New Data Show CIMZIA(R) (certolizumab pegol) Provides Sustained and Significant Symptom Improvement in Moderate to Severe Crohn's Patients

New Data Show CIMZIA(R) (certolizumab pegol) Provides Sustained and
Significant Symptom Improvement in Moderate to Severe Crohn's Patients
Majority of patients continuing in PRECiSE study who take CIMZIA(R) remain in
clinical remission for up to 3.5 years with no dose escalation during that
time

SAN DIEGO, Oct. 26 /PRNewswire/ -- New data from an open-label extension study
evaluating the long-term safety and efficacy of CIMZIA® (certolizumab pegol)
in moderate to severe Crohn's disease patients demonstrate that 82 percent of
patients actively treated with CIMZIA - the only PEGylated anti-TNF-alpha
(Tumor Necrosis Factor alpha) - remained in long-term remission without dose
escalation up to 3.5 years. In a separate analysis, CIMZIA significantly
improved patients' symptoms as early as day 8 as reported in a post-hoc
responder analysis of PRECiSE 2, the original double-blind placebo controlled
study. These data from PRECiSE 2 and the open-label extension PRECiSE 3
studies are being presented this week at the American College of
Gastroenterology (ACG) Annual Meeting in San Diego, Calif.

CIMZIA is indicated 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.

"These data further demonstrate that treatment with a stable dose of CIMZIA
enables patients with Crohn's disease to have sustained symptom relief," said
study investigator Gary R. Lichtenstein, M.D., Director, Inflammatory Bowel
Disease Program, University of Pennsylvania in Philadelphia. "Long-term relief
and control of symptoms are vital to helping Crohn's patients manage their
disease."

At the start of the open-label extension study, PRECiSE 3, 75 percent of
CIMZIA-treated patients (105 out of 141 patients who continued in PRECiSE 3)
were in clinical remission. Eighty-two percent of patients who continued in
the long-term extension trial on active treatment maintained remission for up
to 3.5 years based upon responder analysis. Disease activity was measured by
the Harvey-Bradshaw Index (HBI), which tallies the incidence of five clinical
items, including general well-being, abdominal pain and number of liquid
stools per day, during the previous 24 hours before the assessment. Each item
is scored from 0 to 3 and total scores of less than or equal to 4 signify
remission. Most reported adverse events were of mild to moderate intensity.
The most serious adverse events (some leading to death) reported were
exacerbation of Crohn's disease, serious infections (3 of which were
tuberculosis) and malignancies. (Abstract #P716)

In the original PRECiSE 2 trial, moderate to severe Crohn's patients who
responded to CIMZIA after an open-label induction phase were randomized to
receive CIMZIA or placebo and evaluated for maintenance of clinical response
by week 26, of which a significant majority (62 percent) of CIMZIA treated
patients maintained their overall clinical response compared to placebo (34
percent, p<0.001). In the separate post-hoc analysis of the PRECiSE 2 trial,
three patient-reported Crohn's Disease Activity Index (CDAI) components
(number of loose/liquid stools, abdominal pain, and general well-being) were
examined from baseline (day 0) to day 8 to 14, comparing week 6 responders and
nonresponders to CIMZIA treatment. The CDAI is a patient/physician
questionnaire which incorporates eight CD-related variables. Patients
completed a diary card daily for 7 days prior to each clinic visit. Scores of
<150 indicate remission and scores of >450 indicate severe illness along the
600 point scale. There was a 31 percent (95% CI: -1.7, -1.2) reduction of mean
number of loose/liquid stools among responders versus a 14 percent (95% CI:
-1.0, -0.3) reduction for nonresponders by day 8. Twenty percent of CIMZIA
responders reported no abdominal pain by day 8 versus 16 percent of
nonresponders (p= 0.002). Approximately 21 percent of CIMZIA responders
reported improvement in general well-being scores versus 14 percent of
nonresponders (p=0.001). (Abstract #P286)

"These data further underscore the value of CIMZIA as a therapeutic option for
those living with this devastating and debilitating disease. The long-term
efficacy data solidify CIMZIA's potential to help many patients throughout the
course of their disease," said David Robinson, vice president and general
manager of UCB's Immunology Business Unit.

Earlier this year, UCB announced that CIMZIA is available to 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 the PRECiSE Clinical Trial Program

PRECiSE (PEGylated Antibody Fragment Evaluation in Crohn's Disease: Safety and
Efficacy), one of the largest, most comprehensive development programs for an
anti-TNF for Crohn's disease, is composed of two placebo-controlled studies
and two open-label safety follow-up studies. In 2007, the two former studies
were published in the New England Journal of Medicine (NEJM). The studies
demonstrated that patients with moderate to severe Crohn's disease achieved
and sustained clinical response with CIMZIA for up to six months, compared to
placebo. In the first follow-up study, patients completing both initial
studies were to be given CIMZIA every four weeks for up to seven years. In the
second follow-up study, patients who relapsed in either initial study (defined
as an increase in CDAI of >70 or absolute CDAI of >350) were re-introduced to
CIMZIA every four weeks to be continued for up to seven years, with a single
additional dose at week 2. The most common adverse events reported were
headache, nasopharyngitis, cough and abdominal pain. The incidence of serious
adverse events (SAEs) was 5.6 percent, including one case each of
tuberculosis, pyelonephritis, and pneumonia.

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 greater than or equal to 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 greater than or equal to 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