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News Release

February 9, 2004

Eisai Announces In-Licensing Agreement with Novartis for Rufinamide,
A New Antiepileptic Agent

Eisai Co., Ltd.

Eisai Announces In-Licensing Agreement with Novartis for Rufinamide,
A New Antiepileptic Agent

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced that on February 6, 2004, the company signed an in-licensing agreement with Novartis Pharma AG (Basel, Switzerland) for the exclusive worldwide rights to manufacture, further develop and market rufinamide for pharmaceutical use in treatment of epilepsy.

Rufinamide, a structurally novel compound unrelated to currently marketed antiepileptic drugs, is a broad-spectrum anticonvulsant, which was discovered and developed by Novartis. In Phase III clinical trials completed in the US and the EU, rufinamide demonstrated statistically significant efficacy as adjunctive therapy in the treatment of inadequately controlled partial seizures in adult patients and in seizures associated with Lennox-Gastaut syndrome.

Eisai plans to file the drug application for rufinamide to US and EU health authorities, in order to strengthen its presence in the field of neurology and provide increased benefits to patients who are suffering from epilepsy.

Public Relations Department
Eisai Co., Ltd.
Cathy Pollini
Corporate Public Relations
Eisai Inc.

[Epilepsy background information is attached for reference]

Epilepsy background information - Note to the editor:

Causes: Epilepsy, often referred to as seizure disorder, is a neurological condition that is associated with recurrent electrical discharges in the brain that disrupt the functioning of the nervous system. The intermittent bursts of electrical energy that result may cause seizures, which can affect consciousness, bodily movements or sensations. There are multiple causes of epilepsy in children, including head injuries, lack of oxygen at birth, brain tumors, infections (such as meningitis or encephalitis) and high fevers. In approximately seven out of ten cases of epilepsy, doctors cannot find the underlying cause.
Types of
Symptoms of seizures can range from a brief staring episode to a massive, prolonged, life-threatening convulsion. Seizures fall into two general categories: partial seizures, which occur in one area of the brain and generalized seizures, which affect both sides of the brain. Partial seizures affect up to 60% of people with a seizure disorder, making them the most common type, and are very difficult to control. Three subtypes comprise this category:
  • Simple Partial Seizures: These seizures begin in a small, localized area of the brain; consciousness is not altered.
  • Complex Partial Seizures: This type begins in a small, localized area of the brain; consciousness is altered.
  • Partial Seizures Evolving to Secondarily Generalized Seizures: Abnormal activity begins in one area of the brain and then spreads throughout the brain.
Lennox-Gastaut syndrome: Lennox-Gastaut syndrome is a severe form of generalized epilepsy that develops in early childhood, caused by various brain disorders such as brain hemorrhage, encephalitis, developmental malformations of the brain or metabolic abnormalities. Tonic seizure, where muscles contract continuously, along with developmental delay and behavioral problems are the most typical symptoms associated with Lennox-Gastaut syndrome. At the same time, however, the most characteristic manifestation of the Lennox-Gastaut syndrome is a large variety of seizures, such as myoclonic seizures where a group of muscles involuntary contracts for a short time, and absence seizures where unconsciousness occurs for a short time. It is difficult to manage by pharmacotherapy, and in rare cases surgical treatment can be employed.
Diagnosis: After obtaining a medical history including detailed information about the patient's seizures and what preceded them, a doctor may perform an electroencephalogram (EEG) to analyze brain wave patterns during or between seizures in order to determine the nature of the neurological disorder.

Computerized tomography (CT) or magnetic resonance imaging (MRI) scans may be used to search for possible growths or scars in the brain, which can trigger seizures. Positron emission tomography (PET) is used to identify specific areas of the brain that may be producing seizures.
Prevalence: Major 7 pharmaceutical markets in total - about 5.2 million
US - about 2 million
Europe (major 5 countries) - about 2.2 million
Japan - about 1 million
(based on Eisai's research)
Market size: Major 7 pharmaceutical markets in total - about $ 4 billion
US - about $2.2 billion
Europe (major 5 countries) - about $1.6 billion
Japan - about $200 million
(based on Eisai's research)