Product Profiles: Allergic Rhinitis - Heavily genericized market sees areas of innovation

Introduction

The allergic rhinitis market continues to see areas of innovation, as seen with the April 2011 FDA filing of Dymista (azelastine/fluticasone; Meda/Cipla). Within the immunotherapy class, novel therapies are making progress in the EU, and continuing to pursue development in the US. Amongst established symptomatic therapies, strategies are used to resist generic erosion.

Features and benefits

* Access Datamonitor’s independent clinical and commercial assessment of marketed brands and key pipeline agents for allergic rhinitis.
* Understand to what extent current and future therapies satisfy the main clinical unmet needs in allergic rhinitis.
* Assessment of the strengths, weaknesses, opportunities, and threats for both symptomatic and immunotherapy treatments.
* Review important clinical developments for key pipeline agents with analysis of the latest clinical trial data.

Highlights

The oral antihistamine class has seen an additional over-the-counter (OTC) shift, as the FDA approved Allegra (fexofenadine, Sanofi-Aventis) for OTC use in January 2011, which led to an OTC launch of the product in March 2011. This, and other methods of combating generic erosion, can be seen throughout the allergic rhinitis market.
In April 2011, Meda filed its fixed dose nasal antihistamine/corticosteroid combination Dymista (azelastine/fluticasone) with the FDA for the treatment of seasonal allergic rhinitis in patients aged 12 years and older. If approved, Dymista would be the first of its class to reach the market, addressing unmet needs in treating allergic rhinitis.
Movements have been seen in the allergen immunotherapy class; in January 2011 the FDA announced that it would lift the clinical hold that had been placed on Allergy Therapeutics’ Pollinex Quattro range in 2007. The sublingual tablet based grass allergens Grazax and Oralair continue to roll-out in the EU, and hope remains for their US approval.

Your key questions answered

* How do marketed treatments of allergic rhinitis compare to one another and where will pipeline agents fit in?
* What methods have been used to combat generic erosion post-patent expiry, and which are the most successful?
* How do key opinion leaders differentiate between various treatments for allergic rhinitis?
* What is the status of novel immunotherapy treatments for allergic rhinitis, and what is their commercial potential?
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Executive Summary
Strategic scoping and focus
Datamonitor key findings
Related reports
OVERVIEW
Catalyst
Summary
MARKET DEFINITION AND OVERVIEW
Market definition
Product overview
MARKETED PRODUCT PROFILES
Telfast/Allegra (fexofenadine; Sanofi)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Allegra-D (fexofenadine/pseudoephedrine; Sanofi)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Zyrtec (cetirizine; UCB)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Xyzal (levocetirizine; UCB/Sunovion)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Claritin (loratadine; Merck)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Aerius/Clarinex (desloratadine; Merck)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Nasonex (mometasone; Merck)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Flixonase/Flonase (fluticasone propionate; GlaxoSmithKline)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Veramyst (fluticasone furoate; GlaxoSmithKline)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Rhinocort (budesonide; AstraZeneca)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Omnaris (ciclesonide; Nycomed/Sunovion)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Astepro (azelastine; Meda Pharma)
Product profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Singulair (montelukast; Merck/Kyorin Pharmaceuticals)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Grazax (ALK-Abelló)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Oralair (Stallergenes)
Drug profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Pollinex Quattro Grass (Allergy Therapeutics)
Product profile
Development overview
SWOT analysis
Product positioning
Clinical and commercial attractiveness
Other marketed drugs for allergic rhinitis
Zyrtec-D (cetirizine/pseudoephedrine; UCB/Pfizer)
Clarinex-D (desloratadine/pseudoephedrine; Merck)
Patanase (olopatadine; Alcon)
Onon (pranlukast; Ono Pharmaceuticals)
PIPELINE PRODUCT PROFILES
Dymista (azelastine/fluticasone; Meda/Cipla)
Drug profile
Development overview
SWOT analysis
Satisfaction of unmet need
Clinical and commercial attractiveness
Other drugs in development for allergic rhinitis
CDX-313 (azelastine/budesonide; CyDex)
Actair (dust mite allergen; Stallergenes)
Stalair Betv1 (birch pollen; Stallergenes)
Mitizax (dust mite allergen; ALK-Abelló)
Ragweed allergen (ALK-Abelló)
BIBLIOGRAPHY
Journal papers
Websites
Datamonitor reports
APPENDIX
Contributing experts
Datamonitor drug assessment scorecard methodology
Conferences attended
Report methodology
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