Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced that on March 30 (U.S. Eastern Standard Time), the company signed a product acquisition agreement with Elan Corporation, plc. (Headquarters: Dublin, Ireland, President and CEO: Kelly Martin) for the exclusive North American and European rights to market Zonegran (zonisamide), which was developed and marketed by Elan for the adjunctive treatment of epilepsy. Elan had previously licensed Zonegran from Dainippon Pharmaceutical Co., Ltd. With Dainippon's consent, Eisai will obtain manufacturing, developing and marketing rights for Zonegran in the U.S., Europe, Canada and Mexico. In addition, Elan's US neurology medical representatives will be offered employment by Eisai Inc., the U.S. subsidiary of Eisai Co., Ltd.
Zonegran was approved and launched in March 2000 in the U.S. for adjunctive therapy in the treatment of partial seizures in adults with epilepsy. In Europe, a Marketing Authorization Application was submitted through the European Union's (EUs) Centralized Procedure in November 2003. In Japan, the product was approved in 1989 and is marketed by Dainippon Pharmaceutical Co., Ltd. under the brand name Excegran.
This strategic acquisition will enhance Eisai's neurology product line in the U.S. The addition of Zonegran and the medical representatives demonstrates Eisai Inc.'s continued focus on strengthening its neurology franchise. In Europe, the company expects to obtain approval in 25 E.U. countries including the 10 new anticipated E.U. member countries through the Centralized Procedure in order to expand business opportunities as well as enrich its product line.
Eisai will strengthen its franchise product line, especially in neurology, in the U.S. and Europe in order to fulfil patients' needs and contribute to their benefits.
The transaction is subject to governmental approvals and is expected to close before the end of second quarter 2004.
[Summaries of Zonegran and epilepsy background information are attached for reference]
||Product name :
|Generic name :
||Adjunctive therapy in the treatment of partial seizures in adults with epilepsy (in the U.S.)
|Dosage and Administration :
||Once or twice daily of 25mg, 50mg or 100mg capsules
||Epilepsy 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 including head injuries, lack of oxygen at birth, brain tumors, infections (such as meningitis or encephalitis), cerebrovascular disorders and high fevers. In approximately seven out of ten cases of epilepsy, doctors cannot find the underlying cause.
|Types of Seizures:
||Symptoms of seizures can range from a brief staring episode to massive, prolonged, life-threatening convulsions. 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, the most common type, affect up to 60% of people with a seizure disorder, and are very difficult to control. Three subtypes comprise this category :
- Simple Partial Seizures: Seizures begin in a small, localized area of the brain; consciousness is not altered.
- Complex Partial Seizures: Seizures begin in a small, localized area of the brain; consciousness is altered.
- Partial Seizures Evolving to Secondarily Generalized Seizures: Seizures begin in one area of the brain and then spread throughout the brain.
||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 can be useful to search for possible growths or scars in the brain, which can trigger seizures. Positron emission tomography (PET) may be useful in identifying specific areas of the brain that are producing the seizures.
||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)