Eisai Announces Change in U.S. Submission Schedule for E7389 New Drug Application

Friday, February 1, 2008 General News
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TOKYO and WOODCLIFF LAKE, N.J., Feb. 1 Eisai Co., Ltd.(Headquarters: Tokyo, President & CEO: Haruo Naito) and Eisai's U.S.subsidiary, Eisai Corporation of North America (Headquarters: New Jersey, theUnited States, Chairman & CEO: Hajime Shimizu), today announced a change inthe schedule for submission to the U.S. Food and Drug Administration (FDA) ofa New Drug Application (NDA) for E7389 (generic name: eribulin mesylate) forthird-line treatment of advanced breast cancer in patients who were pretreatedwith anthracycline, taxane and capecitabine.

Eisai is committed to developing E7389 as a potential treatment forpatients with advanced breast cancer. In a Phase II study of 299 patientswith advanced breast cancer who had been heavily pretreated, the compound hasshown promising anti-tumor activity, with a response rate of 14.1% byinvestigator evaluation and 9.3% by independent radiologist evaluation. Ithas also been shown in the Phase II study to be generally well-tolerated, withthe most common Grades 3 and 4 drug-related adverse events being 54% inneutropenia and 14% in leucopenia. Grade 3 peripheral neuropathy occurred in6% of study participants, and there were no Grade 4 events.

Eisai had planned to submit an NDA under Subpart H*, based on Phase IIclinical trial data, to seek accelerated approval for E7389 as a third-linebreast cancer treatment (monotherapy), but is precluded from doing so, becauseFDA approved another drug for this specific indication last October. Eisairemains committed to advancing two Phase III clinical trials for E7389, whichare ongoing in the U.S. and in Europe, Study 301 for second-line and Study 305for third-line breast cancer treatment. Eisai now plans to submit an NDA toFDA with data from these trials and Phase II clinical trial data in fiscalyear 2009-2010. In addition, Eisai continues to evaluate E7389 as a potentialtreatment for a variety of other solid tumors, including non-small cell lungcancer, prostate cancer and sarcoma.

E7389 is a novel compound developed by Eisai as a new potential anti-cancer agent that suppresses the growth of microtubule which is involved invarious cellular processes in the body, such as cell division. E7389 is asynthetic analog of halichondrin B, a naturally-occurring compound which wasfirst isolated from a type of marine sponge in 1992.

Eisai has a strong commitment to the development of new oncology medicinesto address the unmet medical needs of patients with cancer. Currently, sevenother Eisai oncology compounds are in clinical development, in addition toE7389.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company thatdiscovers, develops and markets products throughout the world. Eisai focusesits efforts in three therapeutic areas: neurology, gastrointestinal disordersand oncology/critical care. Through a global network of research facilities,manufacturing sites and marketing affiliates, Eisai actively participates inall aspects of the worldwide healthcare system.

About Eisai Corporation of North America

Eisai Corporation of North America is a wholly-owned subsidiary of EisaiCo., Ltd. and supports the activities of its operating companies in NorthAmerica. These operating companies include: Eisai Research Institute ofBoston, Inc., a discovery operation with strong organic chemistrycapabilities; Morphotek, Inc., a biopharmaceutical company specializing in thedevelopment of therapeutic monoclonal antibodies; Eisai Medical Research Inc.,a clinical development group; Eisai Inc., a commercial operation withmanufacturing and marketing/sales functions; MGI PHARMA, INC., an R&D andcommercial operation with manufacturing and marketing/sales functions; andEisai Machinery U.S.A., which markets and maintains pharmaceuticalmanufacturing machinery.

*Accelerated Approval under Subpart H:

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