REFERENCE CODE GDHC1184DFR PUBLICATION DATE JUNE 2013

Transcription

1 REFERENCE CODE GDHC1184DFR PUBLICATION DATE JUNE 2013 LULICONAZOLE (DERMATOPHYTIC ONYCHOMYCOSIS)

2 Executive Summary Luliconazole: Key Metrics in the US Market 2022 Market Sales US $94.52m Key events ( ) Level of Impact Launch of Palau s albaconazole Source: GlobalData Total US Sales for DO by Route of Administration, % 2012 Total: 0.27bn Sales of Luliconazole in the US DO Market GlobalData expects Topica s to launch Luliconazole in the US in We estimate that 97% 2022 sales of efinaconazole will reach $94.52m in Oral Topical the US. Key factors affecting the uptake of efinaconazole 2022 Total: 1.63bn will include: Strong safety profile with low infiltration for 52% 48% limited systemic bioavailability, which limits the odds of adverse reactions Different MOA that increases its use of in patients who do not respond to triazole-based Oral Topical therapies Source: GlobalData Ease-of-use, given its topical route of administration, for direct antifungal activity in the nail plate 2

3 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. 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 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

4 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 Prognosis Quality of Life Symptoms Disease Management Treatment Overview Diagnosis Clinical Practice Competitive Assessment Overview Strategic Competitor Assessment Opportunity and Unmet Need Overview Unmet Needs Unmet Need: Efficacious Oral and Topical Treatments Unmet Need: Clinical Safety

5 Table of Contents Unmet Need: Patient Awareness Unmet Need: Shorter Treatment Duration Unmet Need: Higher Treatment Rates Unmet Need: Prescribing Guidelines Unmet Need: Differential Diagnosis Unmet Needs Gap Analysis Opportunities Opportunity: Decreased Frequency of Dosing Opportunity: Combinatorial Approaches to Treatment Clinical Pipeline Assessment Overview Promising Drugs in Clinical Development Luliconazole Overview Efficacy Safety Dosing and Formulation Potential Clinical Positioning Potential Commercial Positioning Pricing and Reimbursement SWOT Analysis Forecast Appendix Bibliography Abbreviations Methodology Forecasting Methodology

6 Table of Contents Diagnosed DO patients Percent Drug-Treated Patients Drugs Included in Each Therapeutic Class General Pricing Assumptions Pricing of Pipeline Agents Physicians and Specialists Included in this Study About the Authors Author Reviewer Global Head of Healthcare About GlobalData Disclaimer

7 Table of Contents 1.1 List of Tables Table 1: Symptoms of DO Table 2: Treatment Guidelines for DO Table 3: Most Prescribed Drugs for DO by Class in the US Market, Table 4: Leading Treatments for DO in the US, Table 5: Overall Unmet Needs Current Level of Attainment Table 6: Clinical Unmet Needs Gap Analysis, Table 7: DO Phase Pipeline, Table 8: Product Profile Luliconazole Table 9: Luliconazole SWOT Analysis, Table 10: United States Sales Forecasts ($m) for Luliconazole, List of Figures Figure 1: Structure of Human Nail Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in DO,

8 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 Analysis to 2022, June, 2013, GDHC1166DFR 8

9 Introduction GlobalData (2013). Fluconazole (Dermatophytic Onychomycosis) Forecast and Market Analysis to 2022, June, 2013, GDHC1167DFR GlobalData (2013). Ketoconazole (Dermatophytic Onychomycosis) Forecast and Market Analysis to 2022, June, 2013, GDHC1169DFR GlobalData (2013). Griseofulvin (Dermatophytic Onychomycosis) Forecast and Market Analysis to 2022, June, 2013, GDHC1168DFR GlobalData (2013). Ciclopirox (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). Albaconazole (Dermatophytic Onychomycosis) Forecast and Market Analysis to 2022, June, 2013, GDHC1185DFR 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 9

10 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. 54