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  5. Notice regarding the conclusion of co-development/co-promotion activities in Japan for the anti-epileptic drug "E Keppra"

March 11, 2019

UCB Japan Co., Ltd.
Otsuka Pharmaceutical Co., Ltd.


Notice regarding the conclusion of co-development/co-promotion activities
in Japan for the anti-epileptic drug "E Keppra"

UCB Japan Co., Ltd. (headquarters: Shinjuku-ku, Tokyo; president: Kanako Kikuchi; hereafter referred to as "UCB Japan"; when referring to the global UCB group, "UCB") and Otsuka Pharmaceutical Co., Ltd. (headquarters: Tokyo; president and representative director: Tatsuo Higuchi; hereafter referred to as Otsuka Pharmaceutical) announced today that the co-development and co-promotion agreement for "E Keppra® (levetiracetam)" in Japan will not be renewed, upon the term of the contract in September 2020. The two companies will work together to transfer the development, sales, distribution, promotion and other support activities for E Keppra® to UCB Japan. UCB Japan will assume sole responsibility for these activities after the conclusion of the contract.

Further, and in accordance with the above-mentioned June 2008 contract, Otsuka Pharmaceutical will continue to receive royalties from UCB for a fixed period. There will be no changes in the global agreement between UCB and Otsuka Pharmaceutical for Neupro®.

UCB and Otsuka Pharmaceutical have worked together successfully to provide value to patients suffering from epilepsy in Japan. Over the course of the contract, hundreds of thousands of patients have benefitted from E Keppra® and the programs UCB and Otsuka Pharmaceutical have supported. UCB and Otsuka Pharmaceutical will work closely to smoothly implement the transfer of E Keppra®, and there will be no change in availability of E Keppra® in the Japan market. The companies remain committed to contributing to healthcare by providing drugs that meet the needs of patients and healthcare professionals.

About E Keppra®

Developed by UCB S.A. of Belgium in the early 1980s, E Keppra® is a centrally acting anti-epileptic therapy with a mechanism of action that differs from that of any conventional anti-epileptic drug. Marketed outside of Japan under the brand name Keppra®, the product has accumulated six million patient years of use worldwide. In Japan, it has been used as adjunctive therapy with other anti-epileptic drugs for partial-onset seizures in adult patients since September 2010 through a co-development/co-commercialization alliance between Otsuka Pharmaceutical and UCB Japan. As a result of this co-development, further indications for monotherapy for partial-onset seizures, adjunctive therapy with other anti-epileptic drugs for generalized tonic-clonic seizures, and children aged 4 years and older were added. Additional formulations, including dry syrup and I.V. infusions, have also become available.

Formulations currently available in Japan are:
 E Keppra® Tablets 250mg
 E Keppra® Tablets 500mg
 E Keppra® Dry syrup 50%
 E Keppra® for I.V. infusion 500mg

Information in this news release was current as of the original release date.

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