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Halaven® (eribulin), the First and Only Single-agent Treatment to Extend Survival in Later Stage Metastatic Breast Cancer,



   Halaven® (eribulin), the First and Only Single-agent Treatment to Extend
     Survival in Later Stage Metastatic Breast Cancer, Launches in Russia

  PR Newswire

  HATFIELD, England, September 12, 2013

HATFIELD, England, September 12, 2013 /PRNewswire/ --



Halaven ^® (eribulin) is now available in Russia as a novel treatment for
patients with metastatic breast cancer who have previously received at least
two chemotherapeutic regimens for the treatment of metastatic disease. ^[1]
Prior therapy should have included an anthracycline and a taxane unless
patients were not suitable for these treatments. ^[ ^1 ^] Eribulin is the
first, single-agent chemotherapy to demonstrate a prolonged overall survival
in patients with heavily pre-treated advanced breast cancer, compared to other
single agent chemotherapies. ^[2]

In Russia, breast cancer is the most common cause of death in women aged 45 -
55 years, having increased by 64% over the last 20 years alone. Additionally,
approximately 50,000 Russian women are newly diagnosed with breast cancer each
year with approximately one in every eight women at risk of developing the
disease. ^[3]

"This is a significant step forward for women affected by breast cancer. The
development of medical therapy over the last decade has ensured the
significant increase in the life expectancy of patients. However, a new
medicine means further prospects for effective treatment," commented prof.
Vera Gorbunova, MD, head of the chemical therapy department at the Russian
Blokhin Oncologic Research Centre. "The use of eribulin in Russia will
introduce new treatments and provide women with metastatic breast cancer with
an opportunity to use the new medicine to achieve and maintain remission of
the disease, which means that women will be able to spend more time with their
family and loved ones."

"The rate of metastatic breast cancer in Russia continues to increase at an
alarming rate. We are delighted that the Russian Ministry of Health recognises
the clinical value Halaven offers women with locally advanced or metastatic
breast cancer," commented Gary Hendler, President and CEO, Eisai EMEA. "Eisai
is committed to provide effective treatment options to women in Russia with
advanced breast cancer, in addition to the 500 million patients worldwide in
need of alternate treatment options. The approval today further validates our
human health care (hhc) mission, to satisfy unmet medical needs and contribute
to the health and well-being of people around the world."

Results from the pivotal Phase III study, EMBRACE (Eisai Metastatic Breast
Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin
E7389) showed that patients treated with eribulin survived a median of 2.5
months longer than patients who received (eribulin 13.1 months vs. TPC 10.6
months, HR 0.81 (95% CI 0.66, 0.99) p=0.041). ^[ ^2 ^] An updated analysis
demonstrated that patients treated with eribulin survived a median of 2.7
months longer than patients who received TPC (overall survival of 13.2 months
versus 10.5 months, respectively, HR 0.81 (95% CI 0.067, 0.96), nominal
p=0.014). ^[ ^2 ^] TPC represents active treatment options currently used by
doctors in real world clinical practice.

The most commonly reported adverse reactions among patients treated with
eribulin were asthenia (fatigue), neutropenia, alopecia (hair loss),
peripheral neuropathy (numbness and tingling in arms and legs), nausea and
constipation. ^[ ^2 ^]

Eribulin received European Commission approval on 17 March 2011 based on the
results of the Phase III EMBRACE study. Eribulin is now available in 50
countries worldwide.

Eisai is committed to developing and delivering highly beneficial new
treatments to help improve the lives of people with metastatic breast cancer.
Built on scientific expertise, Eisai 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.

Notes to Editors

Halaven ^®   (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.

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.

Global Phase III Clinical Study (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 patients treated with eribulin versus a Treatment of Physician's
Choice (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 patients with metastatic breast cancer 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 patients
in the TPC arm received chemotherapy.

In the Phase III study population (n=762), eribulin was shown to prolong
overall survival in heavily pre-treated patients with metastatic breast cancer
by 2.5 months compared to patients receiving Treatment of Physicians Choice
(TPC), representing a mix of real-life treatment choices (eribulin 13.1 months
vs. TPC 10.6 months, HR 0.81 (95% CI 0.66, 0.99) p=0.041). Updated data from
the pivotal Phase III EMBRACE trial confirmed these results, showing that
patients treated with eribulin survived a median of 2.7 months longer than
patients who received treatment of physician's choice (overall survival of
13.2 months versus 10.5 months, respectively, HR 0.81 (95% CI 0.067, 0.96),
nominal p=0.014).

The most commonly reported adverse reactions among patients treated with
eribulin in the EMBRACE study were fatigue (asthenia), a decrease in
infection-fighting white blood cells (neutropaenia), 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 patients
involved in the EMBRACE trial. Neutropaenia only led to eribulin
discontinuation for 0.6% patients. 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.

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

Eisai is one of the world's leading research and development (R&D) based
pharmaceutical companies and 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 human health care ( hhc ).

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

  * Oncology including: anticancer therapies; tumour regression, tumour
    suppression, antibodies, etc.
  * Neuroscience, including: Alzheimer's disease, epilepsy, pain and weight
    loss
  * Vascular/Immunological reaction including: thrombocytopenia, rheumatoid
    arthritis, psoriasis, inflammatory bowel disease

With operations in the U.S., Asia, Europe and its domestic home market of
Japan, Eisai employs more than 10,000 people worldwide. From its recently
expandedKnowledge Centre in Hatfield, UK, which now includes an additional
high potency, global packaging capability, Eisai has recently expanded its
business operations to include Europe, the Middle East, Africa, Russia and
Oceania (EMEA). Eisai EMEA has sales and marketing operations in over 20
markets, including the United Kingdom, France, Germany, Italy, Spain,
Switzerland, Sweden, Ireland, Austria, Denmark, Finland, Norway, Portugal,
Czech Republic, Slovakia, Russia, the Netherlands, Belgium, and the Middle
East.

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

References

1. SPC Halaven (updated April 2013). Available at:
http://www.medicines.org.uk/emc/medicine/24382 . Last accessed July 2013.

2. 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

3. Women's Health Empowerment Program Moscow and Central Russia.
http://www.hsph.harvard.edu/breastandhealth/files/ekaterina_bashta.pdf . Last
accessed September 2013

 

Date of preparation: September 2013

Job code: Halaven-UK0204

Contact: Media Enquiries: Eisai Europe Ltd, Cressida Robson / Charlotte
Andrews, +44(0)7908-314-155 / +44(0)7947-231-513, Cressida_Robson@eisai.net,
Charlotte_Andrews@eisai.net; Tonic Life Communications Siobhan Reilly / April
Kenneally, +44(0)207-798-9999 / +44(0)207-798-9263, siobhan.reilly@toniclc.com
april.kenneally@toniclc.com
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