New Data Presented From WELCOME Trial Show Positive Impact of CIMZIA(R) (certolizumab pegol) on Hospitalizations and Surgeries in Patients With Prior Infliximab Failure

New Data Presented From WELCOME Trial Show Positive Impact of CIMZIA(R)
(certolizumab pegol) on Hospitalizations and Surgeries in Patients With Prior
Infliximab Failure
No statistical difference observed between two studied dosing regimens

SAN DIEGO, Oct. 26 /PRNewswire/ -- According to new results from the WELCOME
trial, exploratory data analyzing the impact of treatment with CIMZIA(®)
(certolizumab pegol) - the only PEGylated anti-TNF (alpha) (Tumor Necrosis
Factor alpha) - administered either every two weeks or every four weeks,
showed that the majority of Crohn's disease patients in both dosing groups
experienced no hospitalizations and surgical procedures during the course of
the 26-week study. These exploratory data from the WELCOME trial, which
studied patients who had been on the anti-TNF therapy infliximab, but failed
or developed a hypersensitivity to the treatment, will be presented this week
at the American College of Gastroenterology (ACG) Annual Meeting.

CIMZIA is indicated for reducing the 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.
The recommended initial adult dose of CIMZIA is 400mg at Weeks 0, 2 and 4. In
patients who obtain a clinical response, the recommended maintenance regimen
is 400 mg every four weeks.

In the WELCOME trial, which evaluated moderate to severe Crohn's disease
patients who were intolerant to or no longer responding to infliximab therapy,
more than 60 percent (329 out of 539 patients enrolled) responded to a 6-week,
open label, induction phase with CIMZIA (400 mg subcutaneously at weeks 0, 2,
and 4). Patients were then randomized at week 6 to receive CIMZIA (400 mg)
every two (q2w) or four (q4w) weeks until week 26 in a double-blind,
maintenance comparison phase. Responders were defined as those with a decrease
in CDAI score greater than or equal to 100 points from baseline at week 6.
The number and length of hospitalizations, number of emergency room visits,
and number of medical procedures were recorded during the WELCOME study. The
post-hoc analysis of the WELCOME trial evaluated CIMZIA's impact on the
incidence of hospitalization and surgical procedures during hospital stays.
The majority of patients (86 percent) in both groups (n=139 out of 161 in the
q2w group; n=145 out of 168 in the q4w group) underwent no hospitalizations,
with ten percent in the q2w group (n=16 out of 161) and nine percent in the
q4w group (n=15 out of 168) requiring one hospital stay. (Abstract #P678)

"The data suggest that the recommended 400mg q4w dosing works as well as the
accelerated dosing interval in this refractory population, adding to the
extensive results from the WELCOME trial," said study investigator Douglas
Wolf, M.D., Atlanta Gastroenterology Associates, Atlanta, Ga. "Treatment with
CIMZIA may impact the number of hospital visits and related surgeries based on
these findings."

There were no statistically significant differences in the mean number of
hospital stays (0.193 vs. 0.208; p=0.964), duration of the hospital stay
(1.398 vs. 1.679; p=0.986) and surgical procedures performed during hospital
stays (0.037 vs. 0.030; p=0.950) between the two CIMZIA treatment groups, as
measured by the Wilcoxon signed-rank test.

Additional data from the WELCOME study presented at ACG includes:
-- Improvement in work productivity and daily activities by certolizumab
pegol in Crohn's disease patients with prior loss of response or
intolerance to infliximab (Abstract #P679)
-- Efficacy of certolizumab pegol in Crohn's disease patients with
secondary failure to infliximab is not affected by concomitant
medications (Abstract #P701)
-- Regain of response and remission by dose adjustment in patients with
Crohn's disease who responded to certolizumab pegol: results from the
WELCOME study (Abstract #P699)

-- Efficacy of certolizumab pegol is not affected by baseline
anti-infliximab antibody status in patients with Crohn's disease with
secondary infliximab failure (Abstract #P702)

"Crohn's is highly individualized and these data provide additional insight
into how use of CIMZIA may impact the need for hospitalization or surgery
while treating this complicated disease," said David Robinson, vice president
and general manager of UCB's Immunology Business Unit.

In previously reported data from the WELCOME study, CIMZIA demonstrated a low
incidence of injection site pain, in less than 2% of cases. Common adverse
events (AEs) included: headache; nasopharyngitis, or the common cold; nausea;
vomiting; pyrexia, or fever; and arthralgia, or joint pain. Serious adverse
events (SAEs) were present in 7% of cases, and were most commonly
gastrointestinal (5%) or infections and infestations (2%).

Earlier this year, UCB announced that CIMZIA is available to adult moderate to
severe Crohn's patients in a pre-filled syringe, developed in partnership with
OXO Good Grips(® )for subcutaneous self-administration once every four weeks
after initial dosing. CIMZIA, manufactured by UCB, was approved by the U.S.
Food and Drug Administration on April 22, 2008 for reducing signs and symptoms
of moderate to severe Crohn's disease and maintaining clinical response in
adult patients who have had an inadequate response to conventional therapy.

About WELCOME

The WELCOME study is a 539 patient Phase IIIb multicenter 26-Week trial
Evaluating the clinical benefit and tolerability of certoLizumab pegol
induCtiOn and Maintenance in patients suffering from Crohn's disease with
prior loss of response or intolErance to infliximab. It consists of an
open-label induction phase (400 mg of CIMZIA subcutaneously at Weeks 0, 2 and
4) and a double-blind maintenance period (400 mg of CIMZIA every 2 or 4 weeks
from Week 6). The primary endpoint was defined as the rate of response
(defined as a decrease in CDAI score >=100 points from baseline) at Week 6.
Remission was defined as a CDAI score of <=150 points. The secondary endpoints
are to assess and compare the clinical efficacy of CIMZIA 400 mg maintenance
therapy administered q4w or q2w over 26 weeks; to assess the clinical efficacy
of CIMZIA 400 mg as induction and two regimens of maintenance therapy on
patient reported outcome scores; to evaluate tolerability and safety of
CIMZIA; and to evaluate the effect of certolizumab pegol induction and
maintenance therapy on plasma CRP levels.

About Crohn's Disease

Crohn's disease is a chronic, progressive, destructive disorder that causes
inflammation of the gastrointestinal (GI) tract, most commonly at the end of
the small intestine (the ileum) and beginning of the large intestine (the
colon). The inflammation may be caused by the presence of high levels of Tumor
Necrosis Factor (TNF) found in people with Crohn's disease. If not effectively
treated, it may result in the need for surgery and hospitalization. Crohn's
disease has been estimated to affect as many as half a million Americans.
People with Crohn's can experience an ongoing cycle of flare-up and remission
throughout their lives. Together with ulcerative colitis, Crohn's disease is
an inflammatory bowel disease (IBD).

About CIMZIA(®) (certolizumab pegol)

CIMZIA is the only PEGylated anti-TNF (Tumor 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
immunological 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 moderately to severely active rheumatoid
arthritis (RA). 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. Health Canada and the European
Commission have both approved CIMZIA in combination with methotrexate (MTX),
for the treatment of moderate to severe active RA in adult patients
inadequately responsive to disease-modifying antirheumatic drugs (DMARDs)
including MTX. UCB is also developing CIMZIA in other autoimmune disease
indications. CIMZIA is a registered trademark of UCB PHARMA S.A.

IMPORTANT SAFETY INFORMATION

Risk of Serious Infections
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. 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.

Malignancies

During controlled and open-labeled portions of CIMZIA studies of Crohn's
disease and other diseases , malignancies (excluding non-melanoma skin cancer)
were observed at a rate of 0.5 per 100 patient-years among 4,650
CIMZIA-treated patients versus a rate of 0.6 per 100 patient-years among 1,319
placebo-treated patients. 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.

Heart Failure

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.

Hypersensitivity

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.

Hepatitis B Reactivation

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, with
careful evaluation and monitoring prior to and during treatment. In patients
who develop HBV reactivation, discontinue CIMZIA and initiate effective
anti-viral therapy with appropriate supportive treatment.

Neurologic Reactions

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. Exercise caution in considering the use of
CIMZIA in patients with these disorders.

Hematologic Reactions

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.
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.

Drug Interactions

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, abatcept, rituximab, or natalizumab is
not recommended. 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.

Autoimmunity

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.

Immunizations

Do not administer live vaccines or attenuated vaccines concurrently with
CIMZIA.

Adverse Reactions

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 visit http://cimzia.com/crohns-disease/pdf/Prescribing_Information.pdf
for full prescribing information.

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 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.

SOURCE UCB

Bert Kelly, Manager, U.S. Communications & Public Relations, UCB Group, M:
+1-404-784-6303, Bert.Kelly@ucb.com; or Tanya Jishi, Biosector 2, M:
+1-917-216-9619, tjishi@biosector2.com