STATEMENT REGARDING THE RESULTS OF THE ACCESS TO MEDICINE INDEX 2016

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that Eisai has been highly commended for its initiatives to promote access to medicines and ranked 11th among the world’s leading pharmaceutical companies in the Access to Medicine Index (ATM Index) 2016.

This Index is compiled by the Access to Medicine Foundation (the Foundation), an international non-profit organization dedicated to improving access to medicine for patients in need. Based on publicly disclosed information and individual surveys, the ATM Index independently evaluates companies’ efforts to improve access to medicine for diseases and countries designated by the Index to rank the world’s top 20 pharmaceutical companies leading in initiatives for access to medicine issues in developing and emerging countries. The ATM Index has been published by the Foundation every two years since 2008.

Eisai performed above the Index average in the following four technical areas set by the Foundation: general access to medicine management, market influence & compliance, research & development, as well as product donations.
In the ATM Index 2016 report, Eisai’s commitment to eliminating lymphatic filariasis, a neglected tropical disease, by providing 2.2 billion diethylcarbamazine citrate (DEC) tablets free of charge to endemic countries in collaboration with the World Health Organization (WHO) for a seven year period starting from 2013, was highly commended. In addition, the Foundation highlighted as best practices Eisai’s strategies for using partnerships to accelerate research and development of new treatments for conditions including neglected tropical diseases (NTDs), malaria and tuberculosis, as well as its initiatives to create patient value with all employees around the world using 1% of their total business hours to interact with patients.

Eisai is establishing proactive partnerships with various stakeholders including governments, international organizations and other non-profit private sector organizations to improve access to medicines worldwide under its human health care (hhc) philosophy. Together with accelerating the development of new medicines for infectious diseases endemic in developing and emerging countries through these partnerships, the Eisai Group is committed to additional long-term sustainable strategies including raising disease awareness locally and implementing price setting models that take income levels into account for greater access to medicine worldwide.

Please click the following link for details of the ATM Index 2016 results:
http://www.atmindex.org

U.K. NICE RECOMMENDS ANTICANCER AGENT HALAVEN? AS TREATMENT FOR ADVANCED BREAST CANCER

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its in-house developed anticancer agent Halaven? (eribulin mesylate, “eribulin”) has been recommended by the U.K. National Institute for Health and Clinical Excellence (NICE) as a treatment for patients with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for advanced disease (prior therapy may have included an anthracycline or a taxane, and capecitabine) in NICE’s Final Appraisal Determination (FAD). Eribulin is the first breast cancer treatment to be recommended by NICE since 2007.
Following the issue of the FAD by NICE, eribulin will be eligible for reimbursement for this indication via the National Health Service in England (NHS England).

The Appraisal Committee considered that the models suggest Eribulin offers a mean overall survival benefit of more than 3 months. According to the FAD, “In light of the short life expectancy at this stage of breast cancer, the committee considered this overall survival benefit to be substantial. The committee concluded that eribulin met the end-of-life criteria objectively and robustly and that it can be considered a life-extending, end-of-life treatment.”

Eribulin was approved in Europe in March 2011 as a treatment for patients with locally advanced or metastatic breast cancer who have received at least two chemotherapeutic regimens for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. The agent was launched in the U.K. in April 2011. Furthermore, eribulin was approved in June 2014 for an expanded indication to include patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting, unless patients were not suitable for these treatments).

Eisai regards oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence and expanding patient access for eribulin, and by maximizing the value of the drug, seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

CEO Naito Selected among The Best-Performing CEOs in the World by Harvard Business Review

Harvard Business Review has just announced The Best-Performing CEOs in the World, in which CEO Haruo Naito was ranked 87th. Among Japanese companies, only three other CEOs made the list, including Nidec’s Shigenobu Nagamori (42nd), FAST RETAILING’s Tadashi Yanai (46th) and Softbank’s Masayoshi Son (73rd).

From the pharmaceutical industry, only Novo Nordisk’s Lars Rebien S?rensen (1st), Biogen’s George Scangos (21st) and Regeneron Pharmaceuticals’ Leonard Schliefer (67th) made the list, making CEO Naito the only one selected from the Japanese pharmaceutical industry.

Please refer to the following link for further details on the announcement.
https://hbr.org/2016/11/the-best-performing-ceos-in-the-world

This CEO ranking was based on companies in the S&P Global 1200, from 895 CEO’s of 886 companies in 32 countries. The final ranking is calculated based on a financial element measured by shareholder returns and change in market capitalization since becoming CEO of the company as well as a non-financial element assessing ESG (environment, social and governance) initiatives.

EISAI TO OFFICIALLY LAUNCH “CHOCOLA BB? RICH CERAMIDE” IN STORES JAPAN

EISAI TO OFFICIALLY LAUNCH?“CHOCOLA BB? RICH CERAMIDE”

IN STORES NATIONWIDE

JAPAN’S FIRST FOOD WITH FUNCTION CLAIMS DRINK CONTAINING CERAMIDE

-“DRINK”?TO COUNTER DRY SKIN –

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it will launch its first food with function claims Chocola BB? Rich Ceramide (Notification number: B60) in drugstores, pharmacies and convenience stores throughout Japan on Monday, October 17. The product is Japan’s first drink that is a type of food with function claims containing glucosylceramide derived from rice.

Ceramide is a component of the stratum corneum of the epidermis layer of human skin. Normally, ceramide fills the spaces between cells in the corneum of the skin, and plays a role in restraining the loss of moisture to the outside as well as protecting the skin from external stimuli such as ultraviolet rays. Therefore, a lack of ceramide advances transpiration of skin moisture, potentially leading to dryness in the skin. Since ceramide levels decline with age, it is important to appropriate replenish ceramide to counter dryness.

Containing glucosylceramide as its active component to make it harder for moisture to escape from the skin, Chocola BB Rich Ceramide is a product that you can drink to counter dry skin. Furthermore, in addition to ceramide, the drink also contains collagen and hyaluronic acid which are known for their beauty properties, and is recommended for people who are highly beauty conscious. Chocola BB Rich Ceramide has a delicious, easy to drink pear flavor, is low in calories (8.2 kcal), and with zero caffeine, can be safely consumed before sleep.

Chocola BB Rich Ceramide is now available nationwide through a wide range of retail outlets including drug stores, pharmacies, convenience stores and Eisai’s internet retailing site.

Centered around the signature OTC product Chocola BB? Plus? (Third-class OTC drug) for the relief of skin trouble, acne and mouth ulcers, Eisai has been expanding the Chocola BB brand to suit the needs and lifestyles of its customers such as Chocola BB? Royal 2 (quasi-drug), a nutritional drink for invigoration when physically fatigued, Chocola BB? Joma, a soft drink that contains vitamin B6 (Food with Nutrient Function Claims), and Chocola BB? Mouth Ulcer Repair Shot (Third-class OTC drug), an oral care spray launched in August.

Through the Chocola BB brand, Eisai will continue to respond to the diverse needs of female consumers and support an ever-growing number of people to achieve health and beauty in their everyday lives.

BELVIQ XR? – A NEW ONCE-DAILY FORMULATION OF BELVIQ? FOR CHRONIC WEIGHT MANAGEMENT NOW AVAILABLE IN THE UNITED STATES

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.S. subsidiary Eisai Inc. has launched BELVIQ XR? 20mg tablets, a new once-daily formulation of BELVIQ? (generic name: lorcaserin hydrochloride) for chronic weight management in the United States.

BELVIQ XR is an extended release formulation proven to be slowly absorbed in the body and to last throughout the day. The availability of once-daily BELVIQ XR (20mg) in a single tablet provides patients with another dosing option in addition to the conventional twice-daily BELVIQ (10mg).

Approval for twice-daily BELVIQ was obtained in the United States as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m²?or greater (obese) or 27 kg/m²?or greater (overweight) in the presence of at least one weight-related co-morbid condition from the U.S. Food and Drug Administration (FDA) in 2012 by Arena Pharmaceuticals, Inc. (Headquarters: California, United States, President and CEO: Amit D. Munshi, “Arena”), whom Eisai and Eisai Inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride, and was launched in June 2013. Once-daily BELVIQ XR was approved with the same indication by the FDA in July 2016.

“Eisai is committed to efforts in research and development, disease awareness as well as other activities in order to address the diverse needs of to those living with obesity – a chronic, progressive disease that has serious health consequences,” said Paul Hawthorne, Senior Vice President, Americas Neurology Business Unit, Neurology Business Group, Eisai Inc. “We are excited to offer patients a once-daily option for chronic weight management that may help them achieve and sustain their weight loss goals.”

Through the launch of BELVIQ XR, Eisai continues to make further contributions to address unmet medical needs in the clinical management of obesity and increase the benefits for patients and their families.

EISAI TO INITIATE PHASE III CLINICAL STUDY OF ANTICANCER AGENT LENVATINIB AS POTENTIAL FIRST-LINE THERAPY FOR ADVANCED RENAL CELL CARCINOMA

?SIMULTANEOUS DEVELOPMENT OF TWO COMBINATION THERAPIES LENVATINIB/EVEROLIMUS AND LENVATINIB/PEMBROLIZUMAB

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the initiation of a global Phase III Clinical Study (Study 307, CLEAR Study) of its in-house developed multiple receptor tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in respective combination regimens with the anticancer agent everolimus and the anti-PD-1 antibody pembrolizumab as a potential first-line treatment for advanced renal cell carcinoma.

The CLEAR (Comparison of the efficacy and safety of?Lenvatinib in combination with?Everolimus or pembrolizumab versus sunitinib alone in first-line treatment of subjects with?Advanced?Renal cell carcinoma) study is a multicenter, randomized, open-label Phase III clinical study to compare the efficacy and safety of lenvatinib/everolimus and lenvatinib/pembrolizumab versus sunitinib alone in first-line treatment in patients with advanced renal cell carcinoma. The primary outcome measure will be progression-free survival.

Non-clinical research into the combination of lenvatinib and everolimus suggested synergistic enhancement of antiangiogenic activity and a stronger antitumor effect than either monotherapy in renal cell carcinoma models through the respective inhibition of signaling pathways which facilitate tumor angiogenesis, upstream (vascular endothelial growth factor receptor [VEGFR] and fibroblast growth factor receptor [FGFR]) with lenvatinib and downstream (mammalian target of rapamycin [mTOR]) with everolimus. Furthermore, non-clinical research into the combination of lenvatinib and anti-PD-1 antibody suggested that the combination has a mechanism of action in which lenvatinib enhances the antitumor activity of the anti-PD-1 antibody by reducing immunosuppressive cells.

The number of patients with renal cancer is estimated to be approximately 338,000 worldwide, including approximately 115,000 in Europe, 58,000 in the United States and 17,000 in Japan. Renal cell carcinoma comprises more than 90% of all malignancies of the kidney, and occurs when malignant cells are found in the lining of the tubules of the kidney. The incidence of renal cell carcinoma in people over 55 years of age is rising, and it is more likely to affect men than women. For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

Currently lenvatinib has been approved in over 45 countries including the United States, Japan and in Europe as a treatment for refractory thyroid cancer. In May 2016, lenvatinib was approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior anti-angiogenic therapy by the U.S. Food and Drug Administration in the United States. Furthermore, lenvatinib was approved in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor targeted therapy in Europe in August 2016.

Eisai regards oncology as a key therapeutic area and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

EISAI TO PRESENT LATEST DATA ON LENVATINIB AND ERIBULIN AT ESMO CONGRESS 2016

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a series of abstracts highlighting the latest clinical and pre-clinical data on lenvatinib mesylate (selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, product name: Lenvima?/Kisplyx?, “l(fā)envatinib”) and eribulin mesylate (halichondrin class microtubule dynamics inhibitor, product name: Halaven?, “eribulin”) will be presented during the European Society for Medical Oncology (ESMO) Congress 2016, taking place in Copenhagen, Denmark, from October 7 – 11.

For lenvatinib, six abstract poster presentations (including health economics and outcome research data) are to be given at the meeting with the main presentations featuring the latest data from a Phase Ib trial of lenvatinib in combination with the immune checkpoint inhibitor pembrolizumab in patients with selected solid tumors as well as an analysis of the responses in specific metastases following treatment with lenvatinib from the results of the Phase III SELECT Study.

For eribulin, an abstract poster presentation on a subgroup analysis in leiomyosarcoma (LMS) patients from a Phase III study (Study 309) in patients with advanced liposarcoma (LPS) and LMS is also scheduled to be given at the meeting.

Eisai positions oncology as a key franchise area. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families as well as to healthcare providers.

EISAI RECEIVES LICENSE FOR NEW INDICATION FOR ANTICANCER AGENT KISPLYX? ▼ (LENVATINIB MESYLATE) FOR TREATMENT OF ADVANCED RENAL CELL CARCINOMA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced that its European regional headquarters Eisai Europe Ltd. (Location: U.K.) has received license from the European Commission for anticancer agent Kisplyx? ▼ (generic name: lenvatinib mesylate, “l(fā)envatinib”) in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma following one prior vascular endothelial growth factor (VEGF) targeted therapy. Following the United States, Europe marks the second region where lenvatinib has been licensed for the advanced renal cell carcinoma indication.

This license was based on a Phase II clinical study (Study 205) that evaluated the safety and efficacy of lenvatinib in combination with everolimus in patients with unresectable advanced or metastatic renal cell carcinoma following one prior VEGF-targeted therapy. From the results of the study, the lenvatinib plus everolimus group (n=51) demonstrated a significant extension in the study′s primary endpoint of progression free survival (PFS) compared to the everolimus alone group (n=50) (median PFS for the lenvatinib plus everolimus group: 14.6 months vs median PFS for the everolimus alone group: 5.5 months; Hazard Ratio (HR) 0.40 [95% CI: 0.24-0.68], p=0.0005). Furthermore, updated median overall survival in the study population was 25.5 months in the lenvatinib plus everolimus group compared with 15.4 months in the everolimus alone group (HR 0.59 [95% CI: 0.36-0.97]). The most common treatment-emergent adverse events (TEAEs) reported in the lenvatinib plus everolimus group were diarrhea, decreased appetite and fatigue. The most common TEAEs of Grade 3 or higher (Common Terminology Criteria for Adverse Events) were diarrhea, hypertension and fatigue.

The number of patients with renal cancer is estimated to be approximately 338,000 worldwide, including approximately 115,000 in Europe, 58,000 in the United States and 17,000 in Japan. Renal cell carcinoma comprises more than 90% of all malignancies of the kidney, and originates from malignant cells in the lining of the tubules of the kidney. The incidence of renal cell carcinoma in people over 55 years of age is rising, and it is more likely to affect men than women. For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment is molecular targeted drug therapy, however with low 5-year survival rates, this remains a disease with significant unmet medical need.

In Europe, lenvatinib has been designated as an orphan drug for thyroid cancer and is marketed as Lenvima? for this indication. In Europe, renal cell carcinoma does not meet the criteria for orphan drug designation. Accordingly, under European regulations, any licensed medicine that previously received orphan drug designation for an indication and subsequently receives license for a non-orphan indication must be marketed under a different trade name. As such, lenvatinib will be marketed as Kisplyx? ▼ in the European Union for the indication covering renal cell carcinoma.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai remains committed to providing further clinical evidence for lenvatinib aimed at maximizing value of the drug as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

EISAI SELECTED FOR FOURTH CONSECUTIVE YEAR OF MEMBERSHIP IN DOW JONES SUSTAINABILITY ASIA PACIFIC INDEX 2016

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been selected for a fourth consecutive year of membership in the Dow Jones Sustainability Asia Pacific Index (DJSI Asia Pacific), the Asia Pacific version of the Dow Jones Sustainability Indices (DJSI), which are a family of premier global indices for socially responsible investment (SRI).

The DJSI family was jointly established between RobecoSAM AG (Switzerland) and S&P Dow Jones Indices LLC (United States) in 1999 as the first global SRI indices in the world and assesses the corporate sustainability performance of eligible member companies based on economic, environmental and social criteria. This year, the DJSI Asia Pacific has selected 146 companies leading the way in sustainability (68 of which are from Japan) from among the region’s top 615 companies. Eisai received high scores particularly in categories such as Corporate Governance, Product Quality and Recall Management, Human Capital Development, Occupational Health and Safety as well as Strategy to Improve Access to Drugs or Products.

In addition to the DJSI Asia Pacific, Eisai has been selected for the 15th consecutive year since 2002 as a member of the FTSE4Good Index Series, another global benchmark SRI index.

The Eisai Group’s corporate philosophy is to give first thought to patients and their families, and increase the benefits that health care provides as well as address diverse healthcare needs worldwide. Guided by this philosophy, Eisai will continue to develop innovative new drugs and make them available to patients around the world as early as possible to fulfill its social responsibility and secure the trust of stakeholders.

“Not Only For Classics” — A Record on Eisai China 2016 Peripheral Neuropathy Forum

On September 3rd 2016, the Peripheral Neuropathy Forum is successfully held by Eisai China Inc. in Changsha, China.

Feng Yanhui, Pu Chuanqiang, Liu Zhongjun, Zhu Dalong

On the Forum, Ms. Feng Yanhui, General Manager of Eisai China (Holding) Co., Ltd and Eisai China Inc., firstly delivered a welcome speech. She said, “Welcome to our Forum, all my keynote speakers and fellows, honorable gusts and friends, Eisai China is committed to promoting the development and progress of the field of neuroscience in China, hoping to get together with the country’s elite, to harvest more cutting-edge academic achievements, and to harvest more profound friendship. At the same time, Ms. Feng stressed that, we should consider all kinds of patients and their families in different health needs, as our primary task is to meet these needs; in order to meet the different needs of health, Eisai China is committed to being a valuable and “human health care” company.

Ms. Feng delivers her speech.

The forum invited more than 400 experts from home and abroad, including KOLs, academics and medical doctors, to study and discuss more advanced, more authoritative and professional academic ideas. Professor Liu Zhongjun from the People’s Liberation Army General Hospital, Professor Zhu Dalong from No.3 Hospital of Peking University and Professor Pu Chuanqiang from Nanjing Gulou Hospital jointly served as chairmen of the Main Forum, to organize a number of well-known experts to present with multi angles and to discuss various cases of clinical practices with the participants, from the research history and the development of the peripheral neuropathy disciplines, the new progress in diagnosis and treatment of the disease, the sensory neurons: from animal models to the clinical syndrome, the identification to intermittent claudication related diseases, the diagnosis and treatment of diabetic peripheral neuropathy and etc.

Main Forum Photo

At the same time, the forum set up four special sub-seminars, including Internal Neurology Seminar, Orthopedics Seminar, Endocrine Seminar and Ophthalmic Seminar, to carry out the academic speeches discussing and sharing practical experiences in fields such case studies of the peripheral neuropathy, the treatment of spinal degenerative diseases and the surgery strategies, advances in the screening of diabetic peripheral neuropathy, the diabetic neuropathy, the group consultation among the Diabetes endocrine, the neurological and the ophthalmic, the guide to the interpretation of glaucoma, the Diabetic retinopathy and clinical experiences, and so on.

It is understood that Eisai China has opened several activities accordingly, such as, the Universal Detectives: Difficult Cases of Peripheral Neuropathy, the Super Swordsmen: DDD Difficult Disease Meeting, the EEF Elite Edition: Diabetic Peripheral Neuropathy “Big Consultation”, the Eyeshot Precedents: Ophthalmic Difficult Cases Sharing, and etc., which have been recognized by medical doctors and highly praised the Eisai’s brand, and also those are the best practices of “hhc” (human health care) philosophy and promote the development for the field of neuroscience in China.

For the Starry Night by Van Gogh, the bright Nebula will always shine brightly in the history of art. For Classics, it can cross the river of history, for people to collect and read. Just as the field of neuroscience, it has made the immortal classics. Eisai always gives the first thought to patients and their families, and to increasing the benefits health care provides. And it guides Eisai for the health with the medical researchers, promotes the academic innovation; it is particularly bright on the academic study of the peripheral neuropathy.