) DATAMONITOR
`
`Commercial and
`Stakeholder
`Perspectives: Allergic
`Rhinitis
`
`Is there life after Claritin?
`
`AC Classes: R6AO, R1A1 , R1A4, R1A6, R1A7, R1BO.
`
`Countries: US, Japan, France, Germany, Italy, Spain and UK
`
`Reference Code: DMHC 1936
`
`Publication Date: 09/2004
`
`www.datamonitor.com
`
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`

`

`About Datamonitor Healthcare
`
`) DATAMONITOR
`
`ABOUT DATAMONITOR HEALTHCARE
`
`Datamonitor Healthcare provides a total business solution to the pharmaceutical and
`healthcare industries. Its services reflect its expertise in therapeutic, strategic and
`eHealth market analysis and competitive intelligence. For more details of Datamonitor
`Healthcare's syndicated and customized products and services, please refer to the
`Appendix or contact:
`
`Anne Delaney, Director of Research and Analysis, +44 (0)20 7675 7221,
`adelaney@datamonitor.com
`
`disorders
`immune
`the
`About
`pharmaceutical analysis team
`
`and
`
`inflammation
`
`Datamonitor's therapeutic area studies comprise the following features:
`
`clinical opinion leader intelligence and best-in-class case studies, leading to
`actionable recommendations;
`
`R&D pipeline 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
`
`CHAPTER 1 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:
`
`•
`
`•
`
`•
`
`the impact of patent expiry and changes in government regulation and attitude
`to generics are explained ;
`
`the effect of prescription (Rx) to over-the-counter (OTC) drug switches as a
`strategic move or by governmental pressure and the reaction of the US
`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 Health.
`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
`
`Page 3
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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 Allergy and Respiratory Diseases,
`Department of Internal Medicine, Hanzomon Hospital, Tokyo, Japan;
`
`Dr Eckard Hamelmann, Head of the Respiratory Infections and Asthma work(cid:173)
`group, Charite-Virchow Hospital, Berlin, Germany;
`
`Professor William Reed Henderson, Jr, Professor of Medicine, Head, Allergy
`Section, University of Washington, US;
`
`(Barry) Kay, Professor and Director,
`Professor Anthony Barrington
`Department of Allergy and Clinical Immunology, Imperial College School of
`Medicine, UK.
`
`Datamonitor insight into the allergic rhinitis market
`
`the course of its research and analysis for Commercial and Stakeholder
`In
`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 spent on detailing physicians. Accurately targeting the appropriate physicians
`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;
`
`the impact of patent expiry on Claritin (loratadine) has seen wide-ranging country
`variances, in terms of both revenue and prescription volume sales adjustments for
`the brand, molecule and class. Germany, the US and the UK experienced the
`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
`points as to how other antihistamines may be impacted by similar events. The
`2007 Zyrtec (cetirizine) patent expiry, and a favorable outcome for the generics
`companies in the Allegra (fexofenadine) patent legislation, are two such events.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC1936
`
`Page 4
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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 events utilized
`in forecasting the market. Assesses strategic case studies to provide insight into
`potential market strategies;
`
`2. Excel document: contains forecasts on a country-by-country basis for the seven
`major markets. Country, region and class/brand charts can be generated in this file
`for both volume and value units;
`
`3. PowerPoint executive presentation: shares Datamonitor's key insight into the
`market with supporting data and recommendations.
`
`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
`
`CHAPTER 1
`
`EXECUTIVE SUMMARY
`
`Objective of the analysis
`
`Scope and focus
`
`Datamonitor insight into the allergic rhinitis market
`
`CHAPTER 2
`
`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
`
`CHAPTER 3
`OVERVIEW
`
`GLOBAL
`26
`
`Market definition
`
`Global allergic rhinitis market analysis
`
`Antihistamine market performance
`
`3
`
`3
`
`3
`
`4
`
`13
`
`13
`
`14
`
`15
`
`16
`
`16
`
`16
`
`17
`
`22
`
`23
`
`24
`
`24
`
`25
`
`26
`
`28
`
`29
`
`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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`

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`Table of Contents
`
`) DATAMONITOR
`
`Corticosteroid market performance
`
`BRAND
`KEY
`CHAPTER 4
`FORECASTING ASSUMPTIONS
`
`ASSESSMENT
`
`AND
`
`Key brand strengths and weaknesses
`
`Event type one - antihistamine patent expiry
`
`Event type two - nasal corticosteroid patent expiry
`
`Event type three - new product launch
`
`Alvesco (ciclesonide)
`
`Drug overview
`
`Clinical trial 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
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`36
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`36
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`36
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`37
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`37
`
`38
`
`39
`
`40
`
`41
`
`42
`
`44
`
`45
`
`46
`
`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
`
`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 key facts
`
`Nasonex strategic analysis and forecasting assumptions
`
`us
`
`EU
`
`Japan
`
`Rhinocort analysis
`
`46
`
`47
`
`48
`
`50
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`50
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`50
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`51
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`52
`
`53
`
`53
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`54
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`55
`
`56
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`57
`
`57
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`58
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`59
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`59
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`60
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`61
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`62
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`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
`
`) DATAMONITOR
`
`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
`
`Decongestant analysis
`
`Decongestant market performance
`
`Oral delivery
`
`Nasal delivery
`
`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
`
`64
`
`66
`
`66
`
`66
`
`67
`
`68
`
`69
`
`70
`
`70
`
`71
`
`72
`
`74
`
`75
`
`75
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`75
`
`75
`
`75
`
`76
`
`76
`
`76
`
`77
`
`77
`
`79
`
`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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`

`

`Table of Contents
`
`) DATAMONITOR
`
`Opportunities
`
`Threats
`
`EU: opportunities and threats
`
`Opportunities
`
`Threats
`
`EU country-specific demographics
`
`CHAPTER 6
`
`CASE STUDIES
`
`Case study one -
`rhinitis treatment
`
`Impact of regulatory change on patent protection for allergic
`
`Frivolous patents or genuine discoveries?
`
`New patents no longer protect 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
`
`UK
`
`80
`
`81
`
`81
`
`81
`
`82
`
`82
`
`88
`
`88
`
`88
`
`88
`
`92
`
`92
`
`92
`
`93
`
`94
`
`94
`
`99
`
`99
`
`100
`
`102
`
`107
`
`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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`

`Table of Contents
`
`) DATAMONITOR
`
`Japan
`
`109
`
`Case study three- Impact of Rx to OTC switches in the US allergic rhinitis market 111
`
`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 challenges in Allergic rhinitis
`
`German opinion leader
`
`Patient demographics
`
`Antihistamines
`
`Corticosteroids
`
`Combinations with Decongestants
`
`US opinion leader
`
`112
`
`113
`
`116
`
`116
`
`116
`
`120
`
`121
`
`121
`
`122
`
`122
`
`123
`
`125
`
`126
`
`127
`
`128
`
`129
`
`129
`
`130
`
`132
`
`133
`
`134
`
`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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`

`

`Table of Contents
`
`) DATAMONITOR
`
`Patient demographics
`
`Antihistamines
`
`Corticosteroids
`
`Brand Specific opinions
`
`Combinations with decongestants
`
`Future challenges in Allergic rhinitis
`
`UK opinion leader
`
`Patient demographics
`
`Antihistamines
`
`Corticosteroids
`
`APPENDIX 8
`
`Bibliography
`
`Epidemiology
`
`Clinical trial data
`
`Other
`
`Report methodology
`
`Japanese market data
`
`Standard units
`
`About Datamonitor
`
`About Datamonitor Healthcare
`
`Datamonitor Healthcare's research and analysis methodologies
`
`Datamonitor Healthcare's therapy area capabilities
`
`Disclaimer
`
`134
`
`137
`
`139
`
`140
`
`141
`
`142
`
`143
`
`143
`
`144
`
`146
`
`148
`
`148
`
`148
`
`149
`
`150
`
`151
`
`151
`
`151
`
`152
`
`152
`
`153
`
`153
`
`154
`
`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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`

`

`Patient Potential
`
`) DATAMONITOR
`
`CHAPTER 2 PATIENT POTENTIAL
`
`Patient potential
`
`The number of patients requiring treatment is continually rising, driven by a number of
`factors:
`
`•
`
`•
`
`•
`
`air pollution, specifically particulates;
`
`public awareness resulting in increasing physician diagnosis;
`
`the hygiene hypothesis, which links the adoption of the modern westernized
`lifestyle to rises in allergic disease through a lack of early life exposure to
`microorganisms.
`
`Although allergic rhinitis is not a life-threatening disease it is classified as a major
`chronic respiratory disease due to its:
`
`•
`
`•
`
`•
`
`•
`
`•
`
`prevalence;
`
`impact on quality of life;
`
`impact on work/school performance;
`
`economic burden;
`
`links with asthma.
`
`In March 2003, the US department of Health and Human Services produced an
`evidence report on the management of AR in the working age population, concluding
`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
`estimated $7.7 billion annually (McCrory et at., 2003).
`
`Allergic Rhinitis and its Impact on Asthma (ARIA) is a project carried out by non(cid:173)
`governmental group working with
`the World Health Organization. The ARIA
`investigation has clarified long-suspected links with asthma and rhinitis. 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
`between the two conditions; for example, one French cohort revealed that 22.5% of
`adults with rhinitis had asthma as well (Leynaert et at., 1999).
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
`This report is a licensed product and is not to be photocopied
`
`DMHC1936
`
`Page 13
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`

`Patient Potential
`
`) DATAMONITOR
`
`"The awareness . . . [of allergic rhinitis] . . . is certainly increasing
`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
`disease is defined. It is clinically defined as a symptomatic disorder of the nose
`induced by an lgE-mediated inflammation after exposure of an allergen to the
`membranes
`lining
`the nose. The
`recent ARIA
`initiative
`recommended
`the
`classification of allergic rhinitis symptoms as persistent or intermittent, rather than
`perennial and seasonal.
`
`The four main symptoms of the disease are an itchy nose, sneezes, nasal obstruction
`and rhinorrhea. The reported prevalence varies depending on the number of
`symptoms required to define AR. An
`International Consensus Report on the
`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
`
`Frequency and duration
`Occur over <4 days/week or over <4 weeks
`
`Persistent
`
`Occur over <4 days/week and over >4 weeks
`
`Mild
`
`Severity of symptoms
`Normal sleep
`No impairment of daily activities, sport, leisure, work, school
`No troublesome 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
`
`DMHC1936
`
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`

`Patient Potential
`
`) DATAMONITOR
`
`Age variance
`
`Prevalence is usually higher in adults, peaking at around 20 years of age, than in
`children and pensioners, as shown in Germany in Figure 4. This variance as a result
`of age also makes epidemiology studies difficult to compare, for example the ISAAC
`study was carried out in 13-14 year olds, whereas the ECRHS involved adults
`between the age of 20 and 44. A comparison in Figure 1 between these two large(cid:173)
`scale studies shows that, although a 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 eta/., 2000).
`
`Figure 1:
`
`Correlation of incidence of hayfever ever in ECRHS (II) and
`ISAAC I
`
`•
`
`A
`
`Cl
`
`..
`
`....
`-o. J'
`
`*
`
`v
`
`*
`
`'0 ~------,-------~------~-----,-------,
`40
`10
`0
`3 (1
`5(1
`
`• - Australia
`£.-Belgium
`•- Germany
`T- France
`+-Estonia
`
`0- Spain
`o - Italy
`1:'1 - New Zealand
`•
`- Ireland
`*-US
`
`Source: Pearce eta/. , 2000
`
`DATAMONITOR
`
`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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`
`Global prevalence
`
`The prevalence of allergic rhinitis is estimated in the seven major markets using
`epidemiology studies and research data.
`
`Table 2:
`
`Global prevalence of allergic rhinitis, 2004
`
`Country
`
`US 2
`Japan 3
`France 4
`Germany 5
`Italy 6
`Spain 7
`UK 8
`
`1Total2004
`population
`(OOO's)
`
`Prevalence
`(%)
`
`AR
`population
`(OOO'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
`
`Source: Various (see below)
`1 = UN database figures
`2 = National Health Survey, 2001; Crown, 2003; Slavin, 1994
`3 =Okuda , 2003; Nakamura eta/., 2002
`4 = ECRHS; Charpin eta/., 2000 ; WAO
`5 = ECRHS
`6 =Olivieri eta/. , 2002 ; Verlato eta/., 2003
`7 = ECRHS; Azpiri eta/., 1999
`8 = ECRHS; Sibbald , Rink, 1991
`
`DATAMONITOR
`
`Methodology
`
`us
`The National Health Interview Survey of 2001 , published by the CDC, recorded a total
`of nearly 21 million hayfever sufferers in the US. This refers to the seasonal aspect of
`allergic rhinitis, and each respondent was defined as having been told by a doctor, or
`other healthcare professional in the past 12 months, that they had hayfever.
`However, allergic rhinitis has been reported in up to 80% of asthma sufferers (Slavin,
`1994) and more recently 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
`both seasonal and persistent allergic rhinitis, an average percentage was found ,
`taking into account prevalence rhinitis with comorbid asthma and of PAR giving an
`estimate of 19.8% of the population.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
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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-year olds, from 22 countries.
`
`Fi ure 2:
`
`Relative revalence in the EU
`
`Key
`
`• High
`Medium
`• Low
`
`Source: ECRHS I, 1996
`
`DATAMONITOR
`
`A northwest to southeast diagonal divide exists in AR prevalence rates in Europe.
`The atopy data in Figure 2 exemplifies this, showing Greece, Italy and Spain as
`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.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
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`France
`
`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:
`
`ECRHS results, France, 1996
`
`France
`ECRHS
`
`Bordeaux Grenoble
`
`Montpellier
`
`Paris
`
`Average
`
`30.2
`
`28.1
`
`34.4
`
`30.3
`
`30.75
`
`Source: Burney eta/., 1996
`
`DATAMONITOR
`
`It can be seen in a comparison between all the European figures that the more urban
`areas, or larger cities have a higher prevalence of AR than that found in rural areas.
`Therefore, to obtain a more representative figure for France, Datamonitor combined
`this information with two other sources when estimating an overall figure.
`
`Charpin et a/. (2000) gave prevalence values for hayfever of approximately 18% for
`teenagers and 25% for young adults. The World Allergy Organization gives France a
`prevalence of 5.9%. By taking an average of the comparative age ranges, a figure of
`24.6% prevalence was estimated.
`
`Germany
`
`A number of studies have been carried out in Germany in allergy prevalence in recent
`years. The ECRHS is the largest cohort and provides the basis for this prevalence
`figure. However, a useful study was published in 1993 into two genetically similar
`populations who were exposed
`to different
`levels of living conditions and
`environmental pollution. It was carried out in the former East and West Germany and
`provides insight into the evolution and causative factors of the condition. Typical
`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.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
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`Table 4:
`
`ECRHS results, Germany, 1996
`
`Germany ECRHS
`
`Erfurt
`
`Hamburg
`
`Average
`
`13.4
`
`23
`
`18.2
`
`Source: Burney eta/. , 1996
`
`DATAMONITOR
`
`The age distribution in Germany is displayed in Figure 3 below, and shows that the
`value found in the ECRHS, from ages 20 to 44, falls in the peak to medium
`prevalence range and will not be an accurate representation of other ages.
`
`Figure 3:
`
`Age distribution of allergic rhinitis, Germany(% , 1995
`
`Source: Mosges eta/., 1995
`
`DATAMONITOR
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
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`
`Italy
`
`The Italian prevalence was estimated using the ECRHS data and two more recent
`epidemiological studies in that area.
`
`Table 5:
`
`ECRHS results, Italy, 1996
`
`Italy ECRHS
`
`Pavia
`
`Turin
`
`Verona Average
`
`12.5
`
`16
`
`16.9
`
`15.13
`
`Source: Burney et al, 1996
`
`DATAMONJTOR
`
`A study of data collected in northern Italy showed a higher prevalence of 15.9%
`(Olivieri et at, 2002) than the average figure reported from the ECRHS data.
`
`In 2003, a study into the prevalence of AR showed a clear increase from the data
`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 et at., 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:
`
`ECRHS results, Spain, 1996
`
`Spain ECRHS Albacete Barcelona Galdakao Huelva Oviedo Seville Average
`
`12.1
`
`13.1
`
`12.6
`
`17.6
`
`13.4
`
`15.5
`
`14.05
`
`Source: Burney eta/. , 1996
`
`DATAMONITOR
`
`A 1999 study of 2,216 people, carried out in northern Spain, shows comparable
`results. It also investigated prevalence across regions and age ranges. It was found
`that prevalence was increased in the Atlantic climatic area, when compared to the
`Oceanic area. The peak age was shown to be between 20 and 25 years old (Azpiri et
`at., 1999).
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
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`Patient Potential
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`
`Figure 4:
`
`Pollinosis in different age ranges, Spain %, 1999
`
`14
`
`12
`
`10
`
`~
`
`e...
`~ 8
`u
`s::
`..2:!
`nl >
`~
`0..
`
`6
`
`4
`
`2
`
`0
`
`0
`
`5
`
`10
`
`15
`
`20
`
`Age
`
`25
`
`30
`
`35
`
`40
`
`Source; Azpiri eta/. , 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
`
`Source: Burney eta/., 1996
`
`DATAMONITOR
`
`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.
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
`© Datamonitor (Published 09/2004)
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`Patient Potential
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`
`Japan
`
`Okuda published the most recent study into AR in Japan, in the Annuls of Allergy,
`Immunology,
`in September 2003. This study
`investigated
`the
`Asthma and
`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 et at., published in 2002,
`gives a perennial AR prevalence of 19.8% and it states that allergic rhinitis due to
`causes other than pollen shows similar 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 other allergens.
`
`However, according to Japanese opinion leaders the prevalence of SAR may be
`slightly down this year, mainly due to climatic variations:
`
`"The number of patients coming in for Japanese cedar pollen
`
`allergy was dramatically reduced this year, because the weather in
`July 2003, was too cool for the pollen to mature." - Japanese
`opinion leader
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
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`
`Loratadine: the gold standard in allergic rhinitis
`
`Antihistamines are the most commonly prescribed class of medication for AR
`(Corren, 2000). Loratadine is a second-generation H1 antihistamine and, as of
`December 2002, is available OTC and in a generic form in many countries. Its main
`advantage over the first-generation antihistamines is a non-sedating action, due to a
`larger molecular structure that does not pass through the brain barrier as easily as
`the first generation.
`
`this drug is still considered the best non-sedating
`Although it 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 when this was a
`prescription drug. However, the late 2002 switch to OTC shows that increasing
`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).
`
`Commercial and Stakeholder Perspectives: Allergic Rhinitis
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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.
`
`Fi ure 5:
`
`Relationshi 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 asthma is similar to that which occurs in AR. AR itself
`is a known risk factor for asthma, and the link has been confirmed by the Allergic
`Rhinitis and its Impact on Asthma (ARIA) study. Laynaert et at. published a study in
`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
`of asthma increased in those with rhinitis. It concluded that a strong association
`
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`
`existed betw