Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent regulatory setback for UCB's Cimzia will allow other tumor necrosis factor-alpha (TNF-alpha) inhibitors, including Centocor/Schering-Plough/Mitsubishi Tanabe/Janssen's golimumab and Abbott/Eisai's Humira to experience greater uptake in the rheumatoid arthritis and Crohn's disease markets, respectively. The Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the market authorization application (MAA) in the EU for Cimzia in the treatment of patients with Crohn's disease. Although UCB is disputing this, at best, Cimzia is not expected to enter the European market before 2010 as it waits on the European Medicines Agency's opinion regarding additional clinical trials. This delay to market will negatively impact Cimzia's expected contribution to the forecasted growth in the TNF-alpha inhibitor class for Crohn's disease, which is anticipated to grow 8% annually through 2011.
The new Pharmacor report entitled TNF-Alpha Inhibitors finds that sales of TNF-alpha inhibitors will continue to grow through 2011 due to greater uptake of Humira in all its marketed indications and the rise of Amgen/Wyeth/Takeda's Enbrel in the psoriasis market. However, the increasing number of biologic options in several key markets, including psoriasis and rheumatoid arthritis, and the entry of biogeneric molecules will slow the growth of the TNF-alpha inhibitor class from 2011-2016. The report also finds that golimumab's drug developers, Centocor, Schering-Plough, Mitsubishi Tanabe and Janssen, are positioned to benefit from their earlier successful marketing of Remicade as they prepare for golimumab to enter the TNF-alpha inhibitor market.
"Although golimumab will enter the rheumatoid arthritis drug market in 2009 as the fourth TNF-alpha inhibitor, it will be the only agent with options for self administration and physician administered dosing and the marketing power of Johnson & Johnson and Schering-Plough behind it," said Madhuri Borde, Ph.D., analyst at Decision Resources. "These companies will likely work aggressively to switch patients to golimumab."
About TNF-Alpha Inhibitors
Biologic therapies targeting TNF-alpha are among the most effective agents available to treat a range of immune diseases, including rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. They are also among the most expensive therapies available to treat these diseases, and their high cost limits their use to a small minority of patients.
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