UCB Media Room: UCB Showcases Strength of the Expanding Dermatology Portfolio at the 31st EADV Congress

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 [e-mail]=C2=A0 Corporate Communications Laurent Schots=C2=A0 T +32.2.559.92.64=C2=A0 email [e-mail] Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 email [e-mail]=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. 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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. GenericFile UCB PR EADV Sept 1 2022 ENG (https://mb.cision.com/Public/18595/3624074/85e= 06d415ece042a.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x114695x1x6868579x2400= 0x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium