Confirming previously disclosed plans, UCB ( UCBJF ) recently announced the initiation of an efficacy study (EXXELERATE) on Cimizia (certolizumab pegol). The study is designed to evaluate the short- (12 weeks) and long-term (104 weeks) efficacy of Cimzia plus methotrexate ( MTX ) compared with Humira (adalimumab) plus MTX in the treatment of patients with moderate to severe rheumatoid arthritis ( RA ).
The EXXELERATE study will enroll about 900 adult patients from the US, Canada and Europe, suffering from moderate-to-severe RA, who have inadequately responded to MTX and who previously have not received anti-TNF treatment. The patients will be dosed either Cimzia plus MTX or Humira plus MTX. At the end of 12 weeks, patients who respond to the treatment will continue their initial treatment, while non-responders will switch to the alternative treatment arm until the study ends at 104 weeks. The headline results from the study are expected in 2016.
Abbott Labs ( ABT ) markets Humira as a treatment for RA, psoriatic arthritis (PA), ankylosing spondylitis (AS), CD, plaque psoriasis, and juvenile idiopathic arthritis.
While Cimzia is currently marketed by UCB as a treatment for moderate-to-severe Crohn's disease (CD) in the US and Switzerland, it is marketed as a treatment for RA in the US and European Union ( EU ). The company is also studying the drug as a treatment for juvenile RA, psoriatic arthritis and ankylosing spondylitis. UCB plans to report phase III results on Cimzia in psoriatic arthritis and ankylosing spondylitis in the first quarter of 2012. Further, a phase III trial of the drug in juvenile RA is also expected to begin in the first quarter of 2012.
Approval for any of the aforesaid indications of Cimzia would be a major boost for the stock.
We currently have a Zacks #3 Rank (short-term Hold rating) on UCB.