Eisai Announces Partnership With Newbridge to Market Breast Cancer Treatment Halaven® (Eribulin) Across the Middle East

HATFIELD, England, November 18, 2013 /PRNewswire/ --

Eisai announces today that Halaven^® (eribulin) will be marketed in selected countries within the Middle East region through a new partnership between Eisai EMEA (Europe, the Middle East, Africa, Russia and Oceania) and NewBridge Pharmaceuticals. Eribulin is indicated for the treatment of locally advanced or metastatic breast cancer, which has progressed after at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included two common types of chemotherapy, an anthracycline and a taxane, unless patients were not suitable for these treatments.

"Our partnership with NewBridge is another significant step forward in support of our mission to increase the availability of Halaven worldwide," said Toshitaka Asano, Vice President Market Development Business Unit EMEA.

Breast cancer is one of the major causes of cancer-related death in women and has become the most common malignant disease in the Middle East (ME).^[1] Studies show breast cancer is the most common form among women in Saudi Arabia, representing approximately 22% of all cancers.^[2] Locally advanced disease is very common in Saudi Arabia, Egypt, Tunisia and other ME countries. In the United Arab Emirates, 30% of women with breast cancer present in the third stage of the disease. Overall five-year survival rates in Saudi Arabia,Bahrain and Oman are 60%, 69% and 64% respectively.^[3],[4],[5]

"We are delighted to work in partnership with Eisai to ensure that Halaven reaches women with metastatic breast cancer who need it across the region," said Joe Henein, President and CEO of NewBridge Pharmaceuticals AfMET (Africa, Middle East and Turkey). "We strive to increase the accessibility of innovative medicines such as Halaven in the Middle East to improve health outcomes and quality of life."

Eisai is dedicated to discovering, developing and producing innovative oncology therapies that can make a difference and impact the lives of women 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.

Notes to Editors

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.

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. Research indicates that eribulin may have a novel inhibitory effect on tumour metastasis by suppressing the expression in epithelial-mesenchymal transition (EMT) gene sets.^[6],[7],[8] EMT is a phenomenon in which cells acquire characteristics that allow them to develop into tumours and is highly significant in the infiltration and metastasise of cancer.

Further analysis of the MOA for eribulin has shown that eribulin also improves blood perfusion in tumour tissues meaning that it increases the amount of oxygen available to tumours.^[9] When tumours are deprived of oxygen they are more likely to metastasise and as such eribulin works to inhibit metastasis. Following treatment with eribulin, tumours were less aggressive and invasive.

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, and 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 EMEA Knowledge Centre in Hatfield, UK, 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, the Netherlands, Belgium, the Middle East and Russia.

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

About NewBridge Pharmaceuticals

NewBridge Pharmaceuticals is a specialty therapeutics company focused on pharmaceuticals, biologics, and medical diagnostics serving the AfMET markets (Middle East, Africa, Turkey) to address the unmet medical needs of diseases with high regional prevalence. Headquartered in UAE with strong local and international business network, NewBridge is uniquely positioned as the partner-of-choice for companies seeking to create value for their pharma or medical products in the high growth emerging AfMET markets. NewBridge is financially backed by Burrill & Company, Venture Capital, private equity, merchant banking and media; KLSC the life sciences arm of National Technology Enterprises Company (NTEC) and Elan Corporation plc, a biotechnology company.

For further information please visit: http://www.nbpharma.com

References

1. Salim et al. Cancer Epidemiology and Control in the Arab World - Past, Present and Future. Asian Pacific J Cancer Prev, 2009: 10, 3-16

2. Kingdom of Saudi Arabia Ministry of Health and Saudi Cancer Registry (2008) Cancer Incidence Report Saudi Arabia 2004. tinyurl.com/saudi-cancer-report (Last accessed: November 2013)

3. Ravichandran K, et al. Population based survival of female breast cancer cases in Riyadh Region, Saudi Arabia. Asian Pac J Cancer Prev, 2005: 6, 72-6.

4. Fakhro AE, et al. Breast cancer: patient characteristics and survival analysis at Salmaniya medical complex, Bahrain. East Mediterr Health J, 1999: 5, 430-9.

5. Al-Moundhri M, et al. The outcome of treatment of breast cancer in a developing country Oman. Breast, 2004: 13, 139-45.

6. McCracken P.J, Ito. K, Yanagimachi M, et al. Eribulin alters vascular function in human triple-negative (TN) breast MX-1 and MDA-MB-231 tumor xenograft models as measured by DCE-MRI. AACR abstract 2013 abstract # 4502  

7. Dezso Z, Oestreicher J, Weaver A et al. Gene expression profiling (GEP) reveals Epithelial Mesenchymal Transition (EMT) genes selectively differentiating eribulin sensitive breast cancer cell lines. AACR abstract 2013 abstract # 1522

8. Agoulnik SI, Oestreicher JL, Taylor NH et al. Eribulin and Paclitaxel differentially affect gene expression profiling of blood vessel cells and in vitro angiogenesis in co-cultures of human endothelial cells with pericytes. AACR abstract 2013 abstract # 3830

9. Matsui J, Toyama O, Ino M et al. Eribulin caused re-modeling of tumor vasculature altering gene expression profiling in angiogenesis and Epithelial Mesenchymal Transition (EMT) signaling pathway of host cells within human breast cancer cell (BCC) xenografts in nude mice. AACR abstract 2013 abstract # 1413

Date of preparation: November 2013

Job Code: Halaven-UK0223