This product profile relates to the mesalamine franchise that covers Delzicol (mesalamine; Actavis), Asacol (mesalamine; Zeria/Kyowa Hakko Kirin), and Asacol HD (mesalamine; Actavis/Zeria). Delzicol is an oral delayed-release capsule formulation of the 5-aminosalicylate (5-ASA) mesalamine indicated for the treatment of ulcerative colitis. Delzicol is a reformulation of the Asacol brand, which is no longer produced or marketed in the US. Asacol is an oral delayed-release tablet formulation of mesalamine, which is still produced and marketed in European countries. A high-dose tablet formulation, Asacol HD, is indicated for the treatment of ulcerative colitis and Crohn’s disease. A variety of different mechanisms have been proposed regarding how aminosalicylates like mesalamine work in ulcerative colitis and Crohn’s disease. These include inhibition of cyclooxygenase and lipoxygenase pathways to reduce prostaglandin and leukotriene production, inhibiting production of free radicals, and reversing the anti-proliferative effects of tumor necrosis factor-alpha.
Datamonitor Healthcare rates Delzicol/Asacol HD (mesalamine; Actavis/Zeria/Kyowa Hakko Kirin) as the least clinically attractive of the mesalamine brands because of its unfavorable dosing frequency compared to competitors. The future of the franchise is under threat from generic competition, although despite the expiry of a key patent in the US in 2013, no generic versions of Delzicol have launched to date. An authorized generic of Asacol HD is expected to launch in the US in 2015.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Delzicol/Asacol HD : Inflammatory bowel disease
LIST OF FIGURES
9 Figure 1: Delzicol and Asacol HD for ulcerative colitis and Crohn’s disease – SWOT analysis
10 Figure 2: Datamonitor Healthcare drug assessment of Delzicol (Asacol)/Asacol HD in Crohn’s
10 Figure 3: Datamonitor Healthcare drug assessment of Delzicol (Asacol)/Asacol HD in Crohn’s
11 Figure 4: Datamonitor Healthcare drug assessment of Delzicol (Asacol)/Asacol HD in ulcerative
12 Figure 5: Datamonitor Healthcare drug assessment of Delzicol (Asacol)/Asacol HD in ulcerative
LIST OF TABLES
4 Table 1: Delzicol/Asacol HD drug profile
7 Table 2: Overview of pivotal trial data for Asacol and Asacol HD in ulcerative colitis
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