Eisai Announces Exclusive In-License of All U.S. Promotional Rights for FRAGMIN , an Injectable Anti-Clotting Agent
Eisai Co., Ltd.
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 (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 to Eisai for the duration of the deal.
FRAGMIN 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 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 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.]
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[FRAGMIN Product Outline]