UCB (EBR:UCB) UCB Media Room: First presentation of four-year BIMZELX®(bimekizumab-bkzx) data showed long-term maintenance of complete skin clearance in moderate to severe plaque psoriasis

Transparency directive : regulatory news

09/03/2024 18:00

https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= CyBv9bezcPT-2BuItTLKIHepbxTbo-2FYbVFPSBekB-2Bmk9X7Kl8shoTE6BsSbYYjHYcOVCrOC= rjYrJUHPDVbu1NKaBE-3DRjRk_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33yYgKHnNyeXdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86hmN= nnQOvk5Z-2FsYLsJqDO-2B6UHvpgJMp-2BndCC7xJbSujPrp4p8m5-2BLBt4KfmTrfhbUNXlsCW= dkV8X4QguBcYfzvOKGBVSHPoeyxOGf2SrnxpOGH2Q-2BIoh7bKJNmUpCG3r-2Bi2-2F8TyGrqNm= MalI91s3Sno1Ou7H2ACvgoUYrcTesLXxwHZ9fw-3D ** First presentation of four-year BIMZELX^=C2=AE(bimekizumab-bkzx) data sh= owed long-term maintenance of complete skin clearance in moderate to severe= plaque psoriasis ------------------------------------------------------------ =C2=B7 Late-breaking platform presentation showed that bimekizumab-bkzx rap= idly achieved and maintained high rates of clinical and health-related qual= ity-of-life responses through four years; six out of ten patients achieved = complete skin clearance at Year 4 =C2=B7 Responder-analyses demonstrated that approximately nine out of ten p= atients treated with bimekizumab-bkzx who achieved PASI90 at Week 16, and o= ver seven out of ten patients who achieved complete skin clearance (PASI100= ) maintained their response to Year 4 =C2=B7 Four-year safety data showed that treatment-emergent adverse events = were consistent or decreased with longer bimekizumab-bkzx exposure, with no= new safety signals Brussels (Belgium), 9 March 2024 =E2=80=93 18:00 (CET) =E2=80=93 UCB, a glo= bal biopharmaceutical company, today announced=C2=A0that the first presenta= tions of BIMZELX^=C2=AE (bimekizumab-bkzx) four-year efficacy and safety da= ta in the treatment of adults with moderate to severe plaque psoriasis are = being shared this week at the 2024 American Academy of Dermatology (AAD) An= nual Meeting in San Diego, California, U.S., March 8=E2=80=9312. =E2=80=9CWe are proud to debut the BIMZELX^=C2=AE four-year psoriasis data = at the world=E2=80=99s largest dermatology meeting, showing that the majori= ty of adult patients treated with bimekizumab-bkzx achieved deep and durabl= e clinical response through four years, with a consistent tolerability prof= ile. These results, from the largest pool of Phase 3 data, closely follow t= he U.S. launch, and reinforce our belief that BIMZELX^=C2=AE has the potent= ial to transform the lives of people with moderate to severe plaque psorias= is,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology S= olutions and Head of U.S., UCB. =E2=80=9CModerate to severe plaque psoriasis is a chronic condition with ph= ysical skin manifestations that can place a significant burden on a patient= =E2=80=99s health-related quality-of-life. Analysis shows that through four= years of bimekizumab-bkzx treatment, over six out of ten patients achieved= and maintained complete skin clearance, a clinically meaningful endpoint a= nd outcome for patients. These long-term data will be highly welcomed by th= e dermatology community since they provide important considerations for cli= nical practice,=E2=80=9D said Dr. Bruce Strober, Clinical Professor of Derm= atology at Yale University, and Central Connecticut Dermatology, Connecticu= t, U.S. The late-breaking platform presentation shared bimekizumab-bkzx pooled data= from treatment initiation through four years, showing that high rates of c= linical and health-related quality-of-life responses were rapidly achieved = and were maintained in the long term.^^[1]^ Responder-analyses showed that = approximately nine out of ten patients treated with bimekizumab-bkzx who ac= hieved =E2=89=A590 percent improvement from baseline in the Psoriasis Area = Severity Index (PASI90) and over seven out of ten patients who achieved com= plete skin clearance (PASI100) at Week 16 maintained their responses to Yea= r 4.[2] Pooled analysis from five Phase 3/3b studies showed that bimekizuma= b-bkzx demonstrated good tolerability and a consistent safety profile with = no new safety findings identified up to four years in patients with moderat= e to severe plaque psoriasis.[3] Highlights from the four-year bimekizumab-bkzx data in moderate to severe p= laque psoriasis presented at the 2024 AAD: Treatment initiation through four years: Data were pooled across the 52-wee= k BE VIVID study, the 56-week BE READY and BE SURE studies and their open-l= abel extension (OLE Week 144) BE BRIGHT.^1 Analyzed patients were randomize= d to bimekizumab-bkzx 320 mg every four weeks (Q4W) to Week 16, then bimeki= zumab-bkzx Q4W or Q8W until OLE entry.^1 Clinical and health-related qualit= y of life (PASI90 and PASI100, body surface area [BSA] =E2=89=A41 percent a= nd Dermatology Life Quality Index [DLQI]0/1) responses were assessed throug= h to Year 4 (OLE Week 144).^1 Data are presented below for all patients who= received bimekizumab-bkzx continuously from baseline and entered the OLE (= n=3D771):^1 =C2=B7 90.9 percent achieved PASI90 at Week 16, and 86.1 percent through to= Year 4.^1=C2=A5 =C2=B7 65.8 percent achieved PASI100 at Week 16, and 64.7 percent through t= o Year 4.^1=C2=A5 =C2=B7 78.5 percent achieved BSA=E2=89=A41 percent at Week 16, and 79.8 per= cent through to Year 4.^1=C2=A5 =C2=B7 71.5 percent achieved DLQI0/1 at Week 16, and 78.7 percent through t= o Year 4.^1 =C2=A5 Responder analysis to Year 4: Patients who completed the BE VIVID, BE SURE = and BE READY Phase 3 studies could enter the BE BRIGHT OLE.^2 Analyzed pati= ents were randomized to bimekizumab-bkzx 320 mg Q4W to Week 16, then bimeki= zumab-bkzx Q4W or Q8W until OLE entry, then bimekizumab-bkzx Q4W or Q8W dep= endent on PASI response/prior dose.^2 Maintenance of PASI90 and PASI100 was= assessed in Week 16 responders to Year 4 (OLE Week 144) and is presented b= elow for all patients:^2 =C2=B7 87.7 percent who achieved PASI90 at Week 16 (n=3D693) maintained the= ir response to Year 4.^2=C2=A5 =C2=B7 73.3 percent who achieved PASI100 at Week 16 (n=3D503) maintained th= eir response to Year 4.^2=C2=A5 Safety and tolerability through four years: Data were pooled across the 52-= week BE VIVID study, the 56-week BE READY and BE SURE studies, and the OLE = studies BE BRIGHT and BE RADIANT.^3 The total bimekizumab-bkzx exposure was= 6,324.3 patient-years (PY) across the studies (n=3D2,186).^3 =C2=B7 Exposure-adjusted incidence rates (EAIRs) of treatment-emergent adve= rse events (TEAEs) remained consistent or decreased with longer bimekizumab= -bkzx exposure. Overall, TEAEs occurred at an EAIR of 170.5/100 PY and seri= ous TEAEs at 5.5/100 PY.^3 =C2=B7 The most common TEAEs were nasopharyngitis (12.7/100 PY), oral candi= diasis (8.9/100 PY), and upper respiratory tract infections (5.7/100 PY). O= ral candidiasis decreased from 18.9/100 PY at Year 1 to 5.4/100 PY at Year = 4.^3 Throughout, fewer TEAEs occurred with bimekizumab-bkzx every 8 weeks (= Q8W) (115.4/100 PY) vs. every 4 weeks (Q4W) (224.4/100 PY).^3 ^=C2=A5 Modified non-responder imputation analyses ** Notes to Editors: ------------------------------------------------------------ ** About BIMZELX^=C2=AE =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2= =A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0=C2=A0= =C2=A0=C2=A0=C2=A0=C2=A0Bimekizumab-bkzx is a humanized monoclonal IgG1 ant= ibody that is designed to selectively inhibit both interleukin 17A (IL-17A)= and interleukin 17F (IL-17F), two key cytokines driving inflammatory proce= sses.[4] ------------------------------------------------------------ ** In the U.S., BIMZLEX^=C2=AE is approved for the treatment of moderate to= severe plaque psoriasis in adults who are candidates for systemic therapy = or phototherapy.[5] ------------------------------------------------------------ The approved indications for bimekizumab=E2=96=BC 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.[6] =C2=B7 Psoriatic arthritis: Bimekizumab, alone or in combination with metho= trexate, is indicated for the treatment of active psoriatic arthritis in ad= ults who have had an inadequate response or who have been intolerant to one= or more disease-modifying antirheumatic drugs (DMARDs).^6 =C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment = of adults with active non- radiographic axial spondyloarthritis with object= ive signs of inflammation as indicated by elevated C reactive protein (CRP)= , and/or magnetic resonance imaging (MRI) who have responded inadequately o= r are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for= the treatment of adults with active ankylosing spondylitis who have respon= ded inadequately or are intolerant to conventional therapy.^6 The label information may differ in other countries where approved. Please = check local prescribing information. In the U.S., bimekizumab is not approved for the treatment of psoriatic art= hritis or axial spondyloarthritis and=C2=A0these are investigational indica= tions only. ** BIMZELX U.S. IMPORTANT SAFETY INFORMATION^5 ------------------------------------------------------------ Please see Important Safety Information below and full U.S. prescribing inf= ormation at www.UCB- (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.= b00YhNV2Nr0-2BaZn7eVNAdfGZi1a7X9NeZMGrLhKNUu7h9rj85yIm-2BJQyDHDxAfTjDGCgwTQ= -2Fy3VuTuEtRgHDMw-3D-3DT5gJ_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl= -2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEG= LNn-2B6FohpNoV33yYgKHnNyeXdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86h= mNnnQOvk5Z-2FsYLsJqDO-2B6UHvpgACwroPiQpr-2FLsDYK7cPvE17b1ZGR4MFC91g4e4Vt8Yj= OuxQ-2BlENwmoGgigWxOCLg0eY1SWzGefhtj4lYejgj-2F66GTF19tC1Ab-2F7XXMdm-2BVIx9P= nVE-2BOvfaQBSaar1yJvA52NQ5786lr8qpO4t2mC-2FU-3D USA.com/Innovation/Products= /BIMZELX (https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.b00YhNV2Nr0-= 2BaZn7eVNAdfGZi1a7X9NeZMGrLhKNUu7h9rj85yIm-2BJQyDHDxAfTjDGCgwTQ-2Fy3VuTuEtR= gHDMw-3D-3DsIcW_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2= BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpN= oV33yYgKHnNyeXdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86hmNnnQOvk5Z-2= FsYLsJqDO-2B6UHvpgBT78Ek8-2FzbCfVvJfRGpp2N2-2FXbpnRVLW17p-2B9gPUx8kS4XO7c4D= zBOu-2FjbnFp9GDSIZcuyR12Rm-2F8QC2RuSPsim3WAhM79uUiyuEQ-2F4wTsmCAnHGLnj84g8C= z6aEA1i-2Bjgh-2BCipQSCp9Mpj90jVCpw-3D . Suicidal Ideation and Behavior BIMZELX^=C2=AE (bimekizumab-bkzx) may increase the risk of suicidal ideatio= n and behavior (SI/B). A causal association between treatment with BIMZELX = and increased risk of SI/B has not been established. Prescribers should wei= gh the potential risks and benefits before using BIMZELX in patients with a= history of severe depression or SI/B. Advise monitoring for the emergence = or worsening of depression, suicidal ideation, or other mood changes. If su= ch changes occur, advise to promptly seek medical attention, refer to a men= tal health professional as appropriate, and re- evaluate the risks and bene= fits of continuing treatment. ** Infections ------------------------------------------------------------ BIMZELX may increase the risk of infections. Do not initiate treatment with= BIMZELX in patients with any clinically important active infection until t= he infection resolves or is adequately treated. In patients with a chronic = infection or a history of recurrent infection, consider the risks and benef= its prior to prescribing BIMZELX. Instruct patients to seek medical advice = if signs or symptoms suggestive of clinically important infection occur. If= a patient develops such an infection or is not responding to standard ther= apy, monitor the patient closely and do not administer BIMZELX until the in= fection resolves. ** Tuberculosis ------------------------------------------------------------ Evaluate patients for tuberculosis (TB) infection prior to initiating treat= ment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infe= ction. Initiate treatment of latent TB prior to administering BIMZELX. Cons= ider anti-TB therapy prior to initiation of BIMZELX in patients with a past= history of latent or active TB in whom an adequate course of treatment can= not be confirmed. Closely monitor patients for signs and symptoms of active TB during and aft= er treatment. ** Liver Biochemical Abnormalities ------------------------------------------------------------ Elevated serum transaminases were reported in clinical trials with BIMZELX.= Test liver enzymes, alkaline phosphatase and bilirubin at baseline, period= ically during treatment with BIMZELX and according to routine patient manag= ement. If treatment-related increases in liver enzymes occur and drug-induc= ed liver injury is suspected, interrupt BIMZELX until a diagnosis of liver = injury is excluded. Permanently discontinue use of BIMZELX in patients with= causally associated combined elevations of transaminases and bilirubin. Av= oid use of BIMZELX in patients with acute liver disease or cirrhosis. ** Inflammatory Bowel Disease ------------------------------------------------------------ Cases of inflammatory bowel disease (IBD) have been reported in patients tr= eated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in pat= ients with active IBD. During BIMZELX treatment, monitor patients for signs= and symptoms of IBD and discontinue treatment if new onset or worsening of= signs and symptoms occurs. ** Immunizations ------------------------------------------------------------ Prior to initiating therapy with BIMZELX, complete all age-appropriate vacc= inations according to current immunization guidelines. Avoid the use of liv= e vaccines in patients treated with BIMZELX. ** Most Common Adverse Reactions ------------------------------------------------------------ Most common adverse reactions (=E2=89=A51 percent) are upper respiratory in= fections, oral candidiasis, headache, injection site reactions, tinea infec= tions, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, othe= r Candida infections, and fatigue. ** BIMZELX^=C2=AE=E2=96=BC(bimekizumab) EU/EEA* Important Safety Informatio= n^6 ------------------------------------------------------------ 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 initiating treatment with bimekizumab, patients should be evaluate= d for tuberculosis (TB) infection. Bimekizumab should not be given in patie= nts 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: November 2023. https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0r= C2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQ= d4uSQwA6JMudpi5XOwHZtyAHZJBd6YRdp1RSNV5wqOW9bXtWvsAqZERe5h1aJ-2FJNQ-3D-3Dbs= kI_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz= 3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33yYgKHnNye= Xdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86hmNnnQOvk5Z-2FsYLsJqDO-2B6= UHvpgCZtK-2Bdq-2FqDMeWjZvtlYcfjZOgcegQyGy1VIFM2w0N41bmHNM9IihBLfeFdtLmJykU9= ZsHwkLpV4oxkATx74TNJR0EmkCvP-2B1HhM86wy2fambfteWWUs2mBhSSRhST42WWXbtIgeFQ8g= pN8BWIIEFAg-3D *EU/EEA means European Union/European Economic Area Last accessed: March 20= 24. =E2=96=BCThis medicinal product is subject to additional monitoring. This w= ill allow quick identification of new safety information. Healthcare profes= sionals are asked to report any suspected adverse reactions. For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email antje.witte@ucb.com (mailto:antje.witte@ucb.com) Corporate Communications Laurent Schots T +32.2.559.92.64 email laurent.schots@ucb.com (mailto:laurent.schots@ucb.com) Brand Communications Eimear O=E2=80=99Brien T +32.2.559.92.71 email eimear.obrien@ucb.com (mailto:eimear.obrien@ucb.com) About UCB 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 9,000 peopl= e in approximately 40 countries, the company generated revenue of =E2=82=AC= 5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Foll= ow us on Twitter: @UCB_news. 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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, join= t ventures or licensing collaborations may be subject to differences disput= es between the partners or may prove to be not as safe, effective or commer= cially successful as UCB may have believed at the start of such partnership= . UCB=E2=80=99s efforts to acquire other products or companies and to integ= rate the operations of such acquired companies may not be as successful as = UCB may have believed at the moment of acquisition. Also, UCB or others cou= ld discover safety, side effects or manufacturing problems with its product= s and/or devices after they are marketed. The discovery of significant prob= lems 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 on sales of= the entire class of affected products. Moreover, sales may be impacted by = international and domestic trends toward managed care and health care cost = containment, including pricing pressure, political and public scrutiny, cus= tomer and prescriber patterns or practices, and the reimbursement policies = imposed by third-party payers as well as legislation affecting biopharmaceu= tical pricing and reimbursement activities and outcomes. Finally, a breakdo= wn, cyberattack or information security breach could compromise the confide= ntiality, integrity and availability of UCB=E2=80=99s data and systems. 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. 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. References [1]. Strober B. 2024 AAD. Oral Presentation. [2]. Blauvelt A, Foley P, Langley RG, et al. Bimekizumab 4-year maintenance= of responses in Week 16 responders with moderate to severe plaque psoriasi= s: Results from the BE BRIGHT open label extension phase 3 trial. Abstract = at the 2024 American Academy of Dermatology Annual Meeting, San Diego, CA, = U.S., March 8=E2=80=9312, 2024. [3]. Gordon KB, Tha=C3=A7i D, Gooderham M, et al. Bimekizumab safety and to= lerability in moderate to severe plaque psoriasis: Pooled analysis from up = to 4 years of treatment in 5 phase 3/3b clinical trials. Abstract at the 20= 24 American Academy of Dermatology Annual Meeting, San Diego, CA, U.S., Mar= ch 8=E2=80=9312, 2024. [4]. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of = bimekizumab, a humanized monoclonal antibody and selective dual inhibitor o= f IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991= =E2=80=931001. [5]. BIMZELX^=C2=AE (bimekizumab) U.S. PI. https://u7061146.ct.sendgrid.net= /ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC8ikjD3-2B-2FLuLRRIcxGl3OVRfrTFi= EVtUNeu2NHn-2F-2FuffGxyTakNkkWC5d5THSt3bBtYfzsP-2Bd2mUiXqYvXD6ZWM-3DWcmc_2d= CLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplc= EW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33yYgKHnNyeXdah3= 2zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86hmNnnQOvk5Z-2FsYLsJqDO-2B6UHvpg= JuoygJ8wqKKNwM1FbsMgx1QlEC5yl4vDr9WN2dcwuJfrS05CQUftr-2FKbJvLbNbuuWlxkgdB9B= 3426kXKzgA5tWjfeOUnq0Fq9gaU4Of3112HRYcRfSSo6XQvUfV7iLhapO1WE0XxKyfve8q69UAP= 1c-3D Accessed March 2024. [6]. BIMZELX^=C2=AE (bimekizumab) EU SmPC. https://u7061146.ct.sendgrid.net= /ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rC2tJ60H3Fdk1VajTAIAj7NPJeYj-2Ba-= 2BL1r-2B0jLM-2FtfvSeD3KLQsazq58-2BxwfyV7LSQd4uSQwA6JMudpi5XOwHZtyAHZJBd6YRd= p1RSNV5wqOWwE2cRsny7Ehx4x7oG7pgXg-3D-3DRWbX_2dCLUNbuBjhX746-2FvM63L9Hyn3KnT= FGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIx= s8cV3s33SbkEZvEGLNn-2B6FohpNoV33yYgKHnNyeXdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1= Uf0nCHDhMRh7Q86hmNnnQOvk5Z-2FsYLsJqDO-2B6UHvpgKVTMbYOQkkXDsXnwHaT66FPEsZI0Q= L3u3EXjtjfpSUKz5rSuxQVlNpnnmnBVCI16k7QO49uYa-2FZLrUdU7tS6JbIRtHUfikFQz3cpcy= 576VRlxJ-2F6V-2FOHQY-2FdeyszcXA5HeHEd-2BoMBe14j-2BoFW-2F9yVU-3D Accessed Ma= rch 2024. GenericFile AAD Psoriasis Press Release Saturday09032024 1800 CET (https://u7061146.ct.= sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIuSly0rCyBv9bezcPT-2BuItTLK= IHepZ1ZJySsq-2FzjbU8chrb0nkDVcFmWaLW6RXJt-2FKizPlUxMhvZ-2FzfQ9xHfxmXDGFumzg= -3DpV_3_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2FKl1Z2nt-2BIfez2IJ= 0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLNn-2B6FohpNoV33yYgK= HnNyeXdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86hmNnnQOvk5Z-2FsYLsJqD= O-2B6UHvpgE3m0qn46GgrKeThCyV03B9xSfmxti1cqO94DqyZBY4FYW8csnE7I9huWum1Pbv1MB= SPt7BQDcVRFbS-2BlFwYSBryXBoCxGzcvVJZ6-2B3oerjXtlPeiaEj-2BkI5crWoI3SRiEJva1L= foVMy4HtXgBxDdU4-3D ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://u7061146.ct.sendgrid.net/ls/click?upn=3Du001.gqh-2BaxUzlo7XKIu= Sly0rC3nfmD42E6tJ6HwHGmqtXbhtXDlQ2cTEdRpWV-2BrYPIUN-2FkXZe7H7ZUDAhzUMagX-2B= o386aSFq1N3tImC-2Bv8-2FwH3ZAP1CX2WGfB2276WkJN1czBVAiLl-2B0SfJ6HfVYPIvgJC4r4= A7NRw3z4Tm9AM8Wu38-3DM8Yu_2dCLUNbuBjhX746-2FvM63L9Hyn3KnTFGM-2BPPGCjZgmJl-2= FKl1Z2nt-2BIfez2IJ0TSaz3mplcEW6ZopJ4gUd4Ia3MTdQeFO93DwfIxs8cV3s33SbkEZvEGLN= n-2B6FohpNoV33yYgKHnNyeXdah32zfGKaMovjabIWlHGUdJJ8PPTkKq1Uf0nCHDhMRh7Q86hmN= nnQOvk5Z-2FsYLsJqDO-2B6UHvpgGlTAm6EJP9LGC2alo-2B9yLYoqII8KKTap7UFEcNcITnSPT= vpZ5VdPIi37yt1IB-2BsHANQVw-2Bh-2FaTB9x39-2BAD0nhp6dke9TQlCnEGv7zhhoFaBnZ3DU= 6XNYKTvWQs7ma36bo-2FgGdFNmMuqrcLiJ1uGCRA-3D UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . 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UCB (EBR:UCB) UCB Media Room: First presentation of four-year BIMZELX®(bimekizumab-bkzx) data showed long-term maintenance of complete skin clearance in moderate to severe plaque psoriasis

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