Eisai Continues Global Expansion with New Office in Melbourne, Australia (1)

HATFIELD, England, November 6, 2014 /PRNewswire/ --

PRESS RELEASE FOR EU MEDIA ONLY: NOT FOR SWISS/U.S. JOURNALISTS

New Eisai office will support breast cancer treatment Halaven(R)(eribulin)

and first-in-class epilepsy treatment Fycompa(R)(perampanel)

Eisai today announces the official opening of a new office in Melbourne, Australia, which will further expand the company's geographical presence and increase patient reach. The Melbourne office will provide leading global research and development-based pharmaceutical company, Eisai, with an important platform from which its portfolio of novel oncology and epilepsy products will be marketed.

The opening demonstrates Eisai's continuing commitment to improve access to innovative medicines in emerging economies and developing countries, as set out in the company's mid-term strategic plan.

"The launch of the new Eisai office recognises that Australia has an important and distinctive healthcare system. We are delighted to broaden the reach of our innovative oncology and epilepsy products to benefit patients and their families in this key global market," commented Gary Hendler, President & CEO, Eisai EMEA.

The expansion into Australia underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide.

The first two products to be supported by the new office will be novel breast cancer treatment Halaven(R) (eribulin) and first-in-class epilepsy treatment Fycompa(R) (perampanel).

"We believe Halaven in breast cancer and Fycompa in epilepsy will prove valuable treatment options for clinicians managing these conditions in Australia. While these two products will be our initial focus, Eisai also has an exciting pipeline in oncology, neurology, and the vascular and gastrointestinal fields," commented Dr John Bower PhD, Market Access and Medical Director, Eisai Australia.

Breast cancer is the most common cancer diagnosed in Australian women with one in eight women likely to be diagnosed by the age of 85.[1]

Eribulin received reimbursement in Australia on 1 October 2014. The agent is one of the few breast cancer treatments to be approved by the Australian Pharmaceutical Benefits Scheme (PBS) in recent years. Eribulin is indicated in Australia for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.[2]

Epilepsy is one of the most common neurological conditions in the world.[3] In Australia it is estimated that 225,000 Australians live with epilepsy, and approximately 800,000 will be diagnosed with the condition at some stage in their life.[4]

Perampanel, the first in an entirely new class of treatment for partial onset seizures (the most common form of epilepsy), received reimbursement from the PBS on 1 November 2014. Perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.[5]

Notes to Editors

About Halaven(R) (eribulin)[2]

Eribulin is the first in the halichondrin class of microtubule dynamics inhibitors with a novel mechanism of action. Structurally eribulin is a simplified and synthetically produced version of halichondrin B, a natural product isolated from the marine sponge Halichondria okadai. Eribulin is believed to work by inhibiting the growth phase of microtubule dynamics which prevents cell division.

About Metastatic Breast Cancer

Over 300,000 women are diagnosed with breast cancer in Europe every year, of whom about one third subsequently develop metastatic disease.[6],[7]Metastatic disease is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

About Eisai in Oncology

Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

About Fycompa(R) (perampanel)[5]

In the EU, perampanel is indicated for the adjunctive treatment of partial onset seizures, with or without secondarily generalised seizures, in patients with epilepsy aged 12 years and older.

Perampanel is a highly selective, non-competitive AMPA ( alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid)-type glutamate receptor antagonist that has demonstrated seizure reduction in Phase II and III studies. AMPA receptors, widely present in almost all excitatory neurons, transmit signals stimulated by the excitatory neurotransmitter glutamate within the brain and are believed to play a role in central nervous system diseases characterised by excess neuroexcitatory signalling including epilepsy.

About Epilepsy

Epilepsy is one of the most common neurological conditions in the world, affecting approximately eight in 1,000 people in Europe, and an estimated 50 million people worldwide.[8],[9]Epilepsy is a chronic disorder of the brain that affects people of all ages. It is characterised by abnormal discharges of neuronal activity causing 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:

- Fycompa(R) (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
- Inovelon(R) (rufinamide) for the adjunctive treatment of seizures associated
with Lennox-Gastaut Syndrome in patients >4 years. (Rufinamide was originally
developed by Novartis)
- Zonegran(R) (zonisamide) 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
generalisation, in adults, adolescents and children aged six years and above.
(Zonegran is under license from the originator Dainippon Sumitomo Pharma)
- Zebinix(R) (eslicarbazepine acetate) as adjunctive therapy in adult patients
with partial onset seizures, with or without secondary generalisation. (Zebinix is
under license from BIAL)

About Eisai Co., Ltd.

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