UCB's Cimzia(TM) (certolizumab pegol) approved by Health Canada for adult patients suffering from moderate to severe rheumatoid arthritis



    
    -   Available this week, Cimzia(TM) (certolizumab pegol), the only
        pegylated anti-TNF, offers a new treatment option for Canadian adult
        patients suffering from moderately to severely active rheumatoid
        arthritis.

    -   Cimzia(TM) is available in an exclusively designed, patient-friendly,
        prefilled syringe resulting from the UCB partnership with OXO(R) Good
        Grips.

    -   Cimzia(TM) offers Canadian adult patients flexible maintenance
        dosing, either at two or four weeks after initial doses, and can be
        used together with methotrexate or as a monotherapy.
    

    BURLINGTON, ON, Sept. 1 /CNW/ - regulated information - UCB Canada Inc.
announced today that Health Canada has approved Cimzia(TM), the only PEGylated
anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with
moderately to severely active rheumatoid arthritis (RA). Cimzia(TM) can be
dosed at 400 mg initially and at weeks two and four, followed by 200 mg every
other week; for maintenance dosing, 400 mg every four weeks can be considered.
Cimzia(TM) is available in Canada as of today.
    "Canadians with RA endure severe inflammation and swelling of joints with
stiffness and fatigue which makes it difficult for them to perform many
activities of daily living." "said Dr. Denis Choquette, rheumatologist,
Notre-Dame Hospital, CHUM, University of Montreal. "To inhibit structural
damage, it is essential to treat patients with moderate to severe RA with
treatments that provide a rapid onset and significant sustainable improvements
for signs and symptoms of RA. Additionally, Certolizumab pegol (Cimzia(TM))
has been shown to have a low incidence of injection site pain reactions, which
is an important quality of life indicator for many patients."
    In clinical trials with Cimzia(TM), together with methotrexate (MTX),
patients experienced a significant reduction in the signs and symptoms of RA
at week 24 with some showing clinical responses within one to two weeks,
compared with MTX alone. Additionally, radiographic data showed Cimzia(TM),
together with MTX, inhibited progression of joint damage, with a significantly
smaller change from baseline in modified Total Sharp Score (TSS) at 24 and 52
weeks of treatment, compared with MTX alone (p(less than)0.001).
    "The approval of Cimzia(TM) for moderate to severe rheumatoid arthritis
in Canada is a major milestone for UCB, and more importantly, for Canadian
patients seeking a new treatment option to manage this debilitating
condition," said Anne de Cassini, General Manager, UCB Canada Inc. "UCB is
committed to developing new therapies, such as Cimzia(TM), to help meet the
needs of patients living with rheumatoid arthritis and other immune diseases.
UCB is also proud of its partnership with OXO(R) Good Grips and of the fact
that RA patients were directly involved in the design and development of our
new prefilled syringe, which is designed to make self-administration easy for
people living with rheumatoid arthritis."
    "Rheumatoid arthritis is a complex chronic condition, and it is a good
day for the 300,000 Canadians affected by this disease when there are new
treatment options made available to them." said Steven McNair, Chief Executive
Officer & President of The Arthritis Society.
    The Health Canada approval was based on UCB's comprehensive clinical
program, including data from four multi-center placebo-controlled phase III
trials, involving more than 2 300 patients with RA and over 4 000
patient-years experience. Cimzia(TM) has been studied at dosing intervals of
two or four weeks, and administered together with MTX or as monotherapy.
    In the pivotal clinical trials, reported serious adverse reactions were
infections including tuberculosis and malignancies including lymphoma. The
most commonly occurring adverse events were upper respiratory tract
infections, rash and urinary tract infections. A pooled analysis of the safety
data show there was a low incidence of injection site pain ((less than)2%) and
a low level of discontinuations due to adverse events (5%).
    It is estimated that 5 million people suffer from RA globally.
Approximately one per cent of Canadians of all ages are currently affected by
RA(1). Prevalence is not split evenly between genders, since women are three
times more likely to be affected than men. Although RA can affect people of
all ages, the onset of the disease usually occurs between 35-55 years of age.

    
    Regional Physicians available to conduct media interviews:

        Quebec - Dr. Denis Choquette, Montreal

        Ontario - Dr. Janet Pope, London

        Western Canada - Dr. John Esdaile, Vancouver

        Atlantic Canada - Dr. Majed Khaishi, St. John's


    -------------------------
    (1) Statistics Canada
    

    Notes to the editor:

    About Cimzia(TM) Cimzia(TM) is the only PEGylated anti-TNF (Tumor
Necrosis Factor). Cimzia(TM) 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. In Canada, Cimzia(TM) is approved in
combination with methotrexate for reducing signs and symptoms, inducing major
clinical response, and reducing the progression of joint damage as assessed by
X-ray, in adult patients with moderately to severely active rheumatoid
arthritis (RA). Cimzia(TM) may also be used alone for reducing signs and
symptoms in adult patients with moderately to severely active rheumatoid
arthritis (RA) who do not tolerate MTX.


    
    Cimzia(TM) is a trademark of the UCB Group of Companies

    OXO and GOOD GRIPS are trademarks of Helen of Troy Limited (NASDAQ HELE)
    and are used under license.
    

    IMPORTANT SAFETY INFORMATION

    Serious infections, sepsis, tuberculosis (including miliary, disseminated
and extrapulmonary disease), invasive fungal infections (such as
histoplasmosis) and other opportunistic infections, some of which have been
fatal, have been reported in patients receiving TNF blocking agents including
Cimzia(TM). Many of the serious infections reported have occurred in patients
on concomitant immunosuppressive therapy that, in addition to their rheumatoid
arthritis, could predispose them to infections. Cimzia(TM) should not be given
to patients with a clinically important infection, including chronic or
localized infections. Physicians should exercise caution when considering the
use of Cimzia(TM) in patients with a history of recurring infection. Patients
should be monitored for signs and symptoms of infection while on and after
treatment with Cimzia(TM). Any new infection that develops while on
Cimzia(TM), or after recent treatment, should be closely monitored. Cimzia(TM)
should be discontinued if a patient develops a serious infection.

    Serious and sometimes fatal infection due to bacterial, mycobacterial,
invasive fungal, viral, or other opportunistic pathogens has been reported in
patients receiving TNF blocking agents. Among opportunistic infections,
tuberculosis (TB), histoplasmosis, aspergillosis, candidiasis,
coccidioidomycosis, listeriosis, and pneumocystosis were the most common.
Treatment with Cimzia(TM) should not be initiated in patients with an active
infection, including clinically important localized infections. The risks and
benefits of treatment should be considered prior to initiating therapy in
patients with chronic or recurrent infection, who have been exposed to
tuberculosis, who have resided or traveled in areas of endemic tuberculosis or
endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis,
or with underlying conditions that may predispose them to infection.
    Before initiation of therapy with Cimzia(TM), all patients must be
evaluated for both active and inactive (latent) tuberculosis infection. If
active tuberculosis is diagnosed, Cimzia(TM) therapy must not be initiated. If
latent tuberculosis is diagnosed or suspected, appropriate anti-tuberculosis
prophylaxis should be instituted in accordance with the current Canadian
Tuberculosis Standards guidelines before starting treatment with Cimzia(TM).
In this situation, the benefit/risk balance of therapy with Cimzia(TM) should
be very carefully considered. Cimzia(TM) should be discontinued if a patient
develops a serious infection or sepsis. A patient who develops a new infection
during treatment with Cimzia(TM) should be closely monitored, undergo a prompt
and complete diagnostic workup appropriate for an immunocompromised patient,
and appropriate antimicrobial therapy should be initiated. For patients who
reside or travel in regions where mycoses are endemic, invasive fungal
infection should be suspected if they develop a serious systemic illness.
Appropriate empiric antifungal therapy should be considered while a diagnostic
workup is being performed.
    In clinical studies with Cimzia(TM) and other TNF blocking agents, more
cases of malignancies have been observed among patients receiving active drug
than in placebo patients. In rheumatoid arthritis placebo-controlled and
open-label studies combined, most observed malignancies included lung, breast
and ovarian cancers, basal cell carcinoma, and lymphoma. Three cases of
lymphoma were reported in patients treated with Cimzia(TM) (1 case in the
placebo-controlled studies and 2 in the open-label studies), corresponding to
a rate of 0.09 (0.02-0.27)/100 patient-years among 2367 patients. This is
approximately 2-fold higher than expected in the general population. Patients
with RA, particularly those with highly active disease, are at a higher risk
for the development of lymphoma. Malignancies other than lymphomas and
non-melanoma skin cancers were observed at a rate (95% confidence interval) of
0.61 (0.37-0.94)/100 patient-years among 2367 Cimzia(TM) -treated patients and
0.41 (0.01-2.27)/100 patient-years among 647 placebo-treated patients. The
size of the control groups and limited duration of the controlled portions of
the studies preclude the ability to draw firm conclusions but the possible
risk for the development of lymphomas or other malignancies in patients
treated with a TNF blocker cannot be excluded. The potential role of TNF
blocking therapy in the development of malignancies is not known.
    Cases of worsening congestive heart failure (CHF) and new onset CHF have
been reported with TNF blockers. Cimzia(TM) has not been formally studied in
patients with CHF. Exercise caution in patients with heart failure and monitor
them carefully.
    Use of TNF blockers, including Cimzia(TM), may increase the risk of
reactivation of hepatitis B virus (HBV) in patients who are chronic carriers
of this virus. In some instances, HBV reactivation occurring in conjunction
with TNF blocker therapy has been fatal. Patients at risk for HBV infection
should be evaluated for prior evidence of HBV infection before initiating
Cimzia(TM) therapy. Prescribers should exercise caution in prescribing TNF
blockers for patients identified as carriers of HBV. Patients who are carriers
of HBV and require treatment with TNF blockers should be closely monitored for
clinical and laboratory signs of active HBV infection throughout therapy and
for several months following termination of therapy. In patients who develop
HBV reactivation, Cimzia(TM) should be stopped and effective anti-viral
therapy with appropriate supportive treatment should be initiated.
    Rare reports of pancytopenia, including aplastic anemia, have been
reported with TNF blocking agents. Adverse events of the hematologic system,
including medically significant cytopenia (e.g., leukopenia, pancytopenia,
thrombocytopenia) have been infrequently reported with Cimzia(TM). The causal
relationship of these reports to Cimzia(TM) remains unclear. All patients
should be advised 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(TM). Discontinuation of
Cimzia(TM) therapy should be considered in patients with confirmed significant
hematologic abnormalities.
    Use of TNF blocking agents has been associated with rare cases of new
onset or exacerbation of clinical symptoms and/or radiographic evidence of
demyelinating disease. Prescribers should exercise caution in considering the
use of Cimzia(TM) in patients with pre-existing or recent-onset central
nervous system demyelinating disorders. Neurological disorders, including
seizure disorder, optic neuritis, and peripheral neuropathy have been reported
in patients treated with Cimzia(TM). Causal relationship to Cimzia(TM) remains
unclear.
    An increased risk of serious infections has been seen in clinical studies
of other TNF blocking agents used in combination with anakinra or abatacept,
with no added benefit. Because of the nature of the adverse events seen with
this combination therapy, similar toxicities may also result from the
combination of Cimzia(TM) and other biologic disease modifying anti-rheumatic
drugs (DMARDs). Therefore, the use of Cimzia(TM) in combination with other
biologic DMARDs is not recommended.
    The following symptoms that could be compatible with hypersensitivity
reactions have been reported rarely following Cimzia(TM) administration to
patients: angioedema, dyspnea, hypotension, rash, serum sickness, and
urticaria. If such reactions occur, discontinue further administration of
Cimzia(TM) and institute appropriate therapy.
    Treatment with Cimzia(TM) may result in the formation of autoantibodies.
If a patient develops symptoms suggestive of a lupus-like syndrome following
treatment with Cimzia(TM), treatment should be discontinued.
    Live vaccines should not be administered concurrently with Cimzia(TM).
    Interference with certain coagulation assays has been detected in
patients treated with Cimzia(TM). Cimzia(TM) may cause erroneously elevated
activated partial thromboplastin time (aPTT) assay results in patients without
coagulation abnormalities. There is no evidence that Cimzia(TM) therapy has an
effect on in vivo coagulation.
    The most commonly occurring adverse reactions, reported in a greater
percentage of Cimzia(TM) - treated patients in all placebo-controlled trials
(difference (greater than or equal to)2%) were upper respiratory tract
infections (17.6% for Cimzia(TM), 9.4% for placebo), lower respiratory tract
and lung infections (5.6% for Cimzia(TM), 3.4% for placebo), musculoskeletal
and connective tissue signs and symptoms (6.7% for Cimzia(TM), 4.2% for
placebo), herpes viral infections (3.6% for Cimzia(TM), 1.2% for placebo),
rashes, eruptions and exanthems (4.0% for Cimzia(TM), 1.3% for placebo), and
vascular hypertensive disorders (5.1% for Cimzia(TM), 1.2% for placebo). The
percentage of patients who discontinued treatment due to adverse reactions
during the phase III RA placebo-controlled studies were 5% for Cimzia(TM)
-treated patients and 2.5% for placebo-treated patients.

    About UCB Canada Inc.

    UCB Canada Inc. was officially incorporated in 2006 with the objective of
bringing new-generation therapies to the Canadian market for auto-immune and
central nervous system diseases. As a patient-focused organization, the
company is dedicated to bringing new and innovative programs to patients, and
to the specialists who treat them, to help improve the lives of people living
with severe diseases.

    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
generated revenue of EUR 3.6 billion in 2008. UCB is listed on Euronext
Brussels (symbol: UCB).

    Forward-looking statements

    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.




For further information:

For further information: Sean Webster, Director, Market Access and
Government Relations, UCB Canada Inc., T: (905) 315-5065 ext 5073,
sean.webster@ucb.com; Eric Miller, Corporate Communications & Public
Relations, UCB, T (770) 970-8569, eric.miller@ucb.com

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