REFERENCE CODE GDHC1185DFR | PUBLICATION DATE JUNE 2013

ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) – FORECAST AND MARKET ANALYSIS TO 2022

Albaconazole (Dermatophytic Onychomycosis) – 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. ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) – FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

Albaconazole: Key Metrics in the US Market Total US Sales for DO by Route of Administration, 2012–2022 2022 Market Sales 3% US $769.06m 2012 Key events (2012–2022) Level of Impact Total: 0.27bn Albaconazole’s Launch 2018 Source: GlobalData

Sales of Albaconazole in the US DO Market

GlobalData expects Palau Pharma’s to launch Albaconazole in the US in 2018. We estimate that 97% 2022 sales of will reach $769.06m in Oral Topical

the US. 2022 Total: 1.63bn Key factors affecting the uptake of efinaconazole will include:

48%  Superior efficacy profile and much shorter 52% treatment regimen compare to other new pipeline products, such as Valeant’s efinaconazole and Celtic’s TDT-067

 Only orally-administered therapy among Oral Topical

topically-administered pipeline therapies Source: GlobalData

 Slightly higher mycological cure rates than after 36 weeks of treatment

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) – FORECAST AND MARKET ANALYSIS TO 2022

Executive Summary

What Do the Physicians Think? “I cannot treat DO patients very much because patients are concerned about the risk of treatment. The key opinion leaders (KOLs) interviewed for this I see 300 to 400 of DO patients, from which I treat report shared their insight on current and future only 15 to 20 because of the side effects of market and clinical trends within the US DO available treatment.” market. They indicated that the primary concerns within this market remain for safer and more US Key Opinion Leader, August 2012

efficacious therapies, shorter treatment durations, “I don’t think treatment rates will change because and better differential diagnostic tests. we don’t have any good treatment [options] “Oral requires lab monitoring and [is] currently available.” associated with severe liver reactions. So, when US Key Opinion Leader, September 2013 most patients hear that they say, ‘I don’t want to “The cure rate is very low, even with the effective risk my liver or dying for my nail problems.’ Oral treatments. With oral treatment we might have a medication works only on two or three patients and cure rate ranging from 60-80%. So we still have have [sic] pretty low efficacy. Those patients on 20-40% of patients that do not respond to whom it works well, they will get re-infected. treatment. I am talking about systemic . Topical therapies don’t work at all.” So I think that there is a lot of space for US Key Opinion Leader, September 2012 improvement. This is a situation where I would like to have more effective treatments.”

US Key Opinion Leader, March 2013

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) –

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 ...... 10 3 Disease Overview ...... 11 3.1 Etiology and Pathophysiology ...... 11 3.1.1 Etiology ...... 11 3.1.2 Pathophysiology ...... 12 3.1.3 Prognosis ...... 14 3.1.4 Quality of Life ...... 15 3.2 Symptoms ...... 15 4 Disease Management...... 17 4.1 Treatment Overview ...... 17 4.1.1 Diagnosis ...... 19 4.1.2 Clinical Practice ...... 20 5 Competitive Assessment ...... 25 5.1 Overview ...... 25 5.2 Strategic Competitor Assessment ...... 26 6 Opportunity and Unmet Need ...... 28 6.1 Overview ...... 28 6.2 Unmet Needs ...... 29 6.2.1 Unmet Need: Efficacious Oral and Topical Treatments ...... 29 6.2.2 Unmet Need: Clinical Safety ...... 30

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) –

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

6.2.3 Unmet Need: Patient Awareness ...... 31 6.2.4 Unmet Need: Shorter Treatment Duration ...... 32 6.2.5 Unmet Need: Higher Treatment Rates ...... 32 6.2.6 Unmet Need: Prescribing Guidelines ...... 33 6.2.7 Unmet Need: Differential Diagnosis ...... 33 6.3 Unmet Needs Gap Analysis ...... 34 6.4 Opportunities ...... 35 6.4.1 Opportunity: Decreased Frequency of Dosing ...... 35 6.4.2 Opportunity: Combinatorial Approaches to Treatment ...... 35 7 Clinical Pipeline Assessment ...... 36 7.1 Overview ...... 36 7.2 Promising Drugs in Clinical Development ...... 37 8 Albaconazole ...... 39 8.1 Overview ...... 39 8.2 Efficacy ...... 40 8.3 Safety ...... 41 8.4 Dosing and Formulation ...... 41 8.5 Potential Clinical Positioning ...... 42 8.6 Potential Commercial Positioning ...... 42 8.7 Pricing and Reimbursement ...... 43 8.8 SWOT Analysis ...... 43 8.9 Forecast ...... 44 9 Appendix ...... 45 9.1 Bibliography...... 45 9.2 Abbreviations...... 48 9.3 Methodology ...... 49 9.4 Forecasting Methodology ...... 49

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) –

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

9.4.1 Diagnosed DO patients ...... 49 9.4.2 Percent Drug-Treated Patients ...... 50 9.4.3 Drugs Included in Each Therapeutic Class ...... 50 9.4.4 General Pricing Assumptions ...... 50 9.4.5 Pricing of Pipeline Agents ...... 50 9.5 Physicians and Specialists Included in this Study ...... 51 9.6 About the Authors ...... 52 9.6.1 Author ...... 52 9.6.2 Reviewer ...... 52 9.6.3 Global Head of Healthcare ...... 53 9.7 About GlobalData ...... 54 9.8 Disclaimer ...... 54

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) –

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

1.1 List of Tables

Table 1: Symptoms of DO ...... 16

Table 2: Treatment Guidelines for DO ...... 18

Table 3: Most Prescribed Drugs for DO by Class in the US Market, 2012 ...... 18

Table 4: Leading Treatments for DO in the US, 2012 ...... 27

Table 5: Overall Unmet Needs – Current Level of Attainment ...... 28

Table 6: Clinical Unmet Needs – Gap Analysis, 2012 ...... 34

Table 7: DO – Phase Pipeline, 2012 ...... 37

Table 8: Product Profile – Albaconazole...... 40

Table 9: Results of Phase IIb Multi-Arm Clinical Trial of Albaconazole ...... 41

Table 10: Albaconazole SWOT Analysis, 2012 ...... 43

Table 11: United States Sales Forecasts ($m) for Albaconazole, 2012–2022 ...... 44

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) –

FORECAST AND MARKET ANALYSIS TO 2022

Table of Contents

1.2 List of Figures

Figure 1: Structure of Human Nail ...... 12

Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in DO , 2012–2022 ...... 38

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYC OSIS) – FORECAST AND MARKET ANALYSIS TO 2022

Introduction

2 Introduction

2.1 Catalyst

The generically-driven US dermatophytic onychomycosis (DO) toenail market has experienced a period of stagnation stemming from the lapse of the patent life on many highly-prescribed systemic therapies, such as terbinafine and . However, the introduction of new therapies that offer better safety profiles and a topical route of administration is likely to cause waves in the DO market and increase the market size by introducing patent-protected therapies for the first time in more than six years.

 The launch of topical agents, such as Valeant Pharmaceuticals’ efinaconazole, Celtic Pharma’s TDT-067, and Anacor Pharmaceuticals’ , is expected to provide the market with new mechanisms of action in topical treatments, which is a marked change from the systemic therapies that currently prevail in the market.

 The growth of the elderly population, who are at an elevated risk of developing DO, functions as a driver for the development of new products that are effective and have better safety profiles.

 Laser treatments for DO are seeing a surge in terms of development and adoption as a method to treat , with minimal patient compliance concerns. While this movement is likely to increase patient awareness, GlobalData expects it to pose a small barrier to the growth of the new therapeutic regimens, which require prolonged treatment durations. 2.2 Related Reports

 GlobalData (2013). Dermatophytic Onychomycosis (DO) – Current and Future Players, June, 2013, GDHC1014PFR

 GlobalData (2013). Dermatophytic Onychomycosis (DO) – US Drug Forecast and Market Analysis to 2022 , June, 2013, GDHC101PIDR

 GlobalData (2013). Terbinafine (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC116 5DFR

 GlobalData (2013). Itraconazole (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC116 6DFR

Albaconazole (Dermatophytic Onychomycosis) – 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.

ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYC OSIS) – FORECAST AND MARKET ANALYSIS TO 2022

Introduction

 GlobalData (2013). (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC116 7DFR

 GlobalData (2013). (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC116 9DFR

 GlobalData (2013). (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC116 8DFR

 GlobalData (2013). (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC1186DFR

 GlobalData (2013). Tavaborole (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC1182DFR

 GlobalData (2013). Efinaconazole (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC1181DFR

 GlobalData (2013). TDT-067 (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC1183DFR

 GlobalData (2013). (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 , June, 2013, GDHC1184DFR

2.3 Upcoming Related Reports

 GlobalData (2013). PharmaFocus: Research and Development Strategies in HIV, July, 2013, GDHC003PFR

 GlobalData (2013). PharmaFocus: Market Access Strategies for Gram-Negative Nosocomial Infections, August, 2013, GDHC004PFR

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ALBACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) – FORECAST AND MARKET ANALYSIS TO 2022

Appendix

9.7 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.

9.8 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.

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