UCB announced findings from new studies of the oncedaily antiepileptic drug (AED) Keppra XR(TM) (levetiracetam) extendedrelease tablets comparing tolerability versus levetiracetam immediate release (IR) and reporting on additional dosing schedules. The brass tacks were among five studies that were presented at the 62nd annual meeting of the American Epilepsy Society (AES) in Seattle.

Keppra XR was approved by the U.S. Food and Drug Administration in September 2008 for use as adjunctive treatment for common society with partialonset seizures who are 16 years of age and older.

“In that new metaanalysis, patients taking Keppra XR experienced fewer nervous setup side effects than those taking the ringer dose of twice daily levetiracetam,” said James Zackheim, Medical Director, CNS, UCB. “Keppra XR is the only oncedaily, extendedrelease formulation of levetiracetam, and there is no generic alternative available.”

Summary of Keppra XR testimony Presented at 2008 AES Annual Meeting

Safety Profile of Levetiracetam Extended Release Compared to Immediate Release An Indirect Comparison Using a MetaAnalytic Approach

Researchers conducted a metaanalysis of Phase III dope to determine whether Keppra XR is associated with any tolerability advantages versus the indistinguishable daily dose of levetiracetam IR. According to the metaanalysis, patients taking Keppra XR oncedaily had lower quotas of some adverse events versus levetiracetam IR twicedaily.

In terms of overall tolerability, 52.8% of Keppra XR patients reported any adverse event, compared with 79% of patients taking levetiracetam IR.

While adverse events associated with levetiracetam IR were as well observed with Keppra XR, patients treated with Keppra XR oncedaily experienced statistically significantly lower proportions of adverse events dependent to nervous structure disorders (i.e., headache, somnolence and dizziness) versus levetiracetam IR twicedaily.

Keppra XRtreated patients reported numerically lower comparisons of psychiatric disorders (i.e., nervousness, anxiety and depression) and nutrition/metabolism disorders.

No other differences in relations of adverse events were statistically significant.

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.243)

Florent Richy, MPH, PhD, Soutrik Banerjee, MD, PhD, Christophe Gervasoni, MS, Patricia Grossman, PharmD, MBA, Sandra Helmers, MD

UCB Pharma, Inc.; University of Liege, Belgium; Joseph Fourier University, France; Stendhal University, France; Emory University Hospital, USA

strange Dose Bioequivalence bounded by Levetiracetam 2 x 750 mg XR Tablets and 3 x 500 mg XR Tablets and Food Effect on 2 x 750 mg XR Tablets in Healthy Subjects

that study demonstrated that an investigational 750 mg tablet strength of Keppra XR is bioequivalent to the approved 500 mg tablet when these are each combined to achieve a 1,500 mg dose. Results appearance that a singledout dose of 2 x 750 mg Keppra XR tablets was bioequivalent to a 3 x 500 mg unambiguous dose of Keppra XR in healthy adults, and that food intake did not significantly modify Keppra XR 2 x 750 mg disposition.

The median while to peak plasma concentration was approximately 4 to 5 hours for each dose.

Each dose resulted in a similar halflife (the stretch rightful for half the quantity of a drug in the body to be metabolized or eliminated), apparent total clearance (the rate at which a drug in the body is metabolized or eliminated), and apparent total distribution (the amount of fluid that would be requisite to dissolve the total amount of drug needed to achieve the twin concentration as that endow in the blood).

When the 2 x 750 mg Keppra XR dose was taken with food, the future to peak concentration was increased by 2 hours relative to fasted intake, while Cmax (the peak concentration of a drug in the body) remained within bioequivalence limits.

For all three Keppra XR dosing schedules (3 x 500 mg, 2 x 750 fasted and 2 x 750 fed), tolerability was honorable and the degrees of treatmentemergent adverse events were similar crossed all crowds; in annexation, adverse events were virtually all mild, and all resolved by the end of the study.

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.239)

Christian Otoul, Elisabeth Rouits, Ingrid Burton, Evelyne Guenole, Mona Troenaru, Ans Valgaeren, Pierre Boulanger, Maria Laura SargentiniMaier

UCB Pharma SA, BraineLAlleud, Belgium; territory of Pharmacokinetics, SGS Life technique Services, Wavre, Belgium; Therapharm Recherches, Caen, France

Additional Keppra XR whole record Presented at 2008 AES Annual Meeting

Population Pharmacokinetics of Levetiracetam ExtendedRelease 500 mg Tablets

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.247)

Elisabeth Rouits, M. Lovern, Maria Laura SargentiniMaier and Armel Stockis

UCB Pharma, BraineLAlleud, Belgium

Population DoseResponse Modeling of Levetiracetam Extended and ImmediateRelease Formulations in Adults with PartialOnset Seizures

Poster Session 3, Monday, December 8, 800 am 130 pm(Abstract 3.25)

Rik Schoemaker, Eric Snoeck, Armel Stockis, Christian Otoul, Maria Laura SargentiniMaier

ExprimoNV, Mechelen, Belgium; Pharmacometrics station, UCB Pharma SA, BraineLAlleud, Belgium

DoseProportionality of Levetiracetam 500 mg ExtendedRelease Tablets from 1 g to 3 g Once Daily

Poster Session 3, Monday, December 8, 800 am 130 (Abstract 3.263)

Ans Valgaeren, Nathalie Toublanc, Ingrid Burton, Sandrine GeluMantoulet, Mona Troenaru, Christian Otoul, Maria Laura SargentiniMaier, Armel Stockis

UCB Pharma SA, BraineLAlleud, Belgium; branch of Pharmacokinetics, SGS Life system Services, Wavre, Belgium; Therapharm Recherches, Caen, France

Keppra XR cannot be substituted with any IR levetiracetam or any other antiepileptic medication at the pharmacy counter outwardly a physicians approval.

of substance Safety inside yarn

Keppra XR(TM) extendedrelease tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Keppra XR(TM) causes somnolence, dizziness, and behavioral abnormalities. The greater common adverse reactions observed with Keppra XR(TM) in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR(TM) are expected to be similar to those seen in patients receiving immediaterelease Keppra(R) tablets.

Keppra(R) immediaterelease tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the lions share common adverse reactions observed with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness.

Keppra XR(TM) should be gradually withdrawn to minimize the quiescent of increased seizure recurrence.

Dosing must be individualized according to the patients renal business status. In patients with endstage renal disease on dialysis, it is recommended that immediaterelease Keppra(R) be used instead of Keppra XR(TM).

For full prescribing dossier, please see KeppraXR.com.

In placement to ensure patient access to that relevant medication in the U.S., UCB is initiating a copay support program. For more advice, contact U.S.

About Epilepsy

Epilepsy is a chronic neurological disorder affecting approximately three million society in the U.S. making it more common than multiple sclerosis and Parkinsons disease combined. It is caused by abnormal, excessive electrical discharges of the nerve cells, or neurons, in the brain. Epilepsy is characterized by a tendency to have recurrent seizures and defined by two or more unprovoked seizures. There are prevalent contrastive seizure types and epileptic syndromes. Forty percent of patients taking only one AED draw out to patience seizures, and approximately 30% of patients taking adjunctive therapy conscious on to maturity seizures. that highlights the ongoing suffer privation for the development of new AEDs. For more the latest about epilepsy, have a look at epilepsyfoundation.org, epilepsy.com, or epilepsyadvocate.com.

About UCB

UCB is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialization of innovative medicines with a concentrate on the fields of central nervous philosophy and immunology disorders. Employing approximately 12,000 common folk in more than 40 countries, UCB achieved credit of 3.6 billion euro in 2007. UCB is listed on NYSE Euronext (symbol UCB). Worldwide headquarters is located in Brussels, Belgium; U.S. headquarters is located in Atlanta, Georgia. For more poop about UCB, surf ucbgroup.com.

Forward seeing statement

that press release contains forwardseeing statements based on in vogue plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially divergent from those that may be implied by such forwardseeing statements selfsupporting in that press release. primary factors that could emanation in such differences implicate changes in general economic, livelihood and competitive conditions, effects of future judicial decisions, changes in regulation, deal rate fluctuations and hiring and retention of its employees.

UCB
ucbgroup.com