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Efinaconazole (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.

REFERENCE CODE GDHC1181DFR | PUBLICATION DATE JUNE 2013

EFINACONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS) –

FORECAST AND MARKET ANALYSIS TO 2022

Efinaconazole (Dermatophytic Onychomycosis) – Forecast and Market Analysis to 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.



Executive Summary

Efinaconazole: Key Metrics in the US Market 2022 Market Sales

US $8.99m

Key events (2012–2022) Level of Impact

Launch of Anacor’s tavaborole ↓↓

Outcome of litigation between Anacor and Valeant ↑↑↑

Launch of Celtic Pharma’s TDT-067 ↓↓

Launch of Palau’s albaconazole ↓↓↓

Source: GlobalData

Sales of Efinaconazole in the US DO Market

GlobalData expects Valeant’s to launch

efinaconazole in the US in 2013. We estimate that

2022 sales of efinaconazole will reach $406.98m in

the US.

Key factors affecting the uptake of efinaconazole

will include:

Efinaconazole’s sales are expected to be

driven by Valeant’s commercial strength

Efinaconazole has superior efficacy and safety

profile as compared with generic products that

are currently available for treatment

Growing treatment rate among diagnosed

patients as a result of safer topical options

Total US Sales for DO by Route of Administration, 2012–2022

97%

3%

Oral Topical

2012Total: 0.27bn

48%52%

Oral Topical

2022Total: 1.63bn

Source: GlobalData




Executive Summary

What Do the Physicians Think?

The key opinion leaders (KOLs) interviewed for this

report shared their insight on current and future

market and clinical trends within the US DO

market. They indicated that the primary concerns

within this market remain for safer and more

efficacious therapies, shorter treatment durations,

and better differential diagnostic tests.

“Oral medication requires lab monitoring and [is]

associated with severe liver reactions. So, when

most patients hear that they say, ‘I don’t want to

risk my liver or dying for my nail problems.’ Oral

medication works only on two or three patients and

have [sic] pretty low efficacy. Those patients on

whom it works well, they will get re-infected.

Topical therapies don’t work at all.”

US Key Opinion Leader, September 2012

“I cannot treat DO patients very much because

patients are concerned about the risk of treatment.

I see 300 to 400 of DO patients, from which I treat

only 15 to 20 because of the side effects of

available treatment.”

US Key Opinion Leader, August 2012

“I don’t think treatment rates will change because

we don’t have any good treatment [options]

currently available.”

US Key Opinion Leader, September 2013

“The cure rate is very low, even with the effective

treatments. With oral treatment we might have a

cure rate ranging from 60-80%. So we still have

20-40% of patients that do not respond to

treatment. I am talking about systemic antifungals.

So I think that there is a lot of space for

improvement. This is a situation where I would like

to have more effective treatments.”

US Key Opinion Leader, March 2013




Table of Contents

1 Table of Contents

1 Table of Contents .......................................................................................................................... 4

1.1 List of Tables .......................................................................................................................... 7

1.2 List of Figures ......................................................................................................................... 7

2 Introduction ................................................................................................................................... 8

2.1 Catalyst .................................................................................................................................. 8

2.2 Related Reports ..................................................................................................................... 8

2.3 Upcoming Related Reports ..................................................................................................... 9

3 Disease Overview ....................................................................................................................... 10

3.1 Etiology and Pathophysiology ............................................................................................... 10

3.1.1 Etiology ........................................................................................................................... 10

3.1.2 Pathophysiology ............................................................................................................. 11

3.1.3 Prognosis ....................................................................................................................... 13

3.1.4 Quality of Life .................................................................................................................. 14

3.2 Symptoms ............................................................................................................................ 14

4 Disease Management.................................................................................................................. 16

4.1 Treatment Overview ............................................................................................................. 16

4.1.1 Diagnosis ........................................................................................................................ 18

4.1.2 Clinical Practice .............................................................................................................. 19

5 Competitive Assessment ............................................................................................................. 24

5.1 Overview .............................................................................................................................. 24

5.2 Strategic Competitor Assessment ......................................................................................... 25

6 Opportunity and Unmet Need ...................................................................................................... 27

6.1 Overview .............................................................................................................................. 27

6.2 Unmet Needs ....................................................................................................................... 28

6.2.1 Unmet Need: Efficacious Oral and Topical Treatments ................................................... 28

6.2.2 Unmet Need: Clinical Safety ........................................................................................... 29




Table of Contents

6.2.3 Unmet Need: Patient Awareness .................................................................................... 30

6.2.4 Unmet Need: Shorter Treatment Duration ...................................................................... 31

6.2.5 Unmet Need: Higher Treatment Rates ............................................................................ 31

6.2.6 Unmet Need: Prescribing Guidelines .............................................................................. 32

6.2.7 Unmet Need: Differential Diagnosis ................................................................................ 32

6.3 Unmet Needs Gap Analysis .................................................................................................. 33

6.4 Opportunities ........................................................................................................................ 34

6.4.1 Opportunity: Decreased Frequency of Dosing ................................................................ 34

6.4.2 Opportunity: Combinatorial Approaches to Treatment .................................................... 34

7 Clinical Pipeline Assessment ....................................................................................................... 35

7.1 Overview .............................................................................................................................. 35

7.2 Promising Drugs in Clinical Development ............................................................................. 36

8 Efinaconazole .............................................................................................................................. 38

8.1 Overview .............................................................................................................................. 38

8.2 Efficacy ................................................................................................................................. 39

8.3 Safety ................................................................................................................................... 40

8.4 Dosing and Formulation ....................................................................................................... 40

8.5 Potential Clinical Positioning ................................................................................................. 40

8.6 Potential Commercial Positioning ......................................................................................... 41

8.7 Pricing and Reimbursement ................................................................................................. 41

8.8 SWOT Analysis .................................................................................................................... 42

8.9 Forecast ............................................................................................................................... 42

9 Appendix ..................................................................................................................................... 44

9.1 Bibliography.......................................................................................................................... 44

9.2 Abbreviations........................................................................................................................ 48

9.3 Methodology ......................................................................................................................... 49

9.4 Forecasting Methodology ..................................................................................................... 49




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




Table of Contents

1.1 List of Tables

Table 1: Symptoms of DO .............................................................................................................................. 15

Table 2: Treatment Guidelines for DO ............................................................................................................ 17

Table 3: Most Prescribed Drugs for DO by Class in the US Market, 2012 ....................................................... 17

Table 4: Leading Treatments for DO in the US, 2012 ..................................................................................... 26

Table 5: Overall Unmet Needs – Current Level of Attainment ......................................................................... 27

Table 6: Clinical Unmet Needs – Gap Analysis, 2012 ..................................................................................... 33

Table 7: DO – Phase Pipeline, 2012 .............................................................................................................. 36

Table 8: Product Profile – Efinaconazole ........................................................................................................ 39

Table 9: Efinaconazole SWOT Analysis, 2012 ............................................................................................... 42

Table 10: United States Sales Forecasts ($m) for Efinaconazole, 2012–2022 ................................................ 43

1.2 List of Figures

Figure 1: Structure of Human Nail .................................................................................................................. 11

Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in DO , 2012–2022 .................................... 37




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 itraconazole. 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’ tavaborole, 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 infections, 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, GDHC1165DFR

GlobalData (2013). Itraconazole (Dermatophytic Onychomycosis) – Forecast and Market





Introduction

GlobalData (2013). Fluconazole (Dermatophytic Onychomycosis) – Forecast and Market


GlobalData (2013). Ketoconazole (Dermatophytic Onychomycosis) – Forecast and Market


GlobalData (2013). Griseofulvin (Dermatophytic Onychomycosis) – Forecast and Market


GlobalData (2013). Ciclopirox (Dermatophytic Onychomycosis) – Forecast and Market


GlobalData (2013). Tavaborole (Dermatophytic Onychomycosis) – Forecast and Market


GlobalData (2013). TDT-067 (Dermatophytic Onychomycosis) – Forecast and Market Analysis

to 2022 , June, 2013, GDHC1183DFR

GlobalData (2013). Luliconazole (Dermatophytic Onychomycosis) – Forecast and Market


GlobalData (2013). Albaconazole (Dermatophytic Onychomycosis) – Forecast and Market


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




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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