UCB Presents New Data Demonstrating Commitment to Epilepsy at 2019 American Epilepsy Society Meeting

• 14 scientific presentations will cover UCB’s pipeline assets, epilepsy-specific research, and licensed medicines, including NAYZILAM, now available for the acute treatment of seizure clusters in epilepsy patients 12 years of age and older
• Friday evening symposium on “Epilepsy Treatment Update for Patients Suffering from Seizure Clusters” includes Epilepsy Foundation’s project on seizure emergencies and a panel discussion on the misconceptions around seizure clusters

ATLANTA, Dec. 5, 2019 /PRNewswire/ -- UCB today announced 14 posters have been selected for presentation at this year’s American Epilepsy Society Meeting, taking place in Baltimore, Maryland, December 6-10. The UCB scientific program includes the presentation of clinical data describing BRIVIACT^® (brivaracetam) CV, VIMPAT^® (lacosamide) CV, and NAYZILAM^® (midazolam) Nasal Spray CIV, now available in the U.S. 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.¹ Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

During the meeting, posters on epilepsy research are also scheduled for presentation, as well as UCB’s developmental drug candidate, padsevonil. Padsevonil is not yet approved by the FDA. These scientific presentations provide further insight into UCB’s epilepsy portfolio and reinforce the company’s commitment to generating sustainable patient value for people living with epilepsy around the world.

“Our leadership in epilepsy combines insights from patients and caregivers, collaborations with leading experts from around the world, and cutting-edge scientific methods to address important unmet medical challenges,” explained Charl van Zyl, Head of Neurology & Executive Vice President, UCB. “We are committed to developing solutions that address areas of acute need while delivering sustainable value and improved experiences for people living with epilepsy.”

UCB will be presenting five posters on NAYZILAM and hosting a Symposium “Epilepsy Treatment Update for Patients Suffering from Seizure Clusters” tomorrow, Friday, December 6, 6:00 - 9:00 PM, at the Baltimore Convention Center, Room 314-315. During the symposium, Patty Shafer RN, MN, Senior Director of Health Information and Resources from the Epilepsy Foundation will discuss the rationale for their Seizure Clusters Workgroup and research. Panelists James Wheless, MD; Patricia Penovich, MD; and David Burdette, MD will discuss misconceptions around seizure clusters, followed by a clinical presentation on NAYZILAM.

“We believe in developing medicines for people living with epilepsy that may help them achieve control and return to the lives they want to live,” said Mike Davis, Head of U.S. Neurology. “The availability of NAYZILAM, which coincides with this AES meeting, reinforces our commitment to progressing tailored medicines to provide additional choices and support to the epilepsy community with the first new rescue option in two decades.”

UCB will also present “Therapeutic Update: The Additional Burden of Generalized Tonic-Clonic Seizures” with lunch on Sunday, December 8, 12:00 - 1:00 PM, at the Hilton, Key Ballroom 8, Second Floor. John Stern, MD will discuss generalized tonic-clonic seizures and the possibility of mitigating their risk through earlier and more effective treatment interventions.

UCB is hosting a “Commitment to Epilepsy Care” Scientific Exhibit on Monday, December 9, 8:00 – 11:00 AM, in the Baltimore Convention Center, Level 300, Room 321-323, to give attending healthcare professionals and researchers an opportunity to learn more about UCB’s epilepsy research, clinical studies recruiting, and the company’s approach to the development and discovery of medicines.

The UCB Congress Exhibit Booth is located within the main exhibition hall, Booth 308.

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

BRIVIACT Posters:

Long-term tolerability and retention of adjunctive brivaracetam in children,² Jan-Peer Elshoff, PharmD, PhD, Teresa Gasalla, MD, Sami Elmoufti, MS, Melinda Martin, PhD, Xavier Nondonfaz, MD, Anup D Patel, MD

• Abstract 1.298
• Date/time: December 7, 2019: 12:00 – 6:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Time course of 75%–100% efficacy response of adjunctive brivaracetam in adults with focal (partial-onset) seizures and secondarily generalized seizures: a pooled post hoc analysis,³ Cedric Laloyaux, PhD; Sami Elmoufti, MS; Teresa Gasalla, MD; Melinda Martin, PhD; Pavel Klein, MD

• Abstract 2.227
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Baseline Seizure Related Disability Assessment Scale (SERDAS) scores in an observational study of brivaracetam,⁴ Dale C. Hesdorffer, Melinda Martin, Roger J. Porter, Julie Varner, Anne-Liv Schulz, Ying Zhang, Jacqueline A. French

• Abstract 1.297
• Date/time: December 7, 2019: 12:00 – 6:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Real-world study of brivaracetam in the US: an interim analysis,⁵ Roger J. Porter, MD; Melinda Martin, PhD; Julie Varner, PhD; Anne-Liv Schulz, MD; Dale C. Hesdorffer, PhD; Ying Zhang, MS; Jacqueline A. French, MD

• Abstract 2.226
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

NAYZILAM Posters:

Somnolence and time to return to baseline functionality after midazolam nasal spray delivery in patients with seizure clusters: post hoc analysis of a randomized, double-blind, placebo-controlled trial,⁶ Kamil Detyniecki, MD; Rita Campos, PharmD; Teresa Gasalla, MD; Jody Cleveland, MS; Toufic Fakhoury, MD

• Abstract 2.243
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Tolerability and efficacy of midazolam nasal spray in outpatient treatment of patients with seizure clusters by concomitant AEDs: post hoc analysis of randomized, double-blind, placebo-controlled trial,⁷ Steve S Chung, MD; James W Wheless, MD; Svetlana Dimova, MD, PhD; Eun Jung Choi, MD, PhD; Aliceson King, MD, MPH; Jody Cleveland, MS

• Abstract 1.308
• Date/time: December 7, 2019: 12:00 – 6:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

A systematic review of the clinical, humanistic and economic burden of seizure clusters,⁸ Eun Jung Choi, MD, PhD; Steve S Chung, MD; J Claire Wilson, PhD; Saifuddin Kharawala, DPM, MBBS; Gavneet Kaur, MPharm

• Abstract 2.263
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Rescue medications in seizure clusters: a systematic review of treatment patterns and treatment impact,⁹ Saifuddin Kharawala, DPM, MBBS; Jerzy P. Szaflarski, MD, PhD; Gavneet Kaur, MPharm; Eun Jung Choi, MD, PhD; J Claire Wilson, PhD; Lawrence Hirsch, MD

• Abstract 3.331
• Date/time: December 9, 2019: 8:00 AM - 2:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Abuse liability of midazolam nasal spray (MDZ-NS) in adult recreational benzodiazepine users: phase 1, randomized, double-blind, double-dummy, active- and placebo-controlled, crossover trial,¹⁰ Isabella Szeto, Tze-Chiang Meng, Peter J. Van Ess, Jo McCarthy

• Abstract 3.33
• Date/time: December 9, 2019: 8:00 AM - 2:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

VIMPAT Poster:

A multicenter, observational trial in Taiwan to evaluate the safety and tolerability of lacosamide in clinical practice for the treatment of epilepsy,¹¹ Tony Wu, MD, PhD; Yao-Chung Chuang, MD, PhD; Hui-Chun Huang, MD; Peiyuan F Hsieh, MD; Wang-Tso Lee, MD; Shuo-Bin Jou, MD; Xinlu Du, MD; Scarlett Hellot, MSc; Carrie McClung, MS

• Abstract 1.307
• Date/time: December 7, 2019: 12:00 – 6:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Epilepsy Posters:

Unit cost of epilepsy-related health care encounters in the US,¹² Simon Borghs, MSc; Silky Beaty, PharmD, MSPH; Witesh Parekh, BPharm(Hons), MSc, MRPharmS; Linda Kalilani, MBBS, MPhil, PhD; Nada Boudiaf, MSc; Andrea Loewendorf, MB

• Abstract 1.417
• Date/time: December 7, 2019: 12:00 – 6:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Characterization of an experimental mouse model of epilepsy-associated Focal Cortical Dysplasia: Group housing video-EEG Wireless telemetry recordings,¹³ Natalia Rodriguez Alvarez, Veronique Marie Andre, Lauren Drowley, Martin Armstrong, Stefanie Dedeurwaerdere

• Abstract 2.074
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Molecular and translational characterization of the in vitro organotypic hippocampal slice model for epilepsy using a systems genetics approach,¹⁴ Isabelle Niespodziany, PhD; Liesbeth François, PhD; Patrice Godard, PhD; Catherine Vandenplas; Marek Rajman, PhD; Jonathan Van Eyll, PhD; Stefanie Dedeurwaerdere, PhD

• Abstract 2.2
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

Padsevonil Poster:

Investigation of padsevonil, a new investigational antiepileptic drug candidate, by all-optical electrophysiology (Optopatch) in cultured neuronal networks,¹⁵ Christian Wolff, PhD; Isabelle Niespodziany, PhD; John Ferrante, BS; Himali Shroff, MS; Owen McManus, PhD; Luis Williams, PhD; Graham T. Dempsey, PhD

• Abstract 2.192
• Date/time: December 8, 2019: 10:00 AM - 4:00 PM ET
• Location: Baltimore Convention Center, General Poster Session

* Padsevonil is an investigational drug candidate for epilepsy currently in clinical development. The safety and efficacy of padsevonil have not been established and it is not approved by any regulatory authority worldwide.

About BRIVIACT^® (brivaracetam) CV ¹⁶
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.

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 available at www.BRIVIACTHCP.com.

About VIMPAT^® (lacosamide) CV: ¹⁷
VIMPAT^® was approved in the U.S. in 2008 as an add-on therapy for adult patients. 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^® is available in three formulations: oral tablets, oral solution, and intravenous (IV) injection.

VIMPAT INDICATION AND SELECT IMPORTANT SAFETY INFORMATION

VIMPAT (lacosamide) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of VIMPAT injection in pediatric patients has not been established, VIMPAT injection is indicated for the treatment of partial-onset seizures only in adult patients (17 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.

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%). In the adult adjunctive placebo-controlled trials, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea, and diplopia. Pediatric adverse reactions were similar to those seen in adult patients.

VIMPAT is a Schedule V controlled substance.

Please refer to full Prescribing Information available at www.VIMPATHCP.com.

About NAYZILAM^® (midazolam) nasal spray CIV ¹

NAYZILAM^®, the first and only 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 at www.NAYZILAM.com.

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.¹⁸ It is the fourth most common neurological condition worldwide and affects approximately 65 million people.^19,20 In the U.S. more than 3.4 million people have epilepsy.^19,21 Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures.^19,20

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 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.

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.
©2019 UCB, Inc., Smyrna, GA 30080. All rights reserved.

For further information, UCB:

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 in immunology and neurology. With 7,500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA

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:

1. NAYZILAM^® (midazolam) nasal spray CIV. US Prescribing Information.
2. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421293. Accessed 2 December 2019.
3. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421672. Accessed 2 December 2019.
4. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421292. Accessed 2 December 2019
5. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421671. Accessed 2 December 2019.
6. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421688. Accessed 2 December 2019.
7. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421303. Accessed 2 December 2019.
8. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421707. Accessed 2 December 2019.
9. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2422225. Accessed 2 December 2019.
10. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2422224. Accessed 2 December 2019.
11. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421302. Accessed 2 December 2019.
12. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421410. Accessed 2 December 2019.
13. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421522. Accessed 2 December 2019.
14. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421645. Accessed 2 December 2019.
15. AES Annual Meeting Abstracts. Available at: https://www.aesnet.org/meetings_events/annual_meeting_abstracts/view/2421638. Accessed 2 December 2019.
16. BRIVIACT^® (brivaracetam) CV. U.S. Prescribing Information.
17. VIMPAT^® (lacosamide) CV. U.S. Prescribing Information.
18. The Epilepsy Foundation of America. About epilepsy basics. http://www.epilepsy.com/learn/about-epilepsy-basics. Accessed 22 November 2019.
19. The Epilepsy Foundation of America. Who gets epilepsy? http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy. Accessed 22 November 2019
20. The Epilepsy Foundation of America. What is epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy. Accessed 22 November 2019.
21. Centers for Disease Control and Prevention. Available at https://www.cdc.gov/epilepsy/basics/fast-facts.htm. Accessed 22 November 2019.

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