UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets

    ATLANTA, Dec. 3 /PRNewswire/ -- UCB today announced results of a Phase
 III trial demonstrating that its antiepileptic drug (AED) in development
 Keppra XR(TM) (levetiracetam) extended-release tablets significantly
 reduced partial onset seizure frequency when administered as adjunctive
 therapy for adults with refractory epilepsy. These data were presented
 today at a scientific exhibit at the 61st annual meeting of the American
 Epilepsy Society, Philadelphia.
 
     "These data show that the once-daily, extended-release formulation of
 Keppra(R) reduced the frequency of partial onset seizures in patients with
 uncontrolled epilepsy and was generally well tolerated," said Iris
 Loew-Friedrich, MD, PhD, Global Head of Development, UCB.
 
     The Phase III, multicenter, randomized, double-blind,
 placebo-controlled study evaluated efficacy, safety, and tolerability of
 extended-release levetiracetam tablets (2x500 mg) once-daily as adjunctive
 therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with
 partial onset seizures.
 
     The study met its primary endpoint for seizure reduction over placebo
 during the treatment period (p=0.038). The median percent reduction of
 partial onset seizures in the extended-release levetiracetam group was
 46.1% compared to 33.4% with placebo during the 12 week treatment period.
 Additionally, 24.0% of patients randomized to the extended-release
 levetiracetam group had seizure frequency per week reduced by 75-100%,
 compared with 11.4% of patients in the placebo group. In the
 extended-release levetiracetam group 10.1% of patients had 100% reduction
 in partial onset seizures and 8.9% were free from any type of seizure over
 the treatment period, compared to 2.5% and 1.3% in the placebo group,
 respectively.
 
     The study also found that extended-release levetiracetam tablets were
 generally well tolerated. The most common reported adverse events that
 occurred more frequently in the extended-release levetiracetam group were
 somnolence, influenza, nausea, nasopharyngitis, irritability, and
 dizziness.
 
     "In this study with a new formulation of Keppra(R) about one in ten
 patients with refractory partial onset epilepsy achieved seizure freedom,"
 said Dr. Jukka Peltola, Department of Neurology Tampere University
 Hospital, Finland. "There is an ongoing need for new antiepileptic drug
 options and extended release formulations offer the potential advantages of
 convenience and improved patient compliance."
 
     UCB is in the process of submitting a New Drug Application (NDA) for
 the use of Keppra XR(TM) in the adjunctive treatment of partial onset
 seizures in adults with epilepsy to the U.S. Food and Drug Administration
 (FDA).
 
     About Epilepsy: Epilepsy is a chronic neurological disorder affecting
 40 million people worldwide including 2.5 million people in the US. 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 many different seizure types and epileptic syndromes and effective
 classification guides treatment and prognosis. Between 70-80% of
 individuals are successfully treated with one of the more than 20
 antiepileptic drugs now available. However, 20-30% of patients have either
 intractable or uncontrolled seizures or significant adverse side effects
 secondary to medication highlighting the ongoing need for the development
 of new antiepileptic drugs.
 
     About Keppra(R) in the US: Keppra(R) (levetiracetam) tablets were
 approved by the FDA in 1999 as adjunctive therapy in the treatment of
 partial onset seizures in adults with epilepsy. Since 1999, Keppra(R) has
 received several supplemental indications as adjunctive therapy for
 epilepsy, making it one of the few treatments approved to treat seizure
 types that together account for more than 80 percent of all seizures.
 
     Important Safety Information
 
     Keppra(R) tablets and oral solution are indicated as adjunctive therapy
 in the treatment of partial onset seizures in adults and children 4 years
 of age and older with epilepsy, myoclonic seizures in adults and
 adolescents 12 years of age and older with juvenile myoclonic epilepsy, and
 primary generalized tonic-clonic seizures in adults and children 6 years of
 age and older with idiopathic generalized epilepsy. Keppra(R) injection is
 indicated as adjunctive therapy in the treatment of myoclonic seizures in
 juvenile myoclonic epilepsy and partial onset seizures in adults with
 epilepsy. Keppra(R) injection is an alternative for patients when oral
 administration is temporarily not feasible.
 
     Keppra(R) tablets and oral solution are associated with the occurrence
 of central nervous system adverse events including somnolence and fatigue,
 behavioral abnormalities, as well as hematological abnormalities. In adults
 experiencing partial onset seizures, Keppra(R) is also associated with co-
 ordination difficulties. In adults experiencing partial onset seizures, the
 most common adverse events associated with Keppra(R) in combination with
 other AEDs were somnolence, asthenia, infection and dizziness. In pediatric
 patients 4-16 years of age experiencing partial onset seizures, the most
 common adverse events associated with Keppra(R) in combination with other
 AEDs were somnolence, accidental injury, hostility, nervousness and
 asthenia. In patients 12 years of age and older with juvenile myoclonic
 epilepsy, the most common adverse events associated with Keppra(R) in
 combination with other AEDs were somnolence, neck pain, and pharyngitis. In
 patients 6 years of age and older with idiopathic generalized epilepsy, the
 most common adverse event associated with Keppra(R) in combination with
 other AEDs was nasopharyngitis.
 
     The adverse events that result from Keppra(R) injection use for
 myoclonic seizures in juvenile myoclonic epilepsy and partial onset
 seizures in adults include all of those associated with Keppra(R) tablets
 and oral solution.
 
     U.S. Prescribing information is available at http://www.keppra.com or
 by calling 1-866-822-0068.
 
     About UCB
 
     UCB, Brussels, Belgium (http://www.ucb-group.com) is a global leader in
 the biopharmaceutical industry dedicated to the research, development and
 commercialisation of innovative pharmaceutical and biotechnology products
 in the fields of central nervous system disorders, allergy/respiratory
 diseases, immune and inflammatory disorders and oncology. UCB focuses on
 securing a leading position in severe disease categories. Employing more
 than 10,000 people in over 40 countries, UCB achieved revenue of 3.5
 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the
 Euronext Brussels Exchange and through its affiliate, owns approx. 89% of
 the shares of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) is a
 member of the UCB Group.
 
     Forward looking statement
 
     This press release contains forward-looking statements based on current
 plans, estimates and beliefs of management. Such statements are subject to
 risks and uncertainties that may cause actual results to be materially
 different 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, effects of future judicial decisions, changes in
 regulation, exchange rate fluctuations and hiring and retention of its
 employees.
 
 
 

SOURCE UCB, Inc.