Introduction
- 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
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