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

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

PR Newswire

WOODCLIFF LAKE, N.J., 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
(E7080)           Marker for Clinical Outcomes

Abstract No: 5520 Poster Discussion Session
Lenvatinib        Analysis of Plasma Biomarker and Tumor Genetic Alterations
                  from a Phase II Trial of Lenvatinib in Patients with
(E7080)           Advanced Endometrial Cancer

Abstract No: 5591 Poster Presentation
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
(E7080)           Advanced BRAF Wild-Type Melanoma

Abstract No: 9058 Poster Presentation
Lenvatinib        Lenvatinib Combined with Dacarbazine versus Dacarbazine
                  Alone as First-Line Treatment in Patients with Stage IV
(E7080)           Melanoma

Abstract No: 9027 Poster Discussion Session
                  Quality of Life (QoL) in Patients (pts) with Locally
                  Advanced or Metastatic Breast Cancer (MBC) Previously
Eribulin Mesylate Treated with Anthracyclines and Taxanes who Received
                  Eribulin Mesylate or Capecitabine: a Phase III, Open-Label,
Abstract No: 1050 Randomized Study

                  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
Abstract No: 563  (ER+) Early Stage Breast Cancer: Phase II, Multicenter,
                  Single-Arm Study

                  Poster Presentation
                  A Phase III, Open-Label, Randomized Study of Eribulin
Eribulin Mesylate Mesylate Versus Capecitabine in Patients with Locally
                  Advanced or Metastatic Breast Cancer (MBC) Previously
Abstract No: 1049 Treated with Anthracyclines and Taxanes: Subgroup Analyses

                  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)

  oYour 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.
  oIf 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.
  oNeutropenia with a fever occurred in 5% of patients; 2 patients died from
    complications of neutropenia with a fever.
  oNeutropenia 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 100.5˚F),
    chills, coughing, and burning or pain when you urinate.

Peripheral Neuropathy (Nerve Problems)

  oHalaven 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.
  oSevere 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.
  oPeripheral neuropathy was the most common side effect that caused patients
    to stop taking Halaven.

Pregnancy and Nursing

  oHalaven 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.
  oIt 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)

  oHalaven can cause changes in your heartbeat. This can cause irregular
    heartbeats that may lead to death.
  oBefore you receive Halaven, tell your healthcare provider if you have
    heart problems, including a problem called "congenital long QT syndrome."
  oYour 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

  oBefore 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

  oThe 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.
  oThe 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 productsacross 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.

Website: http://www.eisai.com
 
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