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Eisai Highlights New Research On Melanoma, Breast and Endometrial Cancer at ASCO Annual Meeting

May 16, 2013

WOODCLIFF LAKE, N.J., May 16, 2013 /PRNewswire/ — Eisai Inc. announced today that nine abstracts highlighting new study results in melanoma, breast and endometrial cancer will be presented during the 49(th) Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago from May 31 – June 4, 2013.

(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )

“These studies reinforce Eisai’s strong and growing commitment to oncology, particularly to cancers affecting women,” said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. “Eisai’s portfolio of oncology compounds and products are further testament to our human health care (hhc) mission of keeping the unmet needs of patients with cancer and their families at the forefront of all that we do.”

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

    Product           Abstract Name
    -------           -------------

    Lenvatinib         A Phase II Trial of Lenvatinib in
                       Patients with Advanced or Recurrent
                       Endometrial Cancer: Angiopoietin-2
                       as a Predictive Marker for Clinical
                       Outcomes

    (E7080)           Poster Discussion Session

    Abstract No: 5520
    -----------------

    Lenvatinib         Analysis of Plasma Biomarker and
                       Tumor Genetic Alterations from a
                       Phase II Trial of Lenvatinib in
                       Patients with Advanced Endometrial
                       Cancer

    (E7080)           Poster Presentation

    Abstract No: 5591
    -----------------

    Lenvatinib         A Phase II Study of the Multi-
                       targeted Kinase Inhibitor
                       Lenvatinib in Patients with
                       Advanced BRAF Wild-Type Melanoma

    (E7080)           Poster Discussion Session

    Abstract No: 9026
    -----------------

    Lenvatinib         Analysis of Serum Biomarkers and
                       Tumor Genetic Alterations from a
                       Phase II Study of Lenvatinib in
                       Patients with Advanced BRAF Wild-
                       Type Melanoma

    (E7080)           Poster Presentation

    Abstract No: 9058
    -----------------

    Lenvatinib         Lenvatinib Combined with Dacarbazine
                       versus Dacarbazine Alone as First-
                       Line Treatment in Patients with
                       Stage IV Melanoma

    (E7080)           Poster Discussion Session

    Abstract No: 9027
    -----------------

    Eribulin Mesylate  Quality of Life (QoL) in Patients
                       (pts) with Locally Advanced or
                       Metastatic Breast Cancer (MBC)
                       Previously Treated with
                       Anthracyclines and Taxanes who
                       Received Eribulin Mesylate or
                       Capecitabine: a Phase III, Open-
                       Label, Randomized Study

    Abstract No: 1050 Poster Presentation
    ----------------- -------------------

    Eribulin Mesylate  Quality of Life (QoL) and Content
                       Validity in Objective Tumor
                       Response

    Abstract No: 1055 Poster Presentation
    ----------------- -------------------

    Eribulin Mesylate  Eribulin Mesylate (Erib) Plus
                       Capecitabine (X) for Adjuvant
                       Treatment in Post-Menopausal
                       Estrogen Receptor-Positive (ER+)
                       Early Stage Breast Cancer: Phase
                       II, Multicenter, Single-Arm Study

    Abstract No: 563  Poster Presentation

    ---

    Eribulin Mesylate  A Phase III, Open-Label, Randomized
                       Study of Eribulin Mesylate Versus
                       Capecitabine in Patients with
                       Locally Advanced or Metastatic
                       Breast Cancer (MBC) Previously
                       Treated with Anthracyclines and
                       Taxanes: Subgroup Analyses

    Abstract No: 1049 Poster Presentation
    ----------------- -------------------

The information discussed in this release presents investigational agents that are not Food and Drug Administration (FDA)-approved and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any of these agents will successfully complete clinical development or gain FDA approval.

About Lenvatinib
Lenvatinib is an investigational small molecule tyrosine kinase inhibitor being studied by Eisai as an oral agent in a wide array of tumor types.

HALAVEN® (eribulin mesylate) Injection
Halaven is a prescription medicine used to treat patients with metastatic breast cancer. Halaven is for patients who have already received at least two other types of anticancer medicines for their breast cancer once it has spread to other parts of the body. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.

Important Safety Information about HALAVEN®

Neutropenia (Decreased White Blood Cells)

  • Your doctor should do a blood test to monitor your blood cells before you receive each dose of Halaven, and should monitor you more often if you develop lower white blood cells.
  • If you develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, your next dose of Halaven should be delayed and reduced. In a clinical trial, severe neutropenia occurred in 57% of patients who received Halaven and lasted more than 1 week in 12% of patients.
  • Neutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever.
  • Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Call your health care provider immediately if you have any of the following symptoms: fever (temperature above 100.5F), chills, coughing, and burning or pain when you urinate.

Peripheral Neuropathy (Nerve Problems)

  • Halaven can cause numbness, tingling, or burning in your hands and feet (peripheral neuropathy). You should be monitored closely for signs of neuropathy. If you develop severe neuropathy, treatment with Halaven should be delayed until the neuropathy improves and the next dose of Halaven should be reduced.
  • Severe peripheral neuropathy occurred in 8% of patients who received Halaven. Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days.
  • Peripheral neuropathy was the most common side effect that caused patients to stop taking Halaven.

Pregnancy and Nursing

  • Halaven may harm your unborn baby. Avoid becoming pregnant while you are receiving Halaven. Tell your health care provider right away if you become pregnant or think you are pregnant while you are receiving Halaven.
  • It is not known if Halaven passes into your breast milk. You and your health care provider should decide if you will take Halaven or breast-feed. You should not do both.

QT Prolongation (Heartbeat Changes)

  • Halaven can cause changes in your heartbeat. This can cause irregular heartbeats that may lead to death.
  • Before you receive Halaven, tell your healthcare provider if you have heart problems, including a problem called “congenital long QT syndrome.”
  • Your health care provider will decide if you need heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with Halaven to watch for this problem.

Pre-existing Liver and/or Kidney Problems

  • Before you receive Halaven, tell your healthcare provider if you have liver or kidney problems. A lower starting dose of Halaven is recommended in patients with mild or moderate liver problems, and/or moderate kidney problems.

Most Common Side Effects

  • The most common side effects reported in greater than or equal to 25% of patients receiving Halaven were low white blood cells; low red blood cells; weakness/tiredness; hair loss; numbness, tingling, or burning in the hands and feet; nausea; and constipation.
  • The most common serious side effects reported in patients receiving Halaven were neutropenia with or without a fever.

For full prescribing information for HALAVEN, please visit: http://www.halaven.com/sites/default/files/HALAVEN_full_Prescribing_Information.pdf

Eisai Oncology
Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that may 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, vaccines, and biologic agents across various types of cancer. For more information about Eisai, please visit www.eisai.com/US.

Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer’s disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products across the world through a global network of research facilities, manufacturing sites and marketing subsidiaries. For more information about Eisai’s global operations, please visit www.eisai.com.

    Contact:                    Media                  Investors

                                Laurie Landau          Alex Scott

                                Eisai Inc.             Eisai Inc.

                                201-746-2510           201-746-2177

SOURCE Eisai Inc.


Source: PR Newswire