Cimzia(R) Provides Long-Term Efficacy with Stable Dosing in Crohn's Disease

Data on Newly-Approved Cimzia(R) Presented at Digestive Disease Week (DDW)

SAN DIEGO, May 20 /PRNewswire/ -- UCB announced today that data presented
at Digestive Disease Week reaffirm the long-term, sustainable efficacy and
safety of Cimzia(R) (certolizumab pegol) at stable doses in treating patients
with moderate to severe Crohn's disease. Data also showed continued remission
amongst the majority of responders and the remission rate remained stable in
many of the patients who were re-induced with Cimzia(R). These results
represent data from the PRECiSE trial program, which evaluated more than 1,300
patients receiving continuous treatment with Cimzia(R) (400 mg) for up to 18
months.
"The long-term Cimzia(R) data provide very important information for
clinical practitioners treating people with Crohn's disease," said study
investigator Gary R. Lichtenstein, M.D., professor of medicine, University of
Pennsylvania School of Medicine, Philadelphia, Pa. "In clinical trials,
Cimzia(R) showed remarkable and sustainable long-term results without the need
for dose escalation. Further, patients can achieve long-term symptom relief
and remission regardless of the magnitude and rapidity of onset of the initial
response."
Cimzia(R) is the first and only PEGylated anti-TNF (Tumor Necrosis Factor
alpha) antibody approved for reducing signs and symptoms of Crohn's disease
and maintaining clinical response in adult patients with moderate to severe
active disease who have an inadequate response to conventional therapy.
Cimzia(R) was approved by the U.S. Food and Drug Administration (FDA) on April
22, 2008.
UCB, the manufacturer of Cimzia(R), presented analyses of the PRECiSE 3
and 4 open-label extension studies, which demonstrated the long-term efficacy
of Cimzia(R) in treating Crohn's disease. PRECiSE 3 data showed that eight out
of ten patients who were in remission at six months stayed in remission for up
to 18 months. Furthermore, 35 percent of patients who had relapsed during
PRECiSE 2 but were treated with one additional dose of Cimzia(R) (PRECiSE 4),
achieved and maintained remission at six and 12 months with maintenance dosing
every 4 weeks and no dose escalation. [Abstract #T1133]
"The DDW meeting marks an exciting time to announce additional long-term
data for Cimzia(R), given its recent approval by the FDA," said Olav Hellebo,
Senior Vice President and President of Inflammation Operations, UCB. "UCB
remains committed to providing healthcare professionals with effective
therapies to improve the lives of patients suffering from this debilitating
disease.
In a related analysis of PRECiSE 2 and 3, the durability of long-term
maintenance of response and remission proved not to be related to the rapidity
or magnitude of response or remission following induction of Cimzia(R),
demonstrating that patients can go on to experience positive response and
remission rates regardless of the magnitude and speed of the initial response.
[Abstract #T1126]
The pooled data also shows that the PRECiSE Phase 2 and Phase 3 clinical
trials showed no unexpected safety findings and no increase in the rate of
common adverse events with sustained exposure to Cimzia(R). Results also
demonstrate stable dosing in patients taking the medication for more than six
months. [Abstract #469]
About the PRECiSE Clinical Trial Program
PRECiSE, 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(R)
for up to six months, compared to placebo. The safety and tolerability of
Cimzia(R) was consistent with that expected of an anti-TNF agent. In the first
follow-up study, patients completing both initial studies are to be given
Cimzia(R) 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(R) every
four weeks to be continued for up to seven years, with a single additional
dose at week 2.
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). If not effectively treated, it results in the need for surgery.
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(R) (certolizumab pegol)
Cimzia(R) is the first and only PEGylated anti-TNFa (Tumor Necrosis Factor
alpha). Cimzia(R) 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. UCB is developing Cimzia(R) in Crohn's disease,
rheumatoid arthritis and other autoimmune disease indications. Cimzia(R)
is a registered trademark of UCB Inc. For full prescribing information, please
visit www.Cimzia.com.
IMPORTANT SAFETY INFORMATION
Tuberculosis (frequently disseminated or extrapulmonary at clinical
presentation), invasive fungal infections, and other opportunistic infections,
have been observed in patients receiving Cimzia(R). Some of these infections
have been fatal. Anti-tuberculosis treatment of patients with latent
tuberculosis infection reduces the risk of reactivation in patients receiving
treatment with TNF blockers such as Cimzia(R). However, active tuberculosis
has developed in patients receiving Cimzia(R) whose tuberculin test was
negative. Evaluate patients for tuberculosis risk factors and test for latent
tuberculosis infection prior to initiating Cimzia(R) and during therapy.
Initiate treatment of latent tuberculosis infection prior to therapy with
Cimzia(R). Monitor patients receiving Cimzia(R) for signs and symptoms of
active tuberculosis, including patients who tested negative for latent
tuberculosis infection. Consider anti-tuberculosis therapy prior to initiation
of Cimzia(R) in patients with a past history of latent or active tuberculosis
in whom an adequate course of treatment cannot be confirmed.
Serious infections, sepsis, and cases of opportunistic infections,
including fatalities, have been reported in patients receiving TNF blockers,
including Cimzia(R). Infections have been reported in patients receiving
Cimzia(R) alone or in conjunction with immunosuppressive agents. Do not
initiate treatment with Cimzia(R) in patients with active infections,
including chronic or localized infections. Patients who develop a new
infection while undergoing treatment with Cimzia(R) should be monitored
closely. Discontinue administration of Cimzia(R) if a patient develops a
serious infection. Exercise caution when considering the use of Cimzia(R) in
patients with a history of recurrent infection, concomitant immunosuppressive
therapy, or underlying conditions that may predispose them to infections, or
patients who have resided in regions where tuberculosis and histoplasmosis are
endemic.
Use of TNF blockers, including Cimzia(R), 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(R)
therapy. Exercise caution in prescribing Cimzia(R) for patients identified as
carriers of HBV. Patients who are carriers of HBV and require treatment with
Cimzia(R) 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(R) and initiate effective anti-viral therapy with appropriate
supportive treatment.
During controlled and open-labeled portions of Cimzia(R) studies of
Crohn's disease and other investigational uses, malignancies were observed at
a rate (95% confidence interval) of 0.6 (0.4, 0.8) per 100 patient-years among
4,650 Cimzia(R)-treated patients verses 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(R) for Crohn's
disease and other investigational uses, there was one case of lymphoma among
2,657 Cimzia(R)-treated patients and one case of Hodgkin lymphoma among 1,319
placebo-treated patients. The potential role of TNF blocker therapy in the
development of malignancies is not known.
Symptoms compatible with hypersensitivity reactions, including angioedema,
dyspnea, hypotension, rash, serum sickness, and urticaria, have been reported
rarely following Cimzia(R) administration. If such reactions occur,
discontinue further administration of Cimzia(R) and institute appropriate
therapy.
Use of TNF blockers, including Cimzia(R), 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(R); the causal relationship to
Cimzia(R) remains unclear. Exercise caution in considering the use of
Cimzia(R) 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(R).
The causal relationship of these events to Cimzia(R) 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(R). Consider discontinuation of
Cimzia(R) therapy in patients with confirmed significant hematologic
abnormalities.
Serious infections were seen in clinical studies with concurrent use of
anakinra (an interleukin-1 antagonist) and another TNF blocker, with no added
benefit. Therefore, the combination of Cimzia(R) and anakinra is not
recommended.
Interference with certain coagulation assays has been detected in patients
treated with Cimzia(R). There is no evidence that Cimzia(R) therapy has an
effect on in vivo coagulation.
Cases of worsening congestive heart failure (CHF) and new onset CHF have
been reported with TNF blockers. Cimzia(R) has not been formally studied in
patients with CHF. Exercise caution when using Cimzia(R) in patients who have
heart failure and monitor them carefully.
Treatment with Cimzia(R) 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(R). In controlled Crohn's clinical trials, the most common adverse
events that occurred in greater than or equal to 5% of Cimzia(R) patients
(n=620) and more frequently than with placebo (n=614) were upper respiratory
infection (20% Cimzia(R), 13% placebo), urinary tract infection (7% Cimzia(R),
6% placebo), and arthralgia (6% Cimzia(R), 4% placebo). The proportion of
patients who discontinued treatment due to adverse reactions in the controlled
clinical studies was 8% for Cimzia(R) and 7% for placebo.
Cimzia(R) should be administered by a healthcare professional.
About Digestive Disease Week (DDW)
DDW is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and the
Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008,
at the San Diego Convention Center, San Diego, CA. The meeting showcases
approximately 5,000 abstracts and hundreds of lectures on the latest advances
in GI research, medicine and technology. For more information, visit
www.ddw.org.
About UCB
UCB (Brussels, Belgium) (www.ucb-group.com) is a global leader in the
biopharmaceutical industry dedicated to the research, development and
commercialization of innovative pharmaceutical and biotechnology products in
the fields of central nervous system disorders, allergy/respiratory diseases,
immune and inflammatory disorders and oncology. UCB focuses on securing a
leading position in severe disease categories. Employing around 12,000 people
in over 40 countries, UCB achieved revenue of 3.6 billion euro in 2007. UCB
S.A. is listed on Euronext Brussels.
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.
Further Information
Eric Miller, Director, U.S. Corporate Communications, UCB Group
M: +1 404.519.5163, Eric.Miller@ucb-group.com,

Bert Kelly, Manager, U.S. Communications & Public Relations, UCB Group
M: +1 404.784.6303, Bert.Kelly@ucb-group.com

Antje Witte, Vice President, Corporate Communications & Investor
Relations, UCB Group
T: +32.2.559.9414, Antje.Witte@ucb-group.com

SOURCE UCB

Eric Miller, Director, U.S. Corporate Communications, mobile +1-404-519-5163,
Eric.Miller@ucb-group.com, Bert Kelly, Manager, U.S. Communications & Public
Relations, mobile +1-404-784-6303, Bert.Kelly@ucb-group.com, or Antje Witte,
Vice President, Corporate Communications & Investor Relations, +32-2-559-9414,
Antje.Witte@ucb-group.com, all of UCB Group