Introduction:
Last Updated 27 May 2010Treatment 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.
Established pricing for the interleukin (IL)-12/IL-23
inhibitor ustekinumab (Centocor Ortho Biotech/Janssen-Cilag’s Stelara) for
psoriasis and related agents in this drug class has implications for the CD
market. In this report we analyze physician opinion of two emerging CD
therapies, ustekinumab and briakinumab (from Abbott), and the likely
positioning of these drugs in the CD treatment algorithm, based on available
pricing data in the U.S. and European markets and ongoing clinical trials in
CD.
Recent Events:
- Pricing data for ustekinumab is available for the United States
and many European markets. How will ustekinumab’s established pricing for
psoriasis impact the CD market upon the drug’s expected approval for CD in
2014?
- In December 2009, UCB reported that certolizumab pegol (Cimzia)
failed a primary end point in a Phase IIIb clinical trial for CD. What are
the implications for certolizumab pegol’s forecast in Europe and Japan?
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: 11 drugs; Phase III: 4
drugs; preregistration: 0 drugs; registered: 2 drugs. Coverage of two select
Phase I products.
Alternative Market Scenarios: Centocor Ortho
Biotech/Janssen-Cilag’s ustekinumab (Stelara) is approved for the treatment of
psoriasis as a subcutaneous (SC) injection in two strengths (45 mg and 90 mg);
according to ongoing CD clinical trials, CD patients will require the higher
strength for induction and maintenance of remission. In contrast to our primary
CD market forecast, in which we assume the higher strength of ustekinumab will
be priced at twice the cost of the 45 mg strength, our alternative market
scenario for CD assumes the 90 mg dose of the drug will be priced at a more
modest premium to the 45 mg dose.