»>DATAMONITOR
`
`Commercial and
`
`Stakeholder
`
`Perspectives: Allergic
`Rhinitis
`
`Is there life after Claritin?
`
`AC Classes: R6A0, R1A1, R1A4, R1A6, R1A7, R1B0.
`
`Countries: US, Japan, France, Germany, Italy, Spain and UK
`
`Reference Code: DMHC 1936
`
`Publication Date: 09/2004
`
` Datamonitor Germany
`
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`Box 23
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`Deutschland
`
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`
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`
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`
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`e: deinfo@datamonitor.com
`CIP2138
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`MEDA_APTX03505576
`
`PTX0098-00001
`
`

`

`About Datamonitor Healthcare
`
`» DATAMONITOR
`
`ABOUT DATAMONITOR HEALTHCARE
`
`a total business solution to the pharmaceutical and
`Datamonitor Healthcare provides
`Its services reflect its expertise in therapeutic, strategic and
`healthcare industries.
`eHealth market analysis and competitive intelligence. For more details of Datamonitor
`Healthcare's syndicated and customized products and services, please refer to the
`or contact:
`Appendix
`
`Anne Delaney, Director of Research and Analysis, +44 (0)20 7675 7221,
`adelaney@datamonitor.com
`
`About
`
`the
`
`immune
`
`pharmaceutical analysis
`
`disorders
`team
`
`and
`
`inflammation
`
`Datamonitor's therapeutic area studies comprise the following features:
`—
`
`Clinical opinion leaderintelligence and best-in-class case studies, leading to
`actionable recommendations;
`
`—
`
`—
`
`—
`
`—
`
`R&Dpipeline and unmet need analysis;
`
`analysis of current physician attitudes and perception;
`
` scenario-based revenue and epidemiology forecasting;
`
`supporting presentations and spreadsheets of data and key conclusions.
`
`The IDI team is headed by Simon Wright, he holds an MBA from London Business
`School, and a BSc (Hons) Biological Chemistry and can be contacted on +44
`(0)20
`7675 7844 or
`swright@datamonitor.com.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC1936
`Page 2
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`

`

`Executive Summary
`
`» DATAMONITOR
`
`CHAPTER1 EXECUTIVE SUMMARY
`
`Objective of the analysis
`
`The objective of this analysis of the allergic rhinitis market is to enable the reader to:
`—
`
`quantify future size and scope of market and potential for new
`
`products;
`
`—
`
`—
`
`—
`
`—
`
`benchmark pipeline against currently marketed products;
`
`formulate launch strategies;
`
`quantify the impact of key patent expiries;
`
`develop commercial strategies across the seven
`
`major markets.
`
`Scope and focus
`
`Commercial and Stakeholder Perspectives Allergic Rhinitis explores trends and
`developments within patent expiry and over-the-counter status vs.
`prescription-only
`availability. Qualitative opinion leader research and qualitative IMS data are used to
`analyze current therapeutic dynamics and forecast future sales.
`Issues analyzed
`include:
`
`e
`
`e
`
`e
`
`the impact of patent expiry and changesin government regulation and attitude
`are explained;
`to generics
`
`the effect of prescription (Rx) to over-the-counter (OTC) drug switches as a
`move or
`by governmental pressure and the reaction of the US
`strategic
`insurance market;
`
`sales forecasts for leading brand drugs, based on historical data and event
`analysis.
`
`Analysis in this report is based on sales and promotional data provided by IMS Heaith.
`Datamonitor also interviewed physicians, specialists,
`in the US, Europe and Japan
`about their experiences and opinions on the allergic rhinitis market.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC1936
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`Executive Summary
`
`» DATAMONITOR
`
`The following opinion leaders were interviewed by Datamonitor during the course of
`this report:
`
`Professor Bruce Bochner, Professor of Medicine, Johns Hopkins Asthma and
`Allergy Center, Baltimore, US;
`
`Dr Michiko Haida, Head of the Division of Aliergy and Respiratory Diseases,
`Departmentof Internal Medicine, Hanzomon Hospital, Tokyo, Japan;
`
`Dr Eckard Hamelmann, Head of the Respiratory Infections and Asthma work-
`group, Charité-Virchow Hospital, Berlin, Germany;
`
`Professor William Reed Henderson, Jr, Professor of Medicine, Head, Allergy
`Section, University of Washington, US;
`
`and
`(Barry) Kay, Professor
`Professor Anthony Barrington
`Director,
`Department of Allergy and Clinical Immunology, Imperial College School of
`Medicine, UK.
`
`Datamonitor insight into the allergic rhinitis market
`
`In the course of
`research and analysis for Commercial and Stakeholder
`its
`Perspectives: Allergic Rhinitis, Datamonitor
`identified the following three key
`conclusions:
`
`in 2003, 91% of the total promotional spend in the US and the five EU countries
`was
`on
`detailing physicians. Accurately targeting the appropriate physicians
`spent
`is Critical to effective detailing. The physician specialists prescribing treatments for
`allergic rhinitis are numerous and wide ranging in the US, Germany and Japan.
`However, the other EU countries are
`heavily skewed towards PCP treatment of
`allergic rhinitis;
`
`on Claritin (loratadine) has seen
`the impact of patent expiry
`wide-ranging country
`variances, in terms of both revenue and prescription volume sales adjustments for
`the US and the UK experienced the
`the brand, molecule and class. Germany,
`largest reduction in brand revenue sales values, whereas generic erosion was
`minimal in Japan and the remaining EU countries;
`
`careful consideration of the impact of patent expiry on Claritin, provides several
`as to how other antihistamines may be impacted by similar events. The
`points
`2007 Zyrtec (cetirizine) patent expiry, and a favorable outcome for the generics
`are two such events.
`companiesin the Allegra (fexofenadine) patent legisiation,
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
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`Executive Summary
`
`» DATAMONITOR
`
`The basis for these conclusions, along with supporting data is provided in the
`accompanying PowerPoint presentation. Forecasts for the seven
`major markets are
`provided in the accompanying Excel file.
`
`This report is produced in three parts:
`
`1. Word document: contains key conclusions and a summary of the current market
`and future opportunities and threats. Outlines the assumptions and eventsutilized
`case studies to provide insight into
`in forecasting the market. Assesses strategic
`potential market strategies:
`
`country-by-country basis for the seven
`2. Excel document: contains forecasts on a
`major markets. Country, region and class/brand charts can be generatedin this file
`for both volume and value units;
`
`3. PowerPoint executive presentation: shares Datamonitor’s key insight
`market with supporting data and recommendations.
`
`into the
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC1936
`Page 5
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`

`Table of Contents
`
`» DATAMONITOR
`
`TABLE OF CONTENTS
`
`CHAPTER1
`
`EXECUTIVE SUMMARY
`
`Objective of the analysis
`
`Scope and focus
`
`Datamonitor insight into the allergic rhinitis market
`
`CHAPTER2 PATIENT POTENTIAL
`
`Patient potential
`
`Epidemiology
`
`Age variance
`
`Global prevalence
`
`Methodology
`
`US
`
`EU
`
`Japan
`
`Loratadine: the gold standard in allergic rhinitis
`
`Associated pharmaceutical markets and indications
`
`Asthma and associated market
`
`Idiopathic urticaria and associated market
`
`MARKET
`
`DEFINITION
`
`AND
`
`CHAPTER3 GLOBAL
`OVERVIEW
`26
`
`Marketdefinition
`
`Globalallergic rhinitis market analysis
`
`Antihistamine market performance
`
`13
`
`13
`
`14
`
`15
`
`16
`
`16
`
`16
`
`17
`
`22
`
`23
`
`24
`
`24
`
`25
`
`26
`
`28
`
`29
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
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`
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`Table of Contents
`
`» DATAM 8) NITOR
`
`Corticosteroid market performance
`
`CHAPTER 4
`BRAND
`KEY
`FORECASTING ASSUMPTIONS
`
`ASSESSMENT
`
`AND
`
`Key brand strengths and weaknesses
`—
`
`Event type
`
`one
`
`antihistamine patent expiry
`
`Event type two
`
`—
`
`Event type three
`
`nasal corticosteroid patent expiry
`—
`
`new
`
`product launch
`
`Alvesco (ciclesonide)
`
`Drug overview
`
`Clinicaltrial results
`
`INS37217
`
`Drug overview
`
`Trial results
`
`Antihistamine analysis
`
`Allegra franchise key facts
`
`Allegra strategic analysis and forecast assumptions
`
`US
`
`EU
`
`Japan
`
`Zyrtec franchise key facts
`
`Zyrtec strategic analysis and forecast assumptions
`
`US
`
`EU
`
`30
`
`32
`
`32
`
`34
`
`34
`
`35
`
`35
`
`35
`
`35
`
`36
`
`36
`
`36
`
`37
`
`37
`
`38
`
`39
`
`40
`
`41
`
`42
`
`44
`
`45
`
`46
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
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`
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`Table of Contents
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`> DATAMONITOR
`
`Japan
`
`Xyzal key facts
`
`Xyzal strategic analysis and forecast assumptions
`
`US
`
`EU
`
`Japan
`
`Clarinex key facts
`
`Clarinex strategic analysis and forecasting assumptions
`
`US
`
`EU
`
`Japan
`
`Ebastel analysis
`
`Ebastel strategic analysis and forecasting assumptions
`
`US
`
`EU
`
`Japan
`
`Corticosteroid analysis
`
`Nasonex keyfacts
`
`Nasonexstrategic analysis and forecasting assumptions
`
`US
`
`EU
`
`Japan
`
`Rhinocort analysis
`
`46
`
`47
`
`48
`
`50
`
`50
`
`50
`
`51
`
`52
`
`53
`
`53
`
`54
`
`55
`
`56
`
`57
`
`57
`
`58
`
`59
`
`59
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`60
`
`61
`
`62
`
`62
`
`63
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
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`Table of Contents
`
`» DATAM 8) NITOR
`
`Rhinocort strategic analysis and forecasting assumptions
`
`US
`
`EU
`
`Japan
`
`Flonase analysis
`
`Flonase strategic analysis and forecasting assumptions
`
`US
`
`EU
`
`Japan
`
`Nasacort analysis
`
`Nasacort strategic analysis and forecasting assumptions
`
`US
`
`EU
`
`Decongestantanalysis
`
`Decongestant market performance
`
`Oral delivery
`
`Nasaldelivery
`
`CHAPTER 5
`
`ENVIRONMENTAL ASSESSMENTS
`
`Current and future opportunities and threats in the allergic rhinitis market
`
`US: opportunities and threats
`
`Opportunities
`
`Threats
`
`Japan: opportunities and threats
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product andis not to be photocopied
`
`64
`
`66
`
`66
`
`66
`
`67
`
`68
`
`69
`
`70
`
`70
`
`71
`
`72
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`74
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`75
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`75
`
`75
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`75
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`75
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`76
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`76
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`76
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`77
`
`77
`
`79
`
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`Table of Contents
`
`» DATAMONITOR
`
`Opportunities
`
`Threats
`
`EU: opportunities and threats
`
`Opportunities
`
`Threats
`
`EU country-specific demographics
`
`CHAPTER 6
`
`CASE STUDIES
`
`—
`
`Case study
`rhinitis treatment
`
`one
`
`Impact of regulatory change
`
`on
`
`patent protection for allergic
`
`Frivolous patents or
`
`genuine discoveries?
`
`New patents no longerprotect old drugs
`
`Regulatory positions
`
`on
`
`generic approvals
`
`US
`
`EU
`
`Japan
`-
`
`Case study two
`Variation in degree of country-specific generic erosion for
`antihistamines and corticosteroids
`
`US
`
`EU
`
`France
`
`Germany
`
`Italy
`
`Spain
`
`UK
`
`80
`
`81
`
`81
`
`81
`
`82
`
`82
`
`88
`
`88
`
`88
`
`88
`
`92
`
`92
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`92
`
`93
`
`94
`
`94
`
`99
`
`99
`
`100
`
`102
`
`105
`
`107
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
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`Table of Contents
`
`» DATAMONITOR
`
`Japan
`—
`
`Case study three
`
`Impact of Rx to OTC switchesin the US allergic rhinitis market
`
`Managed
`
`care
`
`organizations and insurance companies
`
`Pricing strategies and co-payments
`—
`
`Case study four
`
`Physician specialty
`
`Definition of allergic rhinitis prescriptions
`
`Physician specialty
`
`Prescription numbers
`—
`
`APPENDIX A
`
`INTERVIEW TRANSCRIPTS
`
`Opinion leader biographies
`
`US opinion leader
`
`Patient demographics
`
`Antihistamines
`
`Corticosteroids
`
`Brand Specific opinions
`
`Combinations with decongestants
`
`Future challengesin Allergic rhinitis
`
`German opinion leader
`
`Patient demographics
`
`Antihistamines
`
`Corticosteroids
`
`Combinations with Decongestants
`
`US opinion leader
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`109
`
`111
`
`112
`
`113
`
`116
`
`116
`
`116
`
`120
`
`121
`
`124
`
`122
`
`122
`
`123
`
`125
`
`126
`
`127
`
`128
`
`129
`
`129
`
`130
`
`132
`
`133
`
`134
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`Table of Contents
`
`» DATAMONITOR
`
`Patient demographics
`
`Antihistamines
`
`Corticosteroids
`
`Brand Specific opinions
`
`Combinations with decongestants
`
`Future challengesin Allergic rhinitis
`
`UK opinion leader
`
`Patient demographics
`
`Antihistamines
`
`Carticosteroids
`
`APPENDIX B
`
`Bibliography
`
`Epidemiology
`
`Clinical trial data
`
`Other
`
`Report methodology
`
`Japanese market data
`
`Standard units
`
`About Datamonitor
`
`About Datamonitor Heaithcare
`
`Datamonitor Healthcare’s research and analysis methodologies
`
`Datamonitor Healthcare’s therapy
`
`area capabilities
`
`Disclaimer
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`134
`
`137
`
`139
`
`140
`
`141
`
`142
`
`143
`
`143
`
`144
`
`146
`
`148
`
`148
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`148
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`149
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`150
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`151
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`

`Patient Potential
`
`» DATAMONITOR
`
`CHAPTER2 PATIENT POTENTIAL
`
`Patient potential
`
`The numberof patients requiring treatment is continually rising, driven by
`factors:
`
`a numberof
`
`e
`
`e®
`
`e
`
`air pollution, specifically particulates;
`
`awareness
`
`public
`
`resulting in increasing physician diagnosis;
`
`the hygiene hypothesis, which links the adoption of the modern westernized
`a lack of early life exposure to
`lifestyle to rises in allergic disease through
`microorganisms.
`
`life-threatening disease it is classified as a
`Although allergic rhinitis is not a
`chronic respiratory disease due toits:
`*®
`
`prevalence;
`
`major
`
`e
`
`e
`
`e
`
`e
`
`impact
`
`on
`
`quality
`
`oflife;
`
`impact
`
`on work/school performance;
`
`economic burden:
`
`links with asthma.
`
`an
`In March 2003, the US department of Health and Human Services produced
`on the management of AR in the working age population, concluding
`evidence report
`that AR is associated with direct costs of up to $4.5 billion. Indirect costs due to 2.5
`million work days and two million school days lost in the US alone add up to an
`eta/., 2003).
`estimated $7.7 billion annually (McCrory
`
`on Asthma (ARIA) is a
`non-
`Allergic Rhinitis and its Impact
`project carried out by
`governmental group working with the World Health Organization. The ARIA
`investigation has clarified long-suspected links with asthma andrhinitis. It also gives
`highlights the fact that rhinitis is considered a
`strong risk factor for asthma. The
`European Community Respiratory Health Survey (ECRHS) found high association
`one French cohort revealed that 22.5% of
`between the two conditions; for example,
`adults with rhinitis had asthma as well (Leynaert et a/., 1999).
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC 1936
`Page 13
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`

`Patient Potential
`
`» DATAMONITOR
`
`...
`
`“The awareness...
`is certainly increasing
`[of allergic rhinitis]
`with more studies on this problem, but also as people are staying
`indoors more with greater exposure to indoor allergens [dust
`mites, animals, cockroaches], and are less active, which is
`—
`contributing to the problem.”
`US opinion leader
`
`Epidemiology
`
`Studies into the prevalence of AR are hampered by a lack of consistency in how the
`is clinically defined as a
`symptomatic disorder of the nose
`It
`disease is defined.
`an
`IgE-mediated inflammation after exposure of an
`allergen to the
`induced by
`the nose. The
`recent ARIA initiative
`membranes
`recommended the
`lining
`as
`or intermittent, rather than
`Classification of allergic rhinitis symptoms
`perennial and seasonal.
`
`persistent
`
`The four main symptoms of the disease are an itchy nose, sneezes, nasal obstruction
`on the number of
`and rhinorrhea. The reported prevalence varies depending
`on the
`symptoms required to define AR. An International Consensus Report
`Diagnosis and Management of Rhinitis in 1994 agreed that the standard should be
`two or more
`symptoms.
`
` Table 1: Classification of allergic rhinitis
`
`
`
`Classification
`
`Symptoms
`
`Intermittent
`
`Persistent
`
`Mild
`
`Frequency and duration
`Occur over <4 days/weekor over <4 weeks
`
`Occur over <4 days/week and
`
`over >4 weeks
`
`Severity of symptoms
`Normal sleep
`No impairmentof daily activities, sport, leisure, work, school
`Notroublesome symptoms
`
`Moderate-severe
`
`Impairment of daily activities, sport, leisure, work, school
`Troublesome symptoms
`
` Source: ARIA
`DATAMONITOR
`
`
`
`
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC 1936
`Page 14
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`

`Patient Potential
`
`» DATAMONITOR
`
`variance
`
`Age
`
`Prevalence is usually higher in adults, peaking at around 20 years of age, than in
`as shown in Germany in Figure 4. This variance as a result
`children and pensioners,
`of age also makes epidemiology studies difficult to compare, for example the ISAAC
`was carried out
`in 13-14 year olds, whereas the ECRHS involved adults
`study
`between the age of 20 and 44. A comparison in Figure 1 between these two large-
`a
`scale studies shows that, although
`good correlation is observed (61%),
`ISAAC
`prevalence results are generally lower due to the study being carried out below the
`age of peak prevalence (Pearce ef a/., 2000).
`
`ever in ECRHS (Il) and
`Correlation of incidence of hayfever
`Figure 1:
`ISAAC(I
`
`50
`
`40
`
`& 30
`
`20
`
`2 i
`
`10
`
`0
`
`0
`
`10
`
`i
`30
`IGAAC %
`
`40
`
`50
`
`
`
`
`
`
`
`a- Australia
`- Spain
`-
`O
`A- Belgium
`Italy
`e-Germany A- New Zealand
`vV-France
`y- Ireland
`#-Estonia
`
`yy-US
`
`Source: Pearce et a/., 2000
`
`DATAMONITOR
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
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`
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`
`Global prevalence
`
`The prevalence of allergic rhinitis is estimated in the seven
`epidemiology studies and research data.
`
`major markets using
`
`Table 2:
`
`Global prevalence
`
`of
`
`allergic rhinitis, 2004
`
`‘Total 2004.
`population
`(000’s)
`
`Prevalence
`
`(%)
`
`AR
`population
`(000’s)
`
`286 376
`127,309
`59,757
`82,335
`56,884
`39,500
`59,081
`
`19.8
`19.6
`24.6
`18.2
`17.1
`14.1
`26.4
`
`56, 702.4
`24 (952.6
`14,700.2
`14,985.0
`9,727.1
`5,569.5
`15,597.4
`
`DATAMONITOR Methodology
`
`Source: Various (see below)
`=
`1
`UN databasefigures
`2 = National Health Survey, 2001; Crown, 2003; Slavin, 1994
`3 =
`Okuda, 2003; Nakamura et a/., 2002
`4 =
`ECRHS; Charpin et a/., 2000 ; WAO
`5 =
`ECRHS
`6 =
`Olivieri ef af, 2002; Verlato et a/., 2003
`7 =
`ECRHS; Azpiri ef a/., 1999
`=
`8
`ECRHS: Sibbald, Rink, 1991
`
`US
`
`The National Health Interview Survey of 2001, published by the CDC, recordeda total
`of nearly 21 million hayfever sufferers in the US. This refers to the seasonal aspect of
`a doctor, or
`allergic rhinitis, and each respondent was defined as
`having been told by
`in the past 12 months,
`other healthcare professional
`that
`they had hayfever.
`However,allergic rhinitis has been reported in up to 80% of asthma sufferers (Slavin,
`1994) and morerecently it has also been reported that 79% of allergic rhinitis patients
`suffer from SAR, leaving 21% with PAR (Crown, 2003). To obtain the prevalence of
`was found,
`both seasonal and persistent allergic rhinitis, an average percentage
`an
`taking into account prevalence rhinitis with comorbid asthma and of PAR giving
`estimate of 19.8% of the population.
`
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`
`EU
`
`The European Community Respiratory Health Survey (ECRHS), completed in 1996,
`is the most comprehensive study of AR in Europe. The study had a
`sample of
`approximately 140,000 20 to 44-yearolds, from 22 countries.
`
`Figure 2:
`Relative prevalence in the EU
`
`
`High
`prevalence
`
`Lower
`
`
`
`prevalence
`
`
`
`
`Key
`
`e
`
`High
`Medium
`e Low
`
`
`
`
`
`Source: ECRHS I, 1996
`
`DATAMONITOR
`
`A northwest to southeast diagonal divide exists in AR prevalence rates in Europe.
`as
`The atopy data in Figure 2 exemplifies this, showing Greece,
`Italy and Spain
`having lower rates than their European neighbors. Atopy refers to the link between
`allergic reactions that create diseases such as allergic rhinitis or urticaria. However,
`the results of new studies show that this line is proceeding south in line with the
`overall global increase in AR.
`
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`France
`
`» DATAMONITOR
`
`The 1996 ECRH survey published prevalence data for nasal allergy in four major
`centers in France. These values were
`significantly higher than the median value for
`the study, which was 20.9%. However, they
`are
`comparable to UK values.
`
` Table 3: ECRHSresults, France, 1996
`
`
`
`France
`ECRHS
`
`Bordeaux Grenoble
`
`Montpellier
`
`Paris
`
`Average
`
`30.2
`
`28.1
`
`34.4
`
`30.3
`
`30.75
`
`
`
`Source: Burney ef a/., 1996 DATAMONITOR
`
`It can be seen in a
`comparison betweenall the European figures that the more urban
`larger cities have a
`areas, or
`higher prevalence of AR than that found in rural areas.
`Therefore, to obtain a more
`representative figure for France, Datamonitor combined
`an overall figure.
`this information with two other sources when estimating
`
`Charpin et af. (2000) gave prevalence values for hayfever of approximately 18% for
`teenagers and 25% for young adults. The World Allergy Organization gives France a
`an average of the comparative age ranges, a
`figure of
`prevalence of 5.9%. By taking
`was estimated.
`24.6% prevalence
`
`Germany
`
`A numberof studies have been carried out in Germanyin allergy prevalence in recent
`years. The ECRHS is the largest cohort and provides the basis for this prevalence
`was
`figure. However, a useful study
`published in 1993 into two genetically similar
`populations who were
`levels of
`exposed to different
`conditions and
`living
`environmental pollution. It was carried out in the former East and West Germany and
`into the evolution and causative factors of the condition. Typical
`provides insight
`symptoms of rhinitis were
`reported of 16.6% in East Germany and 19.7% in West
`Germany. The average of the ECRHS values was used to estimate 2004 prevalence.
`
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`
` Table 4:
`ECRHS results, Germany, 1996
`Germany ECRHS
`
`Erfurt
`
`Hamburg
`
`Average
`
`DATAMONITOR
`Source: Burney ef al., 1996
`
`13.4
`
`23
`
`18.2
`
`The age distribution in Germany is displayed in Figure 3 below, and shows that the
`vaiue found in the ECRHS,
`falls in the peak to medium
`from ages 20 to 44,
`prevalence range and will not be an accurate representation of other ages.
`
` Figure 3: Age distribution of allergic rhinitis, Germany (%), 1995
`
`
`
`
`
` Source: Mosgesef a/., 1995
` Prevalence->
`
`
`
`DATAMONITOR
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`
`Italy
`
`was estimated using the ECRHS data and two more recent
`The Italian prevalence
`epidemiological studies in that area.
`
` EGRHS results, Italy, 1996
`Italy ECRHS
`Verona Average
`
`Pavia
`
`Turin
`
`DATAMONITOR
`Source: Burney et al, 1996
`
`12.5
`
`16
`
`16.9
`
`15.13
`
`A study of data collected in northern Italy showed a higher prevalence of 15.9%
`(Olivieri ef a/, 2002) than the averagefigure reported from the ECRHS data.
`
`study into the prevalence of AR showed a clear increase from the data
`In 2003, a
`collected for the ECRHS. The survey involved 6,876 people between the ages of 20
`and 44 years and resulted in a
`prevalence of 18.3% (Verlato ef a/., 2003). An average
`of the two later studies was taken to estimate 2004 prevalence.
`
`Spain
`
`A total of six centers were involved in the 1996 ECRHS.
`
`Table 6:
`
`ECRHSresults, Spain, 1996
`Spain ECRHS Albacete Barcelona Galdakao Huelva Oviedo Seville Average
`
`12.4
`
`13.1
`
`126
`
`176
`
`13.4
`
`15.5
`
`14.05
`
`
`
`Source: Burney ef al, 1996 DATAMONITOR
`
`in northern Spain, shows comparable
`A 1999 study of 2,216 people, carried out
`results. It also investigated prevalence across
`regions and age ranges. It was found
`was increased in the Atlantic climatic area, when compared to the
`that prevalence
`Oceanic area. The peak age was shownto be between 20 and 25 years old (Azpiri ef
`al,, 1999).
`
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`
` Pollinosis in different age ranges, Spain (%), 1999
`
`(%)
`Prevalence
`
` 40
`
`Age
`
`Source; Azpiri ef af, 1999
`
`DATAMONITOR
`
`
`
`
`
`UK
`
`The UK has a
`considerably higher number of AR sufferers, in comparison to the rest
`of Europe, in most studies. This is illustrated by the data on the UK from the ECRHS.
`
` Table 7:
`ECRHS Results, UK, 1996
`
`UK ECRHS
`
`Caerphilly
`
`Cambridge
`
`Ipswich
`
`Norwich
`
`Average
`
`23.6
`
`29.2
`
`26.7
`
`28.3
`
`26.95
`
`DATAMONITOR
`Source: Burney et a/., 1996
`
`
`This average prevalence correlates closely with a 1991 study at a
`general practice in
`London in which a minimum rhinitis prevalence of 24% was
`reported (Sibbald, Rink,
`1991). This number was added to the ECRHS results and an average was found.
`
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`
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`
`Japan
`Okuda published the most recent study into AR in Japan, in the Annuls of Allergy,
`Asthma
`in September 2003. This
`and Immunology,
`study investigated the
`epidemiology of Japanese cedar pollinosis throughout Japan. This is a form of
`seasonal allergic rhinitis that coincides with the peak of the pollen season for the
`Japanese cedar. The results from a nationwide survey of 5,624 subjects gave an
`age-adjusted prevalence of 19.4%, with an estimated prevalence of 13.1% after
`correction of possible bias. An earlier study by Nakamura ef a/., published in 2002,
`a
`perennial AR prevalence of 19.8% and it states that allergic rhinitis due to
`gives
`causesother than pollen showssimilar results.
`
`Japanese cedar pollinosis does not cover the whole range of causes for AR,
`therefore an average of the two higher rates of prevalence will be taken into account
`for perennial rhinitis and AR caused by otherallergens.
`
`However, according to Japanese opinion leaders the prevalence of SAR may be
`slightly downthis year, mainly due to climatic variations:
`
`“The number of patients coming in for Japanese cedar pollen
`allergy was dramatically reduced this year, because the weatherin
`—
`July 2003, was too cool for the pollen to mature.”
`Japanese
`opinion leader
`
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`
`Loratadine: the gold standardin allergic rhinitis
`
`Antihistamines are the most commonly prescribed class of medication for AR
`(Corren, 2000). Loratadine is a
`second-generation H; antihistamine and, as of
`December2002, is available OTC and in a
`generic form in many countries. Its main
`overthe first-generation antihistamines is a
`non-sedating action, due to a
`advantage
`larger molecular structure that does not pass through the brain barrier as
`as
`easily
`the first generation.
`
`still considered the best non-sedating
`Although it
`this drug is
`is off patent,
`antihistamine for the majority of patients. The large marketing spend used in the
`promotion of Claritin to some extent explains the brand loyalty shown whenthis was a
`the late 2002 switch to OTC showsthat increasing
`prescription drug. However,
`competition has eroded this lead with US prescription sales of Claritin down 83% for
`the third quarter of 2003 to $68m (MIDAS Sales Data, IMS Health, April 2004).
`
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`
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`
`Associated pharmaceutical markets and indications
`
`Allergic rhinitis can be comorbid with other atopic diseases such as asthma and
`eczema. Some treatments are indicated for two or more of these diseases due to the
`similar mechanism of disease action.
`
` Relationship between asthma, rhinitis and eczema
`
`Allergic
`Rhinioconjunctivitis
`
` Atopic eczema
`
`symptoms
`
`All symptoms relate to a 12-month period
`
`Source: ISAAC, 1998
`
`DATAMONITOR
`
`As can be seen in Figure 5, on a
`global basis, 7.2% suffer from at least two of the
`three disorders. This leads to close linking of medication for all these indications.
`
`
`
`
`
`Asthma and associated market
`
`The inflammatory response in asthmais similar to that which occurs in AR. ARitself
`is a known risk factor for asthma, and the link has been confirmed by the Allergic
`a
`on Asthma (ARIA) study. Laynaert ef a/. published
`study in
`Rhinitis and its Impact
`January 2004 into the association between these two conditions and found that 74—
`81%of subjects with asthma also reported suffering from rhinitis. Conversely, the risk
`It concluded that a
`of asthma increased in those with rhinitis.
`strong association
`
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`
`existed between asthma and rhinitis that was not fully explained by shared risk
`factors, including atopy.
`
`The decline in value of the US allergy market, following the OTC switch and patent
`expiry of Claritin, and five separate, ongoing, generic legal challenges to Aventis’s
`Allegra (fexofenadine), will lead to increasing overlap between drugs used to treat
`an asthmaindication for
`these two disease markets. For example, Aventis is pursuing
`its antihistamine drug Allegra and in January 2003,
`the FDA approved Merck’s
`asthma drug Singulair for allergic rhinitis. To date, the only therapy that has been
`concerns and a
`shownto prevent asthma is immunotherapy(IT), but significant safety
`mean that, at best, immunotherapy accounts for 2-4%
`protracted treatment regimen
`of the $9 billion allergy market. A number of biotechnology firms are
`attempting to
`overcome the disadvantages of current IT treatment, but discovery of a
`commercially
`enormous difficulties.
`viable allergy vaccine presents
`
`Idiopathic urticaria and associated market
`
`as
`is a
`Urticaria, also Known as hives,
`dermatological reaction, which presents
`pale
`on any part of the skin.
`a number of agents
`It can be caused by
`red swellings
`or as a response to viral
`including certain food groups, drugs and insect stings
`It can last for anything from a few hours to years, although the majority of
`infection.
`cases
`disappear within 24 hours.
`
`Treatment consists mainly of antihistamines, or an adrenaline injection in the case of
`severe reactions. Loratadine proved
`an efficient agent in the treatment of the chronic
`urticaria in 71% of patients in a 1994 Polish study (Siergiejko ef a/., 1994). Therefore,
`products indicated for allergic rhinitis often have an urticaria indication as well. This
`proves usefulin the highly competitive advertising of new
`drugs; however, some OTC
`are approvedfor.
`are usedfor indications other than those they
`products
`