Eisai Launches Anticancer Agent Halaven as Company's First Produ

Eisai Launches Anticancer Agent Halaven as Company's First Product in Russia 
Tokyo, Sept 12, 2013 - (JCN Newswire) -  Eisai Co., Ltd. (Headquarters: Tokyo,
President & CEO: Haruo Naito, "Eisai") announced today that
Halaven (eribulin mesylate), an anticancer agent, has now been launched in
Russia, making it the first product to be marketed in Russia by the company. 
Halaven is a novel anticancer agent discovered and developed in-house by Eisai
and is currently approved in more than 50 countries, including Japan, the
United States and in Europe. In Russia, Halaven was approved in July 2012 for
the treatment of locally advanced or metastatic breast cancer previously
treated with at least two chemotherapy regimens including an anthracycline and
a taxane. Approximately 50,000 women in Russia are newly diagnosed with breast
cancer each year, with this type of cancer being the leading cause of death in
women aged 45 to 55 years. 
The Russian pharmaceutical market constitutes the 11th largest in the world
and expected to continue to achieve double-digit growth going forward. Eisai
established Limited Liability Company Eisai ("Eisai Russia") as a
pharmaceutical sales company in Moscow in April 2013 and has also received
local marketing approval for the antiepileptic agents Zonegran (zonasamide) and
Exalief (eslicarbazepine acetate; brand name in the EU: Zebinix). Through Eisai
Russia, Eisai plans to follow up the launch of Halaven in Russia with launches
for both products in the country by the end of this fiscal year. Moreover,
Eisai has also filed for regulatory approval in Russia for Fycompa
(perampanel), an AMPA receptor antagonist, and Inovelon (rufinamide), a
treatment for seizures associated with Lennox-Gastaut syndrome. 
As part of Eisai's globalization strategy as defined in its midterm
strategic plan, "HAYABUSA," the company aims to expand its operations
into each of the world's top 20 largest pharmaceutical markets in order to
contribute to more than 500 million patients worldwide. By delivering its
innovative medicines to patients in Russia, Eisai seeks to increase the
benefits provided to patients and their families in this region. 
Please refer to the following notes for further information on Halaven,
Eisai's globalization strategy as outlined under its midterm strategic
plan, "HAYABUSA," and the company's business operations in
Notes to Editors 
1. About Halaven (eribulin mesylate) 
Halaven, a non-taxane, microtubule dynamics inhibitor with a novel mechanism
of action, 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 sequestering tubulin into
nonproductive aggregates. 
In a Phase III clinical study (EMBRACE) of Halaven versus treatment of
physician's choice (TPC) in 762 patients with advanced or recurrent breast
cancer previously treated with an anthracycline and a taxane, Halaven indicated
an extended overall survival (OS) of 2.5 months (OS of 13.1 months versus 10.6
months, respectively; Hazard Ratio (HR) 0.81; p=0.041) when compared to TPC. An
updated analysis of OS (not protocol-specified) in the EMBRACE study was also
performed at the request of European and U.S. regulatory authorities. These
results demonstrated an increase of 2.7 months in OS for Halaven compared with
TPC (OS of 13.2 months versus 10.5 months, respectively; HR 0:81; p=0.014). The
most common adverse reactions (events with an incidence rate of at least 25
percent) among patients treated with Halaven were asthenia (fatigue),
neutropenia, anemia, alopecia (hair loss), peripheral neuropathy (numbness and
tingling in arms, legs and/or other parts of the body), nausea and
constipation. The most common serious side effects reported in patients
receiving Halaven were neutropenia with or without fever (4 percent and 2
percent, respectively). The most common adverse reaction resulting in
discontinuation of treatment with Halaven was peripheral neuropathy (5
percent). Halaven was first approved as a treatment for breast cancer in the
United States in November 2010, and is approved in 50 countries worldwide,
including European Union member states, Japan, Singapore and Switzerland.
Furthermore, with the aim of maximizing value of the drug, Eisai has filed an
application to the European Medicines Agency (EMA) for Halaven as a therapy in
the treatment of breast cancer with fewer prior treatments, and continues to
work on further development of the drug as treatment of soft-tissue sarcoma and
non-small cell lung cancer. 
2. Eisai's Globalization Strategy as Outlined Under Its Midterm Strategic
Eisai has set the goal of entering the world's top 20 largest
pharmaceutical markets as part of the company's globalization strategy
outlined in its midterm strategic plan, "HAYABUSA". Of the eight
countries (Russia, Canada, Brazil, Australia, Turkey, Poland, Mexico, and
Venezuela) that Eisai announced it would enter as part of that strategy when
the "HAYABUSA" plan was launched in March 2011, the company has
already established pharmaceutical sales subsidiaries in Australia (January
2006), Canada (April 2010), Brazil (April 2011), and Mexico (August 2011) in
addition to Russia. Eisai seeks to improve access to medicines through its
provision of comprehensive disease solutions, engagement in public-private
partnerships and other initiatives, and the implementation of its affordable
pricing policy, among other activities. Furthermore, the company aims to
dramatically expand the total number of patients it serves from the just over
200 million it recorded for the period from fiscal 2006 through fiscal 2010, to
its current target of more than 500 million patients for the five-year period
between fiscal 2011 and fiscal 2015. In doing so, Eisai believes it will be
able to better contribute to increasing the benefits provided to as many
patients and their families as possible worldwide. 
3. Eisai's Business Operations in Russia 
In April 2013, Eisai established the pharmaceutical sales company Limited
Liability Company Eisai in Moscow, Russia, and began full-scale business
operations in the country. To coincide with its launch of the anticancer agent
Halaven, Eisai is deploying sales representatives to major cities such as
Moscow and Saint Petersburg and building sales infrastructure. Furthermore,
with the aim of also launching four products from its epilepsy franchise
(Zonegran, Exalief [brand name in the EU: Zebinix], Fycompa and Inovelon),
Eisai plans to further expand its local sales infrastructure as early as fiscal
2014. With business operations in the country focused on its oncology and
epilepsy units, the company seeks to establish its presence and effectively
realize contributions to patients in Russia. 
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Public Relations Department,
Eisai Co., Ltd.
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