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Rigels Allergic Rhinitis Candidate - R112
Datamonitor, Oct 2004, Pages: 39
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.
The scope of this report is as follows:
- 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
The highlights of this report are as follows:
- 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.
The following are reasons to purchase 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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