The text starts here.

News Release

FOR IMMEDIATE RELEASE
September 28, 2005

Eisai Announces Exclusive In-License of All U.S. Promotional Rights for FRAGMIN (R), an Injectable Anti-Clotting Agent

Eisai Co., Ltd.
Eisai Inc.

Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito) announced today that its U.S. pharmaceutical subsidiary, Eisai Inc. (Headquarters: New Jersey, Chairman and CEO: Hajime Shimizu), signed an in-license agreement on September 27 with Pfizer Inc for exclusive U.S. rights to promote FRAGMIN (R) (dalteparin sodium injection), an anti-coagulant. Eisai also will assume responsibility for post-marketing studies and product distribution, as well as book all U.S. sales.  According to this agreement, Pfizer will transfer the New Drug Application for FRAGMIN (R) to Eisai for the duration of the deal.

FRAGMIN (R) is a clot-preventing agent, for subcutaneous injection only, in a class of drugs known as low-molecular-weight heparins. In the United States, FRAGMIN (R) is indicated for prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip replacement surgery, in at-risk patients undergoing abdominal surgery or in at-risk acutely ill patients whose mobility is severely restricted. FRAGMIN (R) is also approved for prophylaxis of ischemic complications resulting from unstable angina and non-Q-wave myocardial infarction (heart attack), when used with aspirin. According to the American Heart Association, DVT occurs in approximately 2 million Americans a year.  An estimated 600,000 people with DVT develop PE, a blood clot that migrates to the lungs and blocks the smaller lung arteries.

Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care.  With this agreement, Eisai aims to strengthen its position in critical care in the United States and help improve the quality of life for patients.



[The product outline and glossary are attached for reference.]

Contacts:
Corporate Communications Dept.    
Eisai Co., Ltd.
03-3817-5120 (Tokyo)
Judee Shuler
Corporate Planning and Communications
Eisai Inc.
1-201-287-2241 (U.S.)



<Notes to editors>

[FRAGMIN (R) Product Outline]
FRAGMIN (R) is a clot-preventing agent, for subcutaneous injection only, in a class of drugs known as low-molecular-weight heparins. FRAGMIN (R) was first approved for marketing by the U.S. Food and Drug Administration in 1994 and was launched in the United States in 1995. Prior to this agreement, it was marketed by Pfizer Inc.
1)   Product Name: Fragmin(R)
2)   Generic Name: Dalteparin sodium
3)   Formulation: Injection (two vial types and four syringe types)
4)   Distributor: Eisai Inc.
5)   Manufacturer: Pfizer Inc
6)   Indications and Usage:
  • Fragmin(R) is indicated for prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE):
    -   in patients undergoing hip replacement surgery
    -   in at-risk patients undergoing abdominal surgery
    -   in at-risk acutely ill patients whose mobility is severely restricted


  • Fragmin(R) is also approved for prophylaxis of ischemic complications resulting from unstable angina and non-Q-wave myocardial infarction (heart attack), when used with aspirin.


[Glossary]
  • Deep Vein Thrombosis (DVT)
    DVT is caused by blood clots in the large veins, which can break away, travel to the lungs and cause pulmonary embolisms. Symptoms of DVT commonly occur in just one leg and include pain or tenderness and swelling or redness. However, half of all DVT patients show no symptoms. According to the American Heart Association, DVT occurs in approximately 2 million Americans a year.

  • Pulmonary Embolism (PE)
    PE is a condition where blood clots formed elsewhere in the body migrate to the lungs and obstruct the pulmonary artery or a branch of it, impairing the arterial circulation in the lungs. Common symptoms of PE involve shortness of breath and chest pain when breathing. An estimated 600,000 people with DVT develop PE.