UCB Announces New Data from its Epilepsy Portfolio Presented on the American Academy of Neurology Virtual Platform

ATLANTA, June 24, 2020 /PRNewswire/ -- UCB today announced six posters selected for presentation at the 72^nd American Academy of Neurology (AAN) annual meeting, available online via the 2020 AAN Science Highlights virtual platform, which replaced the in-person event previously cancelled due to the COVID-19 pandemic. The abstracts were also published in the online supplement to Neurology.

The UCB scientific program includes real-world evidence and clinical data for BRIVIACT^® (brivaracetam) CV, FDA-approved for the treatment of partial-onset seizures in patients 4 years of age and older¹ and NAYZILAM^® (midazolam) nasal spray CIV, FDA-approved for the 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. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.²  See below for additional information including important safety information.

"We know that the healthcare system and people living with epilepsy are experiencing an enormous  amount of pressure due to COVID-19, and we are grateful that AAN is providing a virtual platform to present new data from our epilepsy portfolio," said Mike Davis, head of U.S. Neurology at UCB. "At UCB, we're committed to providing both chronic and acute seizure treatments for people living with epilepsy during this critical time."

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

NAYZILAM Posters

First onset of any treatment-emergent adverse event over the course of repeated midazolam nasal spray (mdz-ns) use for the treatment of seizure clusters: a post hoc*³ Michael Gelfand, MD, PhD; Svetlana Dimova, MD, PhD; Eun Jung Choi, MD, PhD; Aliceson King, MD, MPH; Jody Cleveland, MS

• Poster 4496

BRIVIACT Posters:

Baseline Seizure Related Disability Assessment Scale (SERDAS) scores in an observational study of brivaracetam,⁴ Jacqueline A. French, MD; Roger J. Porter, MD; Julie Varner, PhD; Anne-Liv Schultz, MD; Ying Zhang, MS; Melinda Martin, PhD

• Poster 3789

Long-term retention on adjunctive brivaracetam and reasons for discontinuation by number of lifetime AEDs in adults with focal seizures: a post-hoc analysis,⁵ Pavel Klein, MD; Richard McLachlan, MD, FRCPC; Cedric Laloyaux, PhD; Xavier Nondonfaz, MD; Sami Elmoufti, MS; Svetlana Dimova, MD, PhD; Christian Brandt, MD

• Poster 3787

Long-term tolerability and retention of adjunctive brivaracetam in children with primary generalized or mixed seizure types: interim subgroup analysis of pooled data from two open label trials, ⁶ Anup D. Patel, MD; Teresa Gasalla, MD; Xavier Nondonfaz, MD; Sami Elmoufti, MS; Jan-Peer Elshoff, PharmaD, PhD

• Poster 3786

Real-world study of brivaracetam in the United States: an interim analysis,⁷ Melinda Martin, PhD; Roger J. Porter, MD; Julie Varner, PhD; Anne-Liv Schultz, MD; Ying Zhang, MS; Jacqueline A. French, MD

• Poster 3788

Epilepsy Care Research Poster:

Unit cost of epilepsy-related health care encounters in the United States,⁸ Simon Borghs, MS; Silky Beaty, PharmaD, MSPH; Witesh Parekh, BPharm, MS, MRPharmS; Linda Kalilani, MBBS, MPhil, PhD; Nada Boudiaf, MS; Andrea Loewendorf, MB

• Poster 3061

About NAYZILAM^® (midazolam) nasal spray CIV²
NAYZILAM^® was approved by the U.S. FDA in May 2019 for the acute treatment of seizure clusters in epilepsy patients 12 years and older. More information is available at www.NAYZILAM.com.

NAYZILAM INDICATION AND 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 BRIVIACT^® (brivaracetam) CV¹
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 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.

UCB Response to COVID-19
UCB is committed to helping those impacted by the novel coronavirus, COVID-19. This includes helping patients maintain access to and answering any questions about UCB medicines. We are also working closely with regulatory authorities to ensure the safety of all clinical trial participants and investigators, maintain compliance with good clinical practice, and minimize risks to trial integrity. The evolving COVID-19 pandemic has placed tremendous strain on medical healthcare systems worldwide as they focus on the ongoing extraordinary medical emergency. Taking this into consideration, UCB has taken measures to protect patients, healthcare providers, our employees, and the communities we serve around the world.

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

For further information, UCB:

U.S. Neurology Communications
Erica Puntel
U.S. Communications, UCB
T 404.938.5359, [email protected] 

Global Neurology Communications
Jim Baxter   
Neurology Communications, UCB
T +32-2-559 9368, [email protected] 

Investor Relations
Antje Witte,
Investor Relations, UCB 
T +32.2.559.94.14, [email protected] 

Isabelle Ghellynck,
Investor Relations,
UCB
T+32.2.559.9588, [email protected] 

BRIVIACT^®, NAYZILAM^®, and ucbCARES^® are registered trademarks of the UCB Group of Companies.

^©2020 UCB, Inc., Smyrna, GA 30080. All rights reserved.

Forward looking statements UCB
This press release contains 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: 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, 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 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' 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 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.

____________________________

References:

1. BRIVIACT^® (brivaracetam) CV. U.S. Prescribing Information
2. NAYZILAM^® (midazolam) nasal spray CIV. U.S. Prescribing Information
3. AAN Annual Meeting Posters. Available at:
   https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/4496
4. AAN Annual Meeting Posters. Available at:
   https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/3789
5. AAN Annual Meeting Posters. Available at:
   https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/3787
6. AAN Annual Meeting Posters. Available at:
   https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/3786
7. AAN Annual Meeting Posters. Available at:
   https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/3788
8. AAN Annual Meeting Posters. Available at:
   https://cslide-us.ctimeetingtech.com/aan2020/attendee/eposter/poster/3061

SOURCE UCB, Inc.

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