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News Release

February 10, 2004

E2000, Transdermal Muscle Relaxant Application Withdrawn in Japan

Eisai Co., Ltd. (Headquarters: Tokyo, President: Haruo Naito) and its subsidiary Sannova Co., Ltd. (Headquarters: Gunma Pref. President: Mitsuhiro Ebata) decided to withdraw a New Drug Application (NDA) for E2000 (generic name: eperisone hydrochloride), a new formulation of eperisone, which had been jointly developed by the two companies and filed by Sannova to the Ministry of Health, Labor, and Welfare (MHLW) in Japan.

E2000, a transdermal muscle relaxant preparation, was designed to improve myotonic conditions caused by the diseases such as low back pain or neck-shoulder-arm syndrome, and spastic paralysis caused by cerebrovascular disorders though the action of eperisone absorbed through the skin. This preparation in a new transdermal form was developed with the aim of providing patients with greater ease of use and submitted to the MHLW in 1997. Additional clinical trials using a new objective assessment method were conducted, however, the new formulation did not demonstrate sufficient efficacy when evaluated by the new method, resulting in the withdrawal of the application.

Eisai will continue to work to provide increased benefits to patients with a focus on the fields of neurology, gastroenterology, and oncology.

  << Glossary >>

< Low back pain >
  Low back pain refers here to either stiffness or pain in the muscles of the lower back.

< Neck-shoulder-arm syndrome >
  Stiffness and pain in the muscles from the neck to the shoulders resulting from deformity of the neck vertebrae due to ageing, excessive movement, extended periods sitting in the same posture in front of a VDT, and other factors.

< Myotonic conditions >
  Muscle (skeletal muscle) tone or tension in the neck, shoulder and other areas exacerbated by abnormal posture, overwork, pain stimulation and other factors.

Muscle tension is aggravated by reduced intramuscular blood flow, and generates pain producing substances that, through pain stimulation, further exacerbate muscle tonus, resulting in a cycle of worsening stiffness and pain that persists in the affected area.

< Cerebrovascular disorder >
  Brain function disorder resulting from insufficient cerebral blood flow, stoppage of blood flow or hemorrhage due to cerebral blood vessel abnormalities. Clinical symptoms associated with cerebrovascular disorders include numbness, paralysis and other sensory disorders, movement disorders, and in severe cases, impairment of consciousness.

< Spastic paralysis caused by cerebrovascular disorders >
  A sequela of cerebrovascular disorder, this refers to spasm (in hands and feet) and reduced muscle strength (paralysis). Spasm and paralysis generally occur together, but may occur independently depending on the location of the disorder.

< Transdermal preparation >
  A patch from which pharmaceuticals are absorbed through the skin. Some patches have been developed because the blood concentration of certain drugs taken internally differs widely from person to person, or because of the need for frequent doses of a drug throughout the day. The dosage forms, which differ depending on the characteristics of the drug and the application, include thin pharmaceutical tapes and water-based compresses.