Introduction:
Last Updated 29 December 2009Treatment options for Crohn’s disease (CD) include
conventional, largely generic small molecules and more-potent biological
agents, including tumor necrosis factor-alpha (TNF-α) inhibitors. Despite
the clinical and commercial success of the TNF-α inhibitors, opportunity
remains for agents that can safely and effectively induce and maintain
remission in a significant number of patients with moderate to severe CD.
The recent release of data from the Study of Biologic- and
Immunomodulator-Naive Patients in Crohn’s Disease (SONIC) has implications for
the use of many agents in the CD market. In this report, we analyze physician
reaction to the trial data and the implications for future positioning of
infliximab (Centocor Ortho Biotech/Merck/Mitsubishi Tanabe’s
Remicade), azathioprine (GlaxoSmithKline/UCB’s Imuran, Eisai’s Imurek, Salix’s
Azasan, Recordati’s Zytrim, generics), and other agents in the TNF-α
inhibitor and immunosuppressant drug classes.
Questions Answered in This Report:
*
SONIC data were presented at Digestive Disease Week 2009 in
Chicago.
What are thought leaders’ perceptions of the trial data? Will the
findings affect medical practice? How will the data affect prescriptions of the
other TNF-α inhibitors, adalimumab (Abbott/Eisai’s Humira) and
certolizumab pegol (UCB/Otsuka’s Cimzia)?
*
Two biological agents, certolizumab pegol and natalizumab
(Biogen Idec/Elan’s Tysabri), launched for CD in the United States in 2008.
Why
was uptake of each of these agents slow in 2008? What are the prospects for
their approval for CD in Europe and Japan? Going forward, how well will these
agents compete against infliximab and adalimumab?
*
We forecast that Millennium Pharmaceuticals’ vedolizumab will
be the next novel agent to launch for CD.
How will vedolizumab be positioned
in the CD treatment algorithm? Will it achieve greater sales than that of
natalizumab in the CD market?
*
The interleukin (IL)-12/IL-23 inhibitor ustekinumab (Centocor
Ortho Biotech/Janssen-Cilag’s Stelara) will also launch for CD during our
forecast period.
How will ustekinumab’s approval for psoriasis affect its
potential approval and uptake in CD? How will it perform commercially in
comparison with other agents in the CD pipeline?Scope:
Markets covered: United States, France, Germany,
Italy, Spain, United Kingdom, Japan.
Primary research: 32 country-specific interviews with
thought-leading gastroenterologists.
Epidemiology: Diagnosed prevalence of CD, segmented by
disease activity: remission, low activity, and high activity.
Population segments in market forecast: Acute therapy,
maintenance therapy.
Emerging therapies: Phase II: 12 drugs; Phase III: 4
drugs; preregistration: 0 drugs; registered: 2 drugs. Coverage of two select
Phase I products.