SOURCE: Eisai Inc.

September 28, 2005 02:00 ET

Eisai Announces Exclusive In-License of All U.S. Promotional Rights for Fragmin®, an Injectable Anti-Clotting Agent

TEANECK, NJ -- (MARKET WIRE) -- September 28, 2005 -- Eisai Inc. (Headquarters: Teaneck, Chairman and CEO: Hajime Shimizu), a U.S. pharmaceutical subsidiary of Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito), today announced an in-license agreement 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.

DVT is caused by blood clots in the large veins, which can break away, travel to the lungs and cause PE. The goal of Fragmin® therapy is to prevent blood clots from forming.

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. Symptoms of PE involve shortness of breath and chest pain when breathing. 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 migrating to the lungs and blocking the smaller lung arteries. Of those, 60,000 die.

"Eisai is committed to educating people at risk for developing blood clots and to offering physicians Fragmin® as an important treatment option," said Lonnel Coats, president and COO, Eisai Inc. "In keeping with our human health care mission to put the needs of patients and their families first, we are pleased to make Fragmin® available for this life-threatening condition."

Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. In the United States, Eisai Inc. copromotes or independently markets products through its Central Nervous System, Neurology, Primary Care and Hospital field forces. This agreement with Pfizer Inc represents the companies' third alliance since 1994 and is aimed at strengthening Eisai's position in critical care in the United States. Eisai Inc. will continue its ongoing sales force expansions, focusing on hospital sales capabilities for Fragmin®.

About Fragmin®

Spinal or epidural hematomas can occur with the associated use of low-molecular-weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture, which can result in long-term or permanent paralysis.

The risk of these events is higher with the use of indwelling epidural catheters or concomitant use of additional drugs affecting hemostasis, such as NSAIDs. Patients should be frequently monitored for signs and symptoms of neurological impairment.

Fragmin® is contraindicated in patients undergoing regional anesthesia, who have unstable angina or non-Q-wave myocardial infarction due to an increased risk of bleeding associated with the recommended dosage of Fragmin®.

Fragmin® injection is also contraindicated in patients with active major bleeding or with known hypersensitivity to the drug, heparin, or pork products, or with thrombocytopenia associated with a positive anti-platelet antibody test. It should be used with extreme caution in patients with a history of heparin-induced thrombocytopenia.

Fragmin® cannot be used interchangeably (unit for unit) with unfractionated heparin or other low-molecular-weight heparins.

Please see full prescribing information for Fragmin® at www.fragmin.com.

About Eisai

Eisai Co., Ltd. is a research-based human health care company that discovers, develops and markets products in more than 30 countries. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs more than 7,700 people worldwide. Established in the United States in 1995, Eisai Inc. began marketing its first product in 1997 and has rapidly grown to become an integrated pharmaceutical business with sales of approximately $2 billion in fiscal year 2004 (year ended March 31, 2005).

Eisai Inc. employs approximately 1,200 people at its headquarters in Teaneck, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. Between 1998 and 2004, Eisai Inc. moved up rapidly in the rankings (based on revenues) of U.S. pharmaceutical companies from No. 44 to No. 19.

About Pfizer Inc

Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals and many of the world's best-known consumer brands.

Contact Information

  • Contacts:
    Corporate Communications
    Eisai Co., Ltd.
    011 81 3 3817 5120

    Judee Shuler
    Corporate Planning and
    Communications
    Eisai Inc.
    1-201-287-2241