TNF-alpha inhibitor drug class sales to increase up to $1.1 billion in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in addition to sales of Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe Pharma's Remicade, the two emerging TNF-alpha inhibitors Abbott/Eisai's Humira and Centocor Ortho Biotech/Schering-Plough/Mitsubishi Tanabe Pharma/Janssen's Simponi will drive sales of the TNF-alpha inhibitor drug class to nearly triple by 2018 for the treatment of ulcerative colitis.

The new Pharmacor report entitled Ulcerative Colitis finds that sales of TNF-alpha inhibitors in this indication will grow from $426 million in 2008 to approximately $1.1 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. For the treatment of moderate to severe ulcerative colitis, Humira is expected to receive regulatory approval in 2010 and Simponi is expected to be approved in 2012. The report finds that increased physician acceptance of TNF-alpha inhibitors for moderate to severe ulcerative colitis and patient preference for more conveniently delivered agents in this class will fuel uptake of these two emerging therapies. As a result, by 2018 Humira and Simponi will challenge Remicade's position as the preferred TNF-alpha inhibitor for the treatment of ulcerative colitis.

While TNF-alpha inhibitors such as Humira and Simponi will experience robust uptake, clinical development of additional therapies for moderate to severe ulcerative colitis--where the greatest level of unmet need remains--has been plagued by drug failures in late-stage clinical trials. However, one exception is Millennium's vedolizumab (formerly MLN-0002), which is expected to be approved for the indication in the U.S. and Europe.

"Thought leaders we interviewed consider vedolizumab to be one of the most promising emerging therapies with a novel mechanism of action," said Decision Resources Analyst Kathryn Benton, B.S. "Phase III clinical trials in ulcerative colitis and Crohn's disease are currently under way for vedolizumab in the U.S. and Europe and this agent is expected to be approved for both indications in 2012."

The report also finds that two innovative oral mesalamine reformulations, Shire/Giuliani/Mochida Pharmaceutical's Lialda/Mezavant/Mezavant XL and Salix Pharmaceuticals' Apriso, will garner patient share from established oral aminosalicylates owing to the less-frequent dosing and reduced pill burden that these new therapies offer to patients with mild to moderate ulcerative colitis as compared to established agents in this drug class.