) 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 (
) and the US in combination with methotrexate(
) for the treatment of moderate to severe active rheumatoid
) 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
We currently have a Zacks #3 Rank (short-term Hold rating) on
To read this article on Zacks.com click here.