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Published on 23 July 2010

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E Keppra (levetiracetam) receives regulatory approval in Japan

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Otsuka Pharmaceutical Co, Ltd and UCB 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.

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.

UCB



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