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

HATFIELD, England, January 21, 2011 /PRNewswire/ --

- CHMP Opinion Based on Positive EMBRACE Study Data

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 response.

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 indications.

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 http://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, Italy

[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] http://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: http://info.cancerresearchuk.org/cancerstats/types/breast/index.htm?script=tr 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 ):33-42