In a therapeutic area where mature products dominate, R112 is a promising treatment with a novel mechanism of action, likely to demonstrate clinical superiority to Mercks 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 of this report

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

Research and analysis highlights

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.
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.

Key reasons to read this report

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

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

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

SECTION FOUR: THE FUTURE OF R112

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

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Rigel's Allergic Rhinitis Candidate - R112

Introduction