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Respiratory Viral Infections Respiratory Syncytial Virus antiviral drug

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Respiratory Viral Infections - Respiratory Syncytial Virus,
Parainfluenza Virus and Human Metapneumovirus as Promising
New Targets

Description:    Introduction

                The 2009/10 influenza H1N1 pandemic has boosted awareness of respiratory viral infections.
                Stockpiling has been pivotal for the strong growth of the influenza antivirals market, with 2009
                seven major market sales reaching $1,772m. As the pandemic recedes, other promising targets in
                the sector include respiratory syncytial virus (RSV), parainfluenza virus (PIV) and human
                metapneumovirus (hMPV).

                Scope

                -Analysis of the market for respiratory viral infections across the US, Japan, France, Italy,
                Germany, Spain and the UK

                -Strategic analysis of key marketed brands and pipeline candidates

                -Thorough assessment of key developments shaping the sector

                -In-depth discussion of opportunities and threats for respiratory antivirals across the seven major
                markets

                Highlights

                The pandemic threat has fuelled growth of the influenza antivirals market, with total 7MM sales of
                $1,772m in 2009 and a compound annual growth rate of 31.9% from 2005-09. Convenient oral
                dosing makes Roche's Tamiflu the market leader, with 2009 sales of $1,426m in the 7MM.

                The role of rapid point-of-care diagnostics divides opinion, with uptake deterred by high cost and
                poor performance, although reimbursement in Japan facilitates greater antiviral usage for seasonal
                influenza. Growing resistance to Tamiflu highlights the need for new oral or infrequently dosed
                inhaled antivirals with a strong resistance profile.

                A vaccine is a key unmet need for RSV, with physicians divided on the need for and efficacy of
                antivirals for RSV treatment. Synagis saw 7MM sales of $1,218m in 2009, although high cost is
                increasingly hindering its commercial prospects, highlighting the growing opportunity for vaccines
                and an additional potential role for cheaper therapeutics.

                Reasons to Purchase

                -Identify key opportunities that will impact the use and uptake of new and existing products

                -Understand key internal and external factors shaping the therapeutic landscape for respiratory
                antivirals

                -Gain competitive advantage by identifying key product characteristics and potential roles for new
                therapies



Contents:       Overview
                Catalyst
                Summary

                Executive Summary
Scope of the analysis
Market definition for this report
Datamonitor insight into the respiratory viral infections market
Related reports
Upcoming reports

1. Patient Potential
Key findings
Respiratory viral infections - an overview
Influenza
Respiratory syncytial virus (RSV)
Parainfluenza virus (PIV)
Human metapneumovirus (hMPV)
Epidemiology
Seven major markets
Respiratory viral infections represent a huge burden across the seven major markets
US
Up to one-fifth of the US population suffers from seasonal influenza each year
Population-based data suggest a significantly greater burden from RSV than from influenza in
young children
PIV burden justifies allocation of resources for vaccine candidate development
Japan
Nearly 10% of the Japanese population contracts influenza each year
High burden of RSV in Japan is comparable with that of the US
Five major EU markets
RSV linked with notably more infant hospitalizations than influenza A and B
UK data suggest RSV is the dominant viral respiratory pathogen in young children
Population-based data suggest a higher incidence of hMPV than influenza in Spanish infants
Rest of the world
Current treatment options
Influenza - Tamiflu and Relenza dominate the antivirals market
RSV - blockbuster status for Synagis
No treatments are available for PIV or hMPV
Patient care path
Trigger point 1: Pharmaceutical companies should attempt to increase awareness of RVIs among
physicians and the general public
Trigger point 2: Use of laboratory diagnostics can identify the causative virus and affect the
treatment choice
Trigger point 3: Influence initial brand choice
Unmet need in respiratory viral infections
Influenza: there is a large unmet need for new antivirals with improved resistance profiles and
efficacy
New oral antivirals with improved resistance profiles and efficacy are required to overcome the
emerging shortcomings of Tamiflu
There is an attractive market gap for an intravenously administered influenza antiviral in hospital
inpatients
RSV: high disease burden necessitates investment in new treatment options and vaccine
development
PIV and hMPV: potentially attractive new markets for therapeutics and vaccines
Target product profile versus current level of attainment

2. Market Potential
Key findings
Current market overview
Influenza
Government stockpiling contracts make Roche's Tamiflu the clear market leader
US
Japan
Five major EU countries
Rest of the World
Respiratory syncytial virus (RSV)
MedImmune's Synagis demonstrates the potential of the RSV market
Opportunities and threats
Opportunities
Pandemic threat increases public awareness of influenza and other respiratory viral infections and
fuels the demand for prevention and treatment
Growing use of point-of-care diagnostics
Emergence of antiviral resistance to current therapies
Growing viral respiratory infection burden as a result of aging populations
Limited generic competition in the respiratory antivirals sector
Threats
Cost of point-of-care rapid diagnostics deters use in some markets
Negative press and publicity during the influenza A (H1N1) pandemic could reduce the future
market opportunity for influenza antivirals

3. Brand Dynamics
Key findings
Overview of the competitive landscape
Influenza
Respiratory syncytial virus (RSV)
Tamiflu (oseltamivir, Roche)
Drug profile
Product positioning
SWOT analysis
Relenza (zanamivir, GlaxoSmithKline)
Drug profile
Product positioning
SWOT analysis
Synagis (palivizumab, MedImmune/AstraZeneca)
Drug profile
Product positioning
SWOT analysis

4. Pipeline Analysis
Key findings
Influenza
Pipeline overview
Rapiacta (peramivir; BioCryst/Shionogi)
Drug profile
Development overview
Product positioning
SWOT analysis
Laninamivir (Daiichi Sankyo/Biota)
Drug profile
Development overview
Product positioning
SWOT analysis
Favipiravir (T-705, Toyama)
Fludase (DAS181, NexBio)
Key early-stage compounds
Respiratory syncytial virus (RSV)
Pipeline overview
ALN-RSV01 (Alnylam Pharmaceuticals/Cubist)
RSV604 (Arrow Therapeutics/Novartis)
Motavizumab (MedImmune/AstraZeneca)
Key early-stage compounds
Late-stage development compounds recently discontinued
Parainfluenza virus (PIV) and human metapneumovirus (hMPV)
Outlook - The future of treatment in Respiratory Viral Infections
More favorable cost and improved performance characteristics are required in order to make rapid
point-of-care diagnostics more attractive
New intravenous or infrequently inhaled influenza antivirals have a promising market opportunity
RSV antiviral drugs show promise, although a vaccine remains a distant possibility
Vaccines for PIV and hMPV are needed, while developers shun antivirals
Rhinovirus identified by physicians as a potentially lucrative antiviral target
Bibliography
Journals
Websites
Datamonitor reports

Appendix A
Data definitions, limitations and assumptions
Standard units
Country group definitions
Rest of European Union
Middle East and North Africa (MENA)
Rest of World
Exchange rates

Appendix B
Contributing experts
Conferences attended
Report methodology
Disclaimer

List of Tables
Table 1: Country-specific annual incidence, hospitalization, and mortality data for influenza
Table 2: Country-specific annual incidence, hospitalization, and mortality data for respiratory
syncytial virus (RSV)
Table 3: Country-specific annual incidence and hospitalization data for parainfluenza virus (PIV) in
the US
Table 4: Country-specific annual incidence data for human metapneumovirus (hMPV)
Table 5: Leading treatments for influenza in the seven major markets, 2010
Table 6: Leading treatments for respiratory syncytial virus (RSV), parainfluenza virus (PIV), and
human metapneumovirus (hMPV) in the seven major markets, 2010
Table 7: Target product profile (TPP) for influenza antiviral drugs, 2010
Table 8: Influenza antiviral drug and class sales dynamics across the seven major markets ($m),
2005-09
Table 9: Global sales dynamics of the influenza antivirals market ($m), 2005-09
Table 10: Global influenza market sales by region, 2005-09
Table 11: Respiratory syncytial virus (RSV) drug sales dynamics across the seven major markets
($m), 2005-09
Table 12: Summary of opportunities and threats in the respiratory viral infection (RVI) market
across the seven major markets, 2010
Table 13: Tamiflu (oseltamivir) - drug profile, 2010
Table 14: Relenza (zanamivir) - drug profile, 2010
Table 15: Synagis (palivizumab) - drug profile, 2010
Table 16: Products in late-stage clinical development for influenza treatment, 2010
Table 17: Rapiacta (peramivir) - drug profile, 2010
Table 18: Summary of key clinical trials Rapiacta (peramivir)
Table 19: Laninamivir - drug profile, 2010
Table 20: Summary of key clinical trials for laninamivir, 2010
Table 21: Favipiravir - drug profile, 2010
Table 22: Fludase - drug profile, 2010
Table 23: Key products in the early-stage R&D pipeline for influenza treatment and prophylaxis,
2010
Table 24: Products in late-stage clinical development for respiratory syncytial virus (RSV), 2010
Table 25: ALN-RSV01 - drug profile, 2010
Table 26: RSV604 - drug profile, 2010
Table 27: Motavizumab - drug profile, 2010
Table 28: Key products in early-stage R&D pipeline for respiratory syncytial virus (RSV) treatment
and prevention, 2010
Table 29: Discontinued R&D projects for respiratory syncytial virus (RSV), 2010
Table 30: Key products in the R&D pipeline for parainfluenza virus (PIV), 2010
Table 31: Vaccines in clinical development for respiratory syncytial virus (RSV), 2010
Table 32: Key products in R&D pipeline for parainfluenza virus (PIV), 2010
Table 33: Exchange rates, 2009
            List of Figures
            Figure 1: Epidemiology and burden of respiratory viral infections in selected Rest of the World
            countries
            Figure 2: Infectious Diseases Society of America clinical practice guidelines for seasonal influenza,
            2009
            Figure 3: Respiratory viral infections patient path
            Figure 4: Key unmet needs for the treatment of influenza, 2010
            Figure 5: Key unmet needs for the treatment of respiratory syncytial virus (RSV), parainfluenza
            virus (PIV), and human metapneumovirus (hMPV), 2010
            Figure 6: Sales value of the influenza antiviral market across the seven major markets ($m), 2005-
            09
            Figure 7: Regional sales dynamics of the influenza antiviral market ($m), 2005-09
            Figure 8: Market share of influenza antivirals in the US (%), 2005-09
            Figure 9: Market share of influenza antivirals in Japan (%), 2005-09
            Figure 10: Market share of different influenza antivirals in the five major EU markets (%), 2005-09
            Figure 11: Global influenza antiviral market sales ($m), 2005-09
            Figure 12: Global influenza antiviral market volume use (IMS standard units sold) and value sales
            (%). 2009
            Figure 13: Synagis (palivizumab; MedImmune/AstraZeneca) sales across the seven major markets
            ($m), 2005-09
            Figure 14: Global Synagis (palivizumab MedImmune/AstraZeneca) sales by value (%) and volume
            (SU), 2009
            Figure 15: Regional sales dynamics of Synagis (palivizumab, MedImmune/AstraZeneca) in the
            seven major markets ($m), 2005-09
            Figure 16: Tamiflu - SWOT analysis, 2010
            Figure 17: Relenza - SWOT analysis, 2010
            Figure 18: Synagis - SWOT analysis, 2010
            Figure 19: Rapiacta - SWOT analysis, 2010
            Figure 20: Laninamivir - SWOT analysis, 2010
            Figure 21: Favipiravir (T-705) mechanism of action



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Description: Respiratory Viral Infections Respiratory Syncytial Virus antiviral drug