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UCB gears up to file Cimzia in axial spondyloarthritis

Successful trial supports expansion of indication

UCB has reported positive phase III results with its anti-TNF drug Cimzia in axial spondyloarthritis and says it plans to file for approval in this indication later this year.

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.

The phase III study enrolled 325 patients with axial spondyloarthritis who were assigned to treatment with one of two doses of Cimzia (certolizumab pegol) or placebo over a 24-week period.

It found that a greater proportion of patients on Cimzia achieved a 20 per cent improvement in the Assessment of Spondyloarthritis International Society (ASAS20) response at week 12 compared to placebo.

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 on 2010.

Expanding the labelling for Cimzia is critical if UCB is to make headway against the drug's rivals in the competitive anti-TNF sector, which is currently being fought out by Amgen/Pfizer/Takeda's Enbrel (etanercept), Abbott/Eisai's Humira (adalimumab) and Janssen Biotech/Merck/Mitsubishi Tanabe's Remicade (infliximab) and follow-up Simponi (golimumab).

UCB said last year that in terms of the number of prescriptions written, Cimzia is outpacing the overall arthritis and Crohn's disease market in the US, against a backdrop of slowing anti-TNF sales growth overall.

The sector is also due for a shake-up in 2014 when the first biosimilar anti-TNF agents are set for approval.

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. Altogether, the drug has been launched in around 26 countries worldwide.

17th April 2012

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