Japanese Pharmaceutical Company Announces Transfer of Global Manufacturing for New Epilepsy Medicine to the UK

News provided by

Eisai Europe Limited

24 Sep, 2012, 23:01 GMT

HATFIELD, England, September 25, 2012 /PRNewswire/ --

 

Global solid dose manufacturing for Eisai's new epilepsy medicine Fycompa®▼ (perampanel) to start at £100 million UK based, purpose built, EMEA research and commercial regional headquarters

  • Announcement comes one week after the UK and European launch of Fycompa® (Eisai's new medicine for the treatment of epilepsy), which will be supplied across the world from the company's Hatfield site
  • David Willetts (Minister for Universities and Science) formally opened UK Fycompa solid dose manufacturing facilities on Monday 24th September 2012
  • First global solid dose manufacture supply site outside of Japan for Fycompa

Eisai has announced that their UK production facility has received its licence for solid dose manufacturing for their new first in class partial epilepsy treatment, Fycompa® (perampanel). Discovered and developed in the UK and Japan, Fycompa was launched first globally in the UK on 12 September 2012. Manufacturing will take place at the company's European, Middle-East, Africa (EMEA) and Russia headquarters, situated in Hatfield, UK, representing a significant boost to both the local economy and the wider UK life-sciences environment.

The investment is linked to a comprehensive neurosciences research and development (R&D) programme focusing on illnesses affecting the brain such as dementia and epilepsy. In addition to bolstering the company's product discovery, packaging and supply infrastructure, the increased investment will support a host of partnership initiatives between the NHS, UK academic institutions and commercial partners. Eisai recently presented phase I data for Alzheimer's Disease modifying treatment, the UK/Japan discovered BACE inhibitor E2609, confirming proof of mechanism for preventing amyloid beta by inhibiting BACE. This is added to the continuing development of novel monoclonal antibody BAN2401, also a disease modifying treatment for Alzheimer's Disease targeting amyloid beta protofibrils. Today's announcement further cements the UK's role as a major centre of this Japanese pharmaceutical company's commercial growth strategy and its continuing commitment to dementia and neuroscience research. Eisai has one of the largest private dementia research units in the UK. Around 200 out of 500 employees are currently employed in R&D related positions across multiple therapeutic areas at Eisai's Hatfield site.

Gary Hendler, President and CEO, Eisai EMEA & Russia explained: "This exciting announcement reaffirms Eisai's commitment to and recognition of the unique Life Sciences environment present in the UK today. Manufacturing Fycompa in Hatfield bucks a general trend of decline for pharmaceutical manufacturing in this country." He continued, "It has now become unusual for a company to discover, develop, manufacture and launch a new medicine in the UK. If we want to reverse this trend there is an increasing need for the NHS to embrace these new therapies, encouraging better patient outcomes, and faster uptake of new medicines. Commercial and competitive price freedom around a new product's launch is vital to tackle traditionally low and slow patient access to innovative medicines."

The announcement marks the initiation of the commercial manufacture of Eisai's new medicine in the UK for the treatment of partial epilepsy, Fycompa (perampanel), at the company's EMEA Knowledge Centre (EKC) in Hatfield UK. It represents an exciting milestone for both the product and the company, marking the first time Eisai has manufactured the global supply of a medicine outside of its home country. David Willetts, Minister for Universities and Science, formally opened the production facility for this medicine on Monday morning as part of an official visit to the Eisai site.

Discussing the milestone announcement, Rt Hon. David Willetts commented: "“In the Strategy for UK Life Sciences the Government set out ambitious plans for the UK to be the best place in the world for companies to invest in innovation. This move by Eisai is an excellent example of the continued success of the UK's life sciences industry and will support hundreds of highly skilled jobs. New investments of this nature greatly improve discovery, development and uptake of innovative new medicines in the UK, bringing benefits for patients and driving long-term, sustainable growth."

Sales of Fycompa are expected to top 500 million US dollars by 2015, rising to $1bn in the years beyond that. As a result of Eisai's increased investment and the subsequent production of medicines at company's purpose built Hatfield plant, the company has already announced and is recruiting for additional quality control and production engineering colleagues to support their up-scaled activities.

With four marketed anti-epileptic drugs, Eisai currently market more epilepsy products in Europe than any other company and are aiming to be the number one epilepsy company by sales by 2015.

The announcement is also extremely good news for the UK balance of trade, with a significant proportion of Fycompa produced by Eisai in the UK planned for export to over 70 countries worldwide. In addition, the increased UK focus is likely to provide extra spending with third party suppliers whose business is linked to Eisai, such as logistics companies and packaging component manufacturers (cartons, printing and foils), injecting additional funds into the overall UK life-sciences and pharmaceutical sector.

Eisai are also continuing to invest in their manufacturing facility, a global packaging centre of excellence. The company have just purchased an additional two packaging lines: an automated Halaven® (eribulin) line, significantly increasing global supply quantities of this innovative medicine for the treatment of metastatic breast cancer (the medicine is currently manually packaged by hand at a rate of 27,000 vials per month), and a 'potent compounds' packaging line which will potentially be used to package Eisai's investigational compound lenvatinib, a medicine for the potential future treatment of multiple solid tumour types. This additional capacity will raise Eisai's packaging capabilities from three to five packaging lines by the end of 2013.

# Ends #

Notes to Editors:
Eisai have a long and established history of scientific investment and partnership in the UK:

  • Eisai's first investments into UK R&D began 20 years ago with a landmark partnership with the neurosciences department at University College London (UCL), established to undertake world-leading scientific research into neurodegenerative diseases. This partnership continues to this day.
  • After entering a new phase in 2011, the company's Neuroscience Product Creation Unit (Neuroscience PCU) and UCL are currently engaging in joint research into neurodegenerative diseases, including biomarker research and drug discovery.
  • Eisai is committed to making further contributions to address key unmet medical needs in neurosciences by maintaining and strengthening the relationship built up with UCL, whilst at the same time leveraging the knowledge accumulated over the course of the partnership for the benefit of patients and their families in Europe and beyond.

About Eisai Europe in Epilepsy:

Eisai is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy. The development of AEDs is a major strategic area for Eisai in Europe, the Middle East, Africa and Russia (EMEA).

In the EMEA region, Eisai currently has four marketed treatments including:

  • Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zonegran is under license from the originator Dainippon Sumitomo Pharma)
  • Zebinix® (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. (Zebinix is under license from BIAL)
  • Inovelon® (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients >4 years
  • Fycompa® (perampanel) for use as an adjunctive treatment for partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older

About Eisai:

Eisai recently expanded their UK Hatfield commercial, research and manufacturing facility which now supports the company's growing EMEA business.

Eisai concentrates its R&D activities in three key areas:

  • Neuroscience, including: Alzheimer's disease, epilepsy, depression
  • Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, and inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, Belgium, Luxembourg, the Middle East and Russia.

For further information please visit our web site http://www.eisai.com.

Date of preparation: September 2012
Job code: Corporate-UK2007