Halaven(TM) (Eribulin) Receives European Commission Approval for Advanced Breast Cancer

LONDON, March 22, 2011 /PRNewswire/ -- Eisai announced today that it has received approval from the European Commission for Halaven(TM) (Eribulin) for the treatment of patients with locally advanced or metastatic breast cancer 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. Halaven is a new class of agent which provides statistically significant overall survival improvements compared with current treatment options.[1],[2]

The European Commission approval of Halaven was granted through a centralised procedure, which means that the treatment has now been granted marketing authorisation in the 27 EU member states. Halaven will be launched in the EU during April 2011.

The approval of European Commission is based on the results of the global Phase III EMBRACE study (Eisai Metastatic Breast Cancer Study Assessing Treatment of Physician's Choice (TPC) Versus Eribulin E7389), which demonstrated a statistically significant increase in overall survival (OS) for patients treated with Halaven when compared with TPC[a]. The protocol prespecified analysis at the point of 422 events demonstrated a median OS of 13.1 and 10.6 months, respectively (Hazard Ratio [HR] 0.81; p=0.041);[1] the updated analysis requested by European and US regulatory authorities including 589 events demonstrated a median OS of 13.2 and 10.5 months, respectively (HR 0.81; nominal p=0.014).[2]

Halaven is the first single-agent therapy to demonstrate a significant overall survival benefit in patients with advanced breast cancer. The European Commission approval means that patients across the EU will soon be able to benefit from this treatment, which offers them an average of more than 2 months longer life.

Halaven was approved in the USA in November 2010 and Singapore in February 2011, and has already been launched in USA.The approval by European Commission is the third in the world, other applications are currently under review in Japan, Switzerland and Canada.

Eisai's 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, biologic and supportive care agents for cancer across multiple indications. Through these efforts, Eisai will make further contributions to addressing the diversified needs of and increasing the benefits provided to patients and their families as well as healthcare professionals as it seeks to fulfill its human health care (hhc) mission.

[a] Treatment of Physician's Choice (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.

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.

Geographical exploratory subgroup analyses demonstrated that Halaven significantly improved OS in region 1 (North America, Western Europe & Australia) compared with TPC (median 13.1 and 10.1 months, respectively; p=0.009; HR 0.72).[1]

About EMBRACE

EMBRACE was an open-label, randomised, multi-centre study of 762 women with MBC 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 OS in patients treated with Halaven versus a TPC arm, reflecting a real-world clinical setting where a variety of agents are used to treat patients. The primary endpoint was OS. Secondary endpoints were objective response rate, progression-free survival, safety and duration of response.[1]

About Metastatic Breast Cancer

Worldwide, more than one million women a year are diagnosed with breast cancer, including 421,000 women in Europe.[5,6] Approximately 30 percent of women initially diagnosed with earlier stages of breast cancer eventually develop recurrent or metastatic disease,[7] 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.[8] Most MBC patients have a limited survival time of approximately 18-24 months.[9]

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 Limited

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.

Eisai

Eisai 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.

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1 Cortes J, O'Shaughnessy J, Loesch D, et al. A Phase III open-label randomized study (EMBRACE) or eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer. The Lancet. 2011; 377: 914 -923

2 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.

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 Coughlin, S. Breast cancer as a global health concern. Cancer Epidemiology, October 2009; 33: 315-18.

6 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

7 O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. Oncologist. 2005;10 Suppl 3:20-29

8 Cancer Research UK, Breast Cancer Statistics - Key Facts [updated April 2010]. Available from: http://info.cancerresearchuk.org/cancerstats/types/breast/index.htm?script=true (accessed (04/08/10)

9 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

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