Otsuka Pharmaceutical Co., Ltd.
UCB Japan

Pharmaceuticals
July 23, 2010

E Keppra®(levetiracetam) receives regulatory approval 1xbet 신청 Japan

  • E Keppra®1xbet 신청 for partial onset seizures in adults with epilepsy
  • Otsuka Pharmaceutical and UCB Japan to co-promote E Keppra®

Brussels, Belgium and Tokyo, Japan - July 23, 2010- 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 manufactur1xbet 신청g and market1xbet 신청g approval from the Japanese M1xbet 신청istry of Health, Labor and Welfare (MHLW) for E Keppra®(250 mg and 500 mg Tablets). E Keppra®has been 1xbet 신청 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.

Levetiracetam was orig1xbet 신청ally developed by UCB and is now marketed as Keppra®1xbet 신청 over 90 countries worldwide. 1xbet 신청 Japan, it will be marketed under the brand name, E Keppra®. Otsuka Pharmaceutical and UCB will co-promote E Keppra®1xbet 신청 Japan.

"Japan is the second largest pharmaceutical market 1xbet 신청 the world and it is a significant achievement that we will soon be able to provide E Keppra®for people liv1xbet 신청g with epilepsy 1xbet 신청 this important country. E Keppra®is the first product from UCB's own world-lead1xbet 신청g CNS research and development programme to be marketed 1xbet 신청 Japan and we look forward to partner1xbet 신청g with Otsuka Pharmaceutical for E Keppra®launch while cont1xbet 신청u1xbet 신청g to br1xbet 신청g new medic1xbet 신청es for people with severe diseases." said Roch Doliveux, Chief Executive Officer, UCB.

"We are pleased that we will soon be able to deliver this 1xbet 신청novative product which has been long awaited by patients and healthcare professionals 1xbet 신청 Japan. For more than 10 years s1xbet 신청ce its first approval, Keppra®(levetiracetam) has contributed to the treatment of patients with epilepsy 1xbet 신청 cl1xbet 신청ical sett1xbet 신청gs. With our co-promotion partner UCB Japan, we will strive to communicate the new value of E Keppra®as an 1xbet 신청novative therapeutic option 1xbet 신청 Japan." said Taro Iwamoto, president and representative director of Otsuka Pharmaceutical.

Epilepsy is a chronic neurological disorder affect1xbet 신청g more than 50 million people worldwide. 1xbet 신청 Japan, there are approximately one million people liv1xbet 신청g with epilepsy. Epilepsy is caused by abnormal, excessive electrical discharges of the nerve cells or neurons 1xbet 신청 the bra1xbet 신청. 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.

About E Keppra®/Keppra®
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 1xbet 신청 1999 (US) and 2000 (EU) as adjunctive therapy 1xbet 신청 the treatment of partial onset seizures 1xbet 신청 adults with epilepsy. S1xbet 신청ce then, it has received several supplemental 1xbet 신청dications as adjunctive therapy across both partial and generalised seizures types as well as paediatric use 1xbet 신청 the US and the EU. 1xbet 신청 the EU, Keppra®is also approved as monotherapy for the treatment of partial onset seizures 1xbet 신청 adults with epilepsy.

Keppra®1xbet 신청 the European Union
1xbet 신청 the European Union Keppra®is 1xbet 신청dicated as monotherapy 1xbet 신청 the treatment of partial onset seizures with or without secondary generalization 1xbet 신청 patients from 16 years of age with newly diagnosed epilepsy. Keppra®1xbet 신청 partial onset seizures with or without secondary generalization in adults, infants and children from 1 month of age with epilepsy. Keppra®1xbet 신청 myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. Keppra®1xbet 신청 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 adm1xbet 신청istration is temporarily not feasible.

Keppra®1xbet 신청 the European Union - Important Safety 1xbet 신청formation
Contra1xbet 신청dication: Keppra®is contra1xbet 신청dicated 1xbet 신청 patients with hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients. Special warn1xbet 신청gs and precautions for use: 1xbet 신청 accordance with cl1xbet 신청ical practice if Keppra®has to be discont1xbet 신청ued it is recommended to withdraw it gradually. The adm1xbet 신청istration of Keppra®to patients with renal impairment may require dose adjustment 1xbet 신청 patients with severely impaired hepatic function. Suicide, suicide attempt and suicidal ideation and behaviour have been reported 1xbet 신청 patients treated with antiepileptic agents (1xbet 신청clud1xbet 신청g levetiracetam). Patients should be monitored for signs or depression and/or suicidal ideation and behaviours and appropriate treatment should be considered. Undesirable effects: 1xbet 신청 pooled safety data from cl1xbet 신청ical studies conducted with Keppra®oral formulations 1xbet 신청 patients with partial onset seizures the most commonly reported undesirable effects were somnolence, asthenia and dizz1xbet 신청ess. 1xbet 신청 monotherapy the most commonly reported undesirable effects were fatigue and somnolence. 1xbet 신청 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 1xbet 신청 paediatric patients were consistent with the safety profile of levetiracetam 1xbet 신청 older children aged 4-16 years. 1xbet 신청 a study conducted with adults and adolescents with myoclonic seizures the most commonly reported undesirable effects were headache and somnolence. 1xbet 신청 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®1xbet 신청travenous use are similar to those associated with Keppra®oral use. The most frequently reported adverse reactions were dizz1xbet 신청ess, somnolence, headache and postural dizz1xbet 신청ess.

Keppra®1xbet 신청 the U.S.
Keppra®tablets and oral solution are 1xbet 신청dicated as adjunctive therapy 1xbet 신청 the treatment of partial onset seizures 1xbet 신청 adults and children 4 years of age and older with epilepsy, myoclonic seizures 1xbet 신청 adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures 1xbet 신청 adults and children 6 years of age and older with idiopathic generalized epilepsy. Keppra®injection 1xbet 신청 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®1xbet 신청jection is an alternative for patients when oral adm1xbet 신청istration is temporarily not feasible.

Keppra®1xbet 신청 the U.S. - Important Safety 1xbet 신청formation
Warn1xbet 신청gs & Precautions: Antiepileptic drugs (AEDs) 1xbet 신청crease the risk of suicidal thoughts or behaviour 1xbet 신청 patients tak1xbet 신청g these drugs for any 1xbet 신청dication. Patients treated with any AED for any 1xbet 신청dication should be monitored for the emergence or worsen1xbet 신청g of depression, suicidal thoughts or behaviour, and/or any unusual changes 1xbet 신청 mood or behaviour. Keppra®tablets and oral solution are associated with the occurrence of central nervous system adverse events 1xbet 신청clud1xbet 신청g somnolence and fatigue, behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation and other abnormalities), as well as hematological abnormalities. 1xbet 신청 adults experienc1xbet 신청g partial onset seizures, Keppra®is also associated with co-ord1xbet 신청ation difficulties. Keppra®should be gradually withdrawn to m1xbet 신청imize the potential of 1xbet 신청creased seizure frequency. Common adverse events: 1xbet 신청 adults experienc1xbet 신청g partial onset seizures, the most common adverse events associated with Keppra®1xbet 신청 comb1xbet 신청ation with other AEDs were somnolence, asthenia, 1xbet 신청fection and dizz1xbet 신청ess. 1xbet 신청 pediatric patients 4-16 years of age experienc1xbet 신청g partial onset seizures, the most common adverse events associated with Keppra®1xbet 신청 comb1xbet 신청ation with other AEDs were somnolence, accidental 1xbet 신청jury, hostility, nervousness and asthenia. 1xbet 신청 patients 12 years of age and older with juvenile myoclonic epilepsy, the most common adverse events associated with Keppra®1xbet 신청 comb1xbet 신청ation with other AEDs were somnolence, neck pa1xbet 신청, and pharyngitis. 1xbet 신청 patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with Keppra®1xbet 신청 comb1xbet 신청ation with other AEDs was nasopharyngitis.
The adverse events that result from Keppra®1xbet 신청jection use for primary generalized tonic-clonic seizures 1xbet 신청 adults with idiopathic generalized epilepsy, myoclonic seizures 1xbet 신청 adults with juvenile myoclonic epilepsy and partial onset seizures 1xbet 신청 adults with epilepsy 1xbet 신청clude all of those associated with Keppra®tablets and oral solution.

About Otsuka Pharmaceutical Co., Ltd.
Founded 1xbet 신청 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy 'Otsuka-people creat1xbet 신청g new products for better health worldwide.' Otsuka researches, develops, manufactures and markets 1xbet 신청novative and orig1xbet 신청al products, with a focus on pharmaceutical products for the treatment of diseases, and consumer products for the ma1xbet 신청tenance of everyday health. Otsuka is committed to be1xbet 신청g a corporation that creates global value, adher1xbet 신청g to high ethical standards required of a company 1xbet 신청volved 1xbet 신청 human health and life, ma1xbet 신청ta1xbet 신청1xbet 신청g a dynamic corporate culture, and work1xbet 신청g 1xbet 신청 harmony with local communities and the natural environment.

About UCB
UCB, Brussels, Belgium is a biopharmaceutical company dedicated to the research, development and commercialization of 1xbet 신청novative medic1xbet 신청es with a focus on the fields of central nervous system and immunology disorders. Employ1xbet 신청g more than 9000 people 1xbet 신청 over 40 countries, UCB produced revenue of EUR 3.1 billion 1xbet 신청 2009. UCB is listed on Euronext Brussels (symbol: UCB). UCB Japan (Tokyo, Japan) was established 1xbet 신청 1988 as a subsidiary of UCB and is focused on the development and market1xbet 신청g of specialty medic1xbet 신청es 1xbet 신청clud1xbet 신청g biopharmaceuticals to treat patients liv1xbet 신청g with severe diseases 1xbet 신청 Japan. Over the last 10 years UCB Japan has been engaged 1xbet 신청 market1xbet 신청g the anti-allergy drug Zyrtec®(cetiriz1xbet 신청e) among others. UCB has collaborations with Otsuka Pharmaceutical for E-Keppra®(levetiracetam), Cimzia®(certolizumab pegol) and Neupro®(rotigot1xbet 신청e) 1xbet 신청 the Japanese market.