Introduction:Last Updated 3 October 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 tumor necrosis factor-alpha (TNF-α) inhibitor treatment in the form of SC agents and the uptake of two emerging therapies with novel mechanisms of action for patients with moderate to severe disease will drive strong growth of the UC market throughout our 2012-2022 forecast period, while innovative reformulations of current therapies will expand treatment options for patients with mild to moderate UC.
Questions Answered in This Report:
TNF-α inhibitor golimumab (Janssen/Merck/Mitsubishi Tanabe’s Simponi) received approval in May 2013 in the United States and in September 2013 in Europe, thus expanding treatment options for the underserved moderate to severe UC patient segment. Will the perception of greater efficacy from golimumab compared with adalimumab constrain uptake of adalimumab? Will either of these two 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). This biological agent has been preregistered for moderate to severe UC in Europe and the United States since March 2013 and June 2013, respectively. The small-molecule Janus-activated kinase (Jak) inhibitor tofacitinib (Pfizer’s Xeljanz) is in 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 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 and is expected to launch in Europe in late 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 Kingdom, Japan.
Primary research: 34 country-specific interviews with thought-leading gastroenterologists.
Epidemiology: Diagnosed prevalence.
Emerging therapies: Phase II: 14 drugs; Phase III: 4 drugs; preregistration: 1 drug. Coverage of 15 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 2022.