Eisai Europe Limited

Eisai Oncology to Present New Research on Product Portfolio and Pipeline at ASCO Annual Meeting

Hatfield, England (ots/PRNewswire) - Eisai announced today that 12 abstracts highlighting new study results will be presented during the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, USA, from 1-5 June 2012.

These studies highlight Eisai's current product portfolio and oncology pipeline, reinforcing the company's commitment to patients and their families affected by cancer.

"Our human health care mission is to help address unmet medical needs and increase benefits to patients and their families," said Takashi Owa, Ph.D., Chief Scientific Officer, Eisai Product Creation Systems. "Our portfolio of oncology compounds and therapies underscores our commitment to this important mission."

The following Eisai abstracts are accepted for presentation at this year's ASCO meeting:

        Product           Abstract Name
                          A Phase II Single Arm, Feasibility Study of Dose Dense
                          Doxorubicin and Cyclophosphamide (AC) Followed by
        Eribulin          Eribulin Mesylate for the Adjuvant Treatment of Early
                          Stage Breast Cancer (EBC)
        Abstract No:
        TPS1145           Poster Session
                          A Phase 1b Dose Escalation Study of Eribulin Mesylate in
                          Combination with Capecitabine in Patients with
        Eribulin          Advanced/Metastatic Cancer
        Abstract No: 2552 Poster Session
        (E7080)           Treatment of Refractory Metastatic Renal Cell Carcinoma
                          (RCC) with Lenvatinib (E7080) and Everolimus
        Abstract No:
        TPS4682           Poster Session
                          A Phase IB Study of Lenvatinib (E7080) in Combination
        (E7080)           with Temozolomide for Treatment of Advanced Melanoma
        Abstract No: 8594 Poster Session
                          Lenvatinib Treatment of Advanced RAI-refractory
                          Differentiated Thyroid Cancer (DTC); Cytokine and
        Lenvatinib        Angiongenic Factor (CAF) Profiling in Combination with
                          Tumour Genetic Analysis to Identify Markers Associated
        E7080             with Response
        Abstract No: 5518 Poster Discussion
        Lenvatinib        A Phase II Trial of the Multitargeted Kinase Inhibitor
                          Lenvatinib (E7080) in Advanced Medullary Thyroid Cancer
        (E7080)           (MTC)
        Abstract No: 5591 Poster Session
                          A Phase I Dose-Finding Study of of Golvatinib (E7050) a
                          cMET and Eph Receptor Targeted Multi-Kinase Inhibitor,
                          Administered Orally QD to Patients with Advanced Solid
        E7050             Tumours
        Abstract No: 3030 Poster Discussion
                          A Phase I Dose-Finding Study of Golvatinib (E7050), a
                          c-Met and EPH Receptor Targeted Multi-Kinase Inhibitor
                          Administered Orally BID to Patients with Advanced Solid
        E7050             Tumours
        Abstract No: 3079 Poster Session
                          Phase I Safety Study of Farletuzumab, Carboplatin and
                          Pegylated Liposomal Doxorubicin (PLD) in Patients with
        Farletuzumab      Platinum-Sensitive Epithelial Ovarian Cancer (EOC)
        Abstract No: 5062 Poster Session
                          Phase I and Pharmacokinetic Study of Farletuzumab in
        Farletuzumab      Solid Tumours
        Abstract No: 3084 Poster Session
                          Amatuximab, A Chimeric Monoclonal Antibody to
        Amatuximab        Mesothelin, in Combination with Pemetrexed and Cisplatin
                          in Patients with Unresectable Pleural Mesothelioma
        MORAb-009         Results of a Multicentre Phase II Clinical Trial
        Abstract No: 7030 Poster Discussion
                          A First-in-Human Phase I Study of MORAb-004 (M4), a
                          Humanised Monoclonal Antibody Recognising Endosialin
        MORAb-004         (TEM-1), in Patients with Solid Tumours
        Abstract No: 3016 Poster Discussion 

Notes to Editors

Eisai in Oncology

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, therapeutic vaccines, and biologic and supportive care agents for cancer across multiple indications.

Halaven(R) (eribulin)

Eribulin is a non-taxane, microtubule dynamics inhibitor indicated for the treatment of patients with breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease and whose prior therapy should have included an anthracycline and a taxane.[1] Eribulin belongs to a class of antineoplastic agents, the halichondrins, which are natural products, isolated from the marine sponge Halichondria okadai. It is believed to work by inhibiting the growth phase of microtubule dynamics without affecting the shortening phase and sequesters tubulin into non-productive aggregates.

Lenvatinib (E7080)

Lenvatinib is an orally active inhibitor of multiple receptor tyrosine kinases (RTKs), including KDR (VEGFR-2), Flt-1 (VEGFR-1), FGFR1, PDGFR-beta and c-kit involved in angiogenesis and tumour proliferation.[2,3]

It is currently being investigated as a treatment for thyroid, hepatocellular, endometrial and other solid tumour types.

Farletuzumab (MORAb-003)

Farletuzumab is an investigational, humanized IgG1 monoclonal antibody targeting folate receptor alpha which is over-expressed on a number of epithelial-derived cancers, but largely absent in normal tissue. It is currently being developed as a potential treatment for ovarian and lung cancers. Significantly, farletuzumab has received orphan drug designation for ovarian cancer in the US, EU and Switzerland.


MORAb-004 is an investigational humanized IgG1 monoclonal antibody that recognizes a cell surface protein, endosialin, also called Tumour Endothelial Marker-1 (TEM1) and CD248, which is expressed on tumour associated pericytes, tumour stromal cells and directly on a subset of malignant cells. Pericytes are specialised cells that support the formation of blood vessels that support blood to tumours for their growth and survival. Expression of endosialin in tumours has been observed by several independent laboratories and experiments, and blocking endosialin function has been shown to inhibit tumour growth and metastasis. MORAb-004 is currently being investigated as a monoclonal antibody for its potential treatment of many types of cancer. An Investigational New Drug <http://www.morphotek.com/pipeline/Definitions-(1).aspx> application was opened for MORAb-004 in 2009. MORAb-004 has received US FDA orphan drug designation <http://www.morphotek.com/pipeline/Definitions-(1).aspx> for sarcoma.

Amatuximab (MORAb-009)

Amatuximab (MORAb-009) is an investigational chimeric IgG1 antibody that targets a cell surface glycoprotein, mesothelin, which is over-expressed on a number of cancers. Mesothelin is thought to be involved in cell adhesion. Its presence is associated with a range of cancers, including pancreatic ductal adenocarcinoma, mesothelioma, epithelial ovarian cancer, and lung adenocarcinoma. Researchers at the National Cancer Institute (NCI) and the Johns Hopkins University have independently validated mesothelin as a potential target of immuno-based therapies. Amatuximab is currently being investigated clinically as a monoclonal antibody for its potential treatment of mesothelioma.

About Eisai

Eisai is one of the world's leading R&D-based pharmaceutical companies and has defined its corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call human health care (hhc). Eisai recently expanded their UK Hatfield facility which now supports the company's growing European, Middle Eastern and African (EMEA) business.

Eisai concentrates its R&D activities in three key areas:

        - Neuroscience, including: Alzheimer's disease, multiple sclerosis,
          neuropathic pain, epilepsy, depression
        - Oncology including: anticancer therapies; tumour regression, tumour
          suppression, antibodies, etc and supportive cancer therapies; pain relief, nausea
        - Vascular/Immunological reaction including: acute coronary syndrome,
          atherothrombotic disease, rheumatoid arthritis, psoriasis, Crohn's disease 

With operations in the U.S., Asia, Europe and its domestic home market of Japan, Eisai employs more than 11,000 people worldwide. In Europe, Eisai undertakes sales and marketing operations in over 20 markets, including the United Kingdom, France, Germany, Italy, Spain, Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal, Iceland, Czech Republic, Slovakia, the Netherlands, and Belgium.

For further information please visit our web site http://www.eisai.com

About Morphotek

Morphotek(R), Inc., a subsidiary of Eisai, is a biopharmaceutical company specialising in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications. The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease.

For more information, please visit http://www.morphotek.com.

1. Cortes J, O'Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. The Lancet. 2011; 377: 914 -923.

2. Matsui J et al. Multi-kinase inhibitor E7080 suppresses lymph node and lung metastases of human mammary breast tumour MDA-MB-231 via inhibition of vascular endothelial growth factor-receptor (VEGF-R) 2 and VEGF-R3 kinase. Clin Cancer Res 2008; 14: 5459-65.

3. Matsui J et al. E7080, a novel inhibitor that targets multiple kinases, has potent antitumour activities against stem cell factor producing human small cell lung cancer H146, based on angiogenesis inhibition. Int J Cancer 2008; 122: 664-71.


Media Enquiries: Eisai Europe Ltd, Charlotte Andrews / Cressida
Robson, +44(0)7947-231513 / +44(0)790-831-4155,
/ , cressida_robson@eisai.net ; Tonic Life Communications:
Benjamyn Tan
/ Leah Peyton, +44(0)207-798-9262 / +44(0)7788-191434,
benjamyn.tan@toniclc.com / leah.peyton@toniclc.com

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