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REFERENCE CODE GDHC1176DFR | PUBLICATION DATE MAY 2013

ALZUMAB () - FORECAST AND MARKET ANALYSIS TO 2022

Alzumab (Psoriasis) - Forecast and Market Analysis to 2022 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. ALZUMAB (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

Table below presents key metrics for Alzumab Sales of Alzumab for Psoriasis Market in India, (itolizumab) in India. 2022

GlobalData expects Biocon to launch Alzumab in Alzumab: Key Metrics in the Psoriasis Market India in late 2013. We estimate the 2022 sales of 2022 Market Sales Alzumab will reach $34.0m in India. Key factors India $34.0m Total $34.0m affecting the uptake of Alzumab will include novel Key Events (2012–2022) Level of Impact mechanism of action and cost effectiveness of the Launch of Alzumab in India (2013) ↑↑ drug. Source: GlobalData Figure below presents sales for Alzumab by region

in the PsO market, 2022

Alzumab Sales by Region, 2022

2022 Total: $34.0m

100%

India

Source: GlobalData

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ALZUMAB (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

What do the Physicians Think? The use of biosimilars has also been a hot topic among dermatologists and other physicians who Drug resistance and patients becoming refractory prescribe biologics for the warranted indications. to therapies in less than three years have become However, there is a misconception as to the pricing main issues of discussion in the PsO world. of these biologic generics; we discovered mixed “The resistance issue will be an issue in the five- feelings among physicians regarding their year [time] frame. We need alternative, possible presence due to manufacturing or pricing. alternative choices. The larger the number of “I think it’s an opportunity. This market is highly available drugs, the better.” price-sensitive...when they come to the market; [EU] key opinion leader, January 2013 they will completely grab the market of the anti- The upcoming launches of the IL-17 inhibitors have TNFs, provided the prices are 30 to 50%. It is very KOLs extremely excited, as they hope to be able to significant…If it’s 20%, then I’m disappointed.”

put them to use early in the treatment paradigm. [EU] key opinion leader, January 2013 However, we encountered some physician experts who felt that the current pipeline would not unseat the established anti-TNF drugs. “I’m most excited about the antagonist IL-17. I find these drugs very effective and quite safe. I think they will probably have a role in the future.”

[EU] key opinion leader, January 2013

“I don’t think [the] new biologics coming will have an impact on the use of TNF inhibitors.”

[US] key opinion leader, December 2012

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ALZUMAB (PSORIASIS) -

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

1 Table of Contents

1 Table of Contents ...... 4 1.1 List of Tables ...... 7

1.2 List of Figures ...... 8

2 Introduction ...... 9 2.1 Catalyst ...... 9

2.2 Related Reports ...... 9

2.3 Upcoming Related Reports ...... 11

3 Disease Overview ...... 12 3.1 Etiology and Pathophysiology ...... 12

3.1.1 Etiology ...... 12 3.1.2 Pathophysiology ...... 14 3.2 Symptoms ...... 17

4 Disease Management...... 18 4.1 Treatment Overview ...... 19

5 Competitive Assessment ...... 23 5.1 Overview ...... 23

5.2 Strategic Competitor Assessment ...... 24

6 Opportunity and Unmet Need ...... 25 6.1 Overview ...... 25

6.2 Unmet Needs ...... 26

6.2.1 Improved Drug Safety and Efficacy Profiles ...... 26 6.2.2 Biomarkers for Predicting Remission ...... 27 6.2.3 More Cost-Effective Therapies Through Oral Formulation and Biosimilars ...... 27

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ALZUMAB (PSORIASIS) -

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

6.2.4 Education and Treatment of Psychological Factors Accompanying Psoriasis ...... 28 6.2.5 An Effective Biologic/Systemic Topical Therapy ...... 28 6.2.6 More Effective Treatment for Mild Psoriasis, Specifically UV Therapies ...... 29 6.2.7 Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis .. 29 6.3 Opportunities ...... 30

6.4 Unmet Needs Gap Analysis ...... 30

6.4.1 Predictive Tools for Diagnosis and Treatment ...... 31 6.4.2 Target Specificity ...... 31 6.4.3 Topical Biologic/Systemic Therapeutic Options ...... 32 6.4.4 Helping Patients with Psychological Issues Associated with Psoriasis ...... 32 7 Pipeline Assessment ...... 33 7.1 Overview ...... 33

7.2 Promising Drugs in Clinical Development ...... 34

8 Alzumab (itolizumab) ...... 36 8.1 Overview ...... 36

8.2 Efficacy ...... 37

8.3 Safety ...... 38

8.4 Dosing and Formulation ...... 38

8.5 Potential Clinical Positioning ...... 38

8.6 Potential Commercial Positioning ...... 38

8.7 Pricing and Reimbursement ...... 38

8.8 SWOT Analysis ...... 39

8.9 Forecast ...... 40

9 Appendix ...... 41 9.1 Bibliography...... 41

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ALZUMAB (PSORIASIS) -

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

9.2 Abbreviations...... 43

9.3 Methodology ...... 46

9.4 Forecasting Methodology ...... 46

9.4.1 Diagnosed Psoriasis Patients ...... 46 9.4.2 Percent Drug-Treated Patients ...... 47 9.4.3 General Pricing Assumptions ...... 47 9.4.4 Generic Erosion ...... 48 9.4.5 Pricing of Pipeline agents ...... 48 9.5 Physicians and Specialists Included in this Study ...... 49

9.6 Primary Research – Prescriber Survey ...... 50

9.7 About the Authors ...... 51

9.7.1 Analysts ...... 51 9.7.2 Global Head of Healthcare ...... 52 9.8 About GlobalData ...... 53

9.9 Disclaimer ...... 53

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ALZUMAB (PSORIASIS) -

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

1.1 List of Tables

Table 1: Immune Cells Involved in Lesions ...... 14

Table 2: Symptoms of Psoriasis ...... 17

Table 3: Minimal Investigative Measures Required Before Prescribing Biologics for Psoriasis ...... 20

Table 4: Treatment Guidelines for Psoriasis ...... 22

Table 5: Top Three Biologics Prescribed for Moderate to Severe Psoriasis by Market, 2012...... 22

Table 6: Leading Treatments for Psoriasis, 2013 ...... 24

Table 7: Overall Unmet Needs in Psoriasis – Current Level of Attainment ...... 26

Table 8: Clinical Unmet Needs in Psoriasis – Gap Analysis, 2013 ...... 31

Table 9: Psoriasis – Phase Pipeline, 2013 ...... 34

Table 10: Comparison of Therapeutic Classes in Development for Psoriasis, 2013 ...... 35

Table 11: Product Profile – Alzumab ...... 37

Table 12: Alzumab SWOT Analysis, 2013 ...... 39

Table 13: Global Sales Forecasts ($) for Alzumab, 2012–2022 ...... 40

Table 14: Physicians Surveyed, By Country ...... 50

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ALZUMAB (PSORIASIS) -

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

1.2 List of Figures

Figure 1: Psoriatic Plaque on Elbow of Patient ...... 13

Figure 2: The Three Layers of the Skin and Associated Structures ...... 15

Figure 3: Healthy Skin Versus Psoriatic Skin ...... 16

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Psoriasis, 2012–2022 ...... 34

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ALZUMAB (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022

Introduction

2 Introduction

2.1 Catalyst

The psoriasis market is currently very dynamic, with novel therapies awaiting approval, such as: The drivers for market  Novartis’ -17 (IL-17) inhibitor, growth will also include affordable treatments  throughout the world, as well Merck’s interleukin-23 (IL-23) inhibitor, MK-3222 as the push for long-term drug efficacy. India and  Celgene’s phosphodiesterase-4 (PDE-4) inhibitor, apremilast China will also contribute to market growth as their populations obtain These compounds will challenge the current biologics in an attempt to dislodge the stronghold of increasing access to Psoriasis (PsO) the TNF inhibitors, if their safety and efficacy profiles are proven once they enter the market. pharmacotherapy, but we expect slow growth, The impending patent cliff will allow for the emergence of biosimilars to all the marketed brands. particularly in India. The challenges will be the Patent expiries begin in 2014 for the current market leaders, such as: crowded marketplace, comprising a highly-  diversified field of therapies, Johnson & Johnson’s Remicade () with individual drugs struggling to distinguish  AbbVie’s (Abbott’s pharmaceutical division) Humira () themselves

 Amgen’s Enbrel (etanercept)

 Johnson & Johnson’s Stelara ()

The drivers for market growth will also include affordable treatments throughout the world, as well as the push for long-term drug efficacy. India and China will also contribute to market growth as their populations obtain increasing access to PsO pharmacotherapy, but we expect slow growth, particularly in India. The challenges will be the crowded marketplace, comprising a highly- diversified field of therapies, with individual drugs struggling to distinguish themselves.

2.2 Related Reports

 GlobalData (2013). Psoriasis – US Drug Forecast and Market Analysis to 2022, May 2013, GDHC1106CFR.

 GlobalData (2013). Psoriasis – France Drug Forecast and Market Analysis to 2022, May 2013, GDHC1107CFR.

Alzumab (Psoriasis) - Forecast and Market Analysis to 2022 9 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

ALZUMAB (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022

Introduction

 GlobalData (2013). Psoriasis – Germany Drug Forecast and Market Analysis to 2022, May 2013, GDHC1108CFR.

 GlobalData (2013). Psoriasis – Italy Drug Forecast and Market Analysis to 2022, May 2013, GDHC1109CFR.

 GlobalData (2013). Psoriasis – Spain Drug Forecast and Market Analysis to 2022, May 2013, GDHC1110CFR.

 GlobalData (2013). Psoriasis – United Kingdom Drug Forecast and Market Analysis to 2022, May 2013, GDHC1111CFR.

 GlobalData (2013). Psoriasis – Japan Drug Forecast and Market Analysis to 2022, May 2013, GDHC1112CFR.

 GlobalData (2013). Psoriasis – China Drug Forecast and Market Analysis to 2022, May 2013, GDHC1113CFR.

 GlobalData (2013). Psoriasis – India Drug Forecast and Market Analysis to 2022, May 2013, GDHC1114CFR.

 GlobalData (2013). (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1170DFR.

 GlobalData (2013). Secukinumab (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1171DFR.

 GlobalData (2013). (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1172DFR.

 GlobalData (2013). (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1173DFR.

 GlobalData (2013). Xeljanz (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1174DFR.

 GlobalData (2013). Apremilast (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1175DFR.

Alzumab (Psoriasis) - Forecast and Market Analysis to 2022 10 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

ALZUMAB (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022

Introduction

 GlobalData (2013). Enbrel (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1177DFR.

 GlobalData (2013). Humira (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1178DFR.

 GlobalData (2013). Remicade (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1179DFR.

 GlobalData (2013). Stelara (Psoriasis) –Forecast and Market Analysis to 2022, May 2013, GDHC1180DFR.

 GlobalData (2013). Psoriasis – Current and Future Players. May 2013, GDHC1015FPR.

Alzumab (Psoriasis) - Forecast and Market Analysis to 2022 11 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

ALZUMAB (PSORIASIS) - FORECAST AND MARKET ANALYSIS TO 2022

Appendix

9.8 About GlobalData

GlobalData is a leading global provider of business intelligence in the healthcare industry. GlobalData provides its clients with up-to-date information and analysis on the latest developments in drug research, disease analysis, and clinical research and development. Our integrated business intelligence solutions include a range of interactive online databases, analytical tools, reports, and forecasts. Our analysis is supported by a 24/7 client support and analyst team.

GlobalData has offices in New York, Boston, London, India, and Singapore.

9.9 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior permission of the publisher, GlobalData.

Alzumab (Psoriasis) - Forecast and Market Analysis to 2022 53 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.