UCB (UCBJF - Free Report) recently reported positive results from a late-stage study on Cimzia (certolizumab pegol) in adult patients with active axial spondyloarthritis (AxSpA). The study was conducted to evaluate the efficacy and safety of the drug.
In the phase III study, which enrolled 325 patients with AxSpA, patients were randomized to receive Cimzia 200 mg every two weeks, or 400 mg every four weeks, or placebo. The data demonstrated that at week 12, a statistically significant higher proportion of patients, who were dosed Cimzia, achieved the primary endpoint of at least 20% change in the Assessment of SpondyloArthritis international Society improvement criteria (ASAS20), as compared to those receiving placebo.
On the basis of this data, UCB plans to file for the approval of Cimiza as a treatment for AxSpA by the end of 2012.
We note that Cimzia is currently marketed as a treatment for moderate-to-severe Crohn's disease (CD) in the US. The drug is also approved in the European Union (EU) and the US in combination with methotrexate(MTX) for the treatment of moderate to severe active rheumatoid arthritis (RA) in adults, who have responded inadequately to disease-modifying antirheumatic drugs (DMARDs), including MTX.
UCB has a collaboration with Japanese pharmaceutical company, Astellas Pharma Inc., to jointly develop and commercialize Cimzia for RA in Japan. UCB and Astellas are seeking approval in Japan for the treatment of RA in patients who have responded insufficiently to current therapies.
According to the agreement, UCB will manufacture and supply Cimzia to Astellas for commercialization. Astellas will exclusively distribute the drug and also book sales, while both Astellas and UCB will jointly develop and commercialize Cimzia in Japan. Under the agreement, UCB received an initial cash payment and is eligible to receive clinical, regulatory and commercial milestones payments.
We currently have a Zacks #3 Rank (short-term Hold rating) on UCB.