UCB Announces Positive CHMP Opinion for CIMZIA® (certolizumab pegol) in Patients with Moderate-to-Severe Plaque Psoriasis

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- CIMZIA® (certolizumab pegol) Phase 3 psoriasis data demonstrated
significant and clinically meaningful improvements in
biologic-naïve and previously treated patients, with clinical
benefit maintained up to one year[1]
- This milestone represents UCB's entry into immuno-dermatology,
where there is significant unmet patient need
- This follows a recent European Medicines Agency (EMA) label update
for CIMZIA in pregnancy and breastfeeding, making CIMZIA the first
anti-TNF for potential use in women during both pregnancy and
lactation in its approved indications[2]

UCB today announced that the European Committee for Medicinal
Products for Human Use (CHMP) has recommended approval of a label
extension for CIMZIA® (certolizumab pegol), to include a new
indication in adult patients with moderate-to-severe plaque
psoriasis.[3] CIMZIA is the first Fc-free, PEGylated anti-TNF to
receive a positive CHMP opinion for use in moderate-to-severe plaque
psoriasis.[3] The European Commission's (EC) endorsement of the CHMP
positive opinion for psoriasis is expected in the second quarter of
2018 and would further broaden the clinical value of CIMZIA.

(Logo: https://mma.prnewswire.com/media/683106/UCB_Logo.jpg )

"The Phase 3 clinical development program for CIMZIA in plaque
psoriasis demonstrated clinically meaningful improvements in primary
efficacy endpoints over a 48-week period, as well as improvements in
important patient quality of life measures. The data established the
durable clinical benefit of CIMZIA, with all three studies showing
that the clinical benefit with CIMZIA was maintained for up to one
year. Psoriasis has a significant emotional and physical impact on
patients, and there is still a need for new therapies that
effectively control skin symptoms over time. The availability of
CIMZIA in psoriasis would provide healthcare professionals with an
effective, broad spectrum anti-TNF with 10 years of clinical
experience to help manage this debilitating condition and improve the
quality of patients' lives through durable disease control," said
Diamant Thaçi, Professor, MD, Director of the Institute for
Inflammatory Medicine, University Hospital Schleswig-Holstein, Campus
Lübeck.

"CIMZIA is the first anti-TNF of its kind to receive a CHMP
positive opinion for this challenging disease. We look forward to
offering patients and their dermatologists a new treatment option,
with best-in-class efficacy and two different doses to maximize
disease control, achieve clear skin and face the serious
quality-of-life challenges that often accompany plaque psoriasis.
This new indication is particularly relevant following the CIMZIA
label update for pregnancy and breastfeeding, as a significant
proportion of patients with moderate to severe plaque psoriasis are
women, making CIMZIA an optimal treatment for women of childbearing
age," said Emmanuel Caeymaex, Head of Immunology and Executive Vice
President, Immunology Patient Value Unit, UCB.

The CHMP positive opinion is based on data from a Phase 3 clinical
development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT.
The trials, which enrolled over 1,000 patients, with and without
prior treatment experience with biologic products, confirmed the
efficacy and safety of CIMZIA in the treatment of adult patients with
moderate-to-severe plaque psoriasis.[1] Each of the three studies
included an assessment of the percentage of patients who achieved at
least 75% or greater disease improvement from baseline as measured by
the Psoriasis Area and Severity Index (PASI 75) compared to placebo;
within 16 weeks in CIMPASI-1 and CIMPASI-2, and within 12 weeks in
CIMPACT. CIMPASI-1 and CIMPASI-2 also assessed the percentage of
patients who achieved at least a two-point improvement on a
five-point Physician's Global Assessment (PGA) scale to a final score
representing clear or almost clear skin, each compared with placebo,
at week 16 as a co-primary endpoint. In all three trials, CIMZIA
demonstrated statistically significant improvements for all primary
and co-primary endpoints compared to placebo at all treatment doses,
and the clinical benefit was maintained through to week 48.[1]

According to the updated label, the recommended starting dose of
CIMZIA for adult patients is 400 mg at weeks 0, 2 and 4. After the
starting dose, the maintenance dose of CIMZIA for adult patients with
plaque psoriasis is 200 mg every 2 weeks. A dose of 400 mg every 2
weeks can be considered in patients with insufficient response.[3]

Additionally, the recent European Medicines Agency (EMA) label
update for CIMZIA in pregnancy and breastfeeding, makes CIMZIA the
first anti-TNF for potential use in women during both pregnancy and
lactation in its approved indications.[2] The update included
specific pregnancy and lactation information, based on findings from
two first-of-their-kind studies, CRIB and CRADLE, together with
pregnancy outcomes data.[2],[4],[5] Results from the UCB-sponsored
CRIB study, a prospective pharmacokinetic study, demonstrated no to
minimal placental transfer of CIMZIA from mother to child during
pregnancy.[4] Data from CRADLE, a prospective pharmacokinetic study,
found minimal transfer of CIMZIA into breast milk during
lactation.[5] Both studies included a safety evaluation.[4],[5]
CIMZIA is also approved for the treatment of psoriatic arthritis
(PsA), a frequent co-morbidity of psoriasis patients.[2],[6]

About Psoriasis

Psoriasis is a common, chronic inflammatory disease with primary
involvement of the skin. The skin condition affects men and women of
all ages and ethnicities. Psoriasis signs and symptoms can vary, but
may include red patches of skin covered with silvery scales, dry,
cracked skin that may bleed and thickened, pitted or ridged nails.[7]

Psoriasis affects nearly three per cent of the population, or
approximately 125 million people worldwide.[7] Symptoms vary from
person to person, but for those who are more severely affected,
psoriasis can have a major impact on their quality of life.[7] As
many as 42% of patients with psoriasis will develop PsA,[8],[9] 33%
will develop metabolic syndrome[10] and approximately 46% are often
or always depressed because of their psoriasis.[11] Despite drug
development advances in the past decade, patient survey data suggest
that moderate-to-severe psoriasis is being undertreated.[12]

In pregnancy, psoriasis can present a number of challenges, with
23% of women experiencing a worsening of symptoms during
pregnancy.[13] Multiple studies have shown that psoriasis can
contribute to an increased risk of adverse pregnancy outcomes
including preterm delivery, low birth weight, spontaneous abortion,
caesarean delivery, and babies that are large for gestational age and
of higher than average birth weight.[14],[15],[16] In addition, up to
65% of women with psoriasis experience a worsening of psoriasis
symptoms postpartum.[13] Controlling psoriasis before, during and
after pregnancy is important for the health of both mother and
baby.[17]

About the CIMPASI-1, CIMPASI-2 and CIMPACT Studies[1]

CIMPASI-1, CIMPASI-2 and CIMPACT Phase 3 trials each evaluated the
efficacy and safety of CIMZIA (certolizumab pegol, CZP) in adult
patients with moderate-to-severe plaque psoriasis. The three trials
enrolled approximately 1,000 patients, including patients with and
without prior treatment experience with biologic products.

In CIMPASI-1 and CIMPASI-2, at week 16, the response rate for
patients who achieved a PASI 75 response was 66.5% and 81.4% for
patients receiving CZP 200 mg every two weeks (Q2W), and 75.8% and
82.6% for patients receiving CZP 400 mg every two weeks (Q2W),
compared to 6.5% and 11.6% for patients receiving placebo,
respectively. In addition, the response rate for patients achieving
at least a two-point improvement to a final score of clear or almost
clear skin on the PGA scale (PGA 0/1) at week 16 was 47.0% and 66.8%
for CZP 200 mg Q2W dose-treated patients, and 57.9% and 71.6% for CZP
400 mg Q2W dose-treated patients, compared to 4.2% and 2.0% for
patients receiving placebo, respectively. Responder rates for
maintenance of a PASI 75 response to week 48 were 67.2% and 78.7% for
patients receiving CZP 200 mg Q2W, and 87.1% and 81.3% for patients
receiving CZP 400 mg Q2W, respectively. Responder rates for
maintenance of a PGA 0/1 score through to week 48, were 52.7% and
72.6% for patients receiving CZP 200 mg Q2W, and 69.5% and 66.6% for
patients receiving CZP 400 mg Q2W, respectively.

In CIMPACT, the response rate for patients who achieved a PASI 75
response at week 12, was 61.3% and 66.7% and among patients receiving
CZP 200 mg Q2W and CZP 400 mg Q2W, compared to 5.0% for patients
receiving placebo, respectively. In patients who received CZP 200 mg
Q2W and were PASI 75 responders at week 16, 80.0% of patients who
remained on CZP 200 mg Q2W maintained their response at week 48, and
98.0% of patients who then received CZP 400 mg Q2W from week 16
maintained their response at week 48.

In response to the recognized impact of psoriasis on patient
experience, improvements in Dermatology Life Quality Index (DLQI)
were also observed in all three trials at week 16, and maintained
through to week 48. DLQI is a widely used and recognized quality of
life measurement instrument used across several dermatological
diseases.

In all three trials, CIMZIA demonstrated statistically significant
improvements for all primary or co-primary endpoints compared to
placebo at all treatment doses, and the clinical benefit was
maintained through to 48 weeks. The adverse event profile across all
three trials appears consistent with the known safety profile of
anti-TNF therapy and no new safety signals were observed with CIMZIA
at any dose over 48 weeks.

About the CRIB Study[4]

CRIB was a pharmacokinetic study assessing the potential level of
placental transfer of CZP from pregnant women to their infants. The
study followed sixteen women (>= 30 weeks gestation) who were already
receiving CZP 200 mg Q2W or 400 mg Q4W for locally approved
indications, including rheumatoid arthritis (RA), psoriatic arthritis
(PsA), axial spondylitis (axSpA) or Crohn's Disease (CD). CRIB did
not include any patients suffering from psoriasis nor patients
treated with a CZP 400 mg Q2W dose. In the EU, CIMZIA is not
indicated in CD.

The study found that CZP levels were below the lower limit of
quantification in 13 out of 14 infant blood samples at birth, and in
all samples at weeks four and eight. One infant had a minimal CZP
level of 0.042µg/mL (infant/mother plasma ratio 0.0009%). No anti-CZP
antibodies were detected in mothers, umbilical cords, or infants.
These data indicate no to minimal placental transfer of CZP from
mothers to infants, suggesting lack of in utero fetal exposure during
the third trimester.

In CRIB, adverse events experienced by the infants did not show
any patterns or clusters of events suggesting a specific safety
signal in children. Safety data in the mothers were in line with the
known safety profile of CZP and pregnancy profile of these underlying
diseases.

About the CRADLE Study[5]

The primary objectives of the CRADLE pharmacokinetic study were to
determine the concentration of CZP in human breast milk and the
average daily infant dose, an estimation of the daily dose of
maternal CZP ingested by the infant over the dosing interval.

The study followed 17 lactating women who were already receiving
CZP 200 mg Q2W or 400 mg Q4W suffering from RA, PsA, axSpA or CD.
CRADLE did not include any patients suffering from psoriasis nor
patients treated with a CZP 400 mg Q2W dose.

Among 137 breast milk samples from 17 mothers, all samples had CZP
concentrations that were minimal, less than 3 times the lower limit
of quantification and less than 1% of the plasma concentration
expected with a therapeutic dose. A post-hoc analysis of the relative
infant dose (RID) of CZP in breast milk was calculated and ranged
from 0.04% to 0.30%. The RID is a useful parameter for assessing drug
safety in breastfeeding and experts consider a RID that is less than
10% to be unlikely of concern to infant wellbeing.

In CRADLE, adverse events in the infants of mothers exposed to CZP
were consistent with those occurring in unexposed infants of similar
age. Adverse events in mothers exposed to CZP were consistent with
the known safety profile of CZP.

About CIMZIA® in the EU/EEA

In the EU, CIMZIA® in combination with methotrexate (MTX) is
indicated for the treatment of moderate to severe active RA in adult
patients inadequately responsive to disease-modifying anti-rheumatic
drugs (DMARDs) including MTX.

CIMZIA can be given as monotherapy in case of intolerance to MTX
or when continued treatment with MTX is inappropriate. CIMZIA in
combination with MTX is also indicated for the treatment of severe,
active and progressive RA in adults not previously treated with MTX
or other DMARDs.

CIMZIA has been shown to reduce the rate of progression of joint
damage as measured by X-ray and to improve physical function, when
given in combination with MTX.

CIMZIA, in combination with MTX, is also indicated for the
treatment of active psoriatic arthritis in adults when the response
to previous DMARD therapy has been inadequate. CIMZIA can be given as
monotherapy in case of intolerance to MTX or when continued treatment
with MTX is inappropriate.

CIMZIA is also indicated in the EU for the treatment of adult
patients with severe active axial spondyloarthritis (axSpA),
comprising:

- Ankylosing spondylitis (AS) - adults with severe active AS who have
had an inadequate response to, or are intolerant to non-steroidal
anti-inflammatory drugs (NSAIDs).
- Axial spondyloarthritis (axSpA) without radiographic evidence of AS
- adults with severe active axSpA without radiographic evidence of
AS but with objective signs of inflammation by elevated C-reactive
protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had
an inadequate response to, or are intolerant to NSAIDs.

About CIMZIA® in Fertility, Pregnancy and Lactation in the EU/EEA

Women of childbearing potential

The use of adequate contraception should be considered for women
of childbearing potential. For women planning pregnancy, continued
contraception may be considered for 5 months after the last CIMZIA
dose due to its elimination rate, but the need for treatment of the
woman should also be taken into account (see below).

Pregnancy

Data from more than 500 prospectively collected pregnancies
exposed to CIMZIA with known pregnancy outcomes, including more than
400 pregnancies exposed during the first trimester, does not indicate
a malformative effect of CIMZIA. However, the available clinical
experience is too limited to, with a reasonable certainty, conclude
that there is no increased risk associated with CIMZIA administration
during pregnancy.

Animal studies using a rodent anti-rat TNF? did not reveal
evidence of impaired fertility or harm to the foetus. However, these
are insufficient with respect to human reproductive toxicity. Due to
its inhibition of TNF?, CIMZIA administered during pregnancy could
affect normal immune response in the newborn.

CIMZIA should only be used during pregnancy if clinically needed.
Non-clinical studies suggest low or negligible level of placental
transfer of a homologue Fab-fragment of certolizumab pegol (no Fc
region).

In clinical study 16 women were treated with certolizumab pegol
(200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy.
Certolizumab pegol plasma concentrations measured in 14 infants at
birth were Below the Limit of Quantification (BLQ) in 13 samples; one
was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0.09%.
At Week 4 and Week 8, all infant concentrations were BLQ. The
clinical significance of low levels certolizumab pegol for infants is
unknown. It is recommended to wait a minimum of 5 months following
the mother's last CIMZIA administration during pregnancy before
administration of live or live-attenuated vaccines (e.g. BCG
vaccine), unless the benefit of the vaccination clearly outweighs the
theoretical risk of administration of live or live-attenuated
vaccines to the infants.

Breastfeeding

In a clinical study in 17 lactating women treated with CIMZIA,
minimal transfer of certolizumab pegol from plasma to breast milk was
observed. The percentage of the maternal certolizumab pegol dose
reaching an infant during a 24 hour period was estimated to 0.04% to
0.30 %. In addition, since certolizumab pegol is a protein that is
degraded in the gastrointestinal tract after oral administration, the
absolute bioavailability is expected to be very low in a breastfed
infant. Consequently, CIMZIA can be used during breastfeeding.

Important Safety Information about CIMZIA® in the EU/EEA

CIMZIA® was studied in 4,049 patients with rheumatoid arthritis
(RA) in controlled and open label trials for up to 92 months. The
commonly reported adverse reactions (1-10%) in clinical trials with
CIMZIA® and post-marketing were viral infections (includes herpes,
papillomavirus, influenza), bacterial infections (including abscess),
rash, headache (including migraine), asthaenia, leukopaenia
(including lymphopaenia, neutropaenia), eosinophilic disorder, pain
(any sites), pyrexia, sensory abnormalities, hypertension, pruritus
(any sites), hepatitis (including hepatic enzyme increase), injection
site reactions, and nausea. Serious adverse reactions include sepsis,
opportunistic infections, tuberculosis, herpes zoster, lymphoma,
leukaemia, solid organ tumours, angioneurotic oedema,
cardiomyopathies (includes heart failure), ischemic coronary artery
disorders, pancytopaenia, hypercoagulation (including
thrombophlebitis, pulmonary embolism), cerebrovascular accident,
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal
impairment/nephropathy (includes nephritis). In RA controlled
clinical trials, 4.4% of patients discontinued taking CIMZIA® due to
adverse events vs. 2.7% for placebo.

CIMZIA® is contraindicated in patients with hypersensitivity to
the active substance or any of the excipients, active tuberculosis or
other severe infections such as sepsis or opportunistic infections or
moderate-to-severe heart failure.

Serious infections including sepsis, tuberculosis and
opportunistic infections have been reported in patients receiving
CIMZIA®. Some of these events have been fatal. Monitor patients
closely for signs and symptoms of infections including tuberculosis
before, during, and after treatment with CIMZIA®. Treatment with
CIMZIA® must not be initiated in patients with a clinically important
active infection. If an infection develops, monitor carefully and
stop CIMZIA® if infection becomes serious. Before initiation of
therapy with CIMZIA®, all patients must be evaluated for both active
and inactive (latent) tuberculosis infection. If active tuberculosis
is diagnosed prior to or during treatment, CIMZIA® therapy must not
be initiated and must be discontinued. If latent tuberculosis is
diagnosed, appropriate anti-tuberculosis therapy must be started
before initiating treatment with CIMZIA®. Patients should be
instructed to seek medical advice if signs/symptoms (e.g. persistent
cough, wasting/weight loss, low grade fever, listlessness) suggestive
of tuberculosis occur during or after therapy with CIMZIA®.

Reactivation of hepatitis B has occurred in patients receiving a
TNF-antagonist including CIMZIA® who are chronic carriers of the
virus (i.e. surface antigen positive). Some cases have had a fatal
outcome. Patients should be tested for HBV infection before
initiating treatment with CIMZIA®. Carriers of HBV who require
treatment with CIMZIA® should be closely monitored and in the case of
HBV reactivation CIMZIA® should be stopped and effective anti-viral
therapy with appropriate supportive treatment should be initiated.

TNF-antagonists including CIMZIA® may increase the risk of new
onset or exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease; of formation of autoantibodies and
uncommonly of the development of a lupus-like syndrome; of severe
hypersensitivity reactions. If a patient develops any of these
adverse reactions, CIMZIA® should be discontinued and appropriate
therapy instituted.

With the current knowledge, a possible risk for the development of
lymphomas, leukaemia or other malignancies in patients treated with a
TNF-antagonist cannot be excluded. Rare cases of neurological
disorders, including seizure disorder, neuritis and peripheral
neuropathy, have been reported in patients treated with CIMZIA®.

Adverse reactions of the haematologic system, including medically
significant cytopaenia, have 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 haematological abnormalities.

The use of CIMZIA® in combination with anakinra or abatacept is
not recommended due to a potential increased risk of serious
infections. As no data are available, CIMZIA® should not be
administered concurrently with live vaccines. The 14-day half-life of
CIMZIA® should be taken into consideration if a surgical procedure is
planned. A patient who requires surgery while on CIMZIA® should be
closely monitored for infections.

CIMZIA® was studied in 325 patients with active axial
spondyloarthritis (axSpA) in a placebo-controlled clinical trial for
up to 30 months and in 409 patients with psoriatic arthritis (PsA) in
a placebo-controlled clinical trial for up to 30 months. The safety
profile for axSpA and PsA patients treated with CIMZIA® was
consistent with the safety profile in RA and previous experience with
CIMZIA®.

Please consult the full prescribing information in relation to
other side effects, full safety and prescribing information. European
SmPC date of revision December 2017.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_Information/human/001037/WC500069763.pdf

CIMZIA® is a registered trademark of the UCB Group of Companies.

ots Originaltext: UCB Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
, UCB:
Corporate Communications
France Nivelle
Global Communications, UCB
T +32-2-559-9178
france.nivelle@ucb.com
Laurent Schots
Media Relations, UCB
T+32-2-559-92-64
laurent.schots@ucb.com

Investor Relations
Antje Witte
Investor Relations, UCB
T +32-2-559-94-14
antje.witte@ucb.com
Isabelle Ghellynck
Investor Relations, UCB
T+32-2-559-95-88
Isabelle.ghellynck@ucb.com

Brand Communications
Andrea Christopher
Immunology Communications, UCB
T +1-404-483-7329
andrea.christopher@ucb.com
About UCB
UCB, Brussels, Belgium (http://www.ucb.com ) is a global
biopharmaceutical company focused on the discovery and development of
innovative medicines and solutions to transform the lives of people
living with severe diseases in immunology or neurology. With more than
7 500 people in approximately 40 countries, the company generated
revenue of EUR 4.5 billion in 2017. UCB is listed on Euronext Brussels
(symbol: UCB). Follow us on Twitter: @UCB_news
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HQ/0318/CI/00024 April 2018

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