E Keppra (levetiracetam) receives regulatory approval in Japan®

E Keppra approved in Japan as adjunctive therapy for partial onset seizures in adults with epilepsy® Otsuka Pharmaceutical and UCB Japan to co-promote E Keppra® - Otsuka Pharmaceutical Co., Ltd. (Head Office: Tokyo, Japan, President and Representative Director: Taro Iwamoto) and UCB (UCB Japan, Head Office: Tokyo, Japan, President and Representative Director: Emmanuel Caeymaex; UCB S.A., Head Office: Brussels, Belgium, CEO: Roch Doliveux) today announced that UCB Japan has received manufacturing and marketing approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for E Keppra (250 mg and 500 mg Tablets). E Keppra has been approved in Japan as adjunctive therapy in the treatment of partial onset seizures, with or without secondary generalisation, in adult patients with epilepsy, who have not obtained sufficient response to other antiepileptic drugs.Brussels, Belgium and Tokyo, Japan - July 23, 2010®® Levetiracetam was originally developed by UCB and is now marketed as Keppra in over 90 countries worldwide. In Japan, it will be marketed under the brand name, E Keppra. Otsuka Pharmaceutical and UCB will co-promote E Keppra in Japan.®®® "Japan is the second largest pharmaceutical market in the world and it is a significant achievement that we will soon be able to provide E Keppra for people living with epilepsy in this important country. E Keppra is the first product from UCB's own world-leading CNS research and development programme to be marketed in Japan and we look forward to partnering with Otsuka Pharmaceutical for E Keppra launch while continuing to bring new medicines for people with severe diseases." said Roch Doliveux, Chief Executive Officer, UCB.®®® "We are pleased that we will soon be able to deliver this innovative product which has been long awaited by patients and healthcare professionals in Japan. For more than 10 years since its first approval, Keppra (levetiracetam) has contributed to the treatment of patients with epilepsy in clinical settings. With our co-promotion partner UCB Japan, we will strive to communicate the new value of E Keppra as an innovative therapeutic option in Japan." said Taro Iwamoto, president and representative director of Otsuka Pharmaceutical.®® Epilepsy is a chronic neurological disorder affecting more than 50 million people worldwide. In Japan, there are approximately one million people living with epilepsy. Epilepsy 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. There are many different seizure types and epileptic syndromes, and effective classification guides treatment and prognosis. E Keppra (non-proprietary name: levetiracetam) is marketed as the brand name Keppra outside Japan and is an antiepileptic drug with over 4.1 million patient years' experience. Keppra was first approved in 1999 (US) and 2000 (EU) as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since then, it has received several supplemental indications as adjunctive therapy across both partial and generalised seizures types as well as paediatric use in the US and the EU. In the EU, Keppra is also approved as monotherapy for the treatment of partial onset seizures in adults with epilepsy.About E Keppra/Keppra®® ®®®® In the European Union Keppra is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy. Keppra is indicated as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalization in adults, infants and children from 1 month of age with epilepsy. Keppra is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. Keppra is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy. Keppra concentrate is an alternative for patients when oral administration is temporarily not feasible.Keppra in the European Union® ®®®®® Contraindication: Keppra is contraindicated in patients with hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients. Special warnings and precautions for use: In accordance with clinical practice if Keppra has to be discontinued it is recommended to withdraw it gradually. The administration of Keppra to patients with renal impairment may require dose adjustment in patients with severely impaired hepatic function. Suicide, suicide attempt and suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents (including levetiracetam). Patients should be monitored for signs or depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Undesirable effects: In pooled safety data from clinical studies conducted with Keppra oral formulations in patients with partial onset seizures the most commonly reported undesirable effects were somnolence, asthenia and dizziness. In monotherapy the most commonly reported undesirable effects were fatigue and somnolence. In paediatric patients (4-16 years of age) the most commonly reported undesirable effects were somnolence, hostility, nervousness, emotional lability, agitation, anorexia, asthenia and headache. Safety results in paediatric patients were consistent with the safety profile of levetiracetam in older children aged 4-16 years. In a study conducted with adults and adolescents with myoclonic seizures the most commonly reported undesirable effects were headache and somnolence. In a study conducted with adults and children (4 to 65 years) with idiopathic generalized epilepsy with primary generalized tonic-clonic seizures the most commonly reported undesirable effect was fatigue. Undesirable effects that resulted from Keppra intravenous use are similar to those associated with Keppra oral use. The most frequently reported adverse reactions were dizziness, somnolence, headache and postural dizziness.Keppra in the European Union - Important Safety Information® ®®®®®® Keppra 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 injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy, myoclonic seizures in adults with juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy. Keppra injection is an alternative for patients when oral administration is temporarily not feasible.Keppra in the U.S. ® ®®® Warnings & Precautions: Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behaviour in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behaviour, and/or any unusual changes in mood or behaviour. Keppra tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, Keppra is also associated with co-ordination difficulties. Keppra should be gradually withdrawn to minimize the potential of increased seizure frequency. Common adverse events: In adults experiencing partial onset seizures, the most common adverse events associated with Keppra 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 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 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 in combination with other AEDs was nasopharyngitis.The adverse events that result from Keppra injection use for primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy, myoclonic seizures in adults with juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy include all of those associated with Keppra tablets and oral solution.Keppra in the U.S. - Important Safety Information® ®®®®®®® ®® Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases, and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.About Otsuka Pharmaceutical Co., Ltd. UCB, Brussels, Belgium is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing more than 9000 people in over 40 countries, UCB produced revenue of EUR 3.1 billion in 2009. UCB is listed on Euronext Brussels (symbol: UCB). UCB Japan (Tokyo, Japan) was established in 1988 as a subsidiary of UCB and is focused on the development and marketing of specialty medicines including biopharmaceuticals to treat patients living with severe diseases in Japan. Over the last 10 years UCB Japan has been engaged in marketing the anti-allergy drug Zyrtec (cetirizine) among others. UCB has collaborations with Otsuka Pharmaceutical for E-Keppra(levetiracetam), Cimzia(certolizumab pegol) and Neupro (rotigotine) in the Japanese market.About UCB ®®®®

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