UCB Launches CIMplicity(TM) Program to Enhance Treatment Support for Cimzia(R) (certolizumab...

UCB Launches CIMplicity(TM) Program to Enhance Treatment Support for Cimzia(R)
(certolizumab pegol) Patients and Caregivers
First Patient Receives Cimzia(R) Dose through CIMplicity(TM) within Two Days
of FDA Approval

ATLANTA, April 24 /PRNewswire/ -- UCB announced today the launch of its
CIMplicity(TM) program, designed to enhance treatment support for patients
suffering from moderate to severe Crohn's disease. CIMplicity(TM) provides
Cimzia(R) patients and their caregivers with comprehensive financial,
administrative, compliance and treatment support. The U.S. Food and Drug
Administration (FDA) approved Cimzia(R) for adult patients with moderate to
severe Crohn's disease who have an inadequate response to conventional therapy
on April 22, 2008.
"CIMplicity(TM) was developed by UCB to enhance the Crohn's patient
experience by providing comprehensive treatment support to patients receiving
Cimzia(R)," said David Robinson, vice president and general manager, UCB.
"With the introduction of CIMplicity(TM), our goal is to eliminate some of the
issues patients face when managing the treatment of a complex and debilitating
condition."
Accelerating Access to Treatment
Just two days after approval, David Rubin, M.D. co-director of the
Inflammatory Bowel Disease Center at the University of Chicago Medical Center,
administered the first dose of Cimzia(R) and enrolled the first patient, Donna
Bynes, in the CIMplicity(TM) program. Bynes, a 29-year old nurse from the
Chicago suburbs, diagnosed with Crohn's at age 12, has had to discontinue a
number of Crohn's medications over the years for a variety of reasons. Bynes
received the first dose of Cimzia(R) in Dr. Rubin's clinic and, as part of the
CIMplicity(TM) program, will receive the next three doses through the
Cimzia(R) free trial program. Through CIMplicity(TM), Bynes also has the
option of having Cimzia(R) shipped directly to her home to be administered by
a licensed home health nurse, at no additional cost to her.
"Crohn's disease is a chronic condition often diagnosed in young adults at
a time when individuals are making education, career and relationship
decisions that will affect the rest of their lives," said Dr. Rubin. "There
are many needs for those who suffer from Crohn's disease, and Cimzia(R) is a
very important new option for these patients. Furthermore, in an era of
challenges for providing care, we anticipate that the CIMplicity(TM) program
will help to ensure that people like Donna will be able to focus on important
life experiences and not on the burden of managing their treatment."
How CIMplicity(TM) Works
Enrollment in CIMplicity(TM) is easy. The health care professional faxes
two simple forms to the service center. Once enrollment is complete, a
customer service representative will contact the patient to describe the
CIMplicity(TM) services, explain insurance coverage and answer any questions.
The CIMplicity(TM) service center will then coordinate expedited delivery of
Cimzia(R) either directly to the healthcare provider or to the patient's home
to be administered by a licensed home health nurse.
CIMplicity(TM) Financial Support Program
The CIMplicity(TM) financial support program includes a free trial program
and co-pay assistance (CIMpay(TM)). The free trial program provides patients
with up to three doses at no cost to them. Additionally, CIMpay(TM) is
available to eligible patients and covers co-pay expenses of up to $500 per
month.
In-Home Nurse Support
If a patient chooses to receive Cimzia(R) at home, the free trial doses
and/or subsequent shipments can be administered by a licensed home health
nurse, coordinated by the CIMplicity(TM) program at no additional cost to the
patient. The nurses are trained to answer questions about Crohn's disease and
will provide the patient's physician with ongoing updates on progress and
patient concerns. Patients will also have access to an adherence nurse and a
customized communication plan to facilitate optimal compliance.
CIMplicity(TM) Enrollment is Simple
To enroll, patients and physicians can contact the CIMplicity(TM) service
center at 1-866-4-CIMZIA [1-866-424-6942]. For more information on Cimzia(R),
log onto www.cimzia.com.
Further information
Eric Miller, Director, U.S. Communications & Public Relations, UCB Group
T +1.770.970.8569, Eric.Miller@ucb-group.com
About Cimzia(R) (certolizumab pegol)
Cimzia(R) is the first and only PEGylated anti-TNF (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,
RA and other autoimmune disease indications. For additional information,
including safety information, please refer to the Cimzia(R) factsheet in the
"News" section of UCB's website (www.ucb-group.com).
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).
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 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 more 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 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 the Euronext Brussels (Euronext: UCB). Schwarz Pharma is a
member of UCB-Group.
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

Eric Miller, Director, U.S. Communications & Public Relations, UCB Group,
+1-770-970-8569, Eric.Miller@ucb-group.com