https://mb.cision.com/Public/18595/3624074/9f471eccb18f8110_800x800ar.png
** UCB Showcases Strength of the Expanding Dermatology Portfolio at the 31s=
t EADV Congress
------------------------------------------------------------
=C2=B7 20 abstracts highlight research in key disease areas including psori=
asis and psoriatic arthritis
=C2=B7 New three-year data to be presented on BIMZELX^=C2=AE=E2=96=BC (bime=
kizumab) in the treatment of moderate to severe plaque psoriasis
Brussels (Belgium), 1st September 2022 =E2=80=93 07:00 (CEST) =E2=80=93 UCB=
, a global biopharmaceutical company, today announced that it will present =
20 abstracts across its dermatology portfolio at the 31st European Academy =
of Dermatology and Venereology (EADV) Congress being held in Milan, Italy f=
rom September 7-10. The abstracts, accepted for poster presentation, unders=
core UCB=E2=80=99s commitment to delivering innovative solutions that aim t=
o address the unmet needs of people living with dermatological diseases.=C2=
=A0
=E2=80=9CWe are proud to present new data from our expanding dermatology po=
rtfolio at the 31st EADV Congress. At UCB, our ambition is to transform the=
lives of people living with severe diseases such as psoriasis and psoriati=
c arthritis, and the strength of scientific data at this year=E2=80=99s con=
gress reaffirms our long-standing commitment to raising standards of care,=
=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solu=
tions and Head of U.S., UCB.=C2=A0
Key data to be presented on bimekizumab include new results from the BE BRI=
GHT open-label extension study evaluating maintenance of response with bime=
kizumab through three years in patients with moderate to severe plaque psor=
iasis who responded at week 16. New analysis of pooled safety data from up =
to three years of treatment with bimekizumab in the treatment of moderate t=
o severe plaque psoriasis across Phase 2 and 3 clinical trials will also be=
presented.=C2=A0
For certolizumab pegol, data to be presented include three year data from t=
hree Phase 3 trials evaluating the association of patient reported outcomes=
(Dermatology Life Quality Index, DLQI 0/1) with relative skin clearance im=
provements (Psoriasis Area and Severity Index, PASI) in subgroups of adult =
patients with moderate to severe plaque psoriasis.
The following is a guide to the UCB-sponsored data presentations at the 31s=
t EADV Congress:
Bimekizumab e-Posters: Psoriasis=C2=A0
=C2=B7 Bimekizumab maintenance of response through three years in patients =
with moderate to severe plaque psoriasis who responded at Week 16: Results =
from the BE BRIGHT open-label extension=C2=A0
B. Strober, Y. Tada, U. Mrowietz, M. Lebwohl, P. Foley, R.G. Langley, J. Ba=
rker, M. Wang, V. Vanvoorden, B. Szilagyi, V. Ciaravino, C. Paul=C2=A0=C2=
=A0
#P1491=C2=A0
=C2=B7 Bimekizumab safety in patients with moderate to severe plaque psoria=
sis: Analysis of pooled data from up to three years of treatment in Phase 2=
and 3 clinical trials
K.B. Gordon, R.G. Langley, R.B. Warren, Y. Okubo, D. Rosmarin, M. Lebwohl, =
L. Peterson, C. Madden, D. de Cuyper, N. Nunez Gomez, D. Tha=C3=A7i=C2=A0
#P1569
=C2=B7 Bimekizumab versus secukinumab in plaque psoriasis: Cumulative clini=
cal and health related quality of life benefit through 2 years of the BE RA=
DIANT Phase 3b trial and open label extension
M. Lebwohl, P. Brunner, J. Soung, K. Ghoreschi, J. Weisman, L. Peterson, B.=
Szilagyi, F. Staelens, V. Ciaravino, WH. Boehncke=C2=A0
#P1561=C2=A0
=C2=B7 Bimekizumab efficacy through 96 weeks in patients with moderate to s=
evere plaque psoriasis: patient-reported outcomes from the BE RADIANT Phase=
3b trial
G. Kokolakis, R.G. Langley, A.B. Gottlieb, M. Augustin, N. Magnolo, B. Elew=
ski, R. Vender, A. L=C3=B3pez Ferrer, R. Warham, S. Wiegratz, V. Ciaravino,=
S.R. Feldman=C2=A0
#P1595=C2=A0
=C2=B7 Bimekizumab efficacy and safety through two years in patients with m=
oderate psoriasis: Analysis of pooled data from five Phase 3/3b clinical tr=
ials
A. Blauvelt, L. Stein Gold, M. Gooderham, B. Strober, A. Pinter, J.M. Carra=
scosa, P. Gisondi, J. Bleier, C. Madden, D. Deherder, N. Nunez Gomez, R.B. =
Warren=C2=A0
#1573=C2=A0
=C2=B7 Bimekizumab efficacy in high-impact areas for patients with moderate=
to severe plaque psoriasis: Pooled results through two years from the BE S=
URE and BE RADIANT Phase 3 trials
J.F. Merola, A.B. Gottlieb, A. Morita, J.M. Carrascosa, B. Elewski, N. Tilt=
, S. Wiegratz, K. Wixted, U. Mrowietz=C2=A0
#P1467=C2=A0=C2=A0 =C2=A0
=C2=B7 Bimekizumab efficacy and safety through three years in patients with=
moderate to severe plaque psoriasis: Long-term results from the BE SURE ra=
ndomised controlled trial and the BE BRIGHT open-label extension
D. Tha=C3=A7i, R. Vender, M. de Rie, C. Conrad, J. Soung, B. Strober, M. Wa=
ng, N. Cross, D. Deherder, N. Nunez Gomez, A.B. Gottlieb=C2=A0
#P1572
=C2=B7 Bimekizumab efficacy over two years in patients with moderate to sev=
ere plaque psoriasis with scalp and nail involvement who switched from adal=
imumab, ustekinumab, or secukinumab: Results from the BE SURE, BE VIVID, BE=
BRIGHT, and BE RADIANT Phase 3/3b trials
R.B. Warren, B. Strober, A. Pinter, A. Blauvelt, M. Sebastian, L. Davis, V.=
Vanvoorden, S. Wiegratz, M. Gooderham=C2=A0=C2=A0 =C2=A0
#P1478=C2=A0
=C2=B7 A network meta-analysis of cumulative clinical benefit of anti-IL bi=
ologics for the treatment of moderate to severe psoriasis over 48=E2=80=935=
2 weeks
R.B. Warren, A. Armstrong, M. Lebwohl, K. Gordon, C. Leonardi, N. Nunez Gom=
ez, V. Taieb, S. Vermeersch, S. Kiri, A. K=C3=B6rber=C2=A0
#P1571=C2=A0
=C2=B7 Both IL-17RA and IL-17RC receptor complexes are required for IL-17A-=
and IL-17F-driven inflammation
A. Maroof, A. Manghera, S. Shaw=C2=A0
#P1562=C2=A0
=C2=B7 Single-cell sequencing of freshly isolated cells from lesional and p=
eri-lesional skin to explore cellular origins of IL-17 isoforms in psoriasi=
s
A. Skelton, K. Pappelbaum, X. Li, V. Oji, A. Tsianakas, M. Page, M. Bertoli=
ni, S. Shaw, A. Maroof #P1563=C2=A0=C2=A0 =C2=A0
Bimekizumab e-Posters: Psoriatic Arthritis
=C2=B7 Efficacy and safety of bimekizumab in patients with active psoriatic=
arthritis and inadequate response to tumour necrosis factor inhibitors: 16=
-week results from BE COMPLETE, a Phase 3, randomised, double-blind placebo=
-controlled study
R.B. Warren, A. Asahina, P. Gisondi, L.E. Kristensen, D. McGonagle, P.J. Me=
ase, J.F. Merola, B. Strober, D. Tha=C3=A7i, B. Ink, D. Assudani, R. Bajrac=
harya, J. Coarse, A.B. Gottlieb=C2=A0
#P0479=C2=A0
=C2=B7 Efficacy and safety of bimekizumab in bDMARD-na=C3=AFve patients wit=
h psoriatic arthritis: 24-week results from BE OPTIMAL, a Phase 3, multicen=
tre, randomised, placebo-controlled, active reference study
J.F. Merola, A. Asahina, F. Behrens, A.B. Gottlieb, M. Lebwohl, D. McGonagl=
e, P.J. Mease, L. Puig, W.H. Boehncke, B. Ink, D. Assudani, R. Bajracharya,=
J. Coarse, P. Gisondi=C2=A0
#P0480=C2=A0=C2=A0 =C2=A0
Bimekizumab e-Posters: Axial Spondyloarthritis
=C2=B7 Bimekizumab in patients with active non-radiographic axial spondyloa=
rthritis and active ankylosing spondylitis: 24-week efficacy and safety fro=
m the BE MOBILE Phase 3 studies
D. Tha=C3=A7i, X. Baraliakos, J.F. Merola, D. Poddubnyy, F. van den Bosch, =
M. Oortgiesen, C. Fleurinck, A.M. Ellis, T. Vaux, J. Shepherd-Smith, A. Mar=
ten, D. van der Heijde=C2=A0
#P0477 =C2=A0=C2=A0 =C2=A0=C2=A0 =C2=A0=C2=A0
Certolizumab pegol e-Posters*: Psoriasis
=C2=B7 Stable plasma concentration of certolizumab pegol is associated with=
clinical improvement among patients with moderate to severe plaque psorias=
is: Data from CIMPASI-1 and CIMPASI-2
L. Puig, P. Gisondi, A. Pinter, J.M. L=C3=B3pez Pinto, I.D. Pousa, J. Sidhu=
, N. Tilt, M. Lebwohl=C2=A0
#P1570=C2=A0
=C2=B7 Association of DLQI 0/1 with relative PASI improvements in subgroups=
of patients with moderate to severe plaque psoriasis treated with certoliz=
umab pegol: Three-year results from three Phase 3 trials (CIMPASI-1, CIMPAS=
I-2, and CIMPACT)
S. McBride, J. W=C4=99g=C5=82owska, P. Wolf, P. Foley, F. Fierens, N. Tilt,=
C. de la Loge, B. Elewski
#P1492=C2=A0
=C2=B7 Certolizumab pegol for psoriasis in routine clinical practice (CIMRE=
AL): Patient characteristics and interim results
R.B. Warren, E. Lazaridou, D. Vidal Sarro, O. Vanhooteghem, G. Fabbrocini, =
L. Bianchi, M. Perrussel, H. Kadima, T. Kumke, J. Hee, M. Bari, F. Fierens,=
B. Korge=C2=A0
#P1621=C2=A0
=C2=B7 Certolizumab pegol for psoriasis in routine clinical practice (CIMRE=
AL): Interim results in women of child-bearing potential
K. Asadullah, M. Concetta Fargnoli, C. De Simone, T. Boy=C3=A9, T. Hillary,=
A. Machovcova, A. Makrygeorgou, K. Papp, M. Bari, T. Kumke, I.D. Pousa, F.=
Fierens, =C3=81. Fl=C3=B3rez, E. Papadavid=C2=A0 =C2=A0 #P1623=C2=A0=C2=A0=
=C2=A0
*Certolizumab pegol should only be used during pregnancy if clinically need=
ed
=C2=A0=C2=A0 =C2=A0
Disease State e-Posters: Psoriasis
=C2=B7 Treatment preferences in young bio-na=C3=AFve patients with moderate=
to severe psoriasis =E2=80=93 preliminary results from a mixed-method stud=
y across the Nordic countries
G.L. Mortensen, F. Balieva, L. Catton, B. Wilson Clar=C3=A9us, K. Danielsen=
, F. Fierens, L. Iversen, L. Koulu, R. Pasternack, A. Osmancevic, L. Skov=
=C2=A0
#P1529=C2=A0
=C2=B7 Practical tools to manage women with psoriasis: From dermatologists =
to dermatologists
A. Dattola, M.M. Constantin, I.D. Pousa, =C3=81. Gonz=C3=A1lez-Cantero, T. =
Hillary, C.E. Kleyn, N. Magnolo #P1535=C2=A0=C2=A0 =C2=A0
Notes to editors:
About Bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)=
, two key cytokines driving inflammatory processes.^1
In August 2021, bimekizumab was approved in the European Union (EU)/Europea=
n Economic Area (EEA) and in Great Britain, for the treatment of moderate t=
o severe plaque psoriasis in adults who are candidates for systemic therapy=
.^2,3 The label information may differ in other countries. Please check loc=
al prescribing information.
The safety and efficacy of bimekizumab in psoriatic arthritis and axial spo=
ndyloarthritis have not been established, and it is not approved for use in=
psoriatic arthritis or axial spondyloarthritis by any regulatory authority=
worldwide.
BIMZELX^=C2=AE=C2=A0=E2=96=BC(bimekizumab) EU/EEA Important Safety Informat=
ion in Psoriasis^2
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%) (most frequently nasopharyngitis) and =
oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant active infections (e.g. active tuberculosis).=C2=A0
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be administered in patients with any clinically important active =
infection. Patients treated with bimekizumab should be instructed to seek m=
edical advice if signs or symptoms suggestive of an infection occur. Prior =
to initiating treatment with bimekizumab, patients should be evaluated for =
tuberculosis (TB) infection. Bimekizumab should not be given in patients wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0
Cases of new or exacerbations of inflammatory bowel disease have been repor=
ted with bimekizumab. Bimekizumab is not recommended in patients with infla=
mmatory bowel disease. If a patient develops signs and symptoms of inflamma=
tory bowel disease or experiences an exacerbation of pre-existing inflammat=
ory bowel disease, bimekizumab should be discontinued and appropriate medic=
al management should be initiated. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld be discontinued immediately and appropriate therapy initiated.=C2=A0
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the summary of product characteristics in relation to other =
side effects, full safety and prescribing information. https://www.ema.euro=
pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.=
pdf
EU summary of product characteristics date of revision May 2022.
Last accessed: August 2022.
=E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. =
This will allow quick identification of new safety information. Healthcare =
professionals are asked to report any suspected adverse reactions.=C2=A0
About Certolizumab pegol in the EU/EEA^4
In the EU, CIMZIA^=C2=AE (certolizumab pegol) in combination with methotrex=
ate (MTX) is indicated for the treatment of moderate to severe active RA in=
adult patients when the response to disease-modifying antirheumatic drugs =
(DMARDs) including MTX, has been inadequate. Certolizumab pegol can be give=
n as monotherapy in case of intolerance to MTX or when continued treatment =
with MTX is inappropriate. Certolizumab pegol in combination with MTX is al=
so indicated for the treatment of severe, active and progressive RA in adul=
ts not previously treated with MTX or other DMARDs. Certolizumab pegol 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=
.
Certolizumab pegol, in combination with MTX, is also indicated for the trea=
tment of active psoriatic arthritis in adults when the response to previous=
DMARD therapy has been inadequate. Certolizumab pegol can be given as mono=
therapy in case of intolerance to MTX or when continued treatment with MTX =
is inappropriate.
Certolizumab pegol is also indicated in the EU for the treatment of adult p=
atients with severe active axial spondyloarthritis (axSpA), comprising:=C2=
=A0
=C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w=
ho have had an inadequate response to, or are intolerant to non-steroidal a=
nti-inflammatory drugs (NSAIDs).=C2=A0
=C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS =
=E2=80=93 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 re=
sponse to, or are intolerant to NSAIDs.
Certolizumab pegol is also indicated for the treatment of moderate to sever=
e plaque psoriasis in adults who are candidates for systemic therapy.=C2=A0
Cimzia^=C2=AE (certolizumab pegol) EU/EEA Important Safety Information^4
Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) =
in controlled and open label trials for up to 92 months. The commonly repor=
ted adverse reactions (1-10%) in clinical trials with certolizumab pegol an=
d post-marketing were viral infections (includes herpes =C2=A0zoster, papil=
lomavirus, influenza), bacterial infections (including abscess), rash, head=
ache =C2=A0(including migraine), asthenia, leukopenia (including lymphopeni=
a, neutropenia), eosinophilic disorder, pain (any sites), pyrexia, sensory =
abnormalities, hypertension, =C2=A0pruritus (any sites), hepatitis (includi=
ng hepatic enzyme increase), injection site reactions, and nausea. Serious =
adverse reactions include sepsis, opportunistic infections, tuberculosis (i=
ncluding miliary, disseminated and extrapulmonary), herpes zoster, lymphoma=
, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (i=
ncludes heart failure), ischemic coronary artery disorders, pancytopenia, h=
ypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrova=
scular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), an=
d renal impairment/nephropathy (includes nephritis). In RA controlled clini=
cal trials, 4.4% of patients discontinued taking certolizumab pegol due to =
adverse events vs. 2.7% for placebo.
Certolizumab pegol was initially studied in 325 patients with active axial =
spondyloarthritis (including ankylosing spondylitis and non-radiographic ax=
ial spondyloarthritis) in the AS001 clinical study for up to 4 years, which=
includes a 24-week placebo-controlled phase followed by a 24-week dose-bli=
nd period and a 156-week open-label treatment period. Certolizumab pegol wa=
s subsequently studied in 317 patients with non-radiographic axial spondylo=
arthritis in a placebo-controlled study for 52 weeks (AS0006). Certolizumab=
pegol was also studied in patients with axial spondyloarthritis (including=
ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a =
clinical study for up to 96 weeks, which included a 48-week open-label run-=
in phase (N=3D736) followed by a 48-week placebo-controlled phase (N=3D313)=
for patients in sustained remission (C-OPTIMISE). Certolizumab pegol was a=
lso studied in a 96-week open-label study in 89 axSpA patients with a histo=
ry of documented anterior uveitis flares. In all 4 studies, the safety prof=
ile for these patients was consistent with the safety profile in rheumatoid=
arthritis and previous experience with certolizumab pegol.
Certolizumab pegol was studied in 409 patients with psoriatic arthritis (Ps=
A) in a clinical study for up to 4 years which included a 24-week placebo-c=
ontrolled phase followed by a 24-week dose-blind period and a 168-week open=
-label treatment period.
The safety profile for axSpA and PsA patients treated with certolizumab peg=
ol was consistent with the safety profile in RA and previous experience wit=
h certolizumab pegol.
Certolizumab pegol was studied in 1112 patients with psoriasis in controlle=
d and open-label studies for up to 3 years. In the Phase III program, the i=
nitial and maintenance periods were followed by a 96-week open-label treatm=
ent period. The long-term safety profile of certolizumab pegol 400 mg every=
2 weeks and certolizumab pegol 200 mg every 2 weeks was generally similar =
and consistent with previous experience with certolizumab pegol.
Certolizumab pegol 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, and moderate=
to severe heart failure.
Serious infections including sepsis, tuberculosis and opportunistic infecti=
ons (e.g. histoplasmosis, nocardia, candidiasis) have been reported in pati=
ents receiving certolizumab pegol. Some of these events have been fatal. Be=
fore initiation of therapy with certolizumab pegol, all patients must be ev=
aluated for both active and inactive (latent) tuberculosis infection. If ac=
tive tuberculosis is diagnosed prior to or during treatment, certolizumab p=
egol therapy must not be initiated and must be discontinued. If latent tube=
rculosis is diagnosed, appropriate anti- tuberculosis therapy must be start=
ed before initiating treatment with certolizumab pegol.=C2=A0
Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including certolizumab pegol 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 certol=
izumab pegol. Carriers of HBV who require treatment with certolizumab pegol=
should be closely monitored and in the case of HBV reactivation Certolizum=
ab pegol should be stopped and effective anti-viral therapy with appropriat=
e supportive treatment should be initiated.
TNF antagonists including certolizumab pegol may increase the risk of new o=
nset or exacerbation of clinical symptoms and/or radiographic evidence of d=
emyelinating disease including multiple sclerosis; of formation of autoanti=
bodies and uncommonly of the development of a lupus-like syndrome; of sever=
e hypersensitivity reactions. If a patient develops any of these adverse re=
actions, certolizumab pegol should be discontinued and appropriate therapy =
instituted.
With the current knowledge, a possible risk for the development of lymphoma=
s, leukaemia or other malignancies in patients treated with a TNF antagonis=
t cannot be excluded. Rare cases of neurological disorders, including seizu=
re disorder, neuritis and peripheral neuropathy, have been reported in pati=
ents treated with certolizumab pegol.
Adverse reactions of the haematologic system, including medically significa=
nt cytopenia, have been reported with certolizumab pegol. Advise all patien=
ts to seek immediate medical attention if they develop signs and symptoms s=
uggestive of blood dyscrasias or infection (e.g., persistent fever, bruisin=
g, bleeding, pallor) while on certolizumab pegol. Consider discontinuation =
of certolizumab pegol therapy in patients with confirmed significant haemat=
ological abnormalities.
The use of certolizumab pegol in combination with anakinra or abatacept is =
not recommended due to a potential increased risk of serious infections. As=
no data are available, certolizumab pegol should not be administered concu=
rrently with live vaccines. The 14-day half-life of certolizumab pegol shou=
ld be taken into consideration if a surgical procedure is planned. A patien=
t who requires surgery while on certolizumab pegol should be closely monito=
red for infections.
Please consult the full prescribing information in relation to other side e=
ffects, full safety and prescribing information.=C2=A0
European SmPC date of revision June 2022. https://www.ema.europa.eu/en/docu=
ments/product-information/cimzia-epar-product-information_en.pdf Last Acces=
sed August 2022
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com=C2=A0
About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With approximately 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e actual results, financial condition, performance or achievements of UCB, =
or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
se. Important factors that could result in such differences include: the gl=
obal spread and impact of COVID-19, changes in general economic, business a=
nd competitive conditions, the inability to obtain necessary regulatory app=
rovals or to obtain them on acceptable terms or within expected timing, cos=
ts associated with research and development, changes in the prospects for p=
roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
candidates, competition from other products including biosimilars, changes=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
es in tax laws or the administration of such laws, and hiring and retention=
of its employees. There is no guarantee that new product candidates will b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
results do not guarantee safety and efficacy of product candidates in huma=
ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products, which are the subject of partners=
hips, joint ventures or licensing collaborations may be subject to differen=
ces disputes between the partners or may prove to be not as safe, effective=
or commercially successful as UCB may have believed at the start of such p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
icant problems with a product similar to one of UCB=E2=80=99s products that=
implicate an entire class of products may have a material adverse effect o=
n sales of the entire class of affected products. Moreover, sales may be im=
pacted by international and domestic trends toward managed care and health =
care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and it does not reflect any potenti=
al impact from the evolving COVID-19 pandemic, unless indicated otherwise. =
UCB is following the worldwide developments diligently to assess the financ=
ial significance of this pandemic to UCB. UCB expressly disclaims any duty =
to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
ing statements with regard thereto or any change in events, conditions or c=
ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
n offer to sell or the solicitation of an offer to buy any securities, nor =
shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.=C2=A0
References
1. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual inhibitor of =
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991=
=E2=80=931001.
2. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics, Marc=
h 2022. https://www.ema.europa.eu/en/documents/product-information/bimzelx-=
epar-product-information_en.pdf. Last accessed August 2022.
3. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last ac=
cessed: August 2022
4. CIMZIA^=C2=AE (certolizumab pegol) EU Summary of Product Characteristics=
. June 2022. https://www.ema.europa.eu/en/documents/product-information/cim=
zia-epar-product-information_en.pdf. Last accessed August 2022.
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