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UCB : Sponsors Data Presentations on Epilepsy and Vimpat« (lacosamide) C-V at the 64th Annual Meeting of the American Academy of Neurology

04/18/2012 | 12:52pm US/Eastern
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Guide to UCB-sponsored epilepsy data, including updated analysis for Vimpat« patient-reported health-related quality of life

Brussels (Belgium), 18th April 1800 CEST - UCB, a leading biopharmaceutical company committed to the development of new epilepsy treatments and research, will sponsor 10 sets of key epilepsy data at the 64th Annual Meeting of the American Academy of Neurology (AAN) in New Orleans from April 21-28. The data comprise several posters examining the use of the antiepileptic drug (AED) Vimpat« (lacosamide) C-V, including updated health-related quality of life analysis from pooled open label extension trials.

"UCB is committed to advancing research to better understand the clinical profile of Vimpat«. The research we will present at AAN encompasses several lacosamide studies that measure patient-reported seizure frequency and health-related quality of life over the long-term," said Dr. James Zackheim, PhD, Senior Medical Director, Central Nervous System Business Unit, UCB, Inc.

Vimpat« is indicated as an add-on therapy for the treatment of partial-onset seizures in adults with epilepsy. The most common adverse reactions reported in pivotal trials and occurring in 10 percent or more of Vimpat«-treated patients, and greater than placebo, were dizziness, headache, nausea and diplopia. Additional important safety information for Vimpat« is available at the end of the press release.

Following is a guide to UCB-sponsored posters for Vimpat« and epilepsy being exhibited during AAN. For more information please contact Andrea Levin at 404.483.7329or Andrea.Levin@ucb.com.

UCB-Sponsored Posters

Vimpat« (lacosamide) C-V Posters:
1. Lacosamide as Add-On to Monotherapy in Patients with Partial-Onset Seizures: Interim Results of the Post-Marketing VITOBA Study (VImpaT added to One Baseline AED)
P06.126; Poster Session VI: Thursday, April 26, 7:30 a.m. - 12:00 p.m.

2. Long-Term Adjunctive Lacosamide in Patients with Focal Epilepsy: Seizure Severity and Quality of Life
P01.075; Poster Session I: Monday, April 23, 2:00 p.m. - 6:30 p.m.

3. Seizure Severity, Health-Related Quality of Life and Health Status Reported by Patients During Long-Term Treatment with Lacosamide: Analysis of Pooled Open-Label Data
PD3.008; Poster Session III: Tuesday, April 24, 2:00 p.m. - 6:30 p.m.

4. Lacosamide Added to Concomitant AEDs Grouped by Mechanism of Action: Impact on Patient-Reported Quality of Life in Pooled Phase II/III Trials
P06.114; Poster Session VI: Thursday, April 26, 7:30 a.m. - 12:00 p.m.

5. Evaluation of Long-Term Treatment with Lacosamide for Partial-Onset Seizures: A Pooled Analysis of Open-Label Extension Trials
P06.125; Poster Session VI: Thursday, April 26, 7:30 a.m. - 12:00 p.m.

6. Low Lacosamide Plasma Protein Binding in Lacosamide-Na´ve Patients
P01.077; Poster Session I: Monday, April 23, 2:00 p.m. - 6:30 p.m.

7. Lacosamide Does Not Alter In Vitro Long-Term Potentiation in Mouse Hippocampal CA1 Area
P05.087; Poster Session V: Wednesday, April 25, 2:00 p.m. - 7:00 p.m.

8. Lacosamide Has No Effect on the Enzymatic Activity of CYP3A4
P01.076; Poster Session I: Monday, April 23, 2:00 p.m. - 6:30 p.m.

Epilepsy Posters:

1. Incidence of Congenital Malformations in Infants Born to Patients With Epilepsy: A Comparison of Pregnancy Registries and Cohort Study Data
S56.003; Scientific Sessions: Thursday, April 26, 3:30 p.m.


About Epilepsy
Epilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide and three million people in the U.S. Anyone can develop epilepsy; it occurs across all ages, races, and genders. Uncontrolled seizures and medication side effects pose challenges to independent living, learning, and employment, so the goal of epilepsy treatment is seizure freedom with minimal side effects. In the U.S., more than one million patients continue to have seizures despite initial therapy, and more than 800,000 continue to have seizures despite treatment with two or more therapies. [1],[2]

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 treatment in a hospital setting.

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 patients with epilepsy aged 16 years and older. Vimpat« solution for infusion may be used when oral administration is temporarily not feasible.

The maximum approved daily dose for Vimpat« in the European Union and the U.S. is 400 mg/day.

Important safety information about Vimpat« in the U.S.

Warnings and Precautions
Antiepileptic drugs (AEDs) 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 should be advised that Vimpat« may cause dizziness, ataxia, and syncope. Caution is advised for patients with known cardiac conduction problems, who are taking drugs known to induce PR interval prolongation, or with severe cardiac disease. In patients with seizure disorders, Vimpat« should be gradually withdrawn to minimize the potential of increased seizure frequency. Multiorgan hypersensitivity reactions have been reported with antiepileptic drugs. If this reaction is suspected, treatment with 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
The most common adverse reactions occurring in

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