Abstract
Crohn' s Disease Market
In 2007, Remicade (infliximab/Anti-TNF-?), the current market leader in the
treatment of moderate-to-severe Crohn' s Disease (CD), is expected to
experience fierce challenges for patient share from 2-3 new Anti-TNF class
competitors; Humira, Tysabri,Cimzia. Humira (adalimumab) was approved in
January 2007 for CD and will compete with Remicade based upon relative
efficacy & convenience (Pen Injector); while despite the fact that Tysabri' s
(natalizumab/VLA-4) safety will dampen initial uptake, the product' s novel
mechanism and efficacy could enable it to capture share within the more severe
patient segment. Cimzia' s (certolizumab pegol) 2007 planned launch may be
postponed due to FDA regulatory delays, forcing UCB Pharma to conduct an
additional study-and making a 2008 launch much more plausible.
Ulcerative Colitis Market
Similarly, the competitive landscape for Ulcerative Colitis (UC) treatments
has the potential to shift over the next 2-4 years as more products are
undergoing late-phase clinical trials in an attempt to maximize exposure in
the IBD therapeutic area and garner share from UC market-leader Remicade. In
particular, competitive threats to Remicade may come from programs including;
Humira & Orencia recently initiated large phase III studies in
moderate-to-severe UC, Tysabri is expected to commence trials in UC in 2007,
and novel pipeline programs such as Nuvion (visilizumab) continue to progress.
Scope of Report
The scope of this report will concentrate on the Research & Development (R&D)
competitive landscape for moderate-to-severe CD & UC therapeutics. The focus
of the intelligence is on the clinical elements of competitive products from
a clinical perspective; which provides insight into the strategic
opportunities and challenges facing drug developers and marketers.
Specifically, the focus of our analysis is on the clincial trial protocol
designs and data results for 15 compounds in phase II or beyond that have the
potential to alter the market dynamics in IBD over the next 5-7 years.
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