 DecisionBase PDFs --
2008
 Overview:
Crohn’s disease (CD) is a lifelong chronic inflammatory
bowel disease that can result in extensive inflammation of the gastrointestinal
tract. Current therapies consist largely of older generic agents and, more
recently, tumor necrosis factor-alpha inhibitors. As the first
targeted therapies for the treatment of CD, TNF-alpha inhibitors have offered
significant therapeutic advances for the management of CD. Nonetheless,
considerable unmet need remains for novel therapies that can prevent disease flares,
treat fistulizing disease, and address the underlying cause of CD. Multiple
agents are in late-stage clinical development for the treatment of CD,
including one TNF-alpha inhibitor, two interleukin (IL)-12/IL-23 inhibitors, a
selective costimulation modulator, and a chemokine receptor antagonist. New
agents that can address the remaining unmet needs in CD and improve a patients’
quality of life stand to enjoy significant commercial success in the CD market.
Questions Answered in This Report:
 The induction and maintenance of both a clinical response
and clinical remission are key goals in the treatment of CD. What are the key
primary and secondary clinical trial end points with which new therapies are
evaluated? How do gastroenterologists weight specific efficacy end points and
other drug attributes in their prescribing decisions for CD?
Infliximab (Centocor/Schering-Plough/Mitsubishi Tanabe’s
Remicade), the first biologic approved for CD, is the 2006 major-market sales
leader for CD. How will infliximab and other current therapies fare against
emerging therapies? Will emerging therapies offer improvements in the efficacy
end points and drug attributes that are most influential in physician
prescribing decisions? Will infliximab maintain its status as the market-leading
agent through 2016?
Based on its clinical profile, adalimumab (Abbott/Eisai’s
Humira) is the 2006 clinical gold standard in our drug comparator model.
However, by 2011, certolizumab pegol (UCB’s Cimzia) will emerge as the gold-standard
therapy because of its improved clinical profile over
the current and emerging therapies evaluated in this study. On what
clinical attributes is certolizumab pegol most differentiated from its
competitors? Which current therapies are at greatest risk of being replaced by
certolizumab pegol?
Scope:
Key drug development opportunity tested in our target
product profiles for Crohn’s disease: A parenterally dosed therapy that induces
closure and healing of fistulas in a greater percentage of Crohn’s disease
patients than infliximab does.
Physicians surveyed for this study: 60 gastroenterologists.
Comprehensive List of Therapies Included in Our Research and
Modeling
Current therapies:
- Infliximab (Centocor/Schering-Plough/Mitsubishi Tanabe’s
Remicade)
- Adalimumab (Abbott/Eisai’s Humira)
- Oral ethylcellulose-coated mesalamine (Shire/Ferring/Nisshin
Kyorin’s Pentasa)
- Budesonide (AstraZeneca/Prometheus’s Entocort, Dr. Falk’s
Budenofalk, generics)
- Azathioprine (GlaxoSmithKline/UCB’s Imuran, Eisai’s Imurek
Salix’s Azasan, Recordati’s Zytrim, generics)
Emerging therapies:
- Ustekinumab (Centocor/Janssen-Cilag)
- Certolizumab pegol (UCB’s Cimzia)
- ABT-874 (Abbott)
- Abatacept (Bristol-Myers Squibb’s Orencia)
- Natalizumab (Elan/Biogen Idec’s Tysabri)
About DecisionBase
Crohn’s Disease: Physicians Seek Drugs That Treat
Fistulizing Disease More Effectively than Infliximab is a DecisionBase 2008
study from Decision Resources. DecisionBase 2008 combines market forecasts with
clinical and commercial end points to assess market share projections in 35
indications. These outputs are driven by quantitative and qualitative primary
research. DecisionBase 2008 provides detailed market share, patient share, and
price-per-day projections for emerging drugs in development. The market share
projections are based on prescriber surveys that compare physicians’
expectations of a potential target product profile with an emerging product
profile of the leading drugs in development.
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