2009-09-28 07:05:03 -
London, September, 28, 2009
Brussels (Belgium), 28th Sept, 2009 - 7:00 AM (CEST) - press release,
regulated information - UCB and AstraZeneca announced today that they
have entered into a partnership to register and commercialize UCB's
PEGylated anti-TNF alpha drug Cimzia® (certolizumab pegol) in Brazil.
The drug is to be registered for the treatment of rheumatoid
arthritis and Crohn's disease.
Under the agreement, AstraZeneca will register Cimzia® and upon
approval will be the exclusive distributor of Cimzia® in Brazil. In
partnership with UCB, AstraZeneca will have the right to distribute
future new line extensions related to Cimzia®. UCB retains the right
to co-promote Cimzia® as well as future line extensions in Brazil.
This partnership with AstraZeneca will help UCB commercialize its
rich pipeline of products and foster the growth of UCB's affiliate in
Brazil.
"This is an important strategic partnership for us, and supports our
combined focus on meeting patient needs and developing innovative
medicines," said Mark McDade, COO of UCB. "This relationship will
ensure that as many Brazilian patients as possible get access to our
innovative medicine Cimzia®."
"This partnership with UCB will leverage AstraZeneca's expertise in
regulatory affairs, sales and marketing to help bring the benefits of
Cimzia® to patients in Brazil," said Rubens Pedrosa, president and
representative director of AstraZeneca Brazil. "AstraZeneca has been
one of the fastest growing pharma companies in the country and
Cimzia® will complement our current portfolio of innovative medicines
and support our continued growth in this important market."
For further information
Scott Fleming, Global Communications Manager - Immunology
T +44.770.277.7378, scott.fleming@ucb.com
Nancy Nackaerts, External Communications, UCB
M: +32.473.86.44.14, nancy.nackaerts@ucb.com
Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, richard.simpson@ucb.com
Michael Tuck-Sherman, Investor Relations, UCB
T +32.2.559.9712, michael.tuck-sherman@ucb.com
About CIMZIA®
Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor).
Cimzia® has a high affinity for human TNF-alpha, selectively
neutralizing the pathophysiological effects of TNF-alpha. Over the
past decade, TNF-alpha has emerged as a major target of basic
research and clinical investigation. This cytokine plays a key role
in mediating pathological inflammation, and excess TNF-alpha
production has been directly implicated in a wide variety of
diseases. The U.S. Food and Drug Administration (FDA) has approved
Cimzia® for reducing signs and symptoms of Crohn's disease and
maintaining clinical response in adult patients with moderately to
severely active disease who have had an inadequate response to
conventional therapy and for the treatment of adults with moderately
to severely active rheumatoid arthritis. Cimzia® was approved in
Switzerland for induction of a clinical response and for the
maintenance of a clinical response and a remission in patients with
active Crohn's disease who have not responded adequately to
conventional treatment in September 2007. UCB is also developing
Cimzia® in other autoimmune disease indications. Cimzia® is a
registered trademark of UCB PHARMA S.A.
Important safety information
The most common adverse reactions belonged to the system organ
classes Infections and infestations, reported in 15.5% of patients on
Cimzia and 7.6% of patients on placebo, and General disorders and
administration site conditions, reported in 10.0% of patients on
Cimzia and 9.7% of patients on placebo. The most serious adverse
reactions were serious infections (including tuberculosis and
histoplasmosis), malignancies (including lymphoma) and heart failure.
A pooled analysis of the safety data show there was a low incidence
of injection site pain (1.5 percent) and low level of
discontinuations due to adverse events.
Cimzia® is contraindicated in patients with active tuberculosis or
other severe infections such as sepsis, abscesses and opportunistic
infections and in patients with moderate to severe heart failure.
Before initiation of Cimzia®, evaluate patients for both active or
inactive (latent) tuberculosis infection. Monitor patients for the
development of signs and symptoms of infection during and after
treatment with Cimzia®. If an infection develops, monitor carefully,
and stop Cimzia® if infection becomes serious.
Use of TNF blockers, including Cimzia®, may increase the risk of
reactivation of hepatitis B virus (HBV) in patients who are chronic
carriers of this virus, of new onset or exacerbation of clinical
symptoms and/or radiographic evidence of demyelinating disease, in
the formation of autoantibodies and uncommonly in the development of
a lupus-like syndrome or of severe hypersensitivity reactions
following Cimzia administration. If a patient develops any of these
adverse reactions, Cimzia® should be discontinued and appropriate
therapy instituted.
Adverse reactions of the hematologic system, including medically
significant cytopenia, have been infrequently reported with Cimzia®.
Advise all patients to seek immediate medical attention if they
develop signs and symptoms suggestive of blood dyscrasias or
infection (e.g., persistent fever, bruising, bleeding, pallor) while
on Cimzia®. Consider discontinuation of Cimzia® therapy in patients
with confirmed significant haematological abnormalities.
The use of Cimzia® in combination with biological DMARDS such as
anakinra, abatacept and rituximab is not recommended due to a
potential increased risk of serious infections. As no data are
available, Cimzia® should not be administered concurrently with live
vaccines or attenuated vaccines.
Please see full prescribing information before prescribing.
About UCB
UCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical company
dedicated to the research, development and commercialization of
innovative medicines with a focus on the fields of central nervous
system and immunology disorders. Employing approximately 10 000
people in over 40 countries, UCB produced revenue of 3.6 billion euro
in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statement
This press release contains forward-looking statements based on
current plans, estimates and beliefs of management. Such statements
are subject to risks and uncertainties that may cause actual results
to be materially different from those that may be implied by such
forward-looking statements contained in this press release. Important
factors that could result in such differences include: changes in
general economic, business and competitive conditions, effects of
future judicial decisions, changes in regulation, exchange rate
fluctuations and hiring and retention of its employees.
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