UCB: Positive phase III results
18.04.2012 - UCBs Cimzia has succeeded in a phase III. That raises hope that the TNF-α inhibitor could gain additional sales in the highly competitive anti-inflammation market.
Brussels – The TNF alpha inhibitor has met the primary endpoint in a phase III trial to treat adult onset of active axial spondoyloarthritis (AXSA). The study enrolled 325 patients with AXSA who were assigned to treatment with one of two doses of Cimzia (certolizumab pegol) or placebo over a 24-week period. The trial has shown a 20 per cent improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response at week 12 compared to placebo. UCB expects to file for approval in this indication later this year. The pegylated humanised antibody fragment Cimzia (certolizumab pegol) is already approved in Europe and the US for rheumatoid arthritis and in the US for Crohn's disease, although the EU rejected UCB's application to market the drug in the latter indication in 2008. It is UCB's second-biggest product with sales of €312m last year, up more than 50 per cent compared to 2010. Axial spondyloarthritis is a collective name for a series of inflammatory rheumatic diseases of the spine, joints, ligaments and tendons, and includes a spinal condition known as ankylosing spondylitis. Expanding the labelling for Cimzia in this indication is important for UCB to make headway against the drug's rivals in the competitive anti-TNF alpha sectorlike Enbrel (Amgen, Pfizer and others), Humira (Abbott, Eisai ) and Johnson & Johnson's Remicade. The competitors fear the appearance of biosimilar rivals entering the market after the drug's patent expiry in 2014. In addition to the axial spondyloarthritis indications, UCB is also planning to submit Cimzia for psoriatic arthritis by the end of the year, and is also awaiting approval of the drug for rheumatoid arthritis in Japan, where it has been co-developed by Astellas Pharma.