Top of this page
Skip navigation, go straight to the content

Newsroom Press Releases

New data further reinforcing UCB's commitment to epilepsy to be presented at International Epilepsy Congress

Brussels (Belgium), 20th June 2013 – 0700 CEST – UCB, a global biopharmaceutical company focusing on CNS and immunology treatment and research, is sponsoring seven data presentations at the upcoming 30th International Epilepsy Congress (IEC) in Montreal, Canada, June 23-27, 2013. The UCB-sponsored data comprises three abstracts based on lacosamide data, results from three new epilepsy surveys and one abstract examining new in-vitro phenotypic assays for epilepsy.

VIMPAT® (lacosamide) is indicated as an add-on therapy for the treatment of partial-onset seizures in adults with epilepsy (ages ≥ 17 in the U.S., ages ≥ 16 years in the EU).1,2 In Canada VIMPAT® (lacosamide) is indicated as adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy (≥18 years of age) who are not satisfactorily controlled with conventional therapy. In the US and the European Union the most common adverse reactions reported in pivotal trials and occurring in 10 per cent or more of VIMPAT®-treated patients, and greater than placebo, were dizziness, headache, nausea, and diplopia. Additional important safety information for VIMPAT® in the US, the European Union and Canada is available below.1.2,3

“UCB has a rich heritage in epilepsy and is committed to developing innovative therapies and delivering meaningful support programs for epilepsy. We take a comprehensive, patient-solutions approach and recognize the importance of undertaking research to advance our understanding of the disease.” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President, UCB.

UCB’s strong presence at IEC underpins the company’s long-term commitment to epilepsy and to advancement of research for future management of the disease.

The following is a guide to UCB-sponsored data presentations being presented as posters at the 30th IEC:

Lacosamide:
1. Abstract Title: Multicenter, open-label study evaluating tolerability, safety and efficacy outcomes of lacosamide as adjunctive therapy for patients with partial-onset seizures using a flexible dose escalation schedule and individualized maintenance doses
Abstract 1428: 25th June 2013, 0900-1800 Poster Sessions, poster session: drug therapy B, Poster Area

2. Abstract Title: Seizure freedom in adults with partial-onset seizures treated with adjunctive lacosamide: Pooled analysis of three open-label extension trials
Abstract 1212: 25th June 2013, 0900-1800 Poster Sessions, poster session: drug therapy B, Poster Area

3. Abstract Title: Effect of adjunctive lacosamide on seizure-free intervals in adults with partial-onset seizures: Pooled analysis of double-blind, placebo-controlled clinical trials
Abstract 1174: 25th June 2013, 0900-1800 Poster Sessions, poster session: drug therapy B, Poster Area

Epilepsy:
4. Abstract Title: Measures for improving treatment outcomes for patients with epilepsy – results from a large multinational physician-patient survey
Abstract 1140: 26th June 2013, 0900-1800 Poster Sessions, poster session: adult epileptology C, Poster Area

5. Abstract Title: The impact of epilepsy on Canadians: Regional results from a Canada-wide survey
Abstract 1447: 24th June 2013, 0900-1800 Poster Sessions, poster session: social issues/nursing, Poster Area

6. Abstract Title: Living with epilepsy in Lubumbashi (Southern Democratic Republic of Congo): results of a patient survey
Abstract 1423: 24th June 2013, 0900-1800 Poster Sessions, poster session: developing world, Poster Area

Research:
7. Abstract Title: New in vitro phenotypic assays for epilepsy: fluorescent measurement of synchronized neuronal calcium oscillations
Abstract 190: 24th June 2013, 0900-1800 Poster Sessions, poster session: basic sciences, Poster Area

About VIMPAT®
VIMPAT® tablets and injection were launched in the U.S. in May 2009 as an add-on therapy for the treatment of partial-onset seizures in people with epilepsy who are aged 17 years and older. VIMPAT® injection is a short-term replacement when oral administration is not feasible in these patients. VIMPAT® oral solution was launched in June 2010. The availability of the oral tablets, oral solution, and intravenous (IV) injection allows for consistent patient treatment. Important safety information about VIMPAT® in the US is available below.

In the European Union, VIMPAT® (film-coated tablets, syrup and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy.

In Canada VIMPAT® (film-coated tablets and solution for injection) is approved as adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy (≥18 years of age) who are not satisfactorily controlled with conventional therapy. The solution for injection for intravenous use is an alternative when oral administration is temporarily not feasible. Important safety information about VIMPAT® in Canada is available below.

Important safety information about VIMPAT® in the U.S.

Warnings and Precautions
Antiepileptic drugs (AEDs), including VIMPAT®, increase the risk of suicidal behavior and ideation. Patients taking VIMPAT® should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Patients and caregivers should also be advised to be alert for these behavioral changes and to immediately report them to the healthcare provider.

Patients should be advised that VIMPAT® may cause dizziness and ataxia. Therefore patients should not drive a car or operate complex machinery until they are familiar with the effects of VIMPAT® on their ability to perform such activities.

Dose-dependent PR interval prolongation has been observed in VIMPAT® clinical studies in patients and in healthy volunteers. When VIMPAT® is given with other drugs that prolong the PR interval, further PR prolongation is possible. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheadedness and fainting) and told to contact their physician should any of these occur. VIMPAT® should be used with caution in patients with known cardiac conduction problems or with severe cardiac disease. In such patients, obtaining an ECG before beginning VIMPAT®, and after VIMPAT® is titrated to steady state, is recommended.

VIMPAT® administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Patients should be made aware of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid pulse, shortness of breath) and told to contact their physician should these symptoms occur.

Patients should be advised that VIMPAT® may cause syncope.

VIMPAT® should be gradually withdrawn (over a minimum of 1 week) to minimize the potential of increased seizure frequency.

Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, VIMPAT® should be discontinued.

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.

Common Adverse Reactions
In 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.

Dosage adjustments are recommended for patients with mild or moderate hepatic impairment or severe renal impairment. Use in severe hepatic impairment patients is not recommended. Dose titration should be performed with caution in all renally and hepatically impaired patients.

In clinical trials, adverse reactions with intravenous administration generally appeared 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%).

VIMPAT® (C-V) is a Schedule V controlled substance.

For full prescribing information on VIMPAT®, visit http://www.vimpat.com/pdf/UPDATED_Vimpat_PrescribingInformation_PDF_12.6.12.pdf
(Accessed 17th June, 2013).

For more information on VIMPAT®, visit www.Vimpat.com or contact UCB at 800.477.7877.

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

Important safety information about VIMPAT® in the EU and EEA
VIMPAT® (lacosamide) is indicated as adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT® therapy can be initiated with either oral or IV administration. A single loading dose may be initiated in patients in situations when the physician determines that rapid attainment of lacosamide steady state plasma concentration and therapeutic effect is warranted. It should be administered under medical supervision with consideration of the potential for increased incidence of CNS adverse reactions. Administration of a loading dose has not been studied in acute conditions such as status epilepticus. Contraindications: Hypersensitivity to the active substance or any of the excipients; known second- or third-degree atrioventricular (AV) block. Special warnings and precautions for use: Treatment with VIMPAT® has been associated with dizziness which could increase the occurrence of accidental injury or falls. Therefore, patients should be advised to exercise caution until they are familiar with the potential effects of the medicine. Prolongations in PR interval with VIMPAT® have been observed in clinical studies. Cases with second- and third-degree AV block associated with VIMPAT® treatment have been reported in post-marketing experience. VIMPAT® should be used with caution in patients with known conduction problems or severe cardiac disease such as a history of myocardial infarction or heart failure. Caution should especially be exerted when treating elderly patients as they may be at an increased risk of cardiac disorders or when VIMPAT® is used in combination with products known to be associated with PR prolongation. In the placebo-controlled trials of VIMPAT® in epilepsy patients, atrial fibrillation or flutter were not reported; however both have been reported in open-label epilepsy trials and in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheaded and fainting) and of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath). Patients should be counselled to seek medical advice should any of these symptoms occur. Suicidal ideation and behavior have been reported in patients treated with anti-epileptic agents in several indications. Therefore patients should be monitored for signs of suicidal ideation and behaviors and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behavior emerge. VIMPAT® syrup contains sodium methyl parahydroxybenzoate (E219) which may cause allergic reactions (possibly delayed). It contains 3.7 g sorbitol (E420) per dose (200 mg lacosamide), corresponding to a calorific value of 9.7 kcal. Patients with rare hereditary problems of fructose intolerance should not take this medicine. The syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria. VIMPAT® syrup and the solution for infusion contain sodium, which should be taken into consideration for patients on a controlled sodium diet. Effects on ability to drive and use machines: VIMPAT® may have minor to moderate influence on the ability to drive and use machines. VIMPAT® treatment has been associated with dizziness or blurred vision. Accordingly patients should be advised not to drive a car or to operate other potentially hazardous machinery until they are familiar with the effects of Vimpat® on their ability to perform such activities. Undesirable effects: The most common adverse reactions (≥10%) are dizziness, headache, diplopia, and nausea. They were usually mild to moderate in intensity. Some were dose-related and could be alleviated by reducing the dose. Incidence and severity of CNS and gastrointestinal (GI) adverse reactions usually decreased over time. Incidence of CNS adverse reactions such as dizziness may be higher after a loading dose. Other common adverse reactions (≥1% - <10%) are depression, confusional state, insomnia, balance disorder, coordination abnormal, memory impairment, cognitive disorder, somnolence, tremor, nystagmus, hypoesthesia, dysarthria, disturbance in attention, vision blurred, vertigo, tinnitus, vomiting, constipation, flatulence, dyspepsia, dry mouth, pruritus, rash, muscle spasms, gait disturbance, asthenia, fatigue, irritability, injection site pain or discomfort (specific to solution for infusion), irritation (specific to solution for infusion), fall, and skin laceration. The use of VIMPAT® is associated with dose-related increase in the PR interval. Adverse reactions associated with PR interval prolongation (e.g. atrioventricular block, syncope, bradycardia) may occur. Laboratory abnormalities: Abnormalities in liver function tests have been observed in controlled trials with VIMPAT® in adult patients with partial-onset seizures who were taking 1-3 concomitant antiepileptic drugs. Elevations of ALT to ≥3XULN occurred in 0.7% (7/935) of VIMPAT® patients and 0% (0/356) of placebo patients. Multiorgan Hypersensitivity Reactions: Multiorgan hypersensitivity reactions have been reported in patients treated with some antiepileptic agents. These reactions are variable in expression but typically present with fever and rash and can be associated with involvement of different organ systems. Potential cases have been reported rarely with VIMPAT® and if multiorgan hypersensitivity reaction is suspected, VIMPAT® should be discontinued.
Refer to the European Summary of Product Characteristics for other adverse reactions and full prescribing information. Date of revision: 22nd November 2012. http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed June 2013)

Important safety information about Vimpat® in Canada
VIMPAT® (lacosamide) is indicated as adjunctive therapy in the management of partial-onset seizures in adult patients with epilepsy (≥18 years of age) who are not satisfactorily controlled with conventional therapy. The clinical experience with VIMPAT® in elderly patients with epilepsy (≥65 years of age) is limited. Caution should be exercised during dose titration and age-associated decreased renal clearance should be considered in elderly patients. The safety and efficacy of VIMPAT® in pediatric patients (<18 years of age) have not been established and its use in this patient population is not indicated.

VIMPAT® is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients and in patients with a history of, or presence of, second- or third-degree atrioventricular (AV) block.

Second degree or higher AV block has been reported in post-marketing experience. Patients should be made aware of the symptoms of second-degree or higher AV block (e.g. slow or irregular pulse, feeling of lightheadedness and fainting), and told to contact their physician should any of these symptoms occur. VIMPAT® should be used with caution in patients with known conduction problems (e.g. marked first-degree AV block, sick sinus syndrome without pacemaker), or with a history of severe cardiac disease such as myocardial ischemia or heart failure. In such patients, obtaining an ECG before beginning VIMPAT®, and after VIMPAT® is titrated to steady-state, is recommended. Caution should especially be exerted when treating elderly patients as they may be at increased risk of cardiac disorder or when VIMPAT® is given with other drugs that prolong the PR interval (e.g. carbamazepine, pregabalin, lamotrigine, beta-blockers, and class I antiarrhythmic drugs), as further PR prolongation is possible. In clinical trials of healthy subjects and patients with epilepsy, VIMPAT® treatment was associated with PR interval prolongation in a dose-dependent manner. VIMPAT® administration may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular disease. Patients should be made aware of the symptoms of atrial fibrillation and flutter (e.g. palpitations, rapid or irregular pulse, shortness of breath) and told to contact their physician should any of these symptoms occur. Atrial fibrillation and flutter have been reported in open-label epilepsy trials and in postmarketing experience.

Multiorgan hypersensitivity reactions (including Drug Rash with Eosinophilia and Systemic Symptoms, or DRESS), Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported with anticonvulsants. If any of these hypersensitivity reactions are suspected, VIMPAT® should be discontinued and alternative treatment started.

Treatment with VIMPAT® has been associated with dizziness and ataxia, which could increase the occurrence of accidental injury or falls. Accordingly, patients should be advised not to drive a car or to operate other complex machinery or perform hazardous tasks until they are familiar with the effects of VIMPAT® on their ability to perform such activities.

In controlled trials in patients with partial-onset seizures, VIMPAT® treatment was associated with vision-related adverse events such as blurred vision and diplopia. Patients should be informed that if visual disturbances occur, they should notify their physician promptly. If visual disturbance persists, further assessment, including dose reduction and possible discontinuation of VIMPAT®, should be considered. More frequent assessments should be considered for patients with known vision-related issues or those who are already routinely monitored for ocular conditions.

Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. All patients treated with antiepileptic drugs, irrespective of indication, should be monitored for signs of suicidal ideation and behaviour and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.

There are no studies with VIMPAT® in pregnant women. Since the potential risk for humans is unknown, VIMPAT® should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. It is unknown whether VIMPAT® is excreted in human breast milk. Because many drugs are excreted into human milk, a decision should be made whether to discontinue nursing or to discontinue VIMPAT®, taking into account the importance of the drug to the mother.

As with all antiepileptic drugs, VIMPAT® should be withdrawn gradually (over a minimum of 1 week) to minimize the potential of increased seizure frequency.

In controlled clinical trials in patients with partial-onset seizures, some of the most frequently reported adverse reactions with VIMPAT® treatment were dizziness (16% and 30% for 200 mg and 400 mg treatment groups, respectively, vs. 8% placebo), nausea (7% and 11% vs. 4%), and vision related events [diplopia (6% and 10% vs. 2%) and blurred vision (2% and 9% vs. 3%)]. They were dose-related and usually mild to moderate in intensity. The adverse events most commonly leading to discontinuation were dizziness, coordination abnormal, vomiting, diplopia, nausea, vertigo, and vision blurred.

Please see the Vimpat® Product Monograph for full prescribing information. The full Product Monograph, prepared for health professionals can be provided by contacting the sponsor, UCB Canada Inc. at: 1-866-709-8444

® Registered trademark used under license from Harris FRC Corporation

For further information
Eimear O Brien, Brand Communications, UCB
T
+32.2.559.9271, eimear.obrien@ucb.com
Antje Witte, Investor Relations, UCB
T
+32.2.559.9414, antje.witte@ucb.com
France Nivelle, Global Communications, UCB
T
+32.2.559.9178, france.nivelle@ucb.com
Laurent Schots, Media Relations, UCB
T
+32.2.559.9264, laurent.schots@ucb.com

References
1. VIMPAT® European Summary of Product Characteristics
http://ec.europa.eu/health/documents/community-register/html/h470.htm (Accessed 17th June, 2013)
2. VIMPAT® US Prescribing Information
http://www.vimpat.com/pdf/UPDATED_Vimpat_PrescribingInformation_PDF_12.6.12.pdf
(Accessed 17th June, 2013)
3. VIMPAT® Canada Product Monograph, February 22nd 2013

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 8 500 people in about 40 countries, the company generated revenue of EUR 3.4 billion in 2012. UCB is listed on Euronext Brussels (symbol: UCB).

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.

LCM-PRR-022897-052013


Stay up-to-date on the latest news and information from UCB