UCB's Anti-Epileptic Keppra(R) Meets Primary End-Point In Monotherapy Trial

ATLANTA, Sept. 15 /PRNewswire/ -- UCB today announced that its pivotal Phase III monotherapy clinical trial had met its non-inferiority* primary endpoint. This trial compared Keppra(R) (levetiracetam) to sustained release carbamazepine in newly diagnosed patients, suffering from epilepsy with partial or generalized tonic-clonic seizures. Keppra(R) demonstrated non- inferiority to carbamazepine on seizure freedom. In addition the trial provided further evidence of Keppra's favorable tolerability.

UCB plans to file a marketing authorization application with the European Medicines Agency (EMEA) for the use of Keppra(R) as monotherapy in patients with epilepsy and also plans to review the data with the US Food and Drug Administration (FDA).

About Keppra(R)

In the US, Keppra(R) (levetiracetam) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children four years of age and older with epilepsy. In adults, Keppra(R) use is associated with the occurrence of central nervous system adverse events including somnolence and fatigue, coordination difficulties, and behavioral abnormalities, as well as hematological abnormalities. In pediatric patients 4 to 16 years of age, Keppra(R) is associated with somnolence, fatigue, and behavioral abnormalities, as well as hematological abnormalities. In adults, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection, and dizziness. Of these, most appeared to occur predominantly during the first 4 weeks of treatment. In pediatric patients 4 to 16 years of age, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, accidental injury, hostility, nervousness, and asthenia. Please consult http://www.keppra.com for US full prescribing information.

Note to Editors

* Non-inferiority

The EMEA's Committee for Medicinal Products for Human Use (CHMP) requires demonstrating at least a similar benefit/risk balance of a test product as compared to an acknowledged standard product at its optimal use, through the conduct of a randomized, double-blind, non-inferiority trial.

Optimal use of the comparator implies: -- patients with primary generalized seizures were excluded from the trial -- a low-initial target dose and a slow titration regimen were applied -- carbamazepine's sustained release formulation was used. About UCB

UCB (http://www.ucb-group.com) is a global biopharmaceutical leader dedicated to the research, development and commercialization of innovative products in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. UCB employs over 8,500 people operating in over 40 countries, and achieved revenues of euro 2.1 billion (including net turnover, royalties, and fees) in 2004. UCB is listed on the Euronext Brussels. Worldwide headquarters are located in Brussels, Belgium.

UCB Pharma, Inc. is the North American subsidiary of UCB, with U.S. headquarters located in Smyrna, Georgia. UCB's key products in the U.S. are Keppra(R) (levetiracetam), Zyrtec(R)(1) (cetirizine HCl), Tussionex(R) CIII (hydrocodone polistirex/chlorpheniramine polistirex), and Metadate(R) CD CII (methylphenidate HCl, USP).

(1) Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United

States.

UCB Pharma, Inc.

CONTACT: U.S. Contact: Lisa Garman, of UCB Pharma, Inc., +1-770-970-8569,lisa.garman@ucb-group.com

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