24 scientific abstracts reflect UCB's ongoing commitment to improving outcomes for people living with neurological conditions, including rare epilepsies Dravet syndrome and Lennox-Gastaut syndrome, as well as generalized myasthenia gravis and thymidine kinase 2 deficiency.Research includes disease course data of untreated patients with thymidine kinase 2 deficiency from largest international dataset.Also features new data on generalized myasthenia gravis treatments RYSTIGGO®1 (rozanolixizumab-noli) and ZILBRYSQ®2 (zilucoplan) including an open-label extension study investigating rozanolixizumab self-administration and a phase 3 study on the effect of zilucoplan on specific outcome scores.Data on FINTEPLA®3 (fenfluramine), BRIVIACT®4 (brivaracetam) CV, and investigational therapy STACCATO®* alprazolam showcase commitment to people living with epilepsies and their unmet needs.

Clinical data highlight survival benefits and improvement in functional motor outcomes associated with treatment with doxecitine (dC) and doxribtimine (dT) - an investigational pyrimidine nucleoside therapy - in people living with thymidine kinase 2 deficiency (TK2d).1,2,3Additional patient experience data emphasize the profound physical challenges and severe psychological strain that come with living with TK2d, and the heavy emotional and physical burden experienced by caregivers.4,5Across all study populations, pyrimidine nucleoside and/or nucleotide therapy was generally well tolerated.1,2,3TK2d is an ultra-rare, life-threatening, genetic mitochondrial disease with no currently approved treatment options.6,7,8,9,10,11

FINTEPLA is approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients two years of age and older1Results showed the most common treatment-emergent adverse events were pyrexia, nasopharyngitis and decreased appetite, with no valvular heart disease or pulmonary arterial hypertension observed in this study2FINTEPLA was associated with a statistically significant and clinically meaningful sustained reduction in monthly convulsive seizure frequency (MCSF)2,3

Over half of patients had no draining tunnels (DTs) at two years: In 425 hidradenitis suppurativa (HS) patients with ≥1 DTs at baseline, 55.7% (195/350) had no DTs at two years of treatment.≠ DTs are painful, pus-discharging tunnels under the skin resulting from long-term inflammation, frequently leading to scarringClinically meaningful relief from skin pain: At two years of BIMZELX treatment, 63.6% (279/439) of patients reported no or mild skin pain, compared to 10.0% (55/551) at baseline≠Sustained disease control across patient populations: Improvements in HiSCR50* and HiSCR75* sustained up to two years, regardless of age, sex, disease duration or severity, demonstrating efficacy regardless of patient demographics≠Improved responses with earlier treatment: Patients demonstrated efficacy at high HiSCR90* and HiSCR100* thresholds, and those who had a shorter duration from diagnosis to treatment had better outcomes, emphasizing the importance of early diagnosis and early treatment≠

Sustained complete skin clearance over five years: In a subset of 153 patients from the second extension of BE BRIGHT, 67.7% of patients with moderate-to-severe plaque psoriasis (PSO) treated with BIMZELX® (bimekizumab-bkzx) achieved PASI100+ at five yearsDurable and broad efficacy across patient subgroups at four years: Consistently high rates of complete or near-complete skin clearance seen at four years regardless of baseline weight or baseline cardiometabolic comorbidities such as hypertension, hyperglycemia, or elevated BMIHigh response rates in patients at risk of psoriatic arthritis at three years: Data showed 68.7–71.6% of PSO patients at risk of developing psoriatic arthritis (PsA) achieved complete skin clearance, generally consistent with the overall treated group. Similar results were seen in all patients with PSO, including those with PsA at baselineDual inhibition: BIMZELX® is the first and only approved medicine designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)

Revenue in 2024 increased to € 6.15 billion, a plus of 17% (+19% CER1),Net sales were up by 15% to € 5.61 billion (+17% CER1) driven by a strong, triple- and double-digit growth performance of newly launched growth drivers: BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO® and ZILBRYSQ® as well as solid contribution from CIMZIA® and BRIVIACT® reaching its peak sales two years ahead of targetUnderlying profitability (adj. EBITDA2) went up to € 1.48 billion, a plus of 9% (+18% CER1), 24.0% of revenue; Core EPS3 increased to € 4.98R&D update: Doxecitine and doxribtimine in thymidine Kinase 2 deficiency filed in U.S. – with granted priority review - and in EU; 1st phase 3 with positive results for dapirolizumab pegol in systemic lupus erythematosus (SLE), 2nd phase 3 started; Phase 2a study in atopic dermatitis with UCB9741/galvokimig showed positive and convincing dataSustainability with significant improvement in patient access, CO2 reduction and ESG ratingsFinancial guidance for 2025: Revenue expected to grow to € 6.5-6.7 billion, adjusted EBITDA2 to reach 30% of revenue, Core EPS3 in the range of € 6.80-7.40

BIMZELX® (bimekizumab-bkzx) is now commercially available by prescription in the United States in a 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELXThe single-injection device offers convenience for patients requiring a 320 mg dose of BIMZELX with single-injection administration

ATLANTA, Jan. 16, 2025 /PRNewswire/ -- UCB, a global biopharmaceutical company, announced today that a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of BIMZELX® (bimekizumab-bkzx) is now available. These are in addition to the currently available 1 mL device administration options, each containing 160 mg of BIMZELX.

Results of a social media listening study of women of childbearing age with epilepsy underscore the need for HCPs to provide relevant information at critical time points to support shared decision-making2A quality-of-life survey administered to caregivers of individuals with developmental and epileptic encephalopathies (DEEs) suggests improved understanding of caregiver definitions of normal and disruptive experiences can help researchers prioritize areas of focus to improve outcomes3Study shows prolonged seizures are a key driver in worsening quality of life for people with epilepsy and their caregivers4Pharmacokinetic data from Phase 1 study shows alprazolam administration via the Staccato® hand-held device is an efficient delivery route currently being studied for stereotypical prolonged seizures5New efficacy data on FINTEPLA® (fenfluramine) as a treatment for seizures associated with Lennox-Gastaut syndrome (LGS)6

32 scientific abstracts reflect ongoing commitment to improving outcomes for people living with epilepsiesData include the use of FINTEPLA® (fenfluramine)1 oral solution in seizures associated with Dravet syndrome and Lennox-Gastaut syndrome, BRIVIACT® (brivaracetam) CV2 and VIMPAT® (lacosamide) CV3 in focal-onset seizures, and *Staccato[®] alprazolam4 (investigational treatment) for acute on-demand seizure management, plus latest updates from UCB's pipeline programsAdditional focus on the impact of epilepsy on aspects of everyday life, including research exploring epilepsy and sleep, epilepsy and motherhood, and the consequences of prolonged seizures on the quality of life of patients and caregivers

ACR Convergence 2024 marks UCB's first presentation of data in psoriatic arthritis (PsA), non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS) since the recent approvals of BIMZELX® (bimekizumab-bkzx) in these indications in the U.S.New two-year data demonstrated sustained improvements in clinical and patient-reported outcomes in PsA, nr-axSpA, and AS patients treated with BIMZELXUCB will present 19 BIMZELX abstracts, including two oral presentations, across PsA, nr-axSpA, and AS, as well as plaque psoriasis (PSO)

UCB will contribute 14 presentations, including an oral presentation, selected to feature across the AANEM and MGFA meeting, emphasizing UCB's leadership in neuromuscular researchPresentations showcase new data for UCB's gMG treatments, including post hoc analyses highlighting the long-term safety and efficacy of ZILBRYSQ® (zilucoplan)1 and RYSTIGGO® (rozanolixizumab-noli) 2

BRUSSELS, Oct. 11, 2024 /PRNewswire/ -- UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that it will be presenting results from across its portfolio in generalized myasthenia gravis (gMG) at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) annual meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session taking place October 15—18, 2024 at the Savannah Convention Center in Savannah, Georgia, U.S.

First Phase 3b study in psoriatic arthritis to evaluate the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitorThis first head-to-head study in psoriatic arthritis to use ACR50 at Week 16 as a primary endpointStudy underscores UCB's belief in BIMZELX with top-line results expected in 2026

ATLANTA, Sept. 30, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the start of BE BOLD, a head-to-head Phase 3b study, comparing BIMZELX® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor, with SKYRIZI® (risankizumab), an IL-23 inhibitor, in the treatment of adults with active psoriatic arthritis (PsA). BE BOLD is the first head-to-head study in PsA evaluating the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor.

Clinically meaningful improvements observed with BIMZELX over one year of treatment were maintained up to two years (Week 96)At Week 96, over eight in 10 patients treated with BIMZELX achieved HiSCR50, over seven in 10 achieved HiSCR75, and over four in 10 achieved HiSCR100*Approximately one in three patients treated with BIMZELX reported minimal or no impact of the disease on their health-related quality of life over two years*

ATLANTA, Sept. 27, 2024 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced the first presentation of two-year data from the Phase 3 studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and safety of BIMZELX® (bimekizumab-bkzx), an interleukin (IL)-17A and IL-17F inhibitor, in adults with moderate-to-severe hidradenitis suppurativa (HS).1 These new data are presented today as a late-breaking platform presentation at the 33rd European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands, September 25–28, 2024.

Responder analyses demonstrated that approximately nine out of 10 patients treated with BIMZELX who achieved PASI90 at Year 1, and over seven out of 10 patients who achieved complete skin clearance (PASI100) at Year 1, maintained this response to Year 4Switching adalimumab, secukinumab, or ustekinumab PASI90 non-responders to BIMZELX led to most patients (over 70 percent) rapidly achieving and maintaining PASI90 for up to four years, and a large proportion (over 40 percent) achieved complete skin clearance based on a post-hoc analysis

With three new indications, BIMZELX® (bimekizumab-bkzx) is the first and only IL-17A and IL-17F inhibitor approved in the U.S. for the treatment of four chronic immune-mediated inflammatory diseasesApproval in active PsA is supported by two Phase 3 studies in which BIMZELX showed statistically significant improvements vs. placebo at Week 16 in both joint and skin symptoms, across biologic-naïve and TNF inhibitor-inadequate responder populations, which were sustained to Week 52Approvals in active nr-axSpA and active AS are supported by two Phase 3 studies, in which BIMZELX showed statistically significant improvements vs. placebo in signs and symptoms at Week 16, which were sustained to Week 52

New data presented at the 15th European Epilepsy Congress highlight lengthy delays in Lennox-Gastaut syndrome (LGS) diagnosis in Europe and significant disease burden from both seizure and non-seizure impairments[1]LGS is a severe childhood-onset developmental and epileptic encephalopathy, a group of epilepsies associated with developmental impairment, which is characterized by several different seizure types[2]New treatment options are needed to improve the long-term prognosis of individuals with LGS[3]

The inaugural UCB Hidradenitis Suppurativa (HS) Summit will bring people living with HS, caregivers, advocacy leaders, and invited healthcare providers together on UCB's Atlanta campus to advance understanding of the HS treatment journey and unmet needsThe UCB HS Summit will amplify the Make HStory educational campaign, which offers resources and support for those living with hidradenitis suppurativa and treating healthcare providersRenowned dermatologist and TV personality Dr. Sandra Lee will attend and speak at the Summit