SOURCE: UCB Pharma, Inc.

June 24, 2005 08:00 ET

FDA Approves UCB's Keppra® for Use in Childhood Epilepsy

ATLANTA, GA -- (MARKET WIRE) -- June 24, 2005 -- UCB Pharma, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the company's anti-epilepsy drug Keppra® (levetiracetam) as add-on therapy in the treatment of partial-onset seizures in children four years of age and older with epilepsy. The FDA approved this new pediatric indication for Keppra® under a six-month priority review.

"More than 25% of children with epilepsy experience treatment resistant seizures or intolerable side effects from medication," said Tracy Glauser, M.D., director of the Comprehensive Epilepsy Program, Cincinnati Children's Hospital, and principal investigator of the well-controlled study reviewed for the pediatric indication. Dr. Glauser added that, "Keppra® was effective and well tolerated by the children in the study, many of whom had failed on multiple anti-epileptic drugs (AEDs) prior to trying Keppra®."

"This approval provides another needed treatment option for children who suffer from epilepsy. We applaud the FDA for making this therapeutic option available," said Eric Hargis, President of the Epilepsy Foundation.

Clinical Trial Results

The approval of Keppra® (levetiracetam) for children was based on findings from one multi-center, randomized, double-blind, placebo-controlled pivotal study conducted at 60 sites in North America, in 198 children 4 to 16 years of age with partial onset seizures with or without secondary generalization uncontrolled by standard AEDs.(1) Study participants were taking one or two other AEDs at entry. The study consisted of an 8-week baseline period and a 4-week titration period, followed by a 10-week evaluation period.

When measuring efficacy, those taking Keppra® had a significantly larger reduction (26.8%) in weekly seizure frequency over placebo, on average. Additionally, responder rates (the portion of patients achieving a 50% or greater reduction in seizures) for patients taking Keppra® were 44.6% versus 19.6% for placebo (both with a p=0.0002 compared to placebo).

"We are very pleased the FDA approved Keppra® for children, and look forward to making this therapy available for many of the 300,000 children in the U.S. with epilepsy," said Peter Verdru, M.D., Vice President Clinical Research and head of Neurology, Psychiatry and Clinical Development, UCB Pharma, Inc.

In pediatric patients, 4 to 16 years of age, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. Keppra® is associated with somnolence, fatigue, and behavioral abnormalities as well as hematological abnormalities.

About Keppra®

In the U.S., Keppra® is approved for adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Keppra® is available in 250, 500 and 750 mg tablets and a grape-flavored (100 mg/mL) oral solution for patients who prefer a solution or have difficulty swallowing tablets. Keppra® dosing must be individualized according to renal function status. Since its launch, Keppra® has had more than 600,000 unique patient starts in the United States.(2)

In adults, Keppra® (levetiracetam) 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 well-controlled adult clinical studies, the most frequently reported adverse events associated with the use of Keppra® in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.

Keppra® was approved in 1999 as adjunctive therapy for adults with partial onset seizures and is the most prescribed second-generation AED used in epilepsy.(3) For full prescribing information please visit www.keppra.com.

About UCB

UCB (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 EUR 2.1 billion (including net turnover, royalties, and fees) in 2004. UCB is listed on the Euronext Brussels with a market capitalization of approximately EUR 5.5 billion. Worldwide headquarters are located in Brussels, Belgium.

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

K354-0605

† Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United
States.
*Keppra® (levetiracetam) is a registered trademark of the UCB S.A.
(1)Glauser TA, Gauer LJ, Chen L and LEV N159 Pediatric Study Group.
Multicenter, double-blind, placebo-controlled trial of adjunctive
levetiracetam (Keppra®) therapy (up to 60 mg/kg/day) in pediatric patients
with refractory partial epilepsy. Epilepsia 2004; 45 (supplement 7): 186
(2)NDCHealth Retail Pharmacy Database, May 2000 – April 2005
(3)IMS NDTI Drug Use, Rolling Quarter February – April 2005

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