Eisai is Appalled by Arbitrary Decision to Remove Life-Extending Breast Cancer Therapy Halaven® (Eribulin) From Cancer Drugs Fund

Hatfield, England (ots/PRNewswire) -

Decision means that thousands of women in England with secondary
breast

cancer will no longer have access to this treatment

Eisai today announces its extreme disappointment that the National
Cancer Drugs Fund (NCDF) panel has apparently made the decision to
remove Halaven(R) (eribulin) from the Cancer Drugs Fund (CDF),
following a process of arbitrary evaluation. The decision failed to
recognise the overall survival benefit of eribulin, putting a flawed
and inconsistent methodological process before the overall survival
benefit for people living with terminal cancer. The news is
particularly devastating for the thousands of women living with
secondary breast cancer in the UK who could benefit from this
innovative life-extending treatment.

"Access to the CDF has ensured that drugs like eribulin have
become the standard of care for women with metastatic breast cancer
in England. This evaluation now means that these women can no longer
be treated with the drugs thousands before them have benefited from,"
commented Dr Vivek Misra, Consultant in Clinical Oncology at The
Christie, Manchester.

Metastatic breast cancer is a very difficult condition to treat
and only 13% of women will survive beyond five years. Eribulin
remains the only single agent chemotherapy to significantly improve
overall survival in women with advanced breast cancer after
anthracycline and taxane treatment. To date, eribulin is the sixth
most prescribed treatment in the CDF and has been used by more than
2,000 women in England since 2011.

Eribulin is indicated for the treatment of women with locally
advanced or metastatic breast cancer who have 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.[1]

"Eribulin is an effective drug and thanks to the Cancer Drugs
Fund, I have been able to prescribe it extensively to my patients. I
have witnessed first-hand the positive impact the treatment can have
on women living with metastatic breast cancer, both in quality of
life and overall life extension," commented Dr Hartmut Kristeleit,
Consultant Medical Oncologist at Guy's and St Thomas' NHS Foundation
Trust.

"The NCDF decision implies that doctors have spent years
prescribing ineffective treatments to patients, at an obvious cost to
the NHS. I do not believe this is the case, nor would eribulin have
received Marketing Authorisation Approval here and across the world
without very sound clinical data. It's for this reason that I believe
the decision is a mistake," commented Dr Chris Twelves, Professor of
Clinical Cancer Pharmacology and Oncology, and Honorary Consultant in
Medical Oncology at the University of Leeds and St James's Institute
of Oncology, who presented the benefits of eribulin to the NCDF
panel.

"To say that we are disappointed by this decision would be a gross
understatement; we are outraged. We will engage in further dialogue
with the NCDF and NHS England and firmly stand by the clinical
efficacy of eribulin. We would like to ask the Prime Minister for a
pause in the process and now call on the Government to stop
arbitrarily de-listing these drugs and allow women with secondary
breast cancer to continue to benefit from these treatments,"
commented Gary Hendler, President & CEO Eisai EMEA and President,
Eisai Oncology Global Business Unit.

The NCDF decision is particularly regrettable given the need for
direct foreign investment into the UK and may ultimately mean Eisai
is forced to scale back its operations in the country. This news
comes just weeks after Eisai opened a new multi-million pound
manufacturing plant for a new cancer treatment in Hatfield,
Hertfordshire.

Eribulin was first approved and launched in the UK in 2011 and
Marketing Authorisation Approval was extended for earlier use in
advanced breast cancer from the European Commission on 3 July 2014.
Eribulin is currently approved in more than 55 countries around the
world including all of the European Union, Canada, United States,
Russia, Switzerland, South Korea, Japan and Singapore.

Eisai is dedicated to the discovery, development and production of
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 to
better understand the needs of

patients and their families to increase the benefits health care
provides.

Notes to Editors

Halaven(R) (eribulin)

Eribulin is the first in the halichondrin class of microtubule
dynamics inhibitors with a novel mechanism of action. Structurally
eribulin is a simplified and synthetically produced version of
halichondrin B, a natural product isolated from the marine sponge
Halichondria okadai. Eribulin is believed to work by inhibiting the
growth phase of microtubule dynamics which prevents cell division.

Eribulin is indicated for the treatment of women with locally
advanced or metastatic breast cancer who have 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.[1]

Global Phase III Study 305 (EMBRACE)[2]

EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Treatment
of Physician's Choice (TPC) Versus Eribulin E7389) was an open-label,
randomised, global, multi-centre, parallel two-arm study designed to
compare overall survival in women treated with eribulin versus a TPC
arm. TPC was 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 study included 762 participants with metastatic
breast cancer (MBC) who previously had been treated with at least two
and a maximum of five prior chemotherapies, including an
anthracycline and a taxane. The vast majority (96%) of participants
in the TPC arm received chemotherapy.

In the total Phase III EMBRACE study population, eribulin was
shown to prolong median overall survival in heavily pre-treated women
with MBC compared to women receiving TPC by 2.7 months (13.2 vs. 10.5
HR 0.81 (95% CI 0.67, 0.96) nominal p=0.014). A pre-planned analysis
of participants from Region 1 of the study (North America/Western
Europe/Australia) showed a significant median overall survival
benefit of eribulin over TPC of 3.0 months (nominal p=0.031).

The most commonly reported adverse reactions among people treated
with eribulin in the EMBRACE study were fatigue (asthenia), a
decrease in infection-fighting white blood cells (neutropenia), hair
loss (alopecia), numbness and tingling in arms and legs (peripheral
neuropathy), nausea and constipation. Peripheral neuropathy was the
most common adverse event leading to discontinuation from eribulin,
occurring in less than 5% of the women involved in the EMBRACE trial.
Neutropenia only led to eribulin discontinuation for 0.6%. Death due
to serious side effects, discontinuation and dose interruptions to
treatment were lower in the eribulin arm of the trial compared with
the TPC arm.

Global Phase III Study 301[3]

Study 301 was an open-labelled, randomised, two-parallel-arm,
multicentre study of eribulin versus capecitabine in 1,102 women with
locally advanced or metastatic breast cancer previously treated with
anthracyclines and taxanes, either in the (neo) adjuvant setting or
for locally advanced or metastatic disease. Women in the study
received zero to two previous chemotherapies for advanced disease.

The study opened in 2006 and the last patient was randomised in
2010. Patients were randomised to treatment with either eribulin
1.23mg/m2 (administered intravenously over two to five minutes on
days 1 and 8, every 21 days) or capecitabine 1.25 g/m2, administered
orally twice daily on day 1 to 14, every 21 days.

Study 301 had a co-primary endpoint of overall survival and
progression free survival. The study demonstrated a trend favouring
improved overall survival with eribulin compared to capecitabine in
the ITT population, although the improvement was not statistically
significant. Women treated with eribulin had a median overall
survival of 15.9 months (HR 0.879; 95% CI: 0.770-1.003; p=0.056)
versus 14.5 months with capecitabine. The trial did not meet the
pre-specified endpoint for progression-free survival, with 4.1 and
4.2 months for eribulin and capecitabine (independent review)
respectively (HR 1.079; 95% CI: 0.932-1.250; p=0.305).

1-, 2- and 3- year overall survival rates for eribulin versus
capecitabine showed an early improvement which was maintained
throughout the study (1 year, 64.4% eribulin vs 58.0% capecitabine
(p=0.0351), 2 year 32.8% eribulin vs. 29.8% capecitabine (p=0.324), 3
year, 17.8% eribulin vs. 14.5% capecitabine (p=0.175).

Unlike studies conducted today, Study 301 included all women
regardless of their human epidermal growth factor receptor 2 (HER2),
oestrogen receptor (ER) or progesterone receptor (PR) status.
Patients are usually tested for their HER2 status as there are now
effective treatments specifically for patients with the HER2
mutation. HER2 positive patients would generally be treated with
anti-HER2 positive targeted therapy. For women with HER2 negative MBC
(n=755), overall survival was 15.9 months for eribulin vs. 13.5
months for capecitabine (HR 0.838; 95% CI: 0.715-0.983). In the HER2
positive population, overall survival was 14.3 months for eribulin
vs. 17.1 months for capecitabine (HR; 95% 0.965; CI: 0.688-1.355).

Adverse events in Study 301 were consistent with the known profile
of both drugs.

Metastatic Breast Cancer and the HER2 Protein

Over 300,000 women are diagnosed with breast cancer in Europe
every year, of whom about one third subsequently develop metastatic
disease.[4],[5]Metastatic disease is an advanced stage of the disease
that occurs when cancer spreads beyond the breast to other parts of
the body.

HER2 is a protein that is found on the surface of cells. In
HER2-positive breast cancer there is more (over expression) of this
protein found on the surface of tumour cells compared with normal
breast cells. This protein can be targeted with HER2 targeted
therapies such as Herceptin, in people who overexpress HER2, but not
in people with normal levels of HER2 protein (HER2-negative) breast
cancer. Breast cancers are routinely tested for the presence of HER2
to decide the most appropriate treatment. Triple-negative breast
cancer (TNBC) refers to any breast cancer that does not express the
genes for oestrogen receptor, progesterone receptor (<1%) and HER2
(<30%).

Eisai in Oncology

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.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global research and development-based
pharmaceutical company headquartered in Japan. We define our
corporate mission as "giving first thought to patients and their
families and to increasing the benefits health care provides," which
we call our human health care (hhc) philosophy. With over 10,000
employees working across our global network of R&D facilities,
manufacturing sites and marketing subsidiaries, we strive to realise
our hhc philosophy by delivering innovative products in multiple
therapeutic areas with high unmet medical needs, including Oncology
and Neurology.

As a global pharmaceutical company, our mission extends to
patients around the world through our investment and participation in
partnership-based initiatives to improve access to medicines in
developing and emerging countries.

For more information about Eisai Co., Ltd., please visit
http://www.eisai.com.

References

1. SPC Halaven (updated June 2014). Available at: http://www.medic
ines.org.uk/emc/medicine/24382/SPC/Halaven+0.44+mg+ml+solution+for+in
jection Accessed: January 2015

2. Cortes J 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

3. Kaufman P et al. A Phase III, open-label, randomised,
multicenter study of eribulin mesylate versus capecitabine in
patients with locally advanced or metastatic breast cancer previously
treated with anthracyclines and taxanes. Presented at 2012 CTRC-AACR
San Antonio Breast Cancer Symposium

4. World Health Organisation. Atlas of Health in Europe. 2003.
World Health Organization, Regional Office of Europe, Copenhagen,
Denmark.

5. Cancer Research UK. Breast cancer incidence statistics.
Available at: http://www.cancerresearchuk.org/cancer-info/cancerstats
/types/breast/incidence/#world . Accessed: January 2015

Job code: Halaven-UK0385
Date of preparation: January 2015

ots Originaltext: Eisai Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

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