UCB showcases latest epilepsy research at 2017 Annual Meeting of the American Academy of Neurology

ATLANTA, April 21, 2017 /PRNewswire/ -- UCB is pleased to announce that 12 scientific abstracts have been accepted for presentation at the upcoming Annual Meeting of the American Academy of Neurology (AAN) to be held April 22 to 28, 2017 in Boston, USA.^1-12

Data being presented include posters further describing the efficacy and tolerability profile of VIMPAT^® (lacosamide) CV and BRIVIACT^® (brivaracetam) CV.

Posters will be presented describing the efficacy and tolerability of lacosamide monotherapy in elderly newly diagnosed epilepsy patients and in newly diagnosed epilepsy patients with psychiatric comorbidities. Pooled results from long-term follow-up studies of adjunctive brivaracetam in patients with secondarily generalized tonic-clonic seizures and a poster comparing the healthcare utilization and direct medical costs in newly diagnosed epilepsy patients compared to a non-epilepsy population will also be presented.

In the U.S., VIMPAT^® is approved as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients 17 years and older.¹³ BRIVIACT^® is approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.¹⁴

"At UCB, we are committed to finding solutions for people living with epilepsy. We are therefore excited to share further data at this important meeting that will continue to expand our understanding and enable us to bring new scientific advances to the epilepsy community," explained Jeff Wren, Executive Vice President, Neurology Patient Value Head at UCB. "Around thirty percent of people with epilepsy have seizures that remain uncontrolled on currently available therapies. By sharing our research with the wider neurology community, and by focusing on improving patient treatment journeys, we believe we can make a real difference to the millions of people with epilepsy around the world."

The following is a guide to the 12 UCB-sponsored poster presentations at the Annual Meeting of the American Academy of Neurology (AAN) to be held April 22 to 28, 2017 in Boston, USA.

VIMPAT^® (lacosamide):

1. [#110] Randomized double-blind non-inferiority trial of lacosamide versus controlled-release carbamazepine monotherapy: subgroup analysis of unclassified patients with initial generalized tonic-clonic seizures only
   Werhahn K. et al
   Wednesday, April 26th, Poster Session 4
2. [#227] Efficacy of lacosamide monotherapy in patients with newly diagnosed epilepsy stratified by baseline disease severity: sub-analysis of data from a prospective non-inferiority trial versus controlled-release carbamazepine
   Toledo M. et al
   Thursday, April 27th, Poster Session 5
3. [#228] Efficacy and tolerability of lacosamide monotherapy in patients with newly diagnosed epilepsy: a prospective randomized double-blind non-inferiority trial versus controlled-release carbamazepine
   Baulac M. et al
   Thursday, April 27th, Poster Session 5
4. [#229] Tolerability and efficacy of lacosamide monotherapy in patients with newly diagnosed epilepsy and psychiatric comorbidities: post-hoc analysis of a prospective randomized double-blind trial
   Schmitz B. et al
   Thursday, April 27th, Poster Session 5
5. [#230] Effectiveness of lacosamide monotherapy in clinical practice: a retrospective chart review in patients with focal seizures
   Villanueva V. et al
   Thursday, April 27th, Poster Session 5
6. [#231] Outcomes following exposure to the antiepileptic drug lacosamide during pregnancy: results from a global safety database
   Golembesky A. et al
   Thursday, April 27th, Poster Session 5
7. [#232] Efficacy and tolerability of lacosamide monotherapy in elderly patients with newly diagnosed epilepsy: subgroup analysis of a non-inferiority trial versus controlled-release carbamazepine
   Rosenow F. et al
   Thursday, April 27th, Poster Session 5
    
   BRIVIACT^® (brivaracetam):
    
8. [#109] A review of the drug-drug interactions of the new antiepileptic drug brivaracetam
   Moseley B. et al
   Wednesday, April 26th, Poster Session 4
9. [#233] Brivaracetam enters the brain faster than levetiracetam: a PET study in healthy volunteers
   Finnema S. et al
   Friday, April 28th, Poster Session 6
10. [#238] Efficacy of adjunctive brivaracetam in patients with secondarily generalized tonic-clonic seizures at baseline: pooled results from long-term follow-up studies
    Moseley B. et al
    Friday, April 28th, Poster Session 6
11. [#243] Evaluation of abuse potential of brivaracetam in healthy recreational CNS depressant users
    Schoedel KA. et al
    Friday, April 28th, Poster Session 6
      
    Epilepsy:
      
12. [Session 34] Comparing the healthcare utilization and direct medical costs in newly diagnosed epilepsy patients and a comparator non-epilepsy population: a US database analysis
    Faught E. et al
    Wednesday, April 26th at 15.45, Platform presentation 002

About Epilepsy^15,16,17

Epilepsy is a chronic neurological disease of the brain, defined as one or more unprovoked seizures with a risk of further seizures, and is characterized by the neurobiological, cognitive, psychological, and social consequences of this disorder. Epilepsy is the fourth most common neurological condition worldwide, affecting an estimated 65 million around the world. In the U.S., more than 3 million people have epilepsy. Between 4 and 10 people out of every 1,000 in the world live with active seizures at any one time. Anyone can develop epilepsy; it occurs across all ages, races and genders. One third of patients with epilepsy live with uncontrolled seizures.

About UCB in Epilepsy

UCB has a longstanding commitment to improving the lives of people with epilepsy around the world. With over 20 years of experience in the research and development of antiepileptic drugs, our goal is to become a preferred partner for the global epilepsy community, improving knowledge about and access to effective solutions to help patients better manage their individual epilepsy journeys. We strive to 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 people 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 7500 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

About VIMPAT^®13

VIMPAT^® is approved in the U.S. as film-coated tablets, injection for intravenous use and oral solution, as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy ages 17 years and older. VIMPAT^® injection is indicated as short-term replacement when oral administration is not feasible in these patients.

A single loading dose administration option is also approved in the U.S. for all formulations of VIMPAT^® when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.

Important Safety Information about VIMPAT^® in the U.S.¹³

Warnings and Precautions

• Suicidal Behavior and Ideation: Antiepileptic drugs, including VIMPAT^®, increase the risk of suicidal behavior and ideation. Monitor patients taking VIMPAT^® 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.
    
• Dizziness and Ataxia: VIMPAT^® may cause dizziness and ataxia. The onset of dizziness and ataxia was most commonly observed during titration. Advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they are familiar with the effects of VIMPAT^® on their ability to perform such activities.
    
• Cardiac Rhythm and Conduction Abnormalities:
  
  PR interval prolongation
  
  Dose-dependent prolongations in PR interval with VIMPAT^® have been observed in clinical studies in patients and in healthy volunteers. Second degree and complete AV block have been reported in patients in pain studies and in patients with seizures. When VIMPAT^® is given with other drugs that prolong the PR interval, further PR prolongation is possible.
  
  Use VIMPAT^® with caution in patients with known cardiac conduction problems (e.g., marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), sodium channelopathies (e.g., Brugada Syndrome), or with severe cardiac disease such as myocardial ischemia or heart failure, or structural heart disease. Also, use VIMPAT^® with caution in patients on concomitant medications that prolong PR interval (e.g., beta-blockers and calcium channel blockers) because of a risk of AV block or bradycardia. In such patients, obtaining an ECG before beginning VIMPAT^®, and after VIMPAT^® is titrated to steady-state, is recommended. In addition, closely monitor these patients if they are administered VIMPAT^® through the intravenous route.
  
  Atrial fibrillation and Atrial flutter
  
  VIMPAT^® administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease.
   
• Syncope: VIMPAT^® may cause syncope.
   
• Withdrawal of Antiepileptic Drugs: Gradually withdraw VIMPAT^® (over a minimum of 1 week) to minimize the potential of increased seizure frequency.
   
• Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions (also known as Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS) have been reported with antiepileptic drugs. If this reaction is suspected, discontinue VIMPAT^® and start alternative treatment.
   
• Phenylketonurics: VIMPAT^® oral solution contains aspartame, a source of phenylalanine. A 200 mg dose of VIMPAT^® oral solution (equivalent to 20 mL) contains 0.32 mg of phenylalanine.

Adverse Reactions

• Adjunctive therapy: In the placebo controlled clinical trials, the most frequently seen adverse reaction with VIMPAT^® was dizziness (31% vs 8% placebo). Other common adverse reactions occurring in ≥10 percent of VIMPAT-treated patients, and greater than placebo, were headache, nausea, and diplopia.
    
• Monotherapy: In the 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%).
    
• Injection: In adjunctive therapy clinical trials, adverse reactions with intravenous administration generally were similar to those observed with the oral formulation, although intravenous administration was associated with local adverse events 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.

Dosing Considerations

The loading dose should be administered with medical supervision considering the VIMPAT^® pharmacokinetics and increased incidence of CNS adverse reactions. Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in patients with severe hepatic impairment is not recommended. Perform dose titration with caution in all patients with renal and/or hepatic impairment.

VIMPAT^® is a Schedule V controlled substance.

Please refer to full Prescribing Information provided at http://www.vimpat.com/pdf/vimpat_PI.pdf.

For more information on VIMPAT^®, contact 844-599-CARE (2273).

VIMPAT^® is a registered trademark used under license from Harris FRC Corporation

About BRIVIACT^®14

BRIVIACT^® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT^® exerts its anticonvulsant activity is not known. In the U.S. and European Union, BRIVIACT^® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT^® is available in three formulations (film-coated tablets, oral solution, and injection).¹⁴

Important Safety Information about BRIVIACT^® in the U.S.¹⁴

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. Somnolence and fatigue-related adverse reactions were reported in 25% of patients taking at least 50 mg per day of BRIVIACT^® compared to 14% of patients taking placebo. Dizziness and disturbance in gait and coordination were reported in 16% of patients taking at least 50 mg per day of BRIVIACT^® compared to 10% of patients taking placebo. The risk is greatest early in treatment but can occur at any time. 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 nonpsychotic and psychotic symptoms. These events were reported in approximately 13% of patients taking at least 50 mg per day of BRIVIACT^® compared to 8% of patients taking placebo. A total of 1.7% of adult patients taking BRIVIACT^® discontinued treatment due to psychiatric reactions compared to 1.3% of patients taking placebo. 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.

Adverse Reactions

The most common adverse reactions (at least 5% for BRIVIACT^® and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

BRIVIACT is a Schedule V controlled substance.

Please refer to full Prescribing Information at http://www.briviact.com/briviact-PI.pdf.

For more information on BRIVIACT^®, contact 844-599-CARE (2273).

BRIVIACT^® is a registered trademark of the UCB Group of Companies.

For further information:

References

1-12. AAN Congress posters, presentation details above. Scientific program available online: https://www.aan.com/conferences/2017-annual-meeting/abstracts/ Accessed April 18 2017
13. Vimpat^® U.S. Prescribing Information. Brussels, Belgium: UCB, 2016. http://www.vimpat.com/pdf/vimpat_PI.pdf Accessed 18 April 2017
14. Briviact^® U.S. Prescribing Information. Brussels, Belgium: UCB, 2016. https://www.briviact.com/briviact-PI.pdf Accessed April 18 2017
15. The Epilepsy Foundation of America. Who Gets Epilepsy http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy Accessed April 18 2017
16. The Epilepsy Foundation of America. What is Epilepsy? http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy Accessed April 18 2017
17. The Epilepsy Foundation of America. A Revised Definition of Epilepsy webpage http://www.epilepsy.com/article/2014/4/revised-definition-epilepsy Accessed April 18 2017

Forward looking statements
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. 

SOURCE UCB

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