- For Print
- September 25, 2012
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that its U.K. manufacturing subsidiary Eisai Manufacturing Ltd. (Location: Hatfield, Hertfordshire, “EML”), situated within the company’s European Knowledge Centre (EKC), has received a license (marketing authorization type II variation: addition of manufacturing site) from the European regulatory authorities for solid dose manufacturing of the antiepileptic agent Fycompa® (perampanel), a first-in-class AMPA receptor antagonist discovered and developed in-house, at its Hatfield production plant. Eisai celebrated this occasion with a ceremony to mark the official opening of a new Fycompa manufacturing line. Positioning the Hatfield plant as a global supply hub for Fycompa, Eisai plans to obtain authorization from the regulatory authorities in other countries to use the site to manufacture the drug for supply in each respective market.
The opening ceremony was attended by the Rt Hon. David Willetts, Minister of State for Universities and Science, who expressed his hopes that Eisai, whose activities in the U.Κ are an excellent example of the continued success of the country’s life science industry, will continue its endeavors toward the creation of innovative new medicines that bring benefits to patients.
Discovered and developed at Eisai’s research laboratories in Japan and the U.K., Fycompa was approved in the European Union (EU) ahead of other regions in the world for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalized seizures, in patients aged 12 years and older. It was first launched globally in the U.K. earlier this month, followed by Germany, Austria and Denmark.
Eisai established the EKC, which integrated the company’s discovery research, clinical development, production, marketing and European headquarters functions one site, in Hertfordshire in the U.K. in June 2009 with the aim to expand its business operations across Europe. At present, the facility plays an even more important role as the regional headquarters for Eisai’s Europe, Middle East, and Africa (EMEA) business.
The Hatfield plant, located within the grounds of the EKC, has up until now served predominantly as a manufacturing site for the production of pharmaceuticals for the European market, however, the EU manufacturing license for the new facility marks the first step in Eisai’s plan to obtain manufacturing licenses from the regulatory authorities in other countries and regions as it seeks to expand operations and establish the facility as a site for the global supply of Fycompa.
By strengthening its U.K. value chain, which encompasses discovery, production and marketing, Eisai will enhance its presence in the EMEA region, thereby making contributions to patients on a global scale.
[ Please refer to the following notes for a photograph of the Fycompa solid dose manufacturing line and opening ceremony. ]
Public Relations Department,
Eisai Co., Ltd.
< Notes to editors >
1.Fycompa Solid Dose Manufacturing Line Opening Ceremony
Eisai celebrated the opening of its new Fycompa solid dose global manufacturing line at its Hatfield Plant on Monday, September 24, 2012 (U.K. local time). From right: Rt Hon. David Willetts, Minister of State for Universities and Sciences; Gary Hendler, President Eisai EMEA Region; Yutaka Tsuchiya, Executive Vice President (Representative Corporate Officer), Eisai Co. Ltd.; Catherine Kay, Production Operations Director, Eisai Manufacturing Ltd.; David Jefferys, Senior Vice President, Eisai Europe Ltd.