Bromide SWOT Analysis Table 56: Relovair SWOT Analysis Table 57: Early Phase COPD Development Pipeline Table 58: Vectura Development Pipeline Table 59: Pearl Therapeutics COPD Development Pipeline

List of Figures

Figure 1: COPD Prevalence in Europe Figure 2: Smoking Prevalence Rates in Selected European Countries Figure 3: COPD Mortality, Europe Figure 4: COPD Hospital Admission Rates, Selected Countries Figure 5: Annual Direct and Indirect COPD Costs Figure 6: The Asthma and COPD Market Size Figure 7: Distribution of Development Drugs by Phase Figure 8: Distribution of Active, Industry Sponsored COPD Studies, By Phase Figure 9: Clinical Trial Activity by Sponsor Figure 10: The Geographic Distribution of Active, Industry Sponsored COPD Trials Figure 11: Industry Sponsored COPD Trial Activity by Year





Sample Pages

From the section entitled “COPD Prevalence: Europe”

Europe with highest rates found in Italy and Germany. This does not entirely reflect data from WHO Europe on the prevalence of smoking in Europe (see Figure 2). Germany has one of the highest rates of smoking prevalence, estimated at approximately 34% which correlates with the countries high COPD prevalence, however by comparison Italy reports a smoking prevalence of only 24% but an estimated COPD prevalence as high as that of Germany. Sweden reports a high COPD prevalence but at 16% one of the lowest smoking prevalence rates in Europe (33). Figure 1: COPD Prevalence in Europe

Source: European White Lung Book

Figure 2. Smoking Prevalence Rates in Selected European Countries

Source: WHO





Sample Pages

From the section entitled “R&D Trends in Treatment of COPD”

Chapter 7: Clinical Development Pipeline R&D Trends in the Treatment of COPD Fixed Dose Combination Therapies The development pipeline is dominated by fixed dose combination products. These include both LABA/ICS combinations and LABA/LAMA combinations. Those in the LABA/ICS category are predominantly aimed at combining the “ultra-LABAs” with ICS in order to provide once-daily dosing. The most advanced is GSK’s Relovair, which ultimately hopes to replace the twice-daily Advair which will face generic competition in the short to mid-term. The development of once daily LABAs has brought the possibility of combination with LAMAs in one product. Several of these combinations are now in late-stage development. Both muscarinic antagonists and beta2

agonists cause bronchodilation, but by different mechanisms of action. They also have non-bronchodilator effects that can be complementary and beneficial in patients with COPD. The combination integrates two medications which are often prescribed individually to optimize disease control, into one inhaler, thus cutting the medication burden. This concept is being taken one step further by small biotech company Pearl Therapeutics who are currently investigating a triple combination LABA/LAMA/ICS. In an advance to the direct combination of two agents in one dosage form, GSK is developing a bifunctional long acting bronchodilator, GSK961081, which combines both muscarinic antagonist and beta2 agonist activities in a single molecule. The company’s aim is to combine bifunctional activity and high lung selectivity to develop a product with greater efficacy than single mechanism bronchodilators and with equal or better tolerability. The molecule could then be combined with ICS in a single dose inhaler. Novel Anti-inflammatory Therapies As the understanding of the inflammatory process which underlies COPD grows and develops it raises the possibility of targeting appropriate inflammatory mediators in order to relieve symptoms and affect the underlying disease process. By directly influencing the cellular components of inflammation or interfering with mediators which regulate the migration and activation of inflammatory cells, the inflammatory cascade can be interrupted or inactivated. New entities directed at some of these potential targets are beginning to make their way through the clinical trial process.





Sample Pages

From the section entitled “Respiratory Market Size”

Table 10: Drivers and Constraints on the COPD Market

Market Drivers Market Constraints

Large and expanding patient population

Increased diagnosis and drug treatment

Changing views of respiratory disorders

XXXXXXXXX XXXXXXXXXXX XXXXXXXXXX

XXXXX XXXXXXXXXX

Market with blockbuster potential

XXXXXXXX XXXXXXXXXX XXX XXX XXXX X XXXXX XX XXXX X XXXX

Underserved disease with considerable unmet needs

A number of recently approved therapies with growth potential

Potential for new therapy classes in the short to mid term

New drugs with new mechanisms of action in the longer term

XXXXX XXXX XXXX XXXXXX XX X XXXX XXXX XXXXX XXXXX

XXXXXXXX XXX XXXXXXXXXXX XXXXXXXXXXXXX

Patent expiration on key therapies

Threat of generic entry in near term

Restrictions on healthcare budgets favour generics use

XXXX XXXXXXXXX XXXX XX X XXXXXXXXX

XXXX XXXXXXXX XXX X XXXXXXX XXXXX XXX X XXX XX XXXX XXXXXXXXXXXXXX XXXX XXXXXX XXXXXX XXXXXXXX XXXXXXX XXXXXX XX XXXX XXXXXXX X XXXXXXX

Increased bargaining power of purchasers

Relatively poor understanding of the disease process making it difficult to target new treatments





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