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Rigel's Allergic Rhinitis Candidate - R112Published by: Datamonitor Published: Oct. 19, 2004 - 39 Pages Table of ContentsTABLE OF CONTENTS EXECUTIVE SUMMARY 5 Introduction 5 Scope and coverage of the brief 5 Key findings about the topic 5 SECTION ONE: OVERVIEW 10 Allergic rhinitis 10 Global prevalence of allergic rhinitis 13 About Rigel (www.rigel.com) 13 About syk kinase 14 SECTION TWO: CLINICAL TRIAL RESULTS 15 Phase I/II allergen challenge results — March 2004 15 Phase II park study results — August 2004 15 SECTION THREE: COMPETITION AND COMPARATORS 20 Overview of other novel mechanism pipeline candidates 20 Market leaders trial results 22 SECTION FOUR: THE FUTURE OF R112 27 Phase III trials 27 Commercialization of R112 — Rigel seeking partnership 28 APPENDIX 37 Bibliography 37 AbstractIntroductionIn a therapeutic area where mature products dominate, R112 is a promising treatment with a novel mechanism of action, likely to demonstrate clinical superiority to Merck's Singulair (montelukast) in the treatment of allergic rhinitis. The main drivers for R112 are use as an adjunct therapy to, and moderate switching from the antihistamine class, resulting in forecast sales of > $1 billion by 2015. Scope Assessment of Phase I/II allergen challenge and Phase II 'park study' trials for R112 Forecast peak sales in 2015 based on percentage share of global competitors sales Comparison with other developmental products with novel mechanisms, and with currently marketed products Summary of potential partners for Rigel, including GSK, Pfizer, Merck, AstraZeneca, Sanofi-Aventis, Schering-Plough, Boehringer Ingelheim and UCB Highlights The novel mechanism proposed by Rigel's R112 has a solid scientific rationale, and is favored by opinion leaders. However, success of an allergic rhinitis treatment not only depends on efficacy but, as shown by the FDA approval of Singulair (montelukast), is also highly dependent on side effects. The Phase II park study trial design used by Rigel provides a 'real to life' assessment of the likely clinical efficacy and safety of R112. As predicted by opinion leader research, results showed a conservative 9% improvement over placebo in global allergy scores and did reach the primary endpoint of the trial. In order to collect the required data to bring R112 to market, Rigel is likely to partner with a large pharmaceutical company. Through portfolio, pipeline and strategic analysis the top three contenders are AstraZeneca, Schering-Plough and Pfizer, all of whom have global influence and experience in the allergy market. Reasons to Purchase Understand the challenges facing Rigel as they seek regulatory approval and market penetration for R112 Identify clinical trial design requirements and appropriate phase III outcomes to drive physician uptake Assess leading respiratory company portfolios for partnership potential Get Full Details About This Report >> |
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