UCB ( UCBJF ) and
Astellas Pharma Inc. ( ALPMY ) recently
announced the launch of Cimzia (certolizumab pegol) in Japan for
the treatment of adult patients with rheumatoid arthritis (RA), who
have not responded adequately to conventional treatment. In Dec
2012, Cimzia had received Japanese marketing approval.
In Jan 2012, UCB and Astellas had entered into an agreement to
develop and commercialize Cimzia, for RA, in Japan. Astellas will
make a milestone payment to UCB on the launch of the product.
As per the agreement, UCB will manufacture and supply Cimzia and
Astellas will look after distribution and sales. Together, the
companies will look after marketing activities in Japan.
Data from studies showed that adult patients showed improvements
in the signs and symptoms of RA after one week after receiving
Cimzia with or without methotrexate (MTX).
The safety profile of Cimzia for RA in Japanese trials was in
line with the safety profile reported in earlier studies outside
Japan.
UCB is looking to get Cimzia approved for the treatment of
adults with active psoriatic arthritis (PsA) and active axial
spondyloarthritis (axSpA). UCB's regulatory filings with the US
Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) were based on the phase III RAPID-PsA and RAPID-axSpA
studies.
We note that UCB's Cimzia is currently approved in the US for
the treatment of moderate-to-severe rheumatoid arthritis patients
above 18 years and for reducing the signs and symptoms of Crohn's
disease (CD) and maintaining clinical response in
moderate-to-severe CD patients above 18 years, who have failed
prior therapy.
Cimzia is also approved in the EU in combination with MTX for the
treatment of moderate-to-severe active rheumatoid arthritis in
adults who have responded inadequately to disease-modifying
antirheumatic drugs (DMARDs), including MTX. In case of intolerance
to MTX or inappropriateness with MTX, Cimzia can be given as
monotherapy.
While UCB carries a Zacks Rank #3 (Hold), Astellas carries a
Zacks Rank #4 (Sell). Right now, Lannett Company,
Inc. ( LCI
) and QLT Inc. ( QLTI ) look more
attractive with a Zacks Rank #1 (Strong Buy).
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