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UCB (EBR:UCB) UCB Media Room - UCB showcases new research

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16/04/2021 09:48
https://mb.cision.com/Public/18595/logo/86a99b25f755738d_org.jpg ** UCB showcases new research at the 73rd American Academy of Neurology Ann= ual Meeting to demonstrate broad neurology leadership and future portfolio ------------------------------------------------------------ =C2=B7 UCB reinforces commitment to delivering increased patient value by p= resenting latest research findings in epilepsy, myasthenia gravis and Parki= nson=E2=80=99s disease =C2=B7 Nine scientific presentations illustrate UCB=E2=80=99s dedication to= neurology and highlight the importance of gathering patient insight to tra= nsform patient experience =C2=B7 UCB will also host a virtual symposium to discuss the clinical featu= res of rare autoimmune neuromuscular diseases such as generalized myastheni= a gravis, held on Tuesday 20 April, 09:00 =E2=80=93 10:00 EST Brussels (Belgium), 16 April 20 =E2=80=93 07:00 (CET): UCB is pleased to an= nounce that new data representing three neurological areas will be presente= d at the 73^rd American Academy of Neurology (AAN) Annual Meeting, from 17-= 22 April 2021.^1-9 Spanning across epilepsy and Parkinson=E2=80=99s disease= , posters being presented at this year=E2=80=99s virtual meeting will highl= ight the latest scientific and clinical developments, as well as a patient-= led analysis to demonstrate the experience of living with myasthenia gravis= (MG). During this year=E2=80=99s virtual AAN annual meeting, UCB will build on it= s heritage in epilepsy by presenting the latest data to further describe th= e safety and tolerability of long-term treatment with BRIVIACT^=C2=AE (briv= aracetam) CV for focal seizures.^1-4,10,11 Two abstracts will also highligh= t data from the open-label ARTEMIS-2 trial for NAYZILAM^=C2=AE(midazolam) n= asal spray CIV, for the acute treatment of intermittent, stereotypic episod= es of frequent seizure activity, (i.e., seizure clusters, acute repetitive = seizures) that are distinct from a patient's usual seizure pattern in patie= nts with epilepsy 12 years of age and older.^5,6,12 This will be supplement= ed by a systemic review of real-world studies designed to better understand= the behavioral adverse events which accompany common anti-seizure medicati= ons, and a population study which examined the underlying cause and extent = of treatment delays for individuals with epilepsy. These studies further de= monstrate UCB=E2=80=99s commitment to create patient value by utilizing its= investigational resources. =E2=80=9CAt UCB, we are driven by science to translate patient insights int= o unique, disease-modifying solutions that provide value and transform the = patient experience. Optimizing patient experiences with our company and our= medicines is integral to everything we do.=E2=80=9D said Charl Van Zyl, Ex= ecutive Vice President Neurology & Head of Europe/International Markets at = UCB. =E2=80=9CWe are excited to showcase the scale and passion of our commi= tment at AAN. We are building on our legacy and expertise in epilepsy and P= arkinson=E2=80=99s disease by expanding our leadership and capabilities in = new areas, and further cultivating our patient-centric culture.=E2=80=9D UCB is also focused on understanding the perspective of patients living wit= h rare diseases, such as MG, and how it impacts day-to-day life. To this en= d, UCB convened an international patient council (PC) comprising nine indiv= iduals living with MG who serve as local/national patient advocates in seve= n countries (Europe and US). This patient-led analysis provides important i= nsights into the reality of living with MG and will enable healthcare profe= ssionals to improve their understanding and management of their patients li= ving with MG.^8 =E2=80=9CDespite thousands of people across the world living with the unpre= dictable and, in many cases, debilitating impact of MG, there is still rela= tively little research describing true lived experiences faced by the MG pa= tient community, from their perspective=E2=80=9D explained Nancy Law, forme= r CEO and current Board Chair for the Myasthenia Gravis Foundation of Ameri= ca, and co-author of the abstract. She continued =E2=80=9CMost of the curre= nt data are about others=E2=80=99 perception of patient lived experience. I= t is heartening that in accepting this data for presentation at their meeti= ng, the American Academy of Neurology has recognized the importance of heal= thcare professionals truly understanding the perspectives of patients on th= eir experiences. Patient collaborations, such as this one with the pharmace= utical industry, have potential to raise the patient voice and build better= understanding about this rare neuro-muscular disease.=E2=80=9D Alongside scientific presentations, UCB will be facilitating a virtual symp= osium to discuss the clinical features of rare autoimmune neuromuscular dis= eases, such as MG, back to their origins in the immune system and gain a un= ique perspective on the lived patient experience. The symposium, which will= be hosted virtually on Tuesday 20 April, 09:00-10:00 EST, has an esteemed = faculty of James F. Howard, Jr., The University of North Carolina at Chapel= Hill, Saiju Jacob, University Hospitals Birmingham, UK and Nancy Law, Myas= thenia Gravis Foundation of America. Finally, UCB will also present the latest findings in its research pipeline= , by highlighting the early safety and tolerability data for its investigat= ional molecule in Parkinson=E2=80=99s disease, UCB0599.^9 At AAN, UCB will further demonstrate and reinforce its neurology passion, e= xpertise and commitment to the goal of addressing and improving the lived e= xperiences of people with myasthenia gravis, epilepsy and Parkinson=E2=80= =99s disease. The following is a guide to the nine UCB-sponsored poster presentations at = the 73rd American Academy of Neurology (AAN) Annual Meeting, held virtually= 17-22 April. BRIVIACT^=C2=AE (brivaracetam) CV abstracts 1. A systematic review of behavioral adverse events with brivaracetam, leve= tiracetam, perampanel, and topiramate in real-world studies Steinhoff BJ, Klein P and Klitgaard H. et al. =C2=B7 Poster: P8.080 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP8.080) 2. Intravenous Antiseizure Medication Utilization Patterns Among Seizure Pa= tients Treated in US Hospitals: a Database Analysis Beaty S, Rosenthal N and Gayle J. et al. =C2=B7 Poster: P7.134 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP7.134) 3. Outcomes of Intravenous Use of Brivaracetam and Levetiracetam for the Tr= eatment of Seizures in US Hospitals Beaty S, Rosenthal N and Gayle J. et al. =C2=B7 Poster: P7.135 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP7.135) =C2=A0=C2=A0 4. Safety and Tolerability of Intravenous Brivaracetam in Patients with Epi= lepsy on Concomitant Levetiracetam Treatment Martin MS, Elmoufti S and Dongre P et al. =C2=B7 Poster: P7.110 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP7.110) =C2=A0=C2=A0 NAYZILAM^ ^=C2=AE (midazolam) CV abstracts 1. Treatment Satisfaction, Anxiety Level, and Confidence About Traveling Wi= th Midazolam Nasal Spray in Patients With Seizure Clusters: Phase III, Open= -Label Extension Trial Fakhoury T, Chen L and Bass A. et al. =C2=B7 Poster: P7.128 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP7.128) =C2=A0 2. Return to Full Baseline Functionality After Repeated Intermittent Use of= Midazolam Nasal Spray in Patients With Seizure Clusters: Post-Hoc Analysis= of an Open-Label Extension Trial Detyniecki K, Brunnert M and Campos R. et al. =C2=B7 Poster: P7.131 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP7.131) =C2=A0=C2=A0 Epilepsy treatment delay abstract 1. The Role of Social Determinants in Epilepsy Treatment Delays for Arizona= ns on Medicaid Sirven J, Sprout G and Speer M et al. =C2=B7 Poster: P11.008 (https://index.mirasmart.com/AAN2021/SearchResults= .php?Program_Number=3DP11.008) =C2=A0=C2=A0 Myasthenia Gravis abstract 1. The Lived Experience of Myasthenia Gravis: A Patient-led Analysis Law N, Davio K, and Blunk M et al. =C2=B7 Poster: P2.064 (https://index.mirasmart.com/AAN2021/SearchResults.= php?Program_Number=3DP2.064) =C2=A0=C2=A0=C2=A0 Parkinson=E2=80=99s disease abstract 1. Results from a Phase 1b Study of UCB0599, an Orally Available, Brain-pen= etrant Inhibitor of Alpha-synuclein (ASYN) Misfolding in People Living with= Parkinson's Disease (PD) Genius J, Dastros-Pitei D, and Detalle, L et al. =C2=B7 Poster: P14.137 (https://index.mirasmart.com/AAN2021/SearchResults= .php?Program_Number=3DP14.137) =C2=A0=C2=A0 About Epilepsy Epilepsy is a common neurological condition worldwide and affects approxima= tely 50 million people.^13 Epilepsy and seizures can develop in any person = at any age,^14 and is usually diagnosed after a person has had at least two= seizures (or after one seizure with a high risk for more) that were not ca= used by some known medical condition.^15 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 Seizure Clusters=C2=A0 Seizure clusters are broadly defined as acute episodes of consecutive seizu= res that occur within a short period of time with a patient regaining consc= iousness during the interictal period. These clusters are also distinguisha= ble from a person=E2=80=99s typical seizure pattern.^16,17,18,19,20=C2=A0Ot= her names for seizure clusters include acute-repetitive seizures (ARS), ser= ial seizures, crescendo seizures, and seizure flurries, which highlight the= repetitive nature of the seizures.^21=C2=A0Seizure clustering can increase= the chance of emergency room visits.^16 About Generalized Myasthenia Gravis (gMG) Myasthenia gravis (MG) is a chronic, autoimmune, neuromuscular^22=C2=A0cond= ition where the body=E2=80=99s immune system mistakenly targets the connect= ion between the nerves and the muscles.^23 In people living with MG, volunt= ary muscles don=E2=80=99t respond well to the signals sent by the brain.^24= =C2=A0People with MG may experience weakness of the eye muscles (called ocu= lar myasthenia), drooping of one or both eyelids (ptosis), blurred or doubl= e vision (diplopia), a change in facial expression, difficulty swallowing, = shortness of breath, impaired speech (dysarthria) and weakness in the arms,= hands, fingers legs and neck.^22 The hallmark of myasthenia gravis is musc= le weakness that worsens after periods of activity and improves after perio= ds of rest.^22 About Parkinson=E2=80=99s Disease Parkinson's Disease (PD) is a chronic, degenerative neurological disease wh= ich affects approximately 10 million people worldwide.^25 PD usually affect= s people over the age of 60.^25=C2=A0PD develops with the loss of nerve cel= ls in the brain that produce a chemical called dopamine. The symptoms of PD= can have an impact on many dimensions of patients' lives. As dopamine leve= ls fall, movement (motor) symptoms=E2=80=94tremors (uncontrollable shaking)= , rigidity (stiffness or muscle tensing) and bradykinesia (slowness and los= s of spontaneous movement)=E2=80=94can progress, along with the underlying = symptoms of PD, which are less well recognized and may be under-treated. Un= derlying symptoms can occur in over 90% of PD patients and include sleep di= sturbance, such as insomnia, vivid dreams and daytime drowsiness, mood and = cognitive changes, pain, depression, anxiety, apathy, gastrointestinal diso= rders, sexual dysfunction, bladder problems and fatigue.^25,26 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=C2=A0in 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 10, 11 BRIVIACT^=C2=AE (brivaracetam) CV was approved in the U.S. in 2016 as an ad= d-on therapy for adult patients with partial onset seizures. BRIVIACT was a= pproved as monotherapy for adults in=C2=A0September 2017, and as monotherap= y or adjunctive therapy in patients four years of age and older with partia= l-onset seizures in 2018. In the EU, BRIVIACT^=C2=AE is indicated as adjunctive therapy in the treatm= ent of partial onset seizures with or without secondary generalisation in a= dults, adolescents and children from 4 years of age with epilepsy BRIVIACT^=C2=AE=C2=A0is available in three formulations: oral tablets, oral= solution, and solution for injection/infusion. Important Safety Information about BRIVIACT^=C2=AE in the EU and EEA^10 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= aindicationsHypersensitivity to the active substance, other pyrrolidone der= ivatives or any of the excipients. Special warnings and precautions for use= Suicidal ideation and behaviour have been reported in patients treated wit= h anti-epileptic drugs (AEDs) in several indications, including BRIVIACT=C2= =AE. Patients should be monitored for signs of suicidal ideation and behavi= our and appropriate treatment should be considered. Patients (and caregiver= s) should be advised to seek medical advice should any signs of suicidal id= eation or behaviour emerge. BRIVIACT=C2=AE film-coated tablets contain lact= ose. Patients with rare hereditary problems of galactose intolerance, total= lactase deficiency or glucose-galactose malabsorption should not take BRIV= IACT=C2=AE. Brivaracetam film-coated tablets, solution for injection/infusi= on and oral solution contain less than 1 mmol sodium (23mg) per tablet/vial= /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. Patients w= ith hereditary fructose intolerance (HFI) should not take this medicinal pr= oduct. The oral solution contains methyl parahydroxybenzoate (E218), which = may cause allergic reactions (possibly delayed). Brivaracetam oral solution= contains propylene glycol (E1520). PosologyNo dose adjustment is needed in= adults with impaired renal function. Based on data in adults, no dose adju= stment is necessary neither in paediatric patients with impaired renal func= tion. In adults with hepatic impairment, a 50 mg/day starting dose should b= e considered. In children and adolescents weighing 50 kg or greater, a 50 m= g/day starting dose is recommended. A maximum daily dose of 150 mg administ= ered in 2 divided doses is recommended for all stages of hepatic impairment= . In children and adolescents weighing less than 50 kg, a 1 mg/kg/day start= ing dose is recommended. The maximum dose should not exceed 3 mg/kg/day. No= clinical data are available in paediatric patients with hepatic impairment= . Interaction with other medicinal products and other forms of interaction.= With co-administration of BRIVIACT=C2=AE 200 mg single dose and ethanol 0.= 6 g/L continuous infusion in healthy subjects there was no pharmacokinetic = interaction, but the effect of alcohol on psychomotor function, attention a= nd memory was doubled. Intake of BRIVIACT=C2=AE with alcohol is not recomme= nded. Limited clinical data are available implying that coadministration of= cannabidiol may increase the plasma exposure of brivaracetam, possibly thr= ough CYP2C19 inhibition, but the clinical relevance is uncertain. In healthy 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. http://www.ema.europa.eu/ =C2=A0=C2=A0 BRIVIACT^=C2=AE Indication and Select Important Safety Information in the U= .S.^11 BRIVIACT=C2=AE (brivaracetam) CV=C2=A0is indicated for the treatment of par= tial-onset seizures in patients 4 years of age and older.=C2=A0 As the safe= ty of BRIVIACT injection in pediatric patients has not been established, BR= IVIACT injection is indicated for the treatment of partial-onset seizures o= nly in adult patients (16 years of age and older). =C2=A0 BRIVIACT=C2=AE is associated with important warnings and precautions includ= ing suicidal behavior and ideation, somnolence, fatigue, dizziness, disturb= ance in gait and coordination, psychiatric adverse reactions including nonp= sychotic and psychotic symptoms, and hypersensitivity reactions (bronchospa= sm and angioedema). BRIVIACT=C2=AE is contraindicated in patients with a pr= ior hypersensitivity reaction to brivaracetam or any of the inactive ingred= ients. In adult adjunctive therapy placebo-controlled clinical trials, the most co= mmon adverse reactions (at least 5% for BRIVIACT=C2=AE and at least 2% more= frequently than placebo) were somnolence and sedation, dizziness, fatigue,= and nausea and vomiting symptoms. Adverse reactions reported in clinical s= tudies of pediatric patients 4 years to less than 16 years of age were gene= rally similar to those in adult patients. BRIVIACT=C2=AE is a Schedule V controlled substance. Please refer to full Prescribing Information at https://www.ucb.com/_up/ucb= _com_products/documents/Briviact_current_COL_03_2021.pdf.=C2=A0=C2=A0 =C2= =A0 For more information on BRIVIACT^=C2=AE, contact 844-599-CARE (2273). BRIVIACT^=C2=AE is a registered trademark of the UCB Group of Companies. About NAYZILAM=C2=AE (midazolam) nasal spray CIV in the U.S.^12 NAYZILAM is a benzodiazepine indicated for the acute treatment of intermitt= ent, stereotypic episodes of frequent seizure activity (i.e., seizure clust= ers, acute repetitive seizures) that are distinct from a patient=E2=80=99s = usual seizure pattern in patients with epilepsy 12 years of age and older. Important Safety Information about NAYZILAM=C2=AE in the U.S.^12 CONTRAINDICATIONS NAYZILAM is contraindicated in patients with acute narrow-angle glaucoma. RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines, including NAYZILAM, and opioids may res= ult in profound sedation, respiratory depression, coma, and death. Reserve = concomitant prescribing of these drugs for patients for whom alternative tr= eatment options are inadequate. Limit dosages and durations to the minimum = required. Follow patients for signs and symptoms of respiratory depression = and sedation. ABUSE, MISUSE, AND ADDICTION The use of benzodiazepines, including NAYZILAM, exposes users to risks of a= buse, misuse, and addiction, which can lead to overdose or death. Abuse and= misuse of benzodiazepines commonly involve concomitant use of other medica= tions, alcohol, and/or illicit substances, which is associated with an incr= eased frequency of serious adverse outcomes. Before prescribing NAYZILAM an= d throughout treatment, assess each patient=E2=80=99s risk for abuse, misus= e, and addiction. DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF NAYZILAM MORE FREQUENTLY T= HAN RECOMMENDED The continued use of benzodiazepines may lead to clinically significant phy= sical dependence. The risks of dependence and withdrawal increase with long= er treatment duration and higher daily dose. Although NAYZILAM is indicated= only for intermittent use, if used more frequently than recommended abrupt= discontinuation or rapid dosage reduction of NAYZILAM may precipitate acut= e withdrawal reactions, which can be life-threatening. For patients using N= AYZILAM more frequently than recommended, to reduce the risk of withdrawal = reactions, use a gradual taper to discontinue NAYZILAM. Risks of Cardiorespiratory Adverse Reactions Serious cardiorespiratory adverse reactions have occurred after administrat= ion of midazolam. Warn patients and caregivers about the risks of respirato= ry depression, cardiac and respiratory arrest. Respiratory depression was observed with the administration of NAYZILAM dur= ing clinical trials. Cardiac or respiratory arrest caused by NAYZILAM was n= ot reported during clinical trials. Central Nervous System Depression from Concomitant Use with Other Central N= ervous System Depressants, or Moderate or Strong CYP3A4 Inhibitors Drug products containing midazolam, including NAYZILAM, have a central nerv= ous system (CNS) depressant effect. Risks from Concomitant Use with Other CNS Depressants NAYZILAM may cause an increased CNS-depressant effect when used with alcoho= l or other CNS depressants (e.g., opioids). Warn patients and caregivers th= at the use of NAYZILAM in combination with alcohol or other CNS depressant = drugs may increase the risk of hypoventilation, airway obstruction, desatur= ation, or apnea and may contribute to profound and/or prolonged drug effect. Risks from Concomitant Use with Moderate or Strong CYP3A4 Inhibitors Concomitant use of NAYZILAM with moderate or strong CYP3A4 enzyme inhibitor= s may result in prolonged sedation because of a decrease in plasma clearanc= e of midazolam. Caution patients against engaging in hazardous occupations = requiring mental alertness, such as operating machinery, driving a motor ve= hicle or riding a bicycle until they have completely returned to their leve= l of baseline functioning. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicid= al thoughts or behavior in patients taking these drugs for any indication. = Monitor patients treated with NAYZILAM for the emergence or worsening of de= pression, suicidal thoughts or behavior, and/or any unusual changes in mood= or behavior. Advise patients and caregivers to be alert for these behavior= al changes and to immediately report them to the healthcare provider. Impaired Cognitive Function Midazolam, including NAYZILAM, is associated with a high incidence of parti= al or complete impairment of recall for several hours following an administ= ered dose. Counsel patients on when they can engage in activities requiring= complete mental alertness, operate hazardous machinery, or drive a motor v= ehicle after taking NAYZILAM. Glaucoma Benzodiazepines, including NAYZILAM, can increase intraocular pressure in p= atients with glaucoma. NAYZILAM may be used in patients with open-angle gla= ucoma only if they are receiving appropriate therapy. NAYZILAM is contraind= icated in patients with narrow-angle glaucoma. ADVERSE REACTIONS In the randomized, double-blind, placebo-controlled trial, the most common = adverse reactions (=E2=89=A55% in any NAYZILAM treatment group) were somnol= ence, headache, nasal discomfort, throat irritation, and rhinorrhea. NAYZILAM is a Schedule IV controlled substance. Please refer to the full Prescribing Information at https://www.ucb-usa.com= /nayzilam-prescribing-information.pdf =C2=A0 For additional medical information about NAYZILAM, patient assistance, or a= ny other information please visit our website (https://ucb-usa.com/Healthca= re-Professionals) or call ucbCARES at 1-844-599-2273. Nayzilam and ucbCARES are registered trademarks of the UCB Group of Compani= es. About UCB0599 UCB0599 is an orally administered, brain penetrant, small molecule inhibito= r of ASYN misfolding under investigation for the potential to slow the prog= ression of PD.^28,29 UCB0599 was discovered by NeuroPore and was licenced t= o UCB in 2014 for further development.^28 For further information: Global Neurology CommunicationsScott Fleming, Head of Global Business & R&D= CommsCompany Reputation, UCB T: +44 1753 44 7515, Scott.Fleming@ucb.com =C2=A0 Investor RelationsAntje Witte, Investor Relations, UCB T+32 2 559 94= 14, antje.witte@ucb.com Nick Francis, Neurology Communications Lead, UCBT=C2=A0: +44 7769 307 745, = Nick.Francis@ucb.com =C2=A0 Forward looking statements=C2=A0UCB 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=C2=A0guarantees=C2=A0of future performance and are subj= ect to known and unknown risks, uncertainties and assumptions which might c= ause the actual results, financial condition, performance or achievements o= f UCB, or industry results, to differ materially from those that may be exp= ressed or implied by such forward-looking statements contained in this pres= s release. Important factors that could result in such differences include:= changes in general economic, business and competitive conditions, the inab= ility to obtain necessary regulatory approvals or to obtain them on accepta= ble terms or within expected timing, costs associated with research and dev= elopment, changes in the prospects for products in the pipeline or under de= velopment by UCB, effects of future judicial decisions or governmental inve= stigations, safety, quality, data integrity or manufacturing issues; potent= ial or actual data security and data privacy breaches, or disruptions of ou= r information technology systems, product liability claims, challenges to p= atent protection for products or product candidates, competition from other= products including biosimilars, changes in laws or regulations, exchange r= ate fluctuations, changes or uncertainties in tax laws or the administratio= n of such laws, and hiring and retention of its employees. There is no guar= antee that new product candidates will be discovered or identified in the p= ipeline, or that new indications for existing products will be developed an= d approved. Movement from concept to commercial product is uncertain; precl= inical results do not guarantee safety and efficacy of product candidates i= n humans. So far, the complexity of the human body cannot be reproduced in = computer models, cell culture systems or animal models. The length of the t= iming to complete clinical trials and to get regulatory approval for produc= t marketing has varied in the past and UCB expects similar unpredictability= going forward. Products or potential products which are the subject of par= tnerships, joint ventures or licensing collaborations may be subject to dis= putes between the partners or may prove to be not as safe, effective or com= mercially successful as UCB may have believed at the start of such partners= hip. UCB=E2=80=99 efforts to acquire other products or companies and to int= egrate the operations of such acquired companies may not be as successful a= s UCB may have believed=C2=A0at the moment=C2=A0of acquisition. Also, UCB o= r others could discover safety, side effects or manufacturing problems with= its products and/or devices after they are marketed. The discovery of sign= ificant problems with a product=C2=A0similar to=C2=A0one of UCB=E2=80=99s p= roducts that implicate an entire class of products may have a material adve= rse effect on sales of the entire class of affected products. Moreover, sal= es may be impacted by international and domestic trends toward managed care= and health care cost containment, including pricing pressure, political an= d public scrutiny, customer and prescriber patterns or practices, and the r= eimbursement policies imposed by third-party payers as well as legislation = affecting biopharmaceutical pricing and reimbursement activities and outcom= es. Finally, a breakdown, cyberattack or information security breach could = compromise the confidentiality, integrity and availability of UCB=E2=80=99s= data and systems.=C2=A0=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=C2=A0particular time, nor can there be any guarantee t= hat such 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=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=C2=A0 References 1. Steinhoff BJ, Klein P and Klitgaard H. et al. A systematic review of beh= avioral adverse events with brivaracetam, levetiracetam, perampanel, and to= piramate in real-world studies. 73rd annual meeting of American Academy of = Neurology (AAN), April 17-22, 2021; Virtual, abstract P8.080 2. Beaty S, Rosenthal N and Gayle J. et al. Intravenous Antiseizure Medicat= ion Utilization Patterns Among Seizure Patients Treated in US Hospitals: a = Database Analysis. 73rd annual meeting of American Academy of Neurology (AA= N), April 17-22, 2021; Virtual, abstract: P7.134 3. Beaty S, Rosenthal N and Gayle J. et al. Outcomes of Intravenous Use of = Brivaracetam and Levetiracetam for the Treatment of Seizures in US Hospital= s. 73rd annual meeting of American Academy of Neurology (AAN), April 17-22,= 2021; Virtual, abstract: P7.135=C2=A0 4. Martin MS, Elmoufti S and Dongre P et al. Safety and Tolerability of Int= ravenous Brivaracetam in Patients with Epilepsy on Concomitant Levetiraceta= m Treatment. 73rd annual meeting of American Academy of Neurology (AAN), Ap= ril 17-22, 2021; Virtual, abstract: P7.110=C2=A0 5. Fakhoury T, Chen L and Bass A. et al. Treatment Satisfaction, Anxiety Le= vel, and Confidence About Traveling With Midazolam Nasal Spray in Patients = With Seizure Clusters: Phase III, Open-Label Extension Trial. 73rd annual m= eeting of American Academy of Neurology (AAN), April 17-22, 2021; Virtual, = abstract: P7.128 6. Detyniecki K, Brunnert M and Campos R. et al. Return to Full Baseline Fu= nctionality After Repeated Intermittent Use of Midazolam Nasal Spray in Pat= ients With Seizure Clusters: Post-Hoc Analysis of an Open-Label Extension T= rial. 73rd annual meeting of American Academy of Neurology (AAN), April 17-= 22, 2021; Virtual, abstract: P7.131=C2=A0 7. Sirven J, Sprout G and Speer M et al. The Role of Social Determinants in= Epilepsy Treatment Delays for Arizonans on Medicaid. 73rd annual meeting o= f American Academy of Neurology (AAN), April 17-22, 2021; Virtual, abstract= : P11.008=C2=A0 8. Law N, Davio K, Blunk M et al. The Lived Experience of Myasthenia Gravis= : A Patient-led Analysis. 73rd annual meeting of American Academy of Neurol= ogy (AAN), April 17-22, 2021; Virtual, abstract: P2.064=C2=A0=C2=A0=C2=A0 9. Genius J, Dastros-Pitei D, and Detalle, L et al. Results from a Phase 1b= Study of UCB0599, an Orally Available, Brain-penetrant Inhibitor of Alpha-= synuclein (ASYN) Misfolding in People Living with Parkinson's Disease (PD).= 73rd annual meeting of American Academy of Neurology (AAN), April 17-22, 2= 021; Virtual, abstract: P14.137=C2=A0 10. European Medicines Agency. BRIVIACT^=C2=AE (brivaracetam) Summary of Pr= oduct Characteristics (SmpC). Available at: https://www.ema.europa.eu/en/do= cuments/product-information/briviact-epar-product-information_en.pdf (Last = accessed: 13 April 2021). 11. BRIVIACT=C2=AE (brivaracetam) CV. U.S. Prescribing Information 12. NAYZILAM=C2=AE (midazolam) nasal spray CIV. U.S. Prescribing Information 13. Meyer AC, Dua T and Ma J et al. Global disparities in the epilepsy trea= tment gap: a systemic review. Bull World Health Organ. 2010; 88: 260-266 14. Epilepsy Foundation. Who gets epilepsy? Available at: https://www.epile= psy.com/learn/about-epilepsy-basics/who-gets-epilepsy. (Last accessed: 13 April 2021). 15. Epilepsy Foundation : About Epilepsy : the basics. Available at: https:= //www.epilepsy.com/learn/about-epilepsy-basics. (Last accessed: 13 April 20= 21). 16. Detyniecki K, O=E2=80=99Bryan J, Choezom T et al. Prevalence and predic= tors of seizure clusters: A prospective observational study of adult patien= ts with epilepsy Epilepsy Behav. 2018; 88: 349 - 356 17. Mitchell WG. Status epilepticus and acute repetitive seizures in childr= en, adolescents, and young adults: etiology, outcome, and treatment. Epilep= sia. 1996;37 Suppl 1:S74-S80. 18. Haut SR. Seizure clustering. Epilepsy Behav. 2006;8(1):50-55. 19. Dreifuss FE, Rosman NP, Cloyd JC, et al. A comparison of rectal diazepa= m gel and placebo for acute repetitive seizures. N Engl J Med. 1998;338(26)= :1869-1875. 20. Cereghino JJ, Mitchell WG, Murphy J, et al. Treating repetitive seizure= s with a rectal diazepam formulation: a randomized study. The North America= n Diastat Study Group. Neurology. 1998;51(5):1274-1282. 21. Jafarpour S, Hirsch LJ, Ga=C3=ADnza-Lein M, et al. Seizure cluster: def= inition, prevalence, consequences, and management. 2019Seizure. 68:9-15 22. National Institute of Neurological Disorders and Stroke. Myasthenia gra= vis fact sheet. https://www.ninds.nih.gov/disorders/patient-caregiver-educa= tion/fact-sheets/Myasthenia-gravis-fact-sheet (Last accessed: 13 April 2021= ). 23. Myasthenia Gravis Foundation of America. Myasthenia gravis infographic.= https://myasthenia.org/Portals/0/MG%20Infographic%20Final.pdf. (Last acces= sed: 13 April 2021). 24. Conquer Myasthenia Gravis. What is MG? https://www.myastheniagravis.org= /%20about-mg/what-is-mg/ (Last accessed: 13 April 2021). 25. EPDA: What is Parkinsons. Available at: http://www.epda.eu.com/about-pa= rkinsons/what-is-parkinsons/. (Last accessed: 13 April 2021). 26. Chaudhuri KR, Odin P, Antonini A, et al. Parkinson=E2=80=99s disease: t= he non-motor issues. Parkinsonism Relat Disord. 2011; 17: 717-723. 27. UCB Initiates Phase 1b US-Based Multicenter Clinical Trial in Parkinson= =E2=80=99s Disease Patients with UCB0599, a Compound Arising from the Neuro= pore-UCB Collaboration. Available from: https://www.neuropore.com/media/new= s/neuropore-initiates-phase-1-clinical-trial-in-healthy-volunteers-with-npt= 52034-a-therapeutic-candidate-aimed-at-treating-parkinsons-disease-and-amyo= trophic-lateral-sclerosis9672.htm. (Last accessed: 13 April 2021). 28. Smit JW, Maguire RP, Avbersek A et al. UCB0599 transition to the clinic= : An orally available brain-penetrant inhibitor of =CE=B1synuclein (ASYN) m= isfolding in Phase 1 development for Parkinson=E2=80=99s disease (PD). MDS = Virtual Congress September 12=E2=80=9316 Late-breaking abstract 2020;LBA4. 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