Eisai: FDA OKs UK Site for Zonegran
Eisai's EMEA Operation Becomes the US Supply Centre for Epilepsy Drug Zonegran® (zonisamide)
HATFIELD, England, October 15, 2013 /PRNewswire/ --Japanese pharmaceutical company Eisai today announces that the US Food and Drug Administration (FDA) has approved the US supply of the epilepsy drug Zonegran® (zonisamide) from its EMEA (Europe, Middle East, Africa, Russia and Oceania) Knowledge Centre based in Hatfield, UK. The Hatfield site will manufacture and package three different strengths of Zonegran tablet for export to the US.
The FDA supply approval for zonisamide follows the approval for the US supply of another Eisai epilepsy drug, Fycompa® (perampanel), on 11 September 2013. The manufacturing facility at Hatfield, which also includes Eisai's EMEA sales and marketing and R&D operations, is increasing in significance to the company's worldwide business as it continues becomes a global supply centre for innovative products such as zonisamide and perampanel.
Gary Hendler, President and CEO, Eisai EMEA, comments: "We are pleased to announce this new FDA approval for the US supply of Zonegran from our Hatfield manufacturing facility. This latest achievement, which follows the earlier FDA supply approval for Fycompa, is testament to the commitment our EMEA business has made to the UK."
Zonisamide was approved in the US in 2000 as adjunctive therapy for the treatment of partial seizures in adults with epilepsy.[ 1] It is indicated in Europe as monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy, and as adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents and children aged 6 years and above.[ 2]
The FDA approval for the manufacture and supply of zonisamide and perampanel to the US is another example of Eisai's human health care mission; the company's commitment to increasing access to innovative solutions in disease prevention, cure and care for the health and well-being of people worldwide. Eisai is committed to addressing the unmet medical needs of patients and their families.
Notes to Editors:
Eisai has 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.
Eisai established the £100 million EMEA Knowledge Centre (EKC), in June 2009 in Hatfield Hertfordshire. This site integrates the company's discovery research, clinical development, production, marketing, and EMEA headquarters functions with the aim of expanding business operations further in Europe and around the world.
In 2012, the Eisai Hatfield site became the first global, solid dose manufacture supply site outside of Japan for the antiepilepsy drug Fycompa® (perampanel).
In 2013, it was announced that the Eisai Hatfield site was expanding to include an additional high potency, global packaging capability to handle the blister packaging of Eisai's investigational treatment lenvatinib (E7080). Once fully developed, this site will also increase capacity to package and supply the anti-epilepsy drug (AED) Fycompa® (perampanel) and other new products, to new markets around the world.
In September 2013 the Eisai Hatfield site was approved by the US Food and Drug Administration (FDA) for the supply of epilepsy drug Fycompa® (perampanel) to the US.
In October 2013 the Eisai Hatfield site was approved by the US Food and Drug Administration (FDA) for the supply of epilepsy drug Zonegran® (zonisamide) to the US.
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Epilepsy is one of the most common neurological conditions in the world. There are an estimated six million people who live with epilepsy in Europe, and an estimated 50 million people with the condition worldwide. Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity which causes seizures. Seizures can vary in severity, from brief lapses of attention or jerking of muscles, to severe and prolonged convulsions. Depending on the seizure type, seizures may be limited to one part of the body, or may involve the whole body. Seizures can also vary in frequency from less than one per year, to several per day. Epilepsy has many possible causes but often the cause is unknown.
About Eisai EMEA 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, Russia and Oceania (EMEA).
In the EMEA region, Eisai currently has four marketed treatments including:
Zonegran® (zonisamide) as monotherapy and adjunctive therapy in adults, adolescents and children above the age of 6 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. (Rufinamide was originally developed by Novartis)
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
Eisai is one of the world's leading research and development (R&D) based pharmaceutical companies and we define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc).
Eisai concentrates its R&D activities in three key areas:
Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight loss
Oncology including: anticancer therapies; tumour regression, tumour suppression, antibodies, etc.
Vascular/Immunological reaction including: thrombocytopenia, rheumatoid arthritis, psoriasis, inflammatory bowel disease
With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 10,000 people worldwide. From its EMEA Knowledge Centre in Hatfield, UK, Eisai has recently expanded its business operations to include Europe, the Middle East, Africa, Russia and Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Czech Republic, Slovakia, the Netherlands, Belgium, Russia and the Middle East.
For further information please visit our web site http://www.eisai.co.uk
1. FDA zonisamide safety label 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020789s012lbl.pdf (Accessed September 2013)
2. Eisai Ltd 2013. Zonegran summary of product characteristics (last updated October 2013) https://www.medicines.org.uk/emc/history/16240/SPC/Zonegran+25,+50,+100+...
3. Pugliatti M et al. Estimating the cost of epilepsy in Europe: A review with economic modeling. Epilepsia 2007: 48(12) 2224-2233.
Date of preparation: October 2013
Job code: Corporate-UK2017
CONTACT: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte Andrews, +44(0)7908-314-155/ +44(0)7947-231-513, Cressida_Robson@eisai.net / Charlotte_Andrews@eisai.net ; Tonic Life Communications: Siobhan Reilly / Frances Murphy, +44(0)7900605652/+44(0)207-798-9900, Siobhan.Reilly@toniclc.com / Frances.Murphy@toniclc.com
Posted: October 2013