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UCB Media Room: UCB at the 34th International Epilepsy Congress

INFORMATION REGLEMENTEE


[27/08/2021 | 07:07]
https://mb.cision.com/Public/18595/logo/86a99b25f755738d_org.jpg ** UCB showcases commitment to treatment and management of epilepsy at the = 34th International Epilepsy Congress ------------------------------------------------------------ =C2=B7 Scientific presentations illustrate impact, breadth and real-world v= alue of UCB=E2=80=99s epilepsy treatment portfolio =C2=B7 Sponsored symposia debate clinical approaches in the management of e= pilepsy, as well as discuss latest scientific advances and health-tech supp= ort solutions for people living with epilepsy Brussels (Belgium), 27 August =E2=80=93 07:00 (CET): UCB today reinforced i= ts commitment to the treatment and management of epilepsy at the 34th Inter= national Epilepsy Congress (IEC, 28 Aug- 1 Sep), showcasing a broad range o= f clinical data and real-world experience with its approved anti-seizure me= dicines, as well as highlighting the role that health-technology solutions = can play in helping people living with epilepsy and their healthcare provid= ers manage their condition.=C2=A0 =E2=80=9CIt=E2=80=99s our goal to redefine the future of epilepsy medicine,= aspiring to bring even greater value to people living with seizures,=E2=80= =9D said Charl van Zyl, Executive Vice President Neurology & Head of Europe= /International Markets at UCB. =E2=80=9CFor more than 30 years, we have pro= vided solutions that have helped transform the treatment landscape and impr= oved the lives of millions of people living with epilepsy. Our commitment h= as never been stronger; we are utilizing our experience and expertise to de= velop new differentiated medicines and are dedicated to advancing technolog= y support solutions that address specific unmet patient needs. It is our ai= m that one day, our transformative science will even lead to solutions that= are disease-modifying, impacting the underlying causes of the disease.=E2= =80=9D At the congress, UCB will be reporting data from several studies on BRIVIAC= T^=C2=AE (brivaracetam). These data cover several recent real-world evidenc= e studies for epilepsy patients living with partial onset seizures, reinfor= cing the efficacy and tolerability of the medicine, as well and clinical st= udies on the safety and tolerability of its intravenous formulation for use= in pediatric populations. Additional data will also report the efficacy an= d tolerability of adjunctive Vimpat^=C2=AE (lacosamide) as a treatment for = primary generalized tonic-clonic seizures. =E2=80=9CThese studies further d= emonstrate UCB=E2=80=99s commitment to scientific and medical knowledge exc= hange and creating value for a broad cross-section of people living with ep= ilepsy,=E2=80=9D added Prof. Konrad Werhahn, Global Head Epilepsy Medical A= ffairs at UCB. Alongside the presentation of these data, UCB will be facilitating two sate= llite symposia to debate current issues in epilepsy care and to showcase in= novative digital and scientific approaches to the current and future treatm= ent and management of epilepsy. The first symposium entitled =E2=80=98Bridg= ing the gap: what do patients want from the management of their epilepsy?= =E2=80=99 is hosted by Christian Brandt MD, Head of Department, Bethel Epil= epsy Center in Germany. A key topic of debate will be the importance of man= aging patient preference in the context of efficacy and tolerability, in ch= oosing anti-seizure medications.=C2=A0 The second symposium, entitled =E2=80=98The future of the epilepsies: innov= ation, transformation and evolution=E2=80=99 is introduced by Marte Syverts= en MD, PhD, Department of Neurology at Vestre Viken Hospital Trust in Norwa= y featuring guest speakers from leading epilepsy technology support provide= rs =C2=A0Helpilepsy, Healios, and Neuro event labs. Alexandre Moreau, Head = of Epilepsy at UCB comments: =E2=80=9CIn epilepsy, digital technology offer= s a significant opportunity to enhance treatment decisions and enable coord= ination of care. UCB has a number of investments and partnerships with lead= ing health technology providers, and alongside our own scientific innovatio= n, see this as a key component of future epilepsy treatment and care.=E2=80= =9D=C2=A0 For registered attendees at IEC, the timings for the symposia are: =C2=B7 Bridging the gap: what do patients want from the management of their= epilepsy? Monday 30th August, 19:00=E2=80=9320:00 UTC+1=C2=A0 =C2=B7 The future of the epilepsies: innovation, transformation and evoluti= on. Monday 30th August, 08:00=E2=80=9309:00 UTC+1=C2=A0 The following is a guide to the UCB-sponsored poster presentations at the 3= 4th International Epilepsy Congress (IEC 2021), Virtual Meeting (28th Augus= t to 1st September 2021): Brivaracetam e-Posters =C2=B7 Effectiveness and tolerability of adjunctive brivaracetam in patient= s with secondary generalized (focal to bilateral tonic-clonic) seizures in = Germany. Lerche H, Knake S, Rosenow F, Schulze-Bonhage A, Elmoufti S, Leuni= kava I, Schulz AL, Dimova S, Hopp P=C2=A0 =C2=B7 Cognitive performance and retention after 12-month adjunctive brivar= acetam in difficult-to-treat patients with epilepsy in a real-life setting.= Steinhoff BJ, Christensen J, Doherty CP, Majoie M, Schultz AL, Brock F, Le= unikava I, Leach JP =C2=B7 Pharmacokinetics, safety, and tolerability of intravenous brivaracet= am in pediatric patients with epilepsy: an open-label trial. Farkas K, Kang= H, Fogarasi, Bozorg A, James G, Krauwinkel W, Morita D, Will E, Elshoff JP= =C2=A0 =C2=B7 Tolerability and efficacy of brivaracetam in adults with focal seizu= res by concomitant antiepileptic drug use: post-hoc analysis. Ryvlin P, Dim= ova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V=C2=A0 =C2=B7 Pharmacokinetics, safety, and tolerability of intravenous brivaracet= am in neonates with seizures: interim analysis of a phase 2/3, open label t= rial. Krauwinkel W, Will E, Morita D, Floricel F, Elshoff JP, Pressler R Lacosamide e-Posters =C2=B7 Adjunctive lacosamide as treatment for primary generalized tonic-clo= nic seizures (PGTCS): efficacy and tolerability by baseline PGTCS frequency= . Vossler DG, Knake S, O=E2=80=99Brien TJ, Watanabe M, Dimova S, Steiniger-= Brach B, Williams P, Roebling R About Epilepsy^1-3 Epilepsy is a common neurological condition worldwide and affects approxima= tely 50 million people.^1 Epilepsy and seizures can develop in any person a= t any age,^2 and is usually diagnosed after a person has had at least two s= eizures (or after one seizure with a high risk for more) that were not caus= ed by some known medical condition.^3=C2=A0 About UCB in Epilepsy UCB has a rich heritage in epilepsy with over 20 years of experience in the= research and development of antiepileptic drugs. As a company with a long-= term commitment to epilepsy research, our goal is to address unmet medical = needs. Our scientists are proud to contribute to advances in the understand= ing of epilepsy and its treatment. We partner and create super-networks wit= h world-leading scientists and clinicians in academic institutions, pharmac= eutical companies, and other organizations who share our goals. At UCB, we = are inspired by patients, and driven by science in our commitment to suppor= t patients with epilepsy. 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 more than 8 000 people op= erating in more than 40 countries, the company generated revenue of =E2=82= =AC 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). = Follow us on Twitter: @UCB_news About BRIVIACT^=C2=AE (brivaracetam) Important Safety Information about BRIVIACT^=C2=AE in the EU and EEA^4 BRIVIACT=C2=AE (brivaracetam) is indicated as adjunctive therapy in the tre= atment of partial onset seizures with or without secondary generalisation i= n adults, adolescents and children from 4 years of age with epilepsy. Contr= aindications Hypersensitivity to the active substance, other pyrrolidone de= rivatives or any of the excipients. Special warnings and precautions for us= e Suicidal ideation and behaviour have been reported in patients treated wi= th anti-epileptic drugs (AEDs) in several indications, including BRIVIACT= =C2=AE. Patients should be monitored for signs of suicidal ideation and beh= aviour and appropriate treatment should be considered. Patients (and caregi= vers) should be advised to seek medical advice should any signs of suicidal= ideation or behaviour emerge. BRIVIACT=C2=AE film-coated tablets contain l= actose. Patients with rare hereditary problems of galactose intolerance, to= tal lactase deficiency or glucose-galactose malabsorption should not take B= RIVIACT=C2=AE. Brivaracetam film-coated tablets, solution for injection/inf= usion and oral solution contain less than 1 mmol sodium (23mg) per tablet/v= ial/ml respectively, that is to say essentially =E2=80=98sodium free=E2=80= =99. The oral solution contains 239.8 mg sorbitol (E420) in each ml. Patien= ts with hereditary fructose intolerance (HFI) should not take this medicina= l product. The oral solution contains methyl parahydroxybenzoate (E218), wh= ich may cause allergic reactions (possibly delayed). Brivaracetam oral solu= tion contains propylene glycol (E1520). Posology No dose adjustment is need= ed in adults with impaired renal function. Based on data in adults, no dose= adjustment is necessary neither in paediatric patients with impaired renal= function. In adults with hepatic impairment, a 50 mg/day starting dose sho= uld be considered. In children and adolescents weighing 50 kg or greater, a= 50 mg/day starting dose is recommended. A maximum daily dose of 150 mg adm= inistered in 2 divided doses is recommended for all stages of hepatic impai= rment. In children and adolescents weighing less than 50 kg, a 1 mg/kg/day = starting dose is recommended. The maximum dose should not exceed 3 mg/kg/da= y. No clinical data are available in paediatric patients with hepatic impai= rment. Interaction with other medicinal products and other forms of interac= tion. With co-administration of BRIVIACT=C2=AE 200 mg single dose and ethan= ol 0.6 g/L continuous infusion in healthy subjects there was no pharmacokin= etic interaction, but the effect of alcohol on psychomotor function, attent= ion and memory was doubled. Intake of BRIVIACT=C2=AE with alcohol is not re= commended. Limited clinical data are available implying that coadministrati= on of cannabidiol may increase the plasma exposure of brivaracetam, possibl= y through CYP2C19 inhibition, but the clinical relevance is uncertain. In h= ealthy subjects, co-administration with rifampicin, a strong enzyme-inducer (600 m= g/day for 5 days), decreased BRIVIACT=C2=AE area under the plasma concentra= tion curve (AUC) by 45%. Prescribers should consider adjusting the dose of = BRIVIACT=C2=AE for patients starting or ending treatment with rifampicin. O= ther strong enzyme-inducers (such as St John=C2=B4s wort [Hypericum perfora= tum]) may also decrease the systemic exposure of BRIVIACT=C2=AE. Therefore,= starting or ending treatment with St John=E2=80=99s wort should be done wi= th caution. In vitro studies have shown that brivaracetam exhibits little o= r no inhibition of CYP450 isoforms except for CYP2C19. Brivaracetam may inc= rease plasma concentrations of medicinal products metabolised by CYP2C19 (e= .g., lanzoprazole, omeprazole, diazepam). CYP2B6 induction has not been inv= estigated in vivo and BRIVIACT=C2=AE may decrease plasma concentrations of = medicinal products metabolised by CYP2B6 (e.g. efavirenz). In vitro studies= have also shown that BRIVIACT=C2=AE has inhibitory effects on OAT3. BRIVIA= CT=C2=AE 200 mg/day may increase plasma concentrations of medicinal product= s transported by OAT3. BRIVIACT=C2=AE plasma concentrations are decreased w= hen co-administered with strong enzyme inducing antiepileptic drugs (carbam= azepine, phenobarbital, phenytoin) but no dose adjustment is required. Effe= cts on ability to drive and use machines BRIVIACT=C2=AE, has minor or moder= ate influence on the ability to drive and use machines. Patients should be = advised not to drive a car or to operate other potentially hazardous machin= es until they are familiar with the effects of BRIVIACT=C2=AE, on their abi= lity to perform such activities. Undesirable effects. The most frequently r= eported adverse reactions with BRIVIACT=C2=AE (reported by >10% of patients= ) were somnolence (14.3%) and dizziness (11.0%). They were usually mild to = moderate in intensity. Somnolence and fatigue (8.2 %) were reported at high= er incidences with increasing dose. Very common adverse reactions (=E2=89= =A51% to <10%) were influenza, decreased appetite, depression, anxiety, ins= omnia, irritability, convulsion, vertigo, upper respiratory tract infection= s, cough, nausea, vomiting, constipation and fatigue. Neutropenia has been = reported in 0.5% (6/1,099) BRIVIACT=C2=AE patients and 0% (0/459) placebo-t= reated patients. Four of these patients had decreased neutrophil counts at = baseline, and experienced additional decrease in neutrophil counts after in= itiation of BRIVIACT=C2=AE. None of the six cases were severe, required any= specific treatment, led to BRIVIACT=C2=AE discontinuation or had associate= d infections. Suicidal ideation was reported in 0.3 % (3/1099) of BRIVIACT= =C2=AE treated patients and 0.7 % (3/459) of placebo-treated patients. In s= hort-term clinical studies of BRIVIACT=C2=AE in patients with epilepsy, the= re were no cases of completed suicide and suicide attempt, however both wer= e reported in the long-term open-label extension studies. Reactions suggest= ive of immediate (Type I) hypersensitivity have been reported in a small nu= mber of BRIVIACT=C2=AE patients (9/3022) during clinical development. The s= afety profile of brivaracetam observed in children was consistent with the = safety profile observed in adults. In the open label, uncontrolled, long-te= rm studies suicidal ideation was reported in 4.7 % of paediatric patients (= more common in adolescents) compared with 2.4 % of adults and behavioural d= isorders were reported in 24.8 % of paediatric patients compared with 15.1 = % of adults. The majority of events were mild or moderate in intensity, wer= e non-serious, and did not lead to discontinuation of study drug. An additi= onal adverse reaction reported in children was psychomotor hyperactivity (4= .7 %). There are limited safety data from open-label studies in children fr= om 1 month to <4 years of age. Limited data are available on neurodevelopme= nt in children <4 years of age. No clinical data are available in neonates.= Overdose There is limited clinical experience with BRIVIACT=C2=AE overdose= in humans. Somnolence and dizziness were reported in a healthy subject tak= ing a single dose of 1,400 mg of BRIVIACT=C2=AE. There is no specific antid= ote. Treatment of an overdose should include general supportive measures. S= ince less than 10% of BRIVIACT=C2=AE is excreted in urine, haemodialysis is= not expected to significantly enhance BRIVIACT=C2=AE clearance. Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information. Date of revision: 25 November 2= 020.=C2=A0 http://www.ema.europa.eu/ =C2=A0=C2=A0 About VIMPAT^=C2=AE (lacosamide) Important Safety Information about VIMPAT^=C2=AE in the EU and EEA^5 =C2=A0 VIMPAT^=C2=AE is indicated as monotherapy in the treatment of partial-onset= seizures with or without secondary generalisation in adults, adolescents a= nd children from 4 years of age with epilepsy. VIMPAT^=C2=AE is indicated a= s adjunctive therapy in the treatment of partial-onset seizures with or wit= hout secondary generalisation in adults, adolescents and children from 4 ye= ars of age with epilepsy and in the treatment of primary generalised tonic-= clonic seizures in adults, adolescents and children from 4 years of age wit= h idiopathic generalised epilepsy. VIMPAT^=C2=AE therapy can be initiated w= ith either oral or IV administration. For the paediatric population, the ph= ysician should prescribe the most appropriate formulation and strength acco= rding to weight and dose. A single loading dose may be initiated in patient= s in situations when the physician determines that rapid attainment of laco= samide steady state plasma concentration and therapeutic effect is warrante= d. It should be administered under medical supervision with consideration o= f the potential for increased incidence of serious cardiac arrhythmia and C= NS adverse reactions. Administration of a loading dose has not been studied= in acute conditions such as status epilepticus. Use of a loading dose is n= ot recommended in adolescents and children weighing less than 50 kg. Admini= stration of a loading dose has not been studied in children. A maximum dose= of 300 mg/day is recommended for paediatric patients weighing 50 kg or mor= e and for adult patients with mild to moderate hepatic impairment. =C2=A0Ba= sed on data in adults, in paediatric patients weighing less than 50 kg with= mild to moderate hepatic impairment, a reduction of 25 % of the maximum do= se should be applied. Lacosamide should be administered to adult and paedia= tric patients with severe hepatic impairment only when the expected therape= utic benefits are anticipated to outweigh the possible risks. The dose may = need to be adjusted while carefully observing disease activity and potentia= l side effects in the patient. In adolescents and adults weighing 50 kg or = more with mild to moderate hepatic impairment a loading dose of 200mg may b= e considered, but further dose titration (>200 mg daily) should be performe= d with caution. In paediatric patients weighing 50 kg or more and in adult = patients with mild or moderate renal impairment a loading dose of 200 mg ma= y be considered, but further dose titration (> 200 mg daily) should be perf= ormed with caution. In paediatric patients weighing 50 kg or more and in ad= ult patients with severe renal impairment (CLCR =E2=89=A4 30 ml/min) or wit= h end-stage renal disease, a maximum dose of 250 mg/day is recommended and = the dose titration should be performed with caution. In paediatric patients= weighing less than 50 kg with severe renal impairment (CLCR =E2=89=A4 30 m= l/min) and in those with end-stage renal disease, a reduction of 25 % of th= e maximum dose is recommended. Contraindications: Hypersensitivity to the a= ctive substance or any of the excipients; known second- or third-degree atr= ioventricular (AV) block. Special warnings and precautions for use: Treatme= nt with VIMPAT=C2=AE has been associated with dizziness which could increas= e the occurrence of accidental injury or falls. Therefore, patients should = be advised to exercise caution until they are familiar with the potential e= ffects of the medicine. New onset or worsening of myoclonic seizures has be= en reported in both adult and paediatric patients with PGTCS, in particular= during titration. In patients with more than one seizure type, the observe= d benefit of control for one seizure type should be weighed against any obs= erved worsening in another seizure type. Dose-related prolongations in PR i= nterval with VIMPAT=C2=AE have been observed in clinical studies. =C2=A0VIM= PAT^=C2=AE should be used with caution in patients with underlying proarrhy= thmic conditions such as patients with known cardiac conduction problems or= severe cardiac disease (e.g. myocardial ischaemia/infarction, heart failur= e, structural heart disease or cardiac sodium channelopathies) or patients = treated with medicinal products affecting cardiac conduction, including ant= iarrhythmics and sodium channel blocking antiepileptic medicinal products, = as well as in elderly patients. In these patients it should be considered t= o perform an ECG before a Vimpat dose increase above 400mg/day and after Vi= mpat is titrated to steady-state. In the placebo-controlled studies of VIMP= AT^=C2=AE in epilepsy patients, atrial fibrillation or flutter were not rep= orted; however both have been reported in open-label epilepsy studies and i= n post-marketing experience. In post-marketing experience, AV block (includ= ing second degree or higher AV block) has been reported. In patients with p= roarrhythmic conditions, ventricular tachyarrhythmia has been reported. In = rare cases, these events have led to asystole, cardiac arrest and death in = patients with underlying proarrhythmic conditions. Patients should be made = aware of the symptoms of cardiac arrhythmia (e.g. slow, rapid or irregular = pulse, palpitations, shortness of breath, feeling lightheaded, fainting). P= atients should be counselled to seek immediate medical advice if these symp= toms occur. Suicidal ideation and behaviour have been reported in patients = treated with antiepileptic medicinal products in several indications. There= fore patients should be monitored for signs of suicidal ideation and behavi= ours and appropriate treatment should be considered. Patients (and caregive= rs of patients) should be advised to seek medical advice should signs of su= icidal ideation or behaviour emerge. The safety and efficacy of lacosamide = in paediatric patients with epilepsy syndromes in which focal and generalis= ed seizures may coexist have not been determined. VIMPAT^=C2=AE syrup conta= ins sodium methyl parahydroxybenzoate (E219) which may cause allergic react= ions (possibly delayed). Vimpat Syrup contains sorbitol (E420). Patients wi= th rare hereditary problems of fructose intolerance should not take this me= dicine. Sorbitol may cause gastrointestinal discomfort and mild laxative ef= fect. The syrup contains aspartame (E951), a source of phenylalanine, which= may be harmful for people with phenylketonuria. Vimpat syrup contains prop= ylene glycol (E1520). VIMPAT=C2=AE syrup contains 1.42 mg sodium per ml, eq= uivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodiu= m for an adult. VIMPAT^=C2=AE solution for infusion contains 59.8 mg sodium= per vial, equivalent to 3% of the WHO recommended maximum daily intake of = 2 g sodium for an adult. Effects on ability to drive and use machines: VIMP= AT^=C2=AE may have minor to moderate influence on the ability to drive and = use machines. VIMPAT^=C2=AE treatment has been associated with dizziness or= blurred vision. Accordingly patients should be advised not to drive a car = or to operate other potentially hazardous machinery until they are familiar= with the effects of VIMPAT^=C2=AE on their ability to perform such activit= ies. Undesirable effects: The most common adverse reactions (=E2=89=A510%) = are dizziness, headache, diplopia, and nausea. They were usually mild to mo= derate in intensity. Some were dose-related and could be alleviated by redu= cing the dose. Incidence and severity of CNS and gastrointestinal (GI) adve= rse reactions usually decreased over time. Incidence of CNS adverse reactio= ns such as dizziness may be higher after a loading dose. Other common adver= se reactions (=E2=89=A51% - <10%) are depression, confusional state, insomn= ia, balance disorder, myoclonic seizures, ataxia, memory impairment, cognit= ive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, dist= urbance in attention, paraesthesia, vision blurred, vertigo, tinnitus, vomi= ting, constipation, flatulence, dyspepsia, dry mouth, diarrhoea, pruritus, = rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, fee= ling drunk, injection site pain or discomfort (local adverse events associa= ted with intravenous administration), irritation (local adverse events asso= ciated with intravenous administration), fall, and skin laceration, contusi= on. The use of VIMPAT^=C2=AE is associated with dose-related increase in th= e PR interval. Adverse reactions associated with PR interval prolongation (= e.g. atrioventricular block, syncope, bradycardia) may occur. Additional ad= verse reactions reported in PGTCS patients were myoclonic epilepsy and atax= ia. The most frequently reported adverse reactions were dizziness and somno= lence. The most common adverse reactions resulting in discontinuation of la= cosamide therapy were dizziness and suicidal ideation. The safety profile o= f lacosamide in placebo-controlled and in open-label studies (n=3D408) in a= djunctive therapy in children from 4 years of age with partial- onset seizu= res was consistent with the safety profile observed in adults although the = frequency of some adverse reactions (somnolence, vomiting and convulsion) w= as increased and additional adverse reactions (nasopharyngitis, pyrexia, ph= aryngitis, decreased appetite, lethargy and abnormal behaviour) have been r= eported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %)= , somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.= 8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and= abnormal behaviour (1.7 %).=C2=A0 Laboratory abnormalities: Abnormalities in liver function tests have been o= bserved in placebo-controlled studies with VIMPAT^=C2=AE in adult patients = with partial-onset seizures who were taking 1-3 concomitant antiepileptic m= edicinal products. Elevations of ALT to =E2=89=A53xULN occurred in 0.7% (7/= 935) of VIMPAT^=C2=AE patients and 0% (0/356) of placebo patients. Multiorg= an Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also = known as Drug Reaction with Eosinophilia and Systemic Symptoms, DRESS) have= been reported in patients treated with some antiepileptic medicinal produc= ts. These reactions are variable in expression but typically present with f= ever and rash and can be associated with involvement of different organ sys= tems. If multiorgan hypersensitivity reaction is suspected, VIMPAT^=C2=AE s= hould be discontinued.=C2=A0 Refer to the European Summary of Product Characteristics for other adverse = reactions and full prescribing information. Date of revision: 10 June 2021.= http://www.ema.europa.eu/ For further information:=C2=A0 Media=C2=A0 Nick Francis Neurology Communications, UCB=C2=A0 T: +44 7769 307745=C2=A0 nick.francis@ucb.com=C2=A0 Antje Witte=C2=A0 Investor Relations, UCB=C2=A0 T+32 2 559 9414,=C2=A0 antje.witte@ucb.com Forward looking statements UCB=C2=A0 This press release contains forward-looking statements including, without l= imitation, 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=9Cestimate= s=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccontinu= e=E2=80=9D and similar expressions. These forward-looking statements are ba= sed on current plans, estimates and beliefs of management. All statements, = other than statements of historical facts, are statements that could be dee= med forward-looking statements, including estimates of revenues, operating = margins, capital expenditures, cash, other financial information, expected = legal, arbitration, political, regulatory or clinical results or practices = and other such estimates and results. By their nature, such forward-looking= statements are not guarantees of future performance and are subject to kno= wn and unknown risks, uncertainties and assumptions which might cause the a= ctual 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 release.= Important factors that could result in such differences include: changes i= n general economic, business and competitive conditions, the inability to o= btain necessary regulatory approvals or to obtain them on acceptable terms = or within expected timing, costs associated with research and development, = changes in the prospects for products in the pipeline or under development = by UCB, effects of future judicial decisions or governmental investigations= , safety, quality, data integrity or manufacturing issues; potential or act= ual data security and data privacy breaches, or disruptions of our informat= ion technology systems, product liability claims, challenges to patent prot= ection for products or product candidates, competition from other products = including biosimilars, changes in laws or regulations, exchange rate fluctu= ations, changes or uncertainties 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 be discovered or identified in the pipeline, o= r that new indications for existing products will be developed and approved= . Movement from concept to commercial product is uncertain; preclinical res= ults do not guarantee safety and efficacy of product candidates in humans. = So far, the complexity of the human body cannot be reproduced in computer m= odels, cell culture systems or animal models. The length of the timing to c= omplete clinical trials and to get regulatory approval for product marketin= g has varied in the past and UCB expects similar unpredictability going for= ward. Products or potential products which are the subject of partnerships,= joint ventures or licensing collaborations may be subject to disputes betw= een the partners or may prove to be not as safe, effective or commercially = successful as UCB may have believed at the start of such partnership. UCB= =E2=80=99 efforts to acquire other products or companies and to integrate t= he operations of such acquired companies may not be as successful as UCB ma= y have believed at the moment of acquisition. Also, UCB or others could dis= cover safety, side effects or manufacturing problems with its products and/= or devices after they are marketed. The discovery of significant problems w= ith a product similar to one of UCB=E2=80=99s products that implicate an en= tire class of products may have a material adverse effect on sales of the e= ntire class of affected products. Moreover, sales may be impacted by intern= ational and domestic trends toward managed care and health care cost contai= nment, including pricing pressure, political and public scrutiny, customer = and prescriber patterns or practices, and the reimbursement policies impose= d by third-party payers as well as legislation affecting biopharmaceutical = pricing and reimbursement activities and outcomes. Finally, a breakdown, cy= berattack or information security breach could compromise the confidentiali= ty, integrity and availability 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.=C2=A0 UCB is providing this information, including forward-looking statements, on= ly as of the date of this press release and expressly disclaims any duty to= update any information contained in this press release, either to confirm = the actual results or to report or reflect any change in its forward-lookin= g statements with regard thereto or any change in events, conditions or cir= cumstances on which any such statement is based, unless such statement is r= equired 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. Meyer AC, Dua T and Ma J et al. Global disparities in the epilepsy treat= ment gap: a systemic review. Bull World Health Organ. 2010; 88: 260-266 2. Epilepsy Foundation. Who gets epilepsy? Available at: https://www.epilep= sy.com/learn/about-epilepsy-basics/who-gets-epilepsy. (Last accessed: July = 2021). 3. Epilepsy Foundation : About Epilepsy : the basics. Available at: https:/= /www.epilepsy.com/learn/about-epilepsy-basics (Last accessed: July 2021). 4. European Medicines Agency. BRIVIACT=C2=AE (brivaracetam) Summary of Prod= uct Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/docu= ments/product-information/briviact-epar-product-information_en.pdf (Last ac= cessed: July 2021). 5. European Medicines Agency. VIMPAT=C2=AE (lacosamide) Summary of Product = Characteristics (SmPC). Available at: https://www.ema.europa.eu/en/document= s/product-information/vimpat-epar-product-information_en.pdf (Last accessed= : July 2021). GenericFile UCB at IEC Press Release ENG (https://mb.cision.com/Public/18595/3404181/82= 21a469ee99344c.pdf) ______________________ If you would rather not receive future communications from UCB SA, please g= o to https://eu.vocuspr.com/OptOut.aspx?2973226x20421x80572x1x6868579x24000= x6&Email=3Dregnews%40symexglobal.com. UCB SA, All=C3=A9e de la Recherche, 60 ., Brussels, . B - 1070 Belgium