Eisai Announces Canadian Launch of Halaven™ (eribulin mesylate) Injection For The Treatment of Metastatic Breast Cancer

New Treatment Option Significantly Prolongs Overall Survival in Pre-treated Metastatic Breast Cancer Patients

MISSISSAUGA, ON, April 24, 2012 /PRNewswire/ - Eisai Limited, a wholly-owned Canadian subsidiary of Eisai Inc., announced today the launch of Halaven™ (eribulin mesylate), the latest treatment approved by Health Canada for metastatic breast cancer.  Halaven™ is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.  Prior therapy should have included an anthracycline and taxane either in the adjuvant or metastatic setting. Discovered and developed by Eisai, Halaven™ is a non-taxane microtubule dynamics inhibitor that is a synthetic analogue of halicondrin B, a product isolated from the marine sponge Halichondria okadai.

"Each year, approximately 23,000 Canadian women are diagnosed with breast cancer and everyday 14 women will die from this aggressive disease," says Dr. Shailendra Verma, Medical Oncologist, The Ottawa Hospital, Cancer Centre. "With the approval of Halaven™ in Canada, we can offer a new single-agent therapy that is proven to significantly improve survival in women with metastatic breast cancer."

The approval of Halaven™ is based on the results from the pivotal Phase III clinical study EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice versus Eribulin) which showed that patients treated with Halaven™ survived a median of 2.5 months longer than patients who received a single agent therapy chosen by the physician (Treatment of Physician's Choice (TPC)).  The overall survival results were statistically significantly longer for Halaven™ treated patients versus those receiving TPC. Overall survival was 13.12 months with Halaven versus 10.65 months with TPC (p=0.041).  In an updated survival analysis, conducted when 77 per cent of events had been observed, the result was consistent with the primary analysis.

"Patients dealing with a cancer diagnosis struggle on a daily basis," says Cathy Ammendolea, Board Chair, Canadian Breast Cancer Network.  "Halaven represents a new option for patients with metastatic breast cancer, proven to prolong survival."

"Eisai is pleased to bring Halaven™ to Canada to help women in their fight against metastatic breast cancer," says Takihiro Hirasawa, President, Eisai Limited  "Halaven™ is the first women's oncology product for Eisai and links our corporate mission to fulfill unmet medical needs.  Eisai will continue to develop oncology treatments and supportive therapies to improve the standard of care for patients dealing with a cancer diagnosis in Canada."

The most common side effects reported by patients receiving Halaven™ were low white blood cells, low red blood cells, weakness/tiredness, hair loss, and numbness, tingling or burning in the hands and feet, nausea and constipation.

About Metastatic Breast Cancer

Metastatic breast cancer is an advanced stage of the disease that occurs when cancer spreads beyond the breast to other parts of the body.

In Canada, over 23,000 women will be diagnosed with breast cancer.  It is the second most common cause of cancer death in women, resulting in approximately 5,000 deaths per year.¹

Although statistics on metastatic breast cancer may vary, on average, 64 Canadian women will be diagnosed with breast cancer every day² and a woman diagnosed with early stage breast cancer today has about an 85 per cent chance of being alive and disease free in 5 years.

About Halaven™ (eribulin mesylate) Injection

Halaven™ is the first agent in the halichondrin class of drugs.  Halaven™ is a non-taxane, microtubule dynamics inhibitor, derived 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 nonproductive aggregates.

Halaven™ (eribulin mesylate) is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.  Prior therapy should have included an anthracycline and a taxane administered in either the adjuvant or metastatic setting.

About the EMBRACE Clinical Trial

EMBRACE was an open-label, randomized, global, multi-center study designed to compare overall survival in patients treated with Halaven™ 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 an average of four prior chemotherapies.  The vast majority of patients in the TPC arm received chemotherapy.

About Eisai Limited

Eisai established Canadian pharmaceutical company Eisai Limited in 2010. As a wholly-owned subsidiary of Eisai Inc., Eisai Limited is based in Mississauga, Ontario, one of the largest biopharmaceutical clusters and medical communities in North America.  For more information about Eisai in Canada, please visit www.eisai.ca

About Eisai Co., Ltd.

Eisai Co., Ltd. is one of the world's leading R&D-based pharmaceutical companies that has defined its 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:

• Neuroscience: Alzheimer's disease, multiple sclerosis, neuropathic pain, epilepsy, depression, etc.
• Oncology: Anticancer therapies; tumour regression, tumour suppression, antibodies, etc. and Supportive cancer therapies; pain relief, nausea, etc.
• Vascular/Immunological Reaction: Acute coronary syndrome, atherothrombotic disease, sepsis, rheumatoid arthritis, psoriasis, Crohn's disease, etc.

With operations in Canada, the U.S., Asia, Europe and its domestic home market of Japan, we employ more than 11,000 people worldwide.

About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The Company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The Company serves as the U.S. pharmaceutical operating company of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.

Eisai Inc. has a global product creation organization that includes U.S. - based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The Company's areas of R&D focus include neuroscience, oncology, vascular, inflammatory and immunological reaction, and antibody-based programs.

Broadcast video to support this story is available to download at:
http://cnw.pathfireondemand.com/viewpackage.action?packageid=533

REFERENCES
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¹ http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/breast%20cancer.aspx

² http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/breast%20cancer.aspx

SOURCE Eisai Limited

Video with caption: "Video: New Treatment Option Halaven™, Significantly Prolongs Overall Survival in Pre-treated Metastatic Breast Cancer Patients". Video available at: http://stream1.newswire.ca/cgi-bin/playback.cgi?file=20120424_C8397_VIDEO_EN_12650.mp4&posterurl=http://photos.newswire.ca/images/20120424_C8397_PHOTO_EN_12650.jpg&clientName=Eisai%20Limited&caption=Video%3A%20New%20Treatment%20Option%20Halaven%26%238482%3B%2C%20Significantly%20Prolongs%20Overall%20Survival%20in%20Pre%2Dtreated%20Metastatic%20Breast%20Cancer%20Patients&title=%20New%20Treatment%20Option%20Halaven%26%238482%3B%2C%20Significantly%20Prolongs%20Overall%20Survival%20in%20Pre%2Dtreated%20Metastatic%20Breast%20Cancer%20Patients&headline=Eisai%20Announces%20Canadian%20Launch%20of%20Halaven%26%23x2122%3B%20%28eribulin%20mesylate%29%20Injection%20For%20The%20Treatment%20of%20Metastatic%20Breast%20Cancer

Audio with caption: "Audio: ANR #1 - New Treatment Option Halaven™, Significantly Prolongs Overall Survival in Pre-treated Metastatic Breast Cancer Patients". Audio available at: http://stream1.newswire.ca/media/2012/04/24/20120424_C8397_AUDIO_EN_12656.mp3

Audio with caption: "Audio: ANR #2 - New Treatment Option Halaven™, Significantly Prolongs Overall Survival in Pre-treated Metastatic Breast Cancer Patients". Audio available at: http://stream1.newswire.ca/media/2012/04/24/20120424_C8397_AUDIO_EN_12657.mp3