REFERENCE CODE GDHC1170DFR PUBLICATION DATE M AY 2013

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1 REFERENCE CODE GDHC1170DFR PUBLICATION DATE M AY 2013 BRODALUMAB (PSORIASIS) -

2 Executive Summary Table below presents key metrics for brodalumab in seven of the nine major pharmaceutical markets covered in this report. Brodalumab: Key Metrics in the Psoriasis Markets 2022 Market Sales US $243m 5EU $125m Japan $764k Total 7MM $370m Key Events ( ) Launch of brodalumab in the US & EU in 2016 (in Italy and Spain in 2017) Source: GlobalData Level of Impact *For the purpose of this report, 7MM = US, France, Germany, Italy, Spain, UK, and Japan Sales of Brodalumab in the Global Psoriasis Market, 2022 GlobalData expects Amgen/AstraZeneca to launch brodalumab in the US and EU in 2016 (in Italy and Spain in 2017) and Japan in We estimate the 2022 drug sales of brodalumab will reach $370m across these markets. Key factors affecting the uptake of brodalumab will include: Good efficacy and safety profile compared to the current marketed drugs, specifically Stelara as it went head-to-head in trials; and competing pipeline products, specifically the two other IL-17 inhibitors Amgen s knowledge in the market-space and commercialization of brodalumab Despite these drivers, the PsO market will be crowded, including two other IL-17 inhibitors. Individual drugs will struggle to gain a foothold as they distinguish themselves from each other. 2

3 Executive Summary Figure below presents sales for brodalumab by region in the PsO market, 2022 Brodalumab Sales by Region, % Source: GlobalData 0.2% 65.8% 2022 Total: $370.1m US 5EU Japan What do the Physicians Think? Drug resistance and patients becoming refractory to therapies in less than three years have become main issues of discussion in the PsO world. The resistance issue will be an issue in the fiveyear [time] frame. We need alternative, possible alternative choices. The larger the number of available drugs, the better. [EU] key opinion leader, January 2013 The upcoming launches of the IL-17 inhibitors have KOLs extremely excited, as they hope to be able to put them to use early in the treatment paradigm. 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

4 Executive Summary The use of biosimilars has also been a hot topic among dermatologists and other physicians who prescribe biologics for the warranted indications. However, there is a misconception as to the pricing of these biologic generics; we discovered mixed feelings among physicians regarding their presence due to manufacturing or pricing. I think it s an opportunity. This market is highly price-sensitive...when they come to the market; they will completely grab the market of the anti- TNFs, provided the prices are 30 to 50%. It is very significant If it s 20%, then I m disappointed. [EU] key opinion leader, January

5 Table of Contents 1 Table of Contents 1 Table of Contents List of Tables List of Figures Introduction Catalyst Related Reports Upcoming Related Reports Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Symptoms Disease Management Treatment Overview Competitive Assessment Overview Strategic Competitor Assessment Opportunity and Unmet Need Overview Unmet Needs Improved Drug Safety and Efficacy Profiles Biomarkers for Predicting Remission More Cost-Effective Therapies Through Oral Formulation and Biosimilars

6 Table of Contents Education and Treatment of Psychological Factors Accompanying Psoriasis An Effective Biologic/Systemic Topical Therapy More Effective Treatment for Mild Psoriasis, Specifically UV Therapies Physician Education About the Different Types of Psoriasis, not Just Plaque Psoriasis Opportunities Unmet Needs Gap Analysis Predictive Tools for Diagnosis and Treatment Target Specificity Topical Biologic/Systemic Therapeutic Options Helping Patients with Psychological Issues Associated with Psoriasis Pipeline Assessment Overview Promising Drugs in Clinical Development Brodalumab (AMG 827) Overview Efficacy Safety Dosing and Formulation Potential Clinical Positioning Potential Commercial Positioning Pricing and Reimbursement SWOT Analysis Forecast Appendix Bibliography

7 Table of Contents 9.2 Abbreviations Methodology Forecasting Methodology Diagnosed Psoriasis Patients Percent Drug-Treated Patients General Pricing Assumptions Generic Erosion Pricing of Pipeline agents Physicians and Specialists Included in this Study Primary Research Prescriber Survey About the Authors Analysts Global Head of Healthcare About GlobalData Disclaimer

8 Table of Contents 1.1 List of Tables Table 1: Immune Cells Involved in Lesions Table 2: Symptoms of Psoriasis Table 3: Minimal Investigative Measures Required Before Prescribing Biologics for Psoriasis Table 4: Treatment Guidelines for Psoriasis Table 5: Top Three Biologics Prescribed for Moderate to Severe Psoriasis by Market, Table 6: Leading Treatments for Psoriasis, Table 7: Overall Unmet Needs in Psoriasis Current Level of Attainment Table 8: Clinical Unmet Needs in Psoriasis Gap Analysis, Table 9: Psoriasis Phase Pipeline, Table 10: Comparison of Therapeutic Classes in Development for Psoriasis, Table 11: Product Profile Brodalumab Table 12: Efficacy Results of Phase II Study of Brodalumab vs. Placebo at Week Table 13: Brodalumab SWOT Analysis, Table 14: Global Sales Forecasts ($) for Brodalumab, Table 15: Physicians Surveyed, By Country

9 Table of Contents 1.2 List of Figures Figure 1: Psoriatic Plaque on Elbow of Patient Figure 2: The Three Layers of the Skin and Associated Structures Figure 3: Healthy Skin Versus Psoriatic Skin Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Psoriasis,

10 Introduction 2 Introduction 2.1 Catalyst The psoriasis market is currently very dynamic, with novel therapies awaiting approval, such as: Novartis interleukin-17 (IL-17) inhibitor, secukinumab Merck s interleukin-23 (IL-23) inhibitor, MK-3222 Celgene s phosphodiesterase-4 (PDE-4) inhibitor, apremilast These compounds will challenge the current biologics in an attempt to dislodge the stronghold of the TNF inhibitors, if their safety and efficacy profiles are proven once they enter the market. The impending patent cliff will allow for the emergence of biosimilars to all the marketed brands. Patent expiries begin in 2014 for the current market leaders, such as: Johnson & Johnson s Remicade (infliximab) AbbVie s (Abbott s pharmaceutical division) Humira (adalimumab) 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 Psoriasis (PsO) pharmacotherapy, but we expect slow growth, particularly in India. The challenges will be the crowded marketplace, comprising a highlydiversified field of therapies, with individual drugs struggling to distinguish themselves Amgen s Enbrel (etanercept) Johnson & Johnson s Stelara (ustekinumab) 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 highlydiversified 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. 10

11 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). Secukinumab (Psoriasis) Forecast and Market Analysis to 2022, May 2013, GDHC1171DFR. GlobalData (2013). Ixekizumab (Psoriasis) Forecast and Market Analysis to 2022, May 2013, GDHC1172DFR. GlobalData (2013). tildrakizumab (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. GlobalData (2013). Alzumab (Psoriasis) Forecast and Market Analysis to 2022, May 2013, GDHC1176DFR. 11

12 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. 12

13 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. 59

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