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EISAI TO PRESENT LATEST CLINICAL DATA ON HALAVEN® (ERIBULIN) AND LENVATINIB AT 39TH ESMO CONGRESS

°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a series of abstracts highlighting the latest clinical data on Halaven® (generic name: eribulin mesylate; non-taxane microtubule dynamics inhibitor, “Halaven”) and lenvatinib mesylate (generic name; selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, “lenvatinib”) will be presented during the 39th European Society for Medical Oncology (ESMO) Congress 2014, taking place in Madrid, Spain, from September 26 - 30.

For eribulin, three abstract poster presentations including a quality of life analysis of a Phase Ⅲ study on metastatic breast cancer (Study 301) are to be presented at the meeting. In June this year, Halaven was approved in Europe for an additional indication of locally advanced or metastatic breast cancer which has progressed after at least one chemotherapeutic regimen for advanced disease (prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments).

For lenvatinib, an oral presentation highlighting an analysis of serum biomarker and tumor gene mutation associated with clinical outcomes of a Phase Ⅲ study on radioiodine-refractory differentiated thyroid cancer (the SELECT (Study of E7080 LEnvatinib in differentiated Cancer of the Thyroid) study) as well as four abstract poster presentations are also scheduled to be presented at the meeting. Applications for marketing authorization approval of lenvatinib were submitted in Japan for the indication of thyroid cancer in June 2014 and in Europe and the U.S. for the indication of progressive radioiodine-refractory differentiated thyroid cancer in August 2014.

Eisai positions oncology as a key franchise area. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families as well as healthcare providers.

Major Eisai abstracts accepted for presentation at this year's ESMO meeting include:

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Product Abstract title and scheduled presentation date and time (local time)

Halaven
(Eribulin)

Abstract No: 7367

Impact of treatment with eribulin or capecitabine for metastatic breast cancer on EQ–5D utility derived from EORTC QLQ–C30.

Poster Presentation | September 28 (Sun), 12:45-13:45

Halaven
(Eribulin)

Abstract No: 393P

Efficacy of eribulin in a second-line or later setting in patients with metastatic breast cancer: a pooled analysis.

Poster Presentation | September 27 (Sat), 12:45-13:45

Halaven
(Eribulin)

Abstract No: 6906

HRQOL and disease symptoms in patients with locally advanced or metastatic breast cancer treated with eribulin or capecitabine in a post anthracycline and taxane setting.

Poster Presentation | September 27 (Sat), 12:45-13:45

Lenvatinib
(E7080)

Abstract No:LBA30

Comprehensive analysis of serum biomarker and tumor gene mutation associated with clinical outcomes in the phase Ⅲ Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid (SELECT).

Oral Presentation | September 27 (Sat), 10:20-10:35

Lenvatinib
(E7080)

Abstract No: 4933

Phase Ⅱ study of lenvatinib, a multi-targeted tyrosine kinase inhibitor, in patients with all histologic subtypes of advanced thyroid cancer (differentiated, medullary and anaplastic).

Poster Presentation | September 28 (Sun), 13:00-14:00

Lenvatinib
(E7080)

Abstract No: 6405

Subgroup analyses of a phase Ⅲ, multicenter, double-blind, placebo controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer.

Poster Presentation | September 29 (Mon), 12:45-13:45

Lenvatinib
(E7080)

Abstract No: 5582

Treatment-emergent hypertension and efficacy in the phase Ⅲ Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid (SELECT).

Poster Presentation | September 29 (Mon), 12:45-13:45

Lenvatinib
(E7080)

Abstract No: 5658

Characterization of tumor size changes over time from the phase Ⅲ Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid (SELECT).

Poster Presentation | September 29 (Mon), 12:45-13:45

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