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News Release

FOR IMMEDIATE RELEASE
August 2, 2005

Eisai Receives Approval for Cleactor(R) Inj for Acute Pulmonary Embolism in Japan

Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced that it received yesterday an approval letter dated July 25, 2005 from the Ministry of Health, Labour and Welfare in Japan for thrombolytic agent Cleactor(R) Inj (generic name: monteplase) for the indication of lysis of pulmonary artery thrombosis caused by acute pulmonary embolism in the presence of hemodynamic instability. This product is available in three intravenous dosage forms: Cleactor(R) Inj 400,000; Cleactor(R) Inj 800,000; and Cleactor(R) Inj 1,600,000.

Cleactor(R) Inj was launched with the indication of lysis of coronary thrombus caused by acute myocardial infarction (within 6 hours after onset of symptoms) in June 1998. It has been under development for treatment of acute pulmonary embolism since March 1998 when it was designated as an orphan drug for that indication. Cleactor(R) Inj is now the first thrombolytic agent in Japan which is indicated for both acute myocardial infarction and acute pulmonary embolism.

Cleactor(R), a second-generation t-PA (tissue plasminogen activator), was independently developed by Eisai utilizing recombinant DNA techniques. The administration of Cleactor(R) Inj, when given as a bolus injection, is achieved with an elimination of half-life in blood plasma of greater than 20 minutes.

Eisai expects that with the new indication, Cleactor(R) Inj will further leverage the Company's commitment to the evolution of critical care medicine.

[The content of the approval and glossary are attached for reference]

Contact:

Eisai Co., Ltd.
Corporate Communications Department
Phone 03-3817-5120 (Tokyo)

<Notes to editors>
I.
Description of the Approval(The underlined parts are what were newly added.)
Product Name: Cleactor(R) Inj 400,000 / Cleactor(R) Inj 800,000 / Cleactor(R) Inj 1,600,000
Generic Name:Monteplase (genetical recombination)
Active Ingredient and Content:
Each vial contains active ingredient of 400,000 IU / 800,000 IU / 1,600,000 IU monteplase (genetical recombination), respectively.

Indications:
  • Lysis of coronary thrombus caused by acute myocardial infarction (within 6 hours after the onset of symptoms)
  • Lysis of pulmonary artery thrombus caused by acute pulmonary embolism with hemodynamic instability

<Precautions related to Indications>
  1. It is recommended that acute pulmonary embolism should be diagnosed after thrombosis, other emboli or the obstruction of blood flow have been confirmed by pulmonary angiography or other diagnostic tests. However, if either of these tests is not available, CLEACTOR may be administered to patients who are clinically highly suspected to have acute pulmonary embolism with hemodynamic instability and have been confirmed by tests to have such symptoms as hypoxemia or acute right heart strain.
  2. It is recommended that CLEACTOR should be administered to patients with acute pulmonary embolism in combination with background therapy of anticoagulant medication including heparin.

Dosage and Administration:
  • Lysis of coronary thrombus caused by acute myocardial infarction (within 6 hours after the onset of symptoms):
    The usual adult dosage for intravenous injection is 27,500 IU/kg body weight of monteplase (genetical recombination).

  • Lysis of pulmonary artery thrombus cased by acute pulmonary embolism with hemodynamic instability:
    The usual adult dosage for intravenous injection is 13,750 up to 27,500 IU/kg body weight of monteplase (genetical recombination).

During reconstitution, it should be dissolved in isotonic sodium chloride solution, JP at a concentration of 80,000 IU/mL. The prepared solution should be infused at a rate of about 10 mL (800,000 IU) /min. Administration of CLEACTOR should be initiated as soon as possible after the onset of symptoms.
II.
Glossary
  • What is acute pulmonary embolism?
    Acute pulmonary embolism is a disorder in which a pulmonary artery is blocked by a thrombus that usually forms in leg veins and travels through the bloodstream into the lung, causing impaired breathing and circulation in the lungs.
  • t-PA (tissue plasminogen activator)
    T-PA is an enzyme in the body that is naturally produced in blood vessels and catalyzes the conversion of plasminogen to plasmin. Plasmin is an enzyme that can dissolve fibrin matrix, a component of thrombi.