VLB-01

New analyses from phase 3, long-term, open-label, repeat-dose study of VALTOCO® (diazepam nasal spray) CIV will be presented Additional presentations explore anticipatory anxiety of seizures, short-term impacts of seizures on daily life and comparison of treated versus untreated seizure clusters SAN DIEGO, Dec. 1, 2023 /PRNewswire/ -- Neurelis, Inc., today announced that the company will present six poster presentations at the American Epilepsy Society (AES) Annual Meeting held in Orlando, Florida from December 1 – 5, 2023. Two of the presentations include new analyses of data from the completed long-term phase 3 open-label, repeat-dose safety study of diazepam nasal spray (VALTOCO®) for the treatment of seizure clusters in patients with epilepsy aged ≥6 years, evaluating timing, safety, and effectiveness of treatment. A third presentation focuses on the further assessment of diazepam in a novel preclinical model dosing strategy with potential application for further in vivo studies. Additional presentations explore the concept of anticipatory anxiety of seizures (AAS) through literature review, comparison of treated and untreated seizure clusters in a retrospective analysis from the SeizureTracker® database, and the short-term impact of seizures beyond the seizure itself. "Our ultimate goal is to improve health outcomes by addressing gaps in seizure cluster treatment and control," said Adrian L. Rabinowicz, M.D., Chief Medical Officer. "The data presented this year at the AES annual meeting demonstrate our ongoing commitment to improving the future of epilepsy care by advancing meaningful, patient-focused treatment outcomes for people with epilepsy." "Neurelis is at the forefront of epilepsy research, as evidenced by the wide breadth of data presented at this year's AES annual meeting," said Enrique Carrazana, M.D., Neurelis Senior Vice President, Strategic Initiatives. "We look forward to sharing our latest advances and insights with our colleagues who strive to improve care and outcomes for people with epilepsy, particularly those who experience frequent seizure activity and have a high unmet need." Poster Session Details Poster Session 2: Sunday, December 3rd, 10:00 AM – 4:00 PM ET "Characterization of a Novel Repeat-Dosing Model for Preclinical Diazepam Studies" (POSTER #2.245, Session 2) A novel preclinical repeat-dosing study of diazepam (DZP) in rats was conducted to identify a dosing strategy for in-life efficacy studies in preclinical models. Results showed sustained and measurable DZP levels in plasma and brain, which were similar to levels observed in humans. Brain-to-plasma ratios indicate an increase of diazepam accumulation in the brain with the repeat-dosing paradigm, suggesting that diazepam may be long-acting at the site of action. The results also support that this dosing paradigm could be used as part of in-life efficacy studies of diazepam. "Comparison of Safety and Effectiveness of Diazepam Nasal Spray in Male and Female Patients: Post Hoc Analysis of Data from a Phase 3 Safety Study" (POSTER #2.264, Session 2) In this post hoc analysis from a long-term safety study, the safety and effectiveness by sex of diazepam nasal spray, including use of second doses and time between seizure clusters (SEIzure interVAL [SEIVAL]), was evaluated. The safety profile and use of second doses as a proxy for effectiveness was generally similar between male and female patients. Females and males also both demonstrated significant increases in mean SEIVAL between the beginning and end of the treatment period, showing similar patterns over time. These results suggest that potential sex differences in benzodiazepine pharmacokinetics and/or pharmacodynamics did not meaningfully influence outcomes associated with intermittent use of diazepam nasal spray. "Shorter Time to Treatment Is Associated with Faster Time to Termination of Seizure Clusters in Multiple Subpopulations Treated with Diazepam Nasal Spray" (POSTER #2.265, Session 2) This post hoc analysis from the long-term safety study of diazepam nasal spray evaluated temporal patterns in treated seizure clusters in relation to time to seizure termination. Data showed shorter time to diazepam administration was associated with more rapid seizure cluster termination, a finding applicable to multiple populations including the overall study population, a group with a large number of treated seizure clusters, and adults and pediatric patients. Results of this analysis reinforce the value of prompt recognition and treatment intervention, which may help minimize risk of injury and additional healthcare utilization and potentially increase patients' and caregivers' sense of empowerment. "Importance of Prompt Treatment of Seizure Emergencies: Benefits Beyond Prevention of Status Epilepticus" (POSTER #2.295, Session 2) A systematic review characterized the short-term burden of seizures and discussed the potential benefit of acute treatment to reduce seizure burden apart from preventing status epilepticus. Acute treatment of seizure emergencies, guided by a seizure action plan, may facilitate a return to normal self/daily activities and reduce healthcare resource utilization and is important to prevent progression to status epilepticus. The rationale in support of prompt treatment for seizure emergencies appears to extend beyond prevention of status epilepticus to include outcomes that reduce the impact of seizures on daily life. Poster Session 3: Monday, December 4th, 8:00 AM – 2:00 PM ET "Exploring Anticipatory Anxiety of Seizures in Patients with Epilepsy" (POSTER #3.247, Session 3) A subset of people with epilepsy may experience Anticipatory Anxiety of Seizures (AAS), a distinct psychiatric entity characterized by a pathological process that includes fear of having seizures and associated avoidance behaviors. A literature search retrieved studies that addressed AAS and detailed potential pathologic mechanisms. Possible tools to screen for AAS were also explored. The analyses revealed that there is currently no validated screening tool for AAS, however a portion of the Epilepsy Anxiety Survey Instrument may be applicable. Additionally, review of published studies indicate recognition and treatment of AAS may be integral to comprehensive management of patients with epilepsy, and further investigation of the impact of AAS on these patients is needed. "Timing Of Rescue Medication Administration and Seizure Cluster Termination" (POSTER #3.283, Session 3) Analysis of data from a large, online database of patient/caregiver-reported seizures (SeizureTracker®) for three time intervals (≥2 seizures in 4 hours, 6 hours, or 24 hours) shows that treated seizure clusters were found to be associated with significantly fewer seizures per cluster than untreated seizure clusters. In addition, the time between seizure clusters was longer for treated seizure clusters. These results support the hypothesis that administration of rescue medications early in seizure clusters, once detected, is associated with earlier termination of seizure clusters and suggest a potential treatment effect beyond acute termination of seizure clusters. VALTOCO, a nasal spray for acute treatment of episodes of frequent seizure activity in adult and pediatric patients 6 years of age and older, was approved by the U.S. Food and Drug Administration (FDA) on Jan. 10, 2020. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and orphan neurologic disorders characterized by high unmet medical need. In 2020, the FDA approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®. Intravail's transmucosal absorption enhancement technology enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. In its approval of VALTOCO, the U.S. Food and Drug Administration also granted Neurelis Orphan Drug Exclusivity and recognized VALTOCO's intranasal route of administration as a clinically superior contribution to patient care over the previously approved standard-of-care treatment (a rectal gel formulation of diazepam). For more information on VALTOCO, please visit . In addition, Neurelis is developing NRL-1049 (previously known as BA-1049), an investigational, Phase I stage small molecule Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . For the latest scientific information on VALTOCO, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Neurelis: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2135 Media: Glenn Silver, FINN Partners, +1 646 871 8485 SOURCE Neurelis, Inc.

UCB will present 29 abstracts, including 4 late breakers, at American Epilepsy Society Annual Meeting 2023 highlighting clinical, health economic and demographic studies in epilepsy Presentations showcase diversity, potential and momentum of UCB's epilepsy and rare syndromes portfolio, including important fenfluramine and brivaracetam data Broad data sets reveal insights into different epilepsy types and different populations living with epilepsies Molecular, clinical, and real-world research focuses on current and future patient needs in epilepsy ATLANTA, Dec. 1, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today unveiled its extensive program of 29 studies, including 4 late breakers, accepted for presentation at the AES Annual Meeting 2023, taking place from 1-5 December in Orlando, Florida. "The data being presented at this year's American Epilepsy Society meeting highlight UCB's commitment to transforming outcomes and experiences for people living with epilepsies, redefining the future of epilepsy care. We are proud of the innovation and impact we have been able to deliver over the past three decades with our evolving portfolio of innovative medicines, and look forward to continuing to partner with patients, carers, and the scientific community to address unmet needs and advance the next generation of epilepsy care," said Mike Davis, Global Head of Epilepsy & Rare Syndromes, UCB. Key scientific and patient-focused data include: In focal-onset seizures (FOS) - interim data from a post-marketing non-interventional study on effectiveness and quality of life (QoL) with adjunctive brivaracetam in earlier treatment lines. In Dravet syndrome - an analysis from an open-label extension study of adults treated with fenfluramine. In Lennox-Gastaut syndrome - a post hoc analysis evaluating the percentage of seizure-free days in patients treated with fenfluramine in the 14-week randomized control trial and its open-label extension (median treatment duration, 1 year). In prolonged seizures - three studies evaluating the safety, tolerability, and pharmacokinetics of single-use inhaled alprazolam (an investigational treatment for potential termination of prolonged epileptic seizures) in different populations. In SUDEP (Sudden Unexpected Death in Epilepsy) - a literature review highlighting the differences in provision of information between healthcare professionals and patients. In disease management - data from early research into mechanisms underlying Developmental and Epileptic Encephalopathies (DEE). In health equity - results from a survey of US neurologists on health disparities in black patients living with epilepsy. "Knowledge illuminates a path toward innovative solutions and transformative breakthroughs. At this year's American Epilepsy Society meeting, we converge not just as researchers and clinicians, but as pioneers of progress. For three decades, we've been committed to people living with epilepsy and their families. We aim for a future where every discovery moves us closer to a seizure-free life. In unity, we work to surround the patient and caregiver through every step of their care journey – from diagnosis to treatment to support in helping them navigate those moments in their lives that matter most," said Brad Chapman, Head of U.S. Epilepsy and Rare Syndromes. Symposia and CME UCB will be hosting a symposium on December 2 at 6:00 p.m. ET entitled "The 'window of opportunity': Recognizing the importance of rapid and early seizure termination", to shed further light on seizure emergencies and data being presented at AES on the Seizure Termination Project*. The project consists of an expert consensus group sharing best practice for rapid and early seizure termination (REST) to prevent progression to a higher-level emergency. UCB is also supporting a CME program entitled 'Beyond Seizures: The Evolving Standard of Care in Developmental and Epileptic Encephalopathies' taking place on 1 December. UCB data presentations at AES 2023 Saturday, December 2, 2023 (12:00 PM –2:00 PM ET) Sunday, December 3, 2023 (12:00 PM –2:00 PM ET) *The Seizure Termination Project was funded by UCB Pharma. **The safety and efficacy of STACCATO® alprazolam has not been established and it is not currently approved for use in this indication by any regulatory authority worldwide. Monday, December 4, 2023 (12:00 PM –1:45 PM ET) For further information, contact UCB: Corporate Communications Becky Malone, U.S. Media Relations T +919.605.9600 Email [email protected] Investor Relations Antje Witte T +32.2.559.94.14 Email [email protected] About UCB UCB, Brussels, Belgium () is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. Important Safety Information about FINTEPLA® (fenfluramine) in the US1 FINTEPLA is indicated for the treatment of seizures associated with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) in patients 2 years of age and older. FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS. Further information is available at or by telephone at +1 877 964 3649. IMPORTANT SAFETY INFORMATION BOXED WARNING: VALVULAR HEART DISEASE and PULMONARY ARTERIAL HYPERTENSION There is an association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease and pulmonary arterial hypertension. Echocardiogram assessments are required before, during, and after treatment with FINTEPLA. FINTEPLA is available only through a restricted program called the FINTEPLA REMS. CONTRAINDICATIONS FINTEPLA is contraindicated in patients with hypersensitivity to fenfluramine or any of the excipients in FINTEPLA and with concomitant use, or within 14 days of the administration, of monoamine oxidase inhibitors because of an increased risk of serotonin syndrome. WARNINGS AND PRECAUTIONS Valvular Heart Disease and Pulmonary Arterial Hypertension (see Boxed Warning): Because of the association between serotonergic drugs with 5-HT2B receptor agonist activity, including fenfluramine (the active ingredient in FINTEPLA), and valvular heart disease (VHD) and pulmonary arterial hypertension (PAH), cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment with FINTEPLA concludes. Cardiac monitoring via echocardiogram can aid in early detection of these conditions. In clinical trials for DS and LGS of up to 3 years in duration, no patient receiving FINTEPLA developed VHD or PAH. Monitoring: Prior to starting treatment, patients must undergo an echocardiogram to evaluate for VHD and PAH. Echocardiograms should be repeated every 6 months, and once at 3-6 months post treatment with FINTEPLA. The prescriber must consider the benefits versus the risks of initiating or continuing treatment with FINTEPLA if any of the following signs are observed via echocardiogram: valvular abnormality or new abnormality; VHD indicated by mild or greater aortic regurgitation or moderate or greater mitral regurgitation, with additional characteristics of VHD (eg, valve thickening or restrictive valve motion); PAH indicated by elevated right heart/pulmonary artery pressure (PASP >35 mmHg). FINTEPLA REMS Program (see Boxed Warning): FINTEPLA is available only through a restricted distribution program called the FINTEPLA Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified by enrolling in the FINTEPLA REMS. Prescribers must counsel patients receiving FINTEPLA about the risk of VHD and PAH, how to recognize signs and symptoms of VHD and PAH, the need for baseline (pretreatment) and periodic cardiac monitoring via echocardiogram during FINTEPLA treatment, and cardiac monitoring after FINTEPLA treatment. Patients must enroll in the FINTEPLA REMS and comply with ongoing monitoring requirements. The pharmacy must be certified by enrolling in the FINTEPLA REMS and must only dispense to patients who are authorized to receive FINTEPLA. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at or by telephone at 1-877-964-3649. Decreased Appetite and Decreased Weight: FINTEPLA can cause decreases in appetite and weight. Decreases in weight appear to be dose related. Approximately half of the patients with LGS and most patients with DS resumed the expected measured increases in weight during the open-label extension studies. Weight should be monitored regularly during treatment with FINTEPLA, and dose modifications should be considered if a decrease in weight is observed. Somnolence, Sedation, and Lethargy: FINTEPLA can cause somnolence, sedation, and lethargy. Other central nervous system (CNS) depressants, including alcohol, could potentiate these effects of FINTEPLA. Prescribers should monitor patients for somnolence and sedation and should advise patients not to drive or operate machinery until they have gained sufficient experience on FINTEPLA to gauge whether it adversely affects their ability to drive or operate machinery. Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including FINTEPLA, increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients treated with an AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior. Anyone considering prescribing FINTEPLA or any other AED must balance the risk of suicidal thoughts or behaviors with the risks of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behaviors. Should suicidal thoughts and behaviors emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated. Withdrawal of Antiepileptic Drugs: As with most AEDs, FINTEPLA should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. If withdrawal is needed because of a serious adverse reaction, rapid discontinuation can be considered. Serotonin Syndrome: Serotonin syndrome, a potentially life-threatening condition, may occur with FINTEPLA, particularly during concomitant administration of FINTEPLA with other serotonergic drugs, including, but not limited to, selective serotonin-norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), bupropion, triptans, dietary supplements (eg, St. John's Wort, tryptophan), drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs], which are contraindicated with FINTEPLA), dextromethorphan, lithium, tramadol, and antipsychotics with serotonergic agonist activity. Patients should be monitored for the emergence of signs and symptoms of serotonin syndrome, which include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (eg, hyperreflexia, incoordination), and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea). If serotonin syndrome is suspected, treatment with FINTEPLA should be stopped immediately and symptomatic treatment should be started. Increase in Blood Pressure: FINTEPLA can cause an increase in blood pressure. Rare cases of significant elevation in blood pressure, including hypertensive crisis, has been reported in adult patients treated with fenfluramine, including patients without a history of hypertension. In clinical trials for DS and LGS of up to 3 years in duration, no pediatric or adult patient receiving FINTEPLA developed hypertensive crisis. Monitor blood pressure in patients treated with FINTEPLA. Glaucoma: Fenfluramine can cause mydriasis and can precipitate angle closure glaucoma. Consider discontinuing treatment with FINTEPLA in patients with acute decreases in visual acuity or ocular pain. ADVERSE REACTIONS The most common adverse reactions observed in DS studies (incidence at least 10% and greater than placebo) were decreased appetite; somnolence, sedation, lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue, malaise, asthenia; ataxia, balance disorder, gait disturbance; blood pressure increased; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; fall; status epilepticus. The most common adverse reactions observed in the LGS study (incidence at least 10% and greater than placebo) were diarrhea; decreased appetite; fatigue; somnolence; vomiting. DRUG INTERACTIONS Strong CYP1A2, CYP2B6, or CYP3A Inducers: Coadministration with strong CYP1A2, CYP2B6, or CYP3A inducers will decrease fenfluramine plasma concentrations. If coadministration of a strong CYP1A2, CYP2B6, or CYP3A inducer with FINTEPLA is necessary, monitor the patient for reduced efficacy and consider increasing the dosage of FINTEPLA as needed. If a strong CYP1A2, CYP2B6, or CYP3A inducer is discontinued during maintenance treatment with FINTEPLA, consider gradual reduction in the FINTEPLA dosage to the dose administered prior to initiating the inducer. Strong CYP1A2 or CYP2D6 Inhibitors: Coadministration with strong CYP1A2 or CYP2D6 inhibitors will increase fenfluramine plasma concentrations. If FINTEPLA is coadministered with strong CYP1A2 or CYP2D6 inhibitors, the maximum daily dosage of FINTEPLA is 20 mg. If a strong CYP1A2 or CYP2D6 inhibitor is discontinued during maintenance treatment with FINTEPLA, consider gradual increase in the FINTEPLA dosage to the dose recommended without CYP1A2 or CYP2D6 inhibitors. If FINTEPLA is coadministered with stiripentol and a strong CYP1A2 or CYP2D6 inhibitor, the maximum daily dosage of FINTEPLA is 17 mg. USE IN SPECIFIC POPULATIONS In patients with severe impairment of kidney function (estimated glomerular filtration rate [eGFR]) 15 to 29 mL/min/1.73m2, dosage adjustments are recommended. FINTEPLA has not been studied in patients with kidney failure (eGFR <15 mL/min/1.73m2). Combined molar exposures of fenfluramine and norfenfluramine were increased in subjects with various degrees of hepatic impairment (Child-Pugh Class A, B, and C), necessitating a dosage adjustment in these patients. To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1‑844-599-2273 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information , including Boxed Warning and Medication Guide , for additional Important Safety Information on FINTEPLA. Important Safety Information about BRIVIACT® (brivaracetam) in the US2 BRIVIACT® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. WARNINGS AND PRECAUTIONS Suicidal Behavior and Ideation: Antiepileptic drugs, including BRIVIACT, increase the risk of suicidal behavior and ideation. Monitor patients taking BRIVIACT for the emergence or worsening of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or self-harm. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider. Neurological Adverse Reactions: BRIVIACT causes somnolence, fatigue, dizziness, and disturbance in coordination. Monitor patients for these signs and symptoms and advise them not to drive or operate machinery until they have gained sufficient experience on BRIVIACT. Psychiatric Adverse Reactions: BRIVIACT causes psychiatric adverse reactions, including non-psychotic and psychotic symptoms in adult and pediatric patients. Advise patients to report these symptoms immediately to a healthcare provider. Hypersensitivity: BRIVIACT can cause hypersensitivity reactions. Bronchospasm and angioedema have been reported. Discontinue BRIVIACT if a patient develops a hypersensitivity reaction after treatment. BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients. Withdrawal of Antiepileptic Drugs: As with all antiepileptic drugs, BRIVIACT should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. DOSING CONSIDERATIONS Dose adjustments are recommended for patients with all stages of hepatic impairment. When BRIVIACT is co-administered with rifampin, an increase in the BRIVIACT dose is recommended. ADVERSE REACTIONS In adult adjunctive therapy placebo-controlled clinical trials, the most common adverse reactions (at least 5% for BRIVIACT and at least 2% more frequently than placebo) were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Adverse reactions reported in clinical studies of pediatric patients were generally similar to those in adult patients. Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain. BRIVIACT is a Schedule V controlled substance. Please refer to the full Prescribing Information and visit . Important Safety Information about VIMPAT® (lacosamide) in the US3 VIMPAT® is indicated for treatment of partial-onset seizures in patients 1 month of age and older, and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. VIMPAT IMPORTANT SAFETY INFORMATION VIMPAT is associated with important warnings and precautions including suicidal behavior and ideation, dizziness and ataxia, cardiac rhythm and conduction abnormalities, syncope, and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity. Partial-Onset Seizures In the adult adjunctive placebo-controlled trials for partial-onset seizures, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. In the adult monotherapy clinical trial, adverse reactions were generally similar to those observed and attributed to drug in adjunctive placebo-controlled trials, with the exception of insomnia (observed at a higher rate of ≥2%). Primary Generalized Tonic-Clonic Seizures In the adjunctive therapy placebo-controlled trial for primary generalized tonic-clonic seizures, the adverse reactions were generally similar to those that occurred in the partial-onset seizures trials. The adverse reactions most commonly reported were dizziness, somnolence, headache, and nausea. Pediatric Patients Adverse reactions reported in clinical studies for partial-onset seizures in patients 1 month to less than 17 years of age and for primary generalized tonic-clonic seizures for patients 4 to less than 17 years of age were similar to those seen in adult patients. Injection In adult adjunctive therapy clinical trials for partial-onset seizures, adverse reactions with intravenous administration generally were similar to those that occurred with the oral formulation, although intravenous administration was associated with local adverse reactions such as injection site pain or discomfort (2.5%), irritation (1%), and erythema (0.5%). When administering a loading dose, the incidence of CNS adverse reactions, such as dizziness, somnolence, and paresthesia, may be higher with 15-minute administration than over a 30- to 60-minute period. The adverse reactions associated with VIMPAT injection in adult patients with primary generalized tonic-clonic seizures are expected to be similar to those seen in adults with partial- onset seizures. The adverse reactions associated with VIMPAT injection in pediatric patients are expected to be similar to those noted in adults. Infusion times less than 30 minutes were not adequately studied in pediatric patients. VIMPAT (lacosamide) is a Schedule V controlled substance. Please refer to the full Prescribing Information. ­­­­References: Fintepla® US PI. FINTEPLA (fenfluramine) oral solution: U.S. prescribing information. Smyrna, GA: UCB, Inc. BRIVIACT (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc. VIMPAT (lacosamide): US prescribing information. Smyrna, GA: UCB, Inc. Forward looking statements This press release may contain forward-looking statements including, without limitation, statements containing the words "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will", "continue" and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed 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 known and unknown risks, uncertainties and assumptions which might cause the actual 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: the global spread and impact of COVID-19, changes in general economic, business and competitive conditions, the inability to obtain 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 actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars, changes in laws or regulations, exchange rate fluctuations, changes or 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, will progress to product approval or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in 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 timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products, which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate 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 could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's 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, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future. UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB 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-looking statements with regard thereto or any change in events, conditions or circumstances 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 an 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction. BRIVIACT®, FINTEPLA®, and UCBCares® are registered trademarks of the UCB Group of Companies. VIMPAT® is a registered trademark used under license from Harris FRC Corporation. Staccato® is a registered trademark of Alexza Pharmaceuticals, Inc., and is used by UCB Pharma under license. ©2023 UCB, Inc., Smyrna, GA 30080. All rights reserved. US-BR-2300119 SOURCE UCB