https://mb.cision.com/Public/18595/3849304/8d2c62abe5dd821c_800x800ar.png
** UCB to Present New Bimekizumab Data in Hidradenitis Suppurativa, Psorias=
is and Psoriatic Arthritis at EADV 2023
------------------------------------------------------------
Brussels (Belgium), 9 October 2023 (07:00 CEST) =E2=80=93 UCB, a global bio=
pharmaceutical company, today announced that it will present new data on bi=
mekizumab at the 32nd European Academy of Dermatology and Venereology (EADV=
) Congress, October 11=E2=80=9314th in Berlin, Germany. Data will be presen=
ted in four oral presentations and 14 posters across a range of diseases in=
cluding hidradenitis suppurativa (HS), psoriasis and psoriatic arthritis (P=
sA). Three oral presentations will share bimekizumab data in hidradenitis s=
uppurativa including the first presentation of pooled analyses from the two=
Phase 3 studies.
=E2=80=9CWe are proud to share new clinically relevant and patient-focused =
data at the upcoming EADV Congress. Our expanding dermatology portfolio hig=
hlights our continued dedication to addressing unmet needs and to advancing=
treatment options for people with chronic inflammatory skin diseases,=E2=
=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutio=
ns and Head of U.S., UCB.=C2=A0
=C2=B7 In moderate to severe psoriasis, long-term three-year pooled analyse=
s from five Phase 3/3b bimekizumab studies in moderate to severe plaque pso=
riasis will be presented, including the evaluation of maintenance of respon=
se in Week 16 responders, and the clinical response in high-impact areas. I=
n addition, there will be the first presentations of bimekizumab real-world=
data from Germany.=C2=A0
=C2=B7 In moderate to severe HS, three oral presentations will share the fi=
rst analysis of pooled data from the two Phase 3 studies, BE HEARD I and BE=
HEARD II, evaluating bimekizumab in the treatment of moderate to severe HS=
, including an assessment of disease severity over 48 weeks, as measured by=
the International HS Severity Score System (IHS4), as well as the response=
across weight and body mass index subgroups.
=C2=B7 In PsA, one oral presentation will present 52-week data from the bim=
ekizumab Phase 3 BE OPTIMAL and BE COMPLETE studies and the open-label exte=
nsion, BE VITAL.=C2=A0
In the European Union, bimekizumab is approved for the treatment of moderat=
e to severe plaque psoriasis in adults who are candidates for systemic ther=
apy, for the treatment of adults with active psoriatic arthritis and for th=
e treatment of adults with active axSpA, including non-radiographic axSpA a=
nd ankylosing spondylitis, also known as radiographic axSpA.^1 The label in=
formation may differ in other countries where approved. Please check local =
prescribing information. The efficacy and safety of bimekizumab in HS have =
not been established, and it is not approved for use in this indication by =
any regulatory authority worldwide.
UCB data presentations at EADV 2023
Bimekizumab abstracts
Hidradenitis Suppurativa=C2=A0
=C2=B7 Bimekizumab efficacy and safety in patients with moderate to severe =
hidradenitis suppurativa: Analysis of pooled data from BE HEARD I and II ph=
ase 3, randomised, double-blind, placebo-controlled, multicenter studies
Zouboulis CC, Gottlieb AB, Forman S, Weisman J, Szepietowski JC, Prens EP, =
Fujita H, Dokhe P, Muller E, Madden C, Rolleri R, Kimball AB
Oral Presentation: Thursday, October 12, 14:45 =E2=80=93 15:45 (CEST)
=C2=B7 IHS4 outcomes with bimekizumab in patients with moderate to severe h=
idradenitis suppurativa: Pooled results from the BE HEARD I and II phase 3 =
trials
Zouboulis CC, Kirby JS, Tzellos T, Khattri S, Alavi A, Podda M, del Marmol =
V, Spelman L, Rolleri R, Joshi P, Davis L, Pansar I, Frew JW=C2=A0
Oral Presentation: Thursday, October 12, 15:15 =E2=80=93 15:25 (CEST)
=C2=B7 Bimekizumab efficacy across weight and BMI based subgroups in patien=
ts with moderate to severe hidradenitis suppurativa: 48 week pooled results=
from the randomised, double blind, placebo controlled, multicentre BE HEAR=
D I and II phase 3 trials
Garg A, Lev-Tov H, Naik HB, Hampton P, Martorell A, Fern=C3=A1ndez-Pe=C3=B1=
as P, Tilt N, Madden C, Sidhu J, Dokhe P, Benhadou F
Oral Presentation: Thursday, October 12, 14:25 =E2=80=93 14:35 (CEST)
=C2=B7 Bimekizumab response maintenance to 48 weeks in patients with modera=
te to severe hidradenitis suppurativa: Pooled responder analysis from the p=
hase 3, double-blind, placebo controlled, randomised clinical trials BE HEA=
RD I and II
Ingram JR, Porter M, Chovatiya R, Giamarellos-Bourboulis EJ, Bechara FG, Fu=
jita H, Gulliver W, Muller E, Bari M, Rolleri R, Byerly R, Kirby JS
Poster: P0086
=C2=B7 Bimekizumab safety in patients with moderate to severe hidradenitis =
suppurativa: Analysis of pooled data from the BE HEARD I and II phase 3, ra=
ndomised, double-blind, placebo controlled, multicentre studies
Bechara FG, Hamzavi I, Anadkat MJ, Pinter A, Reguiai Z, Fujita H, Albrecht =
L, Dokhe P, Joshi P, Rolleri R, Deherder D, Peterson L, Jemec G=C2=A0
Poster: P0087
=C2=B7 Bimekizumab efficacy by prior biologic treatment in patients with mo=
derate to severe hidradenitis suppurativa: 48-week pooled data from the ran=
domised, double-blind, placebo controlled, multicentre BE HEARD I and II ph=
ase 3 trials
Sayed C, Shi VY, Hsiao J, Kokolakis G, Kirby B, Piguet V, Davis L, Bari M, =
Madden C, Knowles S, =C2=A0Prens EP=C2=A0
Poster: P0132
Psoriatic Arthritis=C2=A0
=C2=B7 Bimekizumab efficacy and safety in patients with active psoriatic ar=
thritis and psoriasis: 52 week results from two phase 3 randomised, placebo=
-controlled studies
Tha=C3=A7i D, Asahina A, Lebwohl M, McInnes IB, Merola JF, Warren RB, Boehn=
cke W-H, Ink B, Bajracharya R, Coarse J, Gottlieb AB
Oral Presentation: Friday, October 13, 09:00 =E2=80=93 09:10 (CEST)
=C2=B7 Sustained efficacy and safety of bimekizumab in patients with active=
psoriatic arthritis and prior inadequate response to tumour necrosis facto=
r inhibitors: Results from the phase 3 BE COMPLETE study and its open-label=
extension up to 1 year
Coates LC, Landew=C3=A9 R, McInnes IB, Mease PJ, Ritchlin CT, Tanaka Y, Asa=
hina A, Behrens F, Gladman DD, Gossec L, Gottlieb AB, Warren RB, Ink B, Baj=
racharya R, Coarse J, Merola JF
Poster: P0704
=C2=B7 A matching-adjusted indirect comparison of the efficacy of bimekizum=
ab and guselkumab at 52 weeks for the treatment of psoriatic arthritis
Warren RB, Mease PJ, Nash P, Willems D, Taieb V, Eells J, McInnes IB, Groui=
n JM, Lyris N
Poster: P0757
Psoriasis
=C2=B7 Bimekizumab 3-year safety and tolerability in moderate to severe pla=
que psoriasis: Long- term pooled analysis from five phase 3/3b trials
Lebwohl M, Strober B, Langley RG, Okubo Y, Foley P, Warren RB, Peterson L, =
Cross N, Wiegratz S, Deherder D, Tha=C3=A7i D=C2=A0
Poster: P2315
=C2=B7 Bimekizumab response through 3 years in patients with plaque psorias=
is who stopped and re started treatment
Costanzo A, Papp K, Griffiths CEM, Rosmarin D, Puig L, Han G, Tilt N, Wixte=
d K, Szilagyi B, Lambert J, Blauvelt A
Poster: P2511
=C2=B7 Bimekizumab 3-year efficacy in high-impact areas in moderate to seve=
re plaque psoriasis: Pooled results from five phase 3/3b trials
Merola JF, Conrad C, Hampton P, Lambert J, Gottlieb AB, Tilt N, Cross N, Wi=
egratz S, Gooderham M=C2=A0
Poster: P2547
=C2=B7 Bimekizumab 3-year maintenance of response in Week 16 responders wit=
h moderate to severe plaque psoriasis: Results from five phase 3/3b trials
Tha=C3=A7i D, Armstrong A, Gordon KB, Blauvelt A, Paul C, Boehncke WH, Wang=
M, Szilagyi B, Hoepken B, Lambert J, Lebwohl M=C2=A0
Poster: P2540
=C2=B7 Bimekizumab efficacy through 144 weeks in moderate to severe plaque =
psoriasis: Patient reported outcomes from BE RADIANT
Gottlieb AB, Gisondi P, Sator P, Cather J, Feldman SR, Belinch=C3=B3n I, Ve=
nder R, Warham R, Szilagyi B, Lambert J, Augustin M
Poster: P2582
=C2=B7 Bimekizumab impact on cardiovascular inflammation markers in moderat=
e to severe plaque psoriasis: Results from phase 3 trials
Warren RB, Langley RG, Kokolakis G, Kirby B, Krueger JG, Eyerich K, Davis L=
, Davies O, Cross N, Deherder D, Strober B
Poster: P2549
=C2=B7 Real-world patient characteristics and prior treatment history of bi=
mekizumab patients in Germany
Zink A, Ramond A, Shang A, Bley R, Kokolakis G=C2=A0
Poster: P2533
=C2=B7 Treatment history and symptom severity in patients with moderate to =
severe plaque psoriasis being initiated on bimekizumab: Use during the 1st =
year of routine clinical practice
Asadullah K, Korge B, Pinter A, Heidbrede T, Kumke T, Schl=C3=BCter K, Fier=
ens F, Quist S, Stavermann T=C2=A0
Poster: P2594
Axial Spondyloarthritis
=C2=B7 Bimekizumab improves key patient reported symptoms of axial spondylo=
arthritis including spinal pain and fatigue: Results from two phase 3 studi=
es
Mease PJ, Deodhar A, Dougados M, Dubreuil M, Magrey M, Marzo-Ortega H, Rudw=
aleit M, de la Loge C, Ellis A, Fleurinck C, Oortgiesen M, Taieb V, Gensler=
LS
Poster: P0288
CIMZIA^=C2=AE (certolizumab pegol) abstracts
Psoriasis
=C2=B7 Real-world data on the use of certolizumab pegol for the treatment o=
f moderate-to-severe plaque psoriasis: 1-year results from a prospective no=
n-interventional cohort study
Warren RB, Korge B, Sarro DV, Vanhooteghem O, Rodr=C3=ADguez-Cerdeira C, Bi=
anchi L, Perrussel M, Shimizu S, Kadima H, Williams P, Hee J, Pousa ID, Fie=
rens F, Lazaridou E=C2=A0
Poster: P2592
=C2=B7 Real-world data on the 1-year treatment of psoriasis with the use of=
certolizumab pegol in women of child-bearing potential
Asadullah K, Concetta Fargnoli M, De Simone C, Boy=C3=A9 T, Hillary T, Mach=
ovcova A, Makrygeorgou A, Papp K, Fl=C3=B3rez =C3=81, Williams P, Pousa ID,=
Houston N, Fierens F, Papadavid E
Poster: P2590
Disease State abstracts: Psoriasis
=C2=B7 Association of EQ-VAS with treatment benefits and patient-reported b=
enefits in patients with moderate to severe psoriasis =E2=80=93 data from t=
he German national psoriasis registry PsoBest
Augustin M, Janke TM, Heidbrede T, Fierens F=C2=A0
Poster: P2596
=C2=B7 Temporal impact of infection-related treatment emergent adverse even=
ts on patient reported outcomes in patients with moderate to severe psorias=
is =E2=80=93 analysis of the German national registry PsoBest
Augustin M, Janke TM, Heidbrede T, Fierens F=C2=A0
Poster: P2597
Notes to editors:
About certolizumab pegol in the EU/EEA^2=C2=A0
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^2
Cimzia=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) i=
n controlled and open label trials for up to 92 months. The commonly report=
ed adverse reactions (1-10%) in clinical trials with certolizumab pegol and=
post-marketing were viral infections (includes herpes =C2=A0zoster, papill=
omavirus, influenza), bacterial infections (including abscess), rash, heada=
che =C2=A0(including migraine), asthenia, leukopenia (including lymphopenia=
, neutropenia), eosinophilic disorder, pain (any sites), pyrexia, sensory a=
bnormalities, hypertension, =C2=A0pruritus (any sites), hepatitis (includin=
g hepatic enzyme increase), injection site reactions, and nausea. Serious a=
dverse reactions include sepsis, opportunistic infections, tuberculosis (in=
cluding miliary, disseminated and extrapulmonary), herpes zoster, lymphoma,=
leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (in=
cludes heart failure), ischemic coronary artery disorders, pancytopenia, hy=
percoagulation (including thrombophlebitis, pulmonary embolism), cerebrovas=
cular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and=
renal impairment/nephropathy (includes nephritis). In RA controlled clinic=
al trials, 4.4% of patients discontinued taking certolizumab pegol due to a=
dverse 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.=C2=A0
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 April 2023. https://www.ema.europa.eu/en/doc=
uments/product-information/cimzia-epar-product-information_en.pdf Last Acce=
ssed: October 2023
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.^3 The therapeutic indic=
ations in the European Union are:
=C2=B7 Plaque psoriasis: Bimekizumab is indicated for the treatment of mode=
rate to severe plaque psoriasis in adults who are candidates for systemic t=
herapy.^1=C2=A0
=C2=B7 Psoriatic arthritis: Bimekizumab is indicated alone or in combinatio=
n with methotrexate, for the treatment of active psoriatic arthritis in adu=
lts who have had an inadequate response or who have been intolerant to one =
or more disease-modifying antirheumatic drugs (DMARDs).^1
=C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment =
of adults with active non radiographic axial spondyloarthritis with objecti=
ve signs of inflammation as indicated by elevated C-reactive protein (CRP) =
and/or magnetic resonance imaging (MRI) who have responded inadequately or =
are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for t=
he treatment of adults with active ankylosing spondylitis who have responde=
d inadequately or are intolerant to conventional therapy.^1=C2=A0
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA* Important Safety Inform=
ation^1=C2=A0
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO)=
, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respective=
ly) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectiv=
ely). Common adverse reactions (=E2=89=A51/100 to <1/10) were oral candidia=
sis, tinea infections, ear infections, herpes simplex infections, oropharyn=
geal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis=
and eczema, acne, injection site reactions, fatigue. Elderly may be more l=
ikely to experience certain adverse reactions such as oral candidiasis, der=
matitis 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).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be initiated in patients with any clinically important active inf=
ection. Patients treated with bimekizumab should be instructed to seek medi=
cal advice if signs or symptoms suggestive of an infection occur. If a pati=
ent develops an infection the patient should be carefully monitored. If the=
infection becomes serious or is not responding to standard therapy, treatm=
ent should be discontinued until the infection resolves. Prior to initiatin=
g treatment with bimekizumab, patients should be evaluated for tuberculosis=
(TB) infection. Bimekizumab should not be given in patients with active TB=
. Patients receiving bimekizumab should be monitored for signs and symptoms=
of active TB.
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 including anaphylactic reactions have be=
en observed with IL-17 inhibitors. If a serious hypersensitivity reaction o=
ccurs, administration of bimekizumab should be discontinued immediately and=
appropriate therapy initiated.
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.
European SmPC date of revision: June 2023.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-pro=
duct- information_en.pdf
Last accessed: October 2023.
*EU/EEA means European Union/European Economic Area
=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
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 8,700 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follo=
w 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: change=
s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
ulatory approval for product marketing has varied in the past and UCB expec=
ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
ations may be subject to differences disputes between the partners or may p=
rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
or manufacturing problems with its products and/or devices after they are =
marketed. The discovery of significant problems with a product similar to o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, political and public scrutiny, customer and prescriber patterns or=
practices, and the reimbursement policies imposed by third-party payers as=
well as legislation affecting biopharmaceutical pricing and reimbursement =
activities and outcomes. Finally, a breakdown, cyberattack or information s=
ecurity breach could compromise the confidentiality, integrity and availabi=
lity of UCB=E2=80=99s data and systems.=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. UCB expressly disclaims any duty t=
o update any information contained in this press release, either to confirm=
the actual results or to report or reflect any change in its forward-looki=
ng statements with regard thereto or any change in events, conditions or ci=
rcumstances 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. BIMZELX=C2=AE (bimekizumab) EU Summary of Product Characteristics. Avail=
able at:=C2=A0
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-pro=
duct-information_en.pdf. Last accessed: October 2023.
2. CIMZIA=C2=AE (certolizumab pegol) EU Summary of Product Characteristics.=
April 2023. https://www.ema.europa.eu/en/documents/product-information/cim=
zia-epar-product-information_en.pdf. Last accessed October 2023.
3. 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.
GenericFile
UCB PR EADV Data Highliths Oct 09 2023 ENG (https://mb.cision.com/Public/18=
595/3849304/9f298fd1f31d821c.pdf)
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