Ulcerative Colitis

Pharmacor -- August 2008

  Introduction:

Since we last reported on ulcerative colitis (UC) in September of 2006, a considerable number of emerging agents, particularly biological agents currently marketed for other immune and inflammatory diseases, have entered late-stage clinical development for UC. Over the 2007 to 2017 forecast period, new products, including several therapies with novel mechanisms of action, will compete with established drug classes for the moderate to severe patient segment. Furthermore, reformulated versions of therapies belonging to established drug classes will compete for patient share in the mild to moderate patient segment.

  Questions Answered in This Report:

We forecast that two tumor necrosis factor-alpha (TNF-alpha) inhibitors—Abbott/Eisai’s adalimumab (Humira) and Centocor/Schering-Plough/Mitsubishi Tanabe Pharma/Janssen’s golimumab—will receive approval for UC during our study period. Both agents confer delivery advantages over the sole approved TNF-alpha inhibitor for UC, infliximab (Centocor/Schering-Plough/Mitsubishi Tanabe Pharma’s Remicade) and have comparable efficacy profiles. Will these two emerging products compete successfully with infliximab for a share of the UC market? Where do gastroenterologists foresee these drugs fitting into the treatment algorithm for moderate to severe patients?

A total of five agents with novel mechanisms of action are currently in Phase II or Phase III clinical trials for UC. Interviewed thought leaders report that there is considerable unmet need with respect to moderate to severe patients who fail treatment with the available pharmacotherapies. How do these emerging products compare with firmly established agents for moderate to severe UC? Which of these drugs will be most successful? How will these agents be positioned?

The most recently approved oral aminosalicylate (5-ASA), delayed-release mesalamine (Shire/Takeda/Giuliani’s Lialda/Mezavant/Mezavant XL), first entered the UC market in 2007. Delayed-release mesalamine offers mild to moderate patients a significantly reduced dosing burden compared with established oral 5-ASAs. Have gastroenterologists transitioned away from established oral 5-ASAs in favor of delayed-release mesalamine? Will delayed-release mesalamine achieve significant uptake over the forecast period in view of the drug’s advantageous delivery profile?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 37 country-specific interviews with gastroenterologists.

Epidemiology: Diagnosed prevalence by severity (mild, moderate, severe).

Population segments in market forecast: Acute therapy and maintenance therapy.

Emerging therapies: Phase II: 9 drugs; Phase III: 7 drugs; preregistration: 1 drug; registered: 0 drugs.

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). Additionally, we quantify the implications of biosimilar entry during our forecast period.