Rigel's Allergic Rhinitis Candidate - R112

ABOUT DATAMONITOR HEALTHCARE

• About the respiratory pharmaceutical analysis team

EXECUTIVE SUMMARY

• Introduction
• Scope and coverage of the brief
• Key findings about the topic
  • The novel mechanism proposed by Rigels 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. Although no major side effects have been found in the clinical trials already achieved, this will be a significant hurdle for R112 for both approval and market penetration.
  • 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.

SECTION ONE: OVERVIEW

• Allergic rhinitis
  • Unmet need in allergic rhinitis
    • Reduced side effects
    • Drug delivery formulation
    • Greater efficacy
    • Increased patient education
• Global prevalence of allergic rhinitis
• About Rigel (www.rigel.com)
• About syk kinase

SECTION TWO: CLINICAL TRIAL RESULTS

• Phase I/II allergen challenge results - March 2004
  • Disappointment at initial symptom score improvement
• Phase II park study results - August 2004
  • Safety
  • Park study design
  • What does 9% mean?
  • Stuffiness
  • Variations between parks
  • Patient population criteria
  • Rigel should focus on broad seasonal allergic rhinitis population
  • FDA approval - a relatively easy task in allergic rhinitis
  • Asthma indication

SECTION THREE: COMPETITION AND COMPARATORS

• Overview of other novel mechanism pipeline candidates
  • NX-1510
  • RBx-7796
  • MCC-847
  • VLA-4 integrin antagonists
  • AIC
• Market leaders trial results
  • Singulair did not gain statistical significance in an early allergen challenge trial
  • R112 vs. antihistamines - modest penetration, mostly used as adjunct
  • R112 vs. intranasal steroids - cannot match efficacy, but another option welcomed
  • R112 vs. montelukast - head-to-head competition
  • R112 market penetration and forecasts - $1 billion potential
  • Expected scenario: blockbuster in Rigels pipeline

SECTION FOUR: THE FUTURE OF R112

• Phase III trials
• Commercialization of R112 - Rigel seeking partnership
  • Key companies for partnership with Rigel
  • Pfizer - targets the COPD market
  • GlaxoSmithKline - sales dependent on Advair
  • Merck & Co - Singulair is set to be R112s main competition
  • AstraZeneca ( future combination potential
  • Sanofi-Aventis - help for Allegra on the way?
  • Schering-Plough - hurt by delays and shallow pipeline
  • Boehringer Ingelheim - sticking with a COPD only strategy?
  • UCB - smaller US presence

APPENDIX

• Bibliography
  • Opinion Leaders
  • Epidemiology
  • Clinical trial data
  • Research methodology
  • Disclaimer
• List of Tables
  • Table 1: R112 milestones
  • Table 2: Global prevalence of allergic rhinitis, 2004
  • Table 3: Allergen challenge study comparison and symptom scores in subsequent trials
  • Table 4: R112 potential sales
  • Table 5: Comparison of key features of leading allergic rhinitis drug clinical trials
  • Table 6: Partnership opportunities for Rigel ($m)
• List of Figures
  • Figure 1: R112 milestones
  • Figure 2: Relationship between asthma, rhinitis and eczema
  • Figure 3: Key companies with partnership potential