Partnership unites UCB with consumer product innovator OXO®
* UCB offers Cimzia® (certolizumab pegol), a treatment option for
adults with moderately to severely active rheumatoid arthritis
and moderate to severe Crohn's disease, to U.S. patients in an
exclusively designed prefilled syringe resulting from the UCB
partnership with OXO®
* Rheumatoid arthritis patients directly involved with UCB and OXO®
in the development of the new Cimzia® prefilled syringe
* Cimzia® prefilled syringe designed to make self-administration
easy for people living with rheumatoid arthritis
BRUSSELS (14 May, 2009 - 07.00 AM CEST) - In a long-term
partnership agreement, UCB, a global biopharmaceutical leader, has
teamed up with OXO®, a celebrated consumer products company, to offer
patients a syringe and packaging components that take into account
some of the challenges many rheumatoid arthritis (RA) patients face
when self-administrating their medicine. UCB's Cimzia® (certolizumab
pegol) was approved this week by the U.S. Food and Drug
Administration (FDA) and offers a treatment option for adults with
moderately to severely active rheumatoid arthritis. Cimzia® is also
approved for reducing signs and symptoms of Crohn's disease and
maintaining clinical response in adult patients with moderate to
severely active disease who have had an inadequate response to
conventional therapy. The new prefilled syringe is now also available
to U.S. Crohn's patients taking Cimzia® for subcutaneous
self-administration. The new syringe carries the Arthritis
Foundation's Ease-of-Use Commendation, signifying a positive review
of the syringe design by the Arthritis Foundation's(TM) independent
research laboratory.
The companies recognized the importance of designing a syringe and
packaging components that take into account many of the dexterity
challenges RA patients may face. The prefilled syringe resulting from
the partnership with OXO® was designed for use by patients with
different grip styles and strengths.
"This syringe, a result of our partnership with OXO®, demonstrates
UCB's commitment to patients with severe diseases. I am proud of the
fact that people living with rheumatoid arthritis worked directly
with the design and engineering teams to development this syringe. We
have designed a syringe that takes into account some of the
challenges that come with self-injection. UCB has gone beyond
providing a new effective treatment option. Our long-term partnership
with OXO® will allow us to help make everyday living easier for
rheumatoid arthritis patients." said Roch Doliveux, Chief Executive
Officer of UCB. "In addition, we are pleased to offer people with
Crohn's disease in the U.S. the option of self-administering Cimzia®
using this newly designed syringe. Cimzia® patients will now have the
convenience of at-home self-injections," said Doliveux.
"OXO® was built on the foundation of Universal Design, which focuses
on creating easy and comfortable-to-use products for the widest
spectrum of users possible," said Alex Lee, President of OXO®. "In
partnering with UCB, we were able to apply our design principles in a
new setting. The result is a prefilled syringe that helps provide
comfort and control for a wide variety of patient self-administration
abilities and user styles."
The Design Process
The development of UCB's new prefilled syringe was initiated when UCB
patient research identified that self-injection was a challenge for
many people with RA.
UCB and OXO® brought in patients to assess the syringes available in
the market place and the UCB prototype. This led to the redesign of
many aspects of the syringe and its packaging. Specifically, the
prefilled syringe, which is available for use with Cimzia®, is
designed with the following in mind:
* Easy to grip wide flange (finger grips) - soft, non-slip grip
allows patients to hold the syringe steady using various grip
positions.
* Easy to remove needle cover - rounded finger loop for easy
removal of needle cover; flared needle cap designed to reduce
needle pricks due to recoil.
* Easy to push syringe plunger - large and soft thumb pad for
patients to push the plunger.
* Easy to read syringe barrel - magnified barrel helps ensure
patients receive entire dose as they can see the medicine inside
and know when they have injected all of it.
* Easy to grip elliptical barrel - elliptical barrel for patients
to grip and helps prevent slippage during patient handling.
* Easy to open packaging - the cover with a rounded corner uses
Velcro® for easy opening and resealing; large, easy-to-read
directions and clear visuals instruct patients how to use the
pack and administer/inject Cimzia®; and lastly, the plastic
housing inside with a large finger recess allows patients to
easily remove the syringe.
Cimzia® safety information
Reported serious adverse reactions of Cimzia® were infections
(including tuberculosis and histoplasmosis) 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 (<2%) and a low level of
discontinuations due to adverse events (5%).
For further information
Antje Witte, Corporate Communications & Investor Relations, UCB
T +32.2.559.9414, antje.witte@ucb-group.com
Richard Simpson, Investor Relations, UCB
T +32.2.559.9494, Richard.Simpson@ucb-group.com
Michael Tuck-Sherman, Investor Relations, UCB Group
T +32.2.559.9712, Michael.tuck-sherman@ucb-group.com
Nancy Nackaerts, External Communications, UCB
M: +32 473 86 44 14, nancy.nackaerts@ucb.com
Bert Kelly, Manager, U.S. Communications & Public Relations, UCB
M: +1 404.784.6303, bert.Kelly@ucb-group.com
Scott Fleming, Global Communications Manager - Immunology
T +44.770.277.7378, scott.fleming@ucb-group.com
Gretchen Holt, Corporate Communications, OXO®
T +1 212.242.3333, gholt@oxo.com
Notes to the editor
About Cimzia®
Cimzia® is the only PEGylated anti-TNF (Tumour Necrosis Factor).
Cimzia® has a high affinity for human TNF-alpha, selectively
neutralising 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 moderate to
severe active disease who have had an inadequate response to
conventional therapy and for the treatment of adults with moderate 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 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
Patients treated with CIMZIA are at an increased risk for developing
serious infections that may lead to hospitalization or death. Most
patients who developed these infections were taking concomitant
immunosuppressants such as methotrexate or corticosteroids. CIMZIA
should be discontinued if a patient develops a serious infection or
sepsis. Reported infections include:
* Active tuberculosis, including reactivation of latent
tuberculosis. Patients with tuberculosis have frequently
presented with disseminated or extrapulmonary disease. Patients
should be tested for latent tuberculosis before CIMZIA use and
during therapy. Treatment for latent infection should be
initiated prior to CIMZIA use.
* Invasive fungal infections, including histoplasmosis ,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis,
and pneumocystosis. Patients with histoplasmosis or other
invasive fungal infections may present with disseminated, rather
than localized disease. Antigen and antibody testing for
histoplasmosis may be negative in some patients with active
infection. Empiric anti-fungal therapy should be considered in
patients at risk for invasive fungal infections who develop
severe systemic illness .
* Bacterial, viral and other infections due to opportunistic
pathogens.
The risks and benefits of treatment with CIMZIA should be carefully
considered prior to initiating therapy in patients with chronic or
recurrent infection. Patients should be closely monitored for the
development of signs and symptoms of infection during and after
treatment with CIMZIA, including the possible development of
tuberculosis in patients who tested negative for latent tuberculosis
infection prior to initiating therapy.
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,
histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis,
listeriosis, and pneumocystosis were the most common. Treatment with
CIMZIA 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.
Patients should be evaluated for tuberculosis risk factors and tested
for latent infection prior to initiating CIMZIA and periodically
during therapy. Patients should be closely monitored for the
development of signs and symptoms of infections during and after
treatment with CIMZIA, including development of tuberculosis in
patients who tested negative for latent tuberculosis infection prior
to initiating therapy. CIMZIA should be discontinued if a patient
develops a serious infection or sepsis. Patients who develop a new
infection during treatment with CIMZIA should be closely monitored,
undergo a prompt and complete diagnostic workup appropriate for
immunocompromised patients, and appropriate antimicrobial therapy
should be initiated. Appropriate empiric antifungal therapy should
also be considered while a diagnostic workup is performed for
patients who develop a serious systemic illness and reside or travel
in regions where mycoses are endemic.
During controlled and open-labeled portions of CIMZIA studies of
Crohn's disease and other disease , malignancies (excluding
non-melanoma skin cancer) were observed at a rate (95% confidence
interval) of 0.5 (0.4, 0.7 ) per 100 patient-years among 4,650
CIMZIA-treated patients versus a rate of 0.6 (0.2, 1.7) per 100
patient-years among 1,319 placebo-treated patients. The size of the
control group and limited duration of the controlled portions of the
studies preclude the ability to draw firm conclusions. In studies of
CIMZIA for Crohn's disease and other investigational uses, there was
one case of lymphoma among 2,657 CIMZIA-treated patients and one case
of Hodgkin lymphoma among 1,319 placebo-treated patients. In CIMZIA
RA clinical trials (placebo-controlled and open label) a total of
three cases of lymphoma were observed among 2,367 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. The potential role
of TNF blocker 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 has not been formally
studied in patients with CHF. Exercise caution when using CIMZIA in
patients who have heart failure and monitor them carefully.
Symptoms compatible with hypersensitivity reactions, including
angioedema, dyspnea, hypotension, rash, serum sickness, and
urticaria, have been reported rarely following CIMZIA administration.
If such reactions occur, discontinue further administration of CIMZIA
and institute appropriate therapy.
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. Some cases have been fatal. Evaluate patients
at risk for HBV infection for prior evidence of HBV infection before
initiating CIMZIA therapy. Exercise caution in prescribing CIMZIA for
patients identified as carriers of HBV. Patients who are carriers of
HBV and require treatment with CIMZIA 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, discontinue CIMZIA and
initiate effective anti-viral therapy with appropriate supportive
treatment.
Use of TNF blockers, including CIMZIA, has been associated with rare
cases of new onset or exacerbation of clinical symptoms and/or
radiographic evidence of demyelinating disease. Rare cases of
neurological disorders, including seizure disorder, optic neuritis,
and peripheral neuropathy have been reported in patients treated with
CIMZIA; the causal relationship to CIMZIA remains unclear. Exercise
caution in considering the use of CIMZIA in patients with these
disorders.
Rare reports of pancytopenia, including aplastic anemia, have been
reported with TNF blockers. Medically significant cytopenia (e.g.,
leukopenia, pancytopenia, thrombocytopenia) has been infrequently
reported with CIMZIA. The causal relationship of these events to
CIMZIA remains unclear. 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 hematologic abnormalities.
An increased risk of serious infections has been seen in clinical
trials of other TNF blocking agents used in combination with anakinra
or abatacept. Formal drug interaction studies have not been
performed with rituximab or natalizumab; however because of the
nature of the adverse events seen with these combinations with TNF
blocker therapy, similar toxicities may also result from the use of
CIMZIA in these combinations. Therefore, the combination of CIMZIA
with anakinra, abatacept, rituximab, or natalizumab is not
recommended.
Treatment with CIMZIA may result in the formation of autoantibodies
and, rarely, in the development of a lupus-like syndrome. Discontinue
treatment if symptoms of lupus-like syndrome develop.
Do not administer live vaccines or attenuated vaccines concurrently
with CIMZIA.
Interference with certain coagulation assays has been detected in
patients treated with CIMZIA. There is no evidence that CIMZIA
therapy has an effect on in vivo coagulation. CIMZIA may cause
erroneously elevated aPTT assay results in patients without
coagulation abnormalities.
In controlled Crohn's clinical trials, the most common adverse events
that occurred in >=5% of CIMZIA patients (n=620) and more frequently
than with placebo (n=614) were upper respiratory infection (20%
CIMZIA, 13% placebo), urinary tract infection (7% CIMZIA, 6%
placebo), and arthralgia (6% CIMZIA, 4% placebo). The proportion of
patients who discontinued treatment due to adverse reactions in the
controlled clinical studies was 8% for CIMZIA and 7% for placebo.
In controlled RA clinical trials, the most common adverse events that
occurred in >= 3% of patients taking CIMZIA 200 mg every other week
with concomitant methotrexate (n=640) and more frequently than with
placebo with concomitant methotrexate (n=324) were upper respiratory
tract infection (6% CIMZIA, 2% placebo), headache (5% CIMZIA, 4%
placebo), hypertension (5% CIMZIA, 2% placebo), nasopharyngitis (5%
CIMZIA, 1% placebo), back pain (4% CIMZIA, 1% placebo), pyrexia (3%
CIMZIA, 2% placebo), pharyngitis (3% CIMZIA, 1% placebo), rash (3%
CIMZIA, 1% placebo), acute bronchitis (3% CIMZIA,1% placebo), fatigue
(3% CIMZIA, 1% placebo). Hypertensive adverse reactions were observed
more frequently in patients receiving CIMZIA than in controls. These
adverse reactions occurred more frequently among patients with a
baseline history of hypertension and among patients receiving
concomitant corticosteroids and non-steroidal anti-inflammatory
drugs. Patients receiving CIMZIA 400mg as monotherapy every 4 weeks
in RA controlled clinical trials had similar adverse reactions to
those patients receiving CIMZIA 200mg every other week. The
proportion of patients who discontinued treatment due to adverse
reactions in the controlled clinical studies was 5% for CIMZIA and
2.5% for placebo. Please see full prescribing information on
www.Cimzia.com.
About OXO®
Founded in 1990 on the concept of Universal Design, OXO's mission is
to create consumer household products that ease the tasks of everyday
life for the widest range of users possible. Since the original 15
items were introduced, the OXO collection has grown to more than 800
strong covering areas for cooking, cleaning, gardening, storing,
organizing and lighting. Today OXO Good Grips products are sold in 54
countries and are included in the permanent collections of numerous
museums. The company has won more than 100 design and business awards
worldwide. OXO is very frequently used as a case study on how a
well-executed Universal Design philosophy can be a successful
business strategy. OXO is owned by Helen of Troy Limited, a leading
designer, producer and global marketer of brand-name personal care
and household consumer products.
OXO® and GOODGRIPS® are trademarks of Helen of Troy Limited and are
used under license.
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
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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
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