Introduction:Last Updated 20 March 2013
Although colectomy is curative for the potentially fatal
immune disease ulcerative colitis (UC), this procedure is life altering, and
therefore unmet need remains for additional pharmacotherapies that more
effectively treat moderate to severe disease and maintain disease remission
better than existing drugs. Additional lines of TNF-α
inhibitor treatment in the form of SC
agents and the uptake of two emerging therapies with novel mechanisms of action
among patients with moderate to severe disease will drive strong growth of the
UC market throughout our 2011-2021 forecast period, while innovative
reformulations of current therapies will expand treatment options for patients
with mild to moderate UC.
Questions Answered in This Report:
We forecast that TNF-α
inhibitor golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi) will be
approved in 2013 in the United States and Europe and in 2014 in Japan, thus
expanding treatment options for the underserved moderate to severe UC patient
segment. Will golimumab’s perceived greater efficacy than adalimumab in
separate Phase III trials constrain uptake of adalimumab? Will either of the
two SC TNF-α inhibitors overtake infliximab (Janssen/Merck/Mitsubishi
Tanabe’s Remicade) as the UC market leader?
Gastroenterologists interviewed express enthusiasm for the
emerging cell adhesion molecule (CAM) inhibitor vedolizumab (Takeda), a biologic
in late-stage clinical trials for UC. This agent is preregistered for moderate to severe UC in Europe. Another novel agent, the small molecule
Janus-activated kinase (Jak) inhibitor tofacitinib (Pfizer’s Xeljanz), recently
entered Phase III development following a Phase II trial showing promising
efficacy as an acute regimen. What barriers do these two agents face in
terms of gastroenterologists’ prescribing habits and the UC treatment paradigm
in achieving early-line use ahead of the TNF-α inhibitors? Which of these
novel approaches is likely to supersede the other, and which key features will
allow this success?
Nearly all drug-treated UC patients receive oral
aminosalicylates (5-ASAs). Mesalamine products with novel mechanisms of
delivery that have launched more recently, including multimatrix (MMX)
delayed-release mesalamine (Shire/Giuliani/Mochida Pharmaceutical’s
Lialda/Mezavant/Mesavancol) and extended-release mesalamine granules (Salix
Pharmaceuticals’ Apriso), offer attractive alternatives to older agents in this
drug class because of their dosing advantages. Have gastroenterologists
transitioned away from established—and, in some instances, less expensive—oral
5-ASAs to newer mesalamine products? What is the sales potential of these newer
oral 5-ASA products?
Innovative reformulations of oral corticosteroids, including budesonide MMX (Cosmo Pharmaceuticals/Santarus/Ferring's Uceris/Cortiment/Ultesa), which launched in the United States in February 2013 offer potentially improved side-effect profiles compared with established systemic corticosteroids. What is the market
potential for budesonide MMX in the face of stiff competition from entrenched,
largely generic therapies? Are gastroenterologists willing to use them for
longer-term or maintenance treatment?
covered: United States, France, Germany, Italy, Spain, United
Primary research: 33 country-specific interviews with
Epidemiology: Diagnosed prevalence by severity (mild,
Emerging therapies: Phase II: 14 drugs; Phase III: 4
drugs; preregistration: 3 drugs. Coverage of 12 select early-stage products.
Market forecast features: Using a patient-based market
model, we forecast the patient share and sales of available and emerging agents
for two patient populations (acute therapy and maintenance therapy). In
addition, we quantify the implications of biosimilar entry through 2021.