04-Dec-2020

UCB Demonstrates Commitment to Science and Discovery Across Its Epilepsy Portfolio at the American Epilepsy Society's Virtual Event AES2020

ATLANTA, Dec. 4, 2020 /PRNewswire/ -- UCB today announced that 15 scientific posters will be presented at the upcoming American Epilepsy Society's all new virtual event, AES2020, December 4-8, 2020. The scientific program features the latest research on VIMPAT in primary generalized tonic-clonic seizures (PGTCS). VIMPAT was just recently approved by the U.S. Food and Drug Administration (FDA) as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.¹

Key poster presentations also include data on the long-term efficacy and tolerability of adjunctive BRIVIACT in adults with partial-onset seizures, the efficacy and patient satisfaction of NAYZILAM among people living with seizure clusters, and Phase 2 study results for Staccato^® Alprazolam, an investigational drug-device combination designed to be used as a single-use epileptic seizure rescue therapy that combines the Staccato^® delivery technology with alprazolam. Staccato^® Alprazolam is not yet approved by the FDA.

"For the past two years at AES, UCB has been able to share data and introduce new FDA approvals for people living with epilepsy – this year, VIMPAT for primary generalized tonic-clonic seizures, and last year, NAYZILAM for people living with seizure clusters," said Mike Davis, Head of U.S. Neurology at UCB. "We have a genuine and continued commitment to providing new medicines to the healthcare ecosystem and epilepsy community overall to address the unmet needs of people living with epilepsy on their journey to seizure control."

Alongside its scientific presentations, UCB will host a virtual symposium featuring a panel of four neurology experts to examine the urgent and unmet needs of patients living with PGTCS. The panelists will also discuss the Phase 3 trial results for VIMPAT in PGTCS. The symposium is scheduled to take place on Friday, December 4, 6:30 - 9:30 PM ET.

UCB is hosting a "UCB: Inspiring Confidence through the Epilepsy Journey" Scientific Exhibit on Sunday, December 6, 8:00 - 11:00 AM ET. UCB will also be hosting a booth in the Premier Exhibitor Hall.

Following is a guide to the UCB-sponsored data presentations:

BRIVIACT (brivaracetam) CV e-Posters:

Effectiveness and quality of life during 12-month adjunctive brivaracetam treatment in a real-life setting: interim data from a prospective observational study in Europe,B. Steinhoff, J. Christensen, C. Doherty, M. Majoie, A. Schulz, S. Hellot, I. Leunikava, J. Leach²

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 126

Long-term retention, efficacy and tolerability of adjunctive brivaracetam by number of lifetime antiepileptic drugs in adults with focal seizures: a post hoc analysis, S. Dimova, C. Brandt, C. Laloyaux, X. Nondonfaz, S. Elmoufti, P. Klein³

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 134

12-month effectiveness and tolerability of brivaracetam in the real world: the international, non-interventional EXPERIENCE study, V. Villanueva, C. Di Bonaventura, E. Faught, B. Steinhoff, C. Laloyaux, V. Sendersky, K. Ricchetti-Masterson⁴

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 144

NAYZILAM (midazolam) CIV e-Posters:

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, K. Detyniecki, M. Brunnert, R. Campos, S. Dimova, J. Wheless⁵

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 135

Treatment satisfaction, anxiety level, and confidence about traveling with midazolam nasal spray in patients with seizure clusters: Phase III, open-label extension trial, T. Fakhoury, L. Chen, A. Bass, M. Brunnert, R. Campos, T. Meng, P. Van Ess, W. Pullman⁶

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 131

Disease burden, healthcare resource use and healthcare costs in refractory epilepsy patients using rescue medications: retrospective cohort study, G. Pietri, J. Wilson, R. Baxter, E. Choi, H. Kim⁷

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 146

VIMPAT (lacosamide) CV e-Posters:

Efficacy of adjunctive lacosamide in the treatment of primary generalized tonic-clonic seizures: subgroup analyses of a double-blind, randomized, placebo-controlled trial, D. Vossler, S. Knake, T. O'Brien, M. Watanabe, M. Brock, B. Steiniger-Brach, P. Williams, R. Roebling⁸

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 127

Safety of adjunctive lacosamide in patients with primary generalized tonic-clonic seizures (PGTCS) and patients with focal seizures: pooled data for pediatrics and adults,A. Husain, M. Brock, D. Chellun, R. Roebling, B. Steiniger-Brach, P. Williams, D. Vossler⁹

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 129

Long-term safety and efficacy of adjunctive lacosamide in the treatment of primary generalized tonic-clonic seizures: an open-label extension trial,T. O'Brien, D. Vossler, M. Farkas, M. Brock, B. Steiniger-Brach, P. Williams, R. Roebling, M. Watanabe¹⁰

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 128

Patient and physician preferences in epilepsy monotherapy in a real-world study (VOTE): evidence from discrete choice experiments, F. Rosenow, Y. Winter, I. Leunikava, M. Brunnert, J. Sutphin, M. Boeri, F. Villani, C. Brandt¹¹

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 143

Staccato Alprazolam e-Poster:

A double-blind, placebo-controlled, inpatient, dose-ranging efficacy study of Staccato alprazolam in participants with epilepsy with a predictable seizure pattern: Results from part 2, J. French, V. Biton, H. Dave, K. Detyniecki, M. Gelfand, H. Gong, K. Liow, T. O'Brien, A. Sadek, J. Isojarvi¹²

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 90

Epilepsy Real-World Data e-Posters:

Epidemiology of seizures amongst patients treated in U.S. hospitals during 2016-2019, S. Beaty, N. Rosenthal, J. Gayle, P. Dongre, K. Ricchetti-Masterson¹³

Poster session: Monday, December 7, 2020 9:00AM – 10:30AM ET
Abstract 778

Implementation of an epilepsy education program into an ambulatory care clinic, M. Siodlak, B. Gidal, S. Hunter-Banks S, J. Thompson, A. Margolis¹⁴

Poster session: Sunday, December 6, 2020 5:15PM – 6:45PM ET
Abstract 615

Keppra® (levetiracetam) e-Poster:

Safety and efficacy of oral levetiracetam as adjunctive therapy for Japanese patients with primary generalised tonic-clonic seizures in clinical practice: results of the post-marketing surveillance, T. Tokumasu, D. Hirai, E. Watanabe, K. Hirano¹⁵

Poster session: Monday, December 7, 2020 9:00AM – 10:30AM ET
Abstract 777

Padsevonil e-Poster:

Efficacy and safety of adjunctive padsevonil in adults with drug-resistant focal seizures: a double-blind, randomized, placebo-controlled dose-finding trial, M. Rademacher, M. Toledo, W. Van Paesschen, K. Liow, M. Esch, E. Webster, N. Wang, K. Werhahn, J. French¹⁶

Poster session: Saturday, December 5, 2020 9:00AM – 10:30AM ET
Abstract 130

About VIMPAT^® (lacosamide) CV in the U.S.
VIMPAT was approved in the U.S. in 2008 as an add-on therapy for the treatment of partial-onset seizures in adult patients with epilepsy. VIMPAT was approved as monotherapy for adults in August 2014, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2017. VIMPAT was approved by the FDA in November 2020 as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. VIMPAT is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.

VIMPAT INDICATION AND SELECT IMPORTANT SAFETY INFORMATION

VIMPAT^® is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.

VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.

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%). Pediatric adverse reactions were similar to those seen in adult patients.

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.

VIMPAT is a Schedule V controlled substance.
Please refer to full Prescribing Information.

About BRIVIACT^® (brivaracetam) CV
BRIVIACT was approved in the U.S. in 2016 as an add-on therapy for adult patients. BRIVIACT was approved as monotherapy for adults in September 2017, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2018. BRIVIACT^® is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection. More information is available at www.BRIVIACTHCP.com

BRIVIACT INDICATION AND SELECT IMPORTANT SAFETY INFORMATION

BRIVIACT^® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of BRIVIACT injection in pediatric patients has not been established, BRIVIACT injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).

BRIVIACT is associated with important warnings and precautions including suicidal behavior and ideation, somnolence, fatigue, dizziness, disturbance in gait and coordination, psychiatric adverse reactions including nonpsychotic and psychotic symptoms, and hypersensitivity reactions (bronchospasm and angioedema). BRIVIACT is contraindicated in patients with a prior hypersensitivity reaction to brivaracetam or any of the inactive ingredients.

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 4 years to less than 16 years of age were generally similar to those in adult patients.

BRIVIACT is a Schedule V controlled substance.
Please refer to full Prescribing Information.

About NAYZILAM^® (midazolam) nasal spray CIV
NAYZILAM, the first and only midazolam nasal spray for the acute treatment of seizure clusters in epilepsy patients 12 years and older, was approved by the U.S. FDA in May 2019.

NAYZILAM INDICATION AND SELECT IMPORTANT SAFETY INFORMATION
NAYZILAM^® (midazolam) nasal spray CIV is a benzodiazepine 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 12 years of age and older.

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 result in profound sedation, respiratory depression, coma, and death.
Reserve concomitant prescribing of these drugs for use in 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.

RISKS OF CARDIORESPIRATORY ADVERSE REACTIONS
Serious cardiorespiratory adverse reactions have occurred after administration of midazolam. Warn patients and caregivers about the risks of respiratory depression, cardiac and respiratory arrest.

Respiratory depression was observed with the administration of NAYZILAM during clinical trials. Cardiac or respiratory arrest caused by NAYZILAM was not reported during clinical trials.

CENTRAL NERVOUS SYSTEM DEPRESSION FROM CONCOMITANT USE WITH OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS, OR MODERATE OR STRONG CYP3A4 INHIBITORS
Drug products containing midazolam, including NAYZILAM, have a central nervous system (CNS) depressant effect.

Risks from Concomitant Use with Other CNS Depressants
NAYZILAM may cause an increased CNS-depressant effect when used with alcohol or other CNS depressants (e.g., opioids). Warn patients and caregivers that the use of NAYZILAM in combination with alcohol or other CNS depressant drugs may increase the risk of hypoventilation, airway obstruction, desaturation, 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 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. Caution patients against engaging in hazardous occupations requiring mental alertness, such as operating machinery, driving a motor vehicle or riding a bicycle until they have completely returned to their level of baseline functioning.

SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with NAYZILAM for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients and caregivers to be alert for these behavioral changes and to immediately report them to the healthcare provider.

IMPAIRED COGNITIVE FUNCTION
Midazolam, including NAYZILAM, is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Counsel patients on when they can engage in activities requiring complete mental alertness, operate hazardous machinery, or drive a motor vehicle after taking NAYZILAM.

GLAUCOMA
Benzodiazepines, including NAYZILAM, can increase intraocular pressure in patients with glaucoma. NAYZILAM may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. NAYZILAM is contraindicated in patients with narrow-angle glaucoma.

ADVERSE REACTIONS
In the randomized, double-blind, placebo-controlled trial, the most common adverse reactions (≥5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.

NAYZILAM is a Schedule IV controlled substance.
Please refer to the full Prescribing Information.

For additional medical information about NAYZILAM, patient assistance, or any other information please visit our website or call ucbCARES^® at 1-844-599-2273.

About Epilepsy
Epilepsy is a chronic neurological disorder of the brain.¹⁷ It is the fourth most common neurological condition worldwide and affects approximately 65 million people.¹⁸ Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked epileptic seizures with a risk of further seizures.¹⁹

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 30 years of experience in the research and development of anti-epileptic 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 understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies, and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support 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 solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,600 people in approximately 40 countries, the company generated revenue of € 4.9 billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

For further information, UCB:

U.S. Neurology Communications
Erica Puntel
U.S. Communications, UCB
T 404.938.5359, erica.puntel@ucb.com

Investor Relations
Antje Witte
Investor Relations, UCB
T +32.2.559.94.14, antje.witte@ucb.com

Isabelle Ghellynck
Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com

BRIVIACT^®, NAYZILAM^®, and ucbCARES^® are registered trademarks of the UCB Group of Companies.
VIMPAT^® is a registered trademark used under license from Harris FRC Corporation.
©2020 UCB, Inc., Smyrna, GA 30080. All rights reserved.

Forward looking statements – UCB

This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, 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, product liability claims, challenges to patent protection for products or product candidates, 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.

UCB is providing this information 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 a change in its expectations. There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.

References:

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Last Updated: 04-Dec-2020