Eisai's Halaven(TM) (Eribulin) Receives CHMP Positive Opinion for use in Metastatic Breast Cancer

By Eisai Europe Ltd, PRNE
Thursday, January 20, 2011

CHMP Opinion Based on Positive EMBRACE Study Data

HATFIELD, England, January 21, 2011 - The Committee for Medicinal Products for Human Use (CHMP), the scientific
committee of the European Medicines Agency (EMA), today gave a positive
opinion for the use of Eisai Europe, Ltd.'s Halaven as a monotherapy
indicated in the treatment of patients with locally advanced (LA) or
metastatic breast cancer (MBC) who have progressed after at least two
chemotherapeutic regimens for advanced disease. Prior therapy should have
included an anthracycline and a taxane unless patients were not suitable for
these treatments.

The CHMP submission was supported by results from the global Phase III
EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of
Physician's Choice (TPC) Versus Eribulin E7389) which demonstrated an overall
survival (OS) benefit for patients treated with eribulin of 2.7 months
compared with TPC (13.2 months versus 10.5 months, hazard ratio 0.805,
nominal p=0.014).[1] This is the first time that a monotherapy has provided
statistically significant OS improvements in MBC patients previously treated
with an anthracycline and a taxane in this patient population.[2]

"EMBRACE is a pivotal study in locally advanced and metastatic breast
cancer, demonstrating eribulin to be an effective and well-tolerated
treatment for heavily pretreated patients" said Dr. Chris Twelves, lead
investigator for the EMBRACE study and Professor of Clinical Cancer
Pharmacology and Oncology from the University of Leeds and St. James's
University Hospital, Leeds, United Kingdom "Eribulin has a proven survival
benefit and looks set to become the new standard of care in this disease
setting and the positive CHMP opinion is a welcome step in making this
important treatment available to the patients that need it".

"This is very positive news for women with pretreated locally advanced or
metastatic breast cancer" added Professor Gordon McVie, senior consultant at
the European Institute of Oncology in Milan. "Halaven is a promising therapy
for these patients who currently have very limited treatment options".

Halaven, a new type of chemotherapy, is a non-taxane, microtubule
dynamics inhibitor belonging to the halichondrin class of antineoplastic
agents. It is a structurally simplified synthetic analogue of halichondrin B,
a natural product isolated from the marine sponge Halichondria okadai.[3],[4]

If it receives European Commission marketing authorisation, Eisai intends
to make Halaven available throughout Europe. Halaven received approval in the
United States
in November 2010 and applications are currently in progress in
Japan, Canada, Singapore and Switzerland. The UK's National Institute for
Health and Clinical Excellence (NICE) proposed Halaven as a Single Technology
Appraisal (STA) in Wave 23.[5]

"The CHMP positive opinion further supports Halaven's role in this
disease and draws us closer to making this important treatment available to
patients" said Uday Bose, Head of Institutional Care, Eisai Europe Ltd. "True
to our human health care philosophy, we remain committed to patients and
their families and will continue to work closely with payers to ensure rapid
and sustained patient access to Halaven across Europe"

About The EMBRACE Study[1]

EMBRACE was an open-label, randomized, multi-center study of 762 patients
with locally recurrent or metastatic breast cancer who were previously
treated with at least two and a maximum of five prior chemotherapies
(greater than or equal to 2 for advanced disease), including an anthracycline
and a taxane. Patients must have been refractory to the most recent
chemotherapy, documented by progression on or within six months of
therapy. The study was designed to compare overall survival in patients
treated with eribulin versus a TPC arm, reflecting a real-world clinical
setting where a variety of agents are used to treat patients with
advanced breast cancer. TPC is defined as any single-agent chemotherapy,
hormonal treatment or biologic therapy approved for the treatment of
cancer, or palliative treatment or radiotherapy administered according to
local practice. The primary endpoint was OS. Secondary endpoints were
objective response rate, progression-free survival, safety and duration of

Notes to Editors

About Halaven(TM)

Halaven is a non-taxane, microtubule dynamics inhibitor, belonging to a
class of antineoplastic agents, the halichondrins, which are natural products
isolated from the marine sponge Halichondria okadai.3,4 Halaven targets
microtubules, the major cytoskeletal component of cells which play a pivotal
role in cell replication. Alteration of microtubule dynamics can cause a cell
to stop dividing and self destruct.

About Metastatic Breast Cancer

Worldwide, more than one million women a year are diagnosed with breast
cancer, including 421,000 women in Europe.[6],[7] Approximately 30 percent of
women initially diagnosed with earlier stages of breast cancer eventually
develop recurrent or metastatic disease,[8] and while around 9 out of 10 of
women diagnosed with early stage breast cancer survive beyond five years,
this drops to around 1 in 10 among women first diagnosed with MBC.[9] Most
MBC patients have a limited survival time of approximately 18-24 months.[10]

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, biologic and supportive care agents for cancer across multiple

Eisai Europe, Ltd.

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

    - Integrative Neuroscience, including: Alzheimer's disease, multiple
      sclerosis, neuropathic pain, epilepsy, depression

    - Integrative Oncology, including: anticancer therapies; vaccines, tumor
      regression, tumor suppression, antibodies and supportive cancer
      therapies; pain relief, nausea

    - Vascular/Immunological reaction, including: acute coronary syndrome,
      atherothrombotic disease, severe sepsis, rheumatoid arthritis,
      psoriasis, Crohn's disease

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, Hungary and Slovakia.

Eisai Co., Ltd.

Eisai Co., Ltd. is a research-based human health care (hhc) company that
discovers, develops and markets products throughout the world. Through a
global network of research facilities, manufacturing sites and marketing
subsidiaries, Eisai actively participates in all aspects of the worldwide
health care system. Eisai employs approximately 11,000 employees worldwide.

For further information, please visit www.eisai.co.jp.


[1] Twelves C et al. Updated Survival Analysis of a Phase III Study
(EMBRACE) of Eribulin Mesylate Versus Treatment of Physician's Choice in
Subjects with Locally Recurrent or Metastatic Breast Cancer Previously
Treated with an Anthracycline and a Taxane. San Antonio Breast Cancer
Symposium (SABCS) 2010; Poster P6-14-18.

[2] Twelves C, Akerele C, Wanders J, Cortes J. Eribulin Mesylate (E7389)
vs. Treatment of Physician's Choice (TPC) in Patients with Metastatic Breast
Cancer: Subgroup Analyses from the EMBRACE Study.

Abstract 2750, presented at the ESMO Congress, 8th September 2010, Milan,

[3] Kuznetsov G, Towle MJ, Cheng H, et al: Induction of morphological and
biochemical apoptosis following prolonged mitotic blockage by halichondrin B
macrocyclic ketone analog E7389. Cancer Res 2004; 64: 5760-5766

[4] Towle MJ, et al. In Vitro and In Vivo Anticancer Activities of
Synthetic Macrocyclic Ketone Analogues of Halichondrin B. Cancer Res 2001;
61: 1013-1021

[5] guidance.nice.org.uk/TA/Wave23/32

[6] Coughlin, S. Breast cancer as a global health concern. Cancer
Epidemiology, October 2009; 33: 315-18.

[7] Ferlay J, Parkin DM, Steliarova-Foucher E. Estimates of cancer
incidence and mortality in Europe in 2008. Eur J Cancer.2010: 46(4):765-781

[8] O'Shaughnessy J. Extending survival with chemotherapy in metastatic
breast cancer. Oncologist. 2005;10 Suppl 3:20-29

[9] Cancer Research UK, Breast Cancer Statistics - Key Facts [updated
April 2010]. Available from:
ue (accessed (04/08/10)

[10] Fernandez Y, Cueva J, Palomo AG, et al. Novel therapeutic approaches
to the treatment of metastatic breast cancer. Cancer Treat Rev.2010:36(1

Media Inquiries: Eisai Europe Ltd, Cressida Robson, +44-7908-314-155, Cressida_Robson at eisai.net. Ingenda Communications, Robyn Cabarrao, +44-7913-216-896, RCabarrao at ingendacommunications.com

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