EISAI TO LAUNCH CHOCOLA BB? MOUTH ULCER REPAIR SHOT — FIRST MOUTH ULCER SPRAY FOR THE CHOCOLA BB BRAND

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it will launch “Chocola BB? Mouth Ulcer Repair Shot” (Third-class OTC drug) for mouth ulcers in Japan on Thursday, August 25. The product is the first oral care spray to be marketed under the Chocola BB brand.

Mouth ulcer is a general term that refers to any inflammation of the mucous membrane in the mouth. In many cases, it is thought that nutritional imbalances, lifestyle changes and/or stress lead to a decrease in the mucous membrane’s ability to regenerate, allowing bacteria to penetrate the membrane and cause an ulcer to form.

Chocola BB Mouth Ulcer Repair Shot is a medicated spray that is effective for mouth ulcers and soothing pain caused by inflammation in the throat. Containing antiseptic cetylpyridinium chloride (CPC) that keeps the mouth clean, as well as azulene which acts to repair the mucous membrane, the spray alleviates the symptoms of mouth ulcers by allowing the active ingredients to be directly applied into the mouth. It also comes in a compact form making it portable and easy to use anywhere without having to directly touch the affected area.

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, and Chocola BB? Joma, a soft drink that contains vitamin B6 (Food with Nutrient Function Claims).

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.

U.S. FDA CONFIRMS SUFFICIENT DATA TO ADVANCE INVESTIGATIONAL BACE INHIBITOR E2609 FOR TREATMENT OF EARLY ALZHEIMER’S DISEASE TO PHASE III PLANNING UNDERWAY TOWARDS PHASE III STUDY INITIATION IN FY2016

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that, at its recent meeting with the U.S. Food and Drug Administration (FDA), the FDA confirmed there was sufficient data to support the advancement of its novel investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 into Phase III clinical studies. E2609 was discovered by Eisai and is being jointly developed by Eisai and Biogen Inc. (Headquarters: Massachusetts, United States, CEO: George A. Scangos, “Biogen”) for early Alzheimer’s disease.

Based on the clinical and pre-clinical data presented to the FDA at the Study 202 end of Phase II meeting, the FDA confirmed that the data package was sufficient to commence Phase III studies, and acknowledged the outlines of the two Phase III clinical study protocol designs. The study protocol will be a placebo-controlled design in patients with early Alzheimer’s disease where the treatment group will be administered a dosage of 50 mg/day of E2609 with the primary outcome endpoint assessed at 24 months. The primary endpoint will be the Clinical Dementia Rating Sum of Boxes (CDR-SB), with routine safety assessment.

Following this discussion with the FDA on the Phase III clinical study designs, Eisai and Biogen intend to have similar discussions with the regulatory authorities in Japan and the EU, and to conduct the study as a global, multicenter study.

Study 202 was a multicenter, randomized, double-blind, placebo-controlled parallel-group study to evaluate the safety of E2609 administered in patients with early to moderate Alzheimer’s disease (including prodromal Alzheimer’s disease) with confirmed accumulation of amyloid beta (Aβ) by PET (positron emission tomography) screening. The study included three doses of E2609: 5, 15, and 50mg/day. Plasma and cerebrospinal fluid (CSF) Aβ (Aβ1-x)* levels were measured in patients prior to receiving E2609 and during the study.

The results of an analysis of Study 202 presented at the end of Phase II meeting suggested favorable safety at all doses of E2609 and that total Aβ levels in the plasma and CSF were reduced in a dose-dependent manner. Furthermore, according to an analysis of safety and pharmacokinetic/pharmacodynamic data from pre-clinical studies as well as Study 202 and Phase I clinical studies overall, the optimal dose of E2609 was identified as 50 mg/day.

Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer of Eisai Neurology Business Group commented, “We believe that the Phase III clinical study design outline agreed upon will enable us to efficiently conduct studies on BACE inhibitors aimed at realizing preemptive medicine, and will accelerate the development of E2609. We are striving to deliver E2609 to patients around the world as soon as possible, and contribute to increasing the benefit for patients.”

EISAI RECEIVES POSITIVE CHMP OPINION ON NEW INDICATION FOR ANTICANCER AGENT LENVATINIB IN COMBINATION WITH EVEROLIMUS FOR TREATMENT OF ADVANCED RENAL CELL CARCINOMA

The CHMP’s positive opinion 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 group who received the combination of lenvatinib plus everolimus demonstrated a significant extension in progression free survival, the study’s primary endpoint, as well as a higher objective response rate compared to the everolimus alone group. 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 were diarrhea, hypertension and fatigue.

The number of patients with renal cancer in Europe is estimated to be 115,000, and renal cell carcinoma comprises more than 90% of all malignancies of the kidney. For advanced or metastatic renal cell carcinoma that is difficult to treat with surgery, the standard treatment method 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 launched in countries including the United States, Japan and in Europe under the product name Lenvima^??as a treatment for refractory thyroid cancer. Furthermore, in May 2016, lenvatinib was approved in combination with everolimus for the treatment of patients with advanced renal cell carcinoma following one prior VEGF-targeted therapy by the U.S. Food and Drug Administration in the United States.

Eisai positions oncology as a key therapeutic area, and is aiming to discovery 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.

U.S. FDA APPROVES BELVIQ XR?, A ONCE-DAILY FORMULATION OF LORCASERIN FOR CHRONIC WEIGHT MANAGEMENT

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for BELVIQ XR^?, a once-daily formulation of lorcaserin hydrochloride (generic name, U.S. brand name: BELVIQ^?) for chronic weight management. BELVIQ XR is scheduled for launch in autumn 2016.

BELVIQ XR is a sustained release formulation which enables once-daily treatment, increasing the convenience of administration compared to twice-daily BELVIQ tablets. This approval was based on clinical data that confirmed bioequivalence of once-daily 20 mg BELVIQ XR with twice-daily 10 mg BELVIQ tablets. Eisai believes BELVIQ XR will offer patients the potential benefits of the full FDA approved 20 mg dose in a simple once daily tablet.

This approval was obtained by Arena Pharmaceuticals, Inc. (Headquarters: California, United States, President and CEO: Amit D. Munshi, “Arena”), whom Eisai and its U.S. subsidiary Eisai Inc. have an exclusive licensing agreement with to commercialize lorcaserin hydrochloride.

BELVIQ was approved by the FDA in 2012 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, and has been available to patients in the United States since June 2013. In July 2016, lorcaserin hydrochloride was approved in Mexico under the brand name VENESPRI^?.

Through obtaining approval for 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.

ANTIOBESITY AGENT VENESPRI? (LORCASERIN) APPROVED IN MEXICO – FIRST COUNTRY IN LATIN AMERICA TO APPROVE LORCASERIN

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its pharmaceutical sales subsidiary in Mexico, Eisai Laboratorios, S. de R.L. de C.V. (Location: Mexico City, “Eisai Mexico”) has received approval for the antiobesity agent VENESPRI? (lorcaserin hydrochloride, U.S. brand name: BELVIQ?, “l(fā)orcaserin”) 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 (e.g., hypertension, dyslipidemia, type 2 diabetes) by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), the Mexico regulatory authority. Mexico marks the first country in Latin America where lorcaserin is approved. Lorcaserin will be marketed in Mexico under the brand name VENESPRI.

Discovered and developed by Arena Pharmaceuticals, Inc. (Headquarters: California, United States, President and CEO: Amit D. Munshi, “Arena”), lorcaserin is a novel chemical entity that is believed to decrease food consumption and promote satiety by selectively activating serotonin 2C receptors in the brain. Eisai’s U.S. subsidiary Eisai Inc. has an exclusive licensing agreement with Arena to commercialize lorcaserin in most countries and territories worldwide, including Europe, Japan and China (excluding South Korea, Chinese Taiwan, Australia, New Zealand and Israel).

In 2014, Mexico‘s pharmaceutical market was worth 11.3 billion U.S. dollars, making it the 16th biggest pharmaceutical market in the world, and the third biggest in Latin America after Brazil and Venezuela. In 2019, Mexico’s pharmaceutical market is expected to grow to a scale of 13.4 billion U.S. dollars. In August 2011, Eisai established Eisai Mexico, which currently markets the anticancer agents Lenvima?, Halaven? and Gliadel?. Regarding antiepileptic agents, Eisai Mexico has received approval for Inovelon? and has submitted Fycompa? for regulatory review.

Eisai is committed to delivering innovative new treatments to patients in Mexico while enhancing its product lineup as it seeks to further increase the benefits it provides to patients and their families in the country.

Eisai China, Trip to Guizhou – Record on Guizhou Green Expo, Big Health & Pharmaceutical Industry Fair and Summit

Eco Forum Global Annual Conference Guiyang 2016, Guizhou Green Expo-Big Health & Pharmaceutical Industry Fair and Summit has been held successfully in July 8-10, 2016 in Guiyang City, Guizhou Province. Chairman Mr. Norio Kaneko and General Manager Ms. Yanhui Feng of Eisai (China) Holding Co., Ltd and Eisai China Inc. are invited to attend the Forum and Expo. Eisai China Inc. and Eisai (Liaoning) Pharmaceutical Co., Ltd equip with special show-booths at the Expo.

At the Expo, Ms. Feng introduced to the Vice Chairman of the 10th People’s Congress Madam Gu Xiulian and other VIP members on Eisai’s?“hhc”?and “Compliance” concepts, the high speed development of Eisai in China, social contributions, pharmaceutical products and Chocola BB products and etc. Ms. Feng said “Eisai, since the 70s of last century, has been committed to introduce more and better drugs and other products into China to improve the well-being of patients and their families; in the future, we will introduce more and more health products and service to Chinese population.” During the event, Ms. Feng was invited by a number of media for a detailed introduction of the development and future of Eisai in China as well as the framework and ideas of cooperation with Guizhou Province.

Ms. Feng introduces Eisai to VIP members

At the Summit, Mr. Kaneko delivered a speech on the topic of “Pharmaceutical Innovation and Drug Access” to share the current situation and future development of Japan’s pharmaceutical industry, Eisai’s?“hhc”?concept and cooperate culture, Eisai’s contribution on the Access to Medicines and the framework of cooperation with Guizhou Province, etc. Mr. Kaneko stressed that Eisai will in future focus on the drug research and development of CNS (such as: Alzheimer’s disease) and Oncology, and rapidly introduce those drugs into China and serve Chinese patients. He pointed out that Eisai and Guizhou Province have reached a cooperation framework, four areas, such as, the disease management, the health support, the industry cooperation and the personnel training, to carry out more exchanges and cooperation and support the development of Guizhou’s green and healthy economic.

Mr. Kaneko delivers speech on the Summit

The Expo and Summit, as an important part of Eco Forum Global Annual Conference Guiyang 2016, is to promote the feature of “Colorful Guizhou and Valuable Health”, and to raise a voice of a “Health-and-Fitness Regimen in Guizhou”, with a total of more than 20 activities in the big-health filed, more than 400 domestic and foreign politicians, academicians and entrepreneurs and scholars guests carrying out in-depth discussion around big health industry, enterprise organizational system and etc., and 2500 exhibitors, of which more than 40 exhibitors from World Top 500 and China Top 500, attracting many visitors and social concerns.

Eisai China participated in the 2nd Annual Scientific Session of Chinese Stroke Association (CSA) and Tiantan International Stroke Conference (TISC) — Focus on Post-Stroke Cognitive Impairment (PSCI)

The 2nd Annual Scientific Session of Chinese Stroke Association (CSA) and Tiantan?International Stroke Conference (TISC)?were?held at Beijing National Convention Center?in Beijing on June 24-26, 2016. And medical doctors and experts visited Eisai China Inc. (Eisai China)’s booth area continuously which received a great attention.

Picture: Release the test questionnaires for “Clock Drawing”

Stroke is one of the most common neurological diseases, and becomes the first disability / fatal disease in China. Post-stroke cognitive impairment (PSCI）refers to a series of cognitive disorder syndrome after stroke in the clinical events; its incidence rate is high, and it has a significant influence on the prognosis of stroke,? increases the rates of the mortality and the disability, and brings a heavy burden on patients, families and the society.

At the booth of Eisai China, the theme is to “follow the rationale of the consensus and reshape the cognition: focus on PSCI”; and at the booth, it sets up the product information consulting, while carrying out the “PSCI” survey, releasing the “clock-drawing” test questionnaires and playing the memory game. In this PSCI event, Eisai China gathered the strength and transferred a positive energy to the society.

At the TISC, experts from Huashan Hospital affiliated of Fudan University held a press conference for an interpretation on the expert consensus of PSCI management as a hot spot in current international stroke research and intervention, and it received great attention from doctors and industry experts.

OSD Facility Relocation Groundbreaking Ceremony of Eisai China

The OSD Facility Relocation Groundbreaking Ceremony of Eisai China Inc. (hereinafter referred to as “Eisai China”) was held at Suzhou Industrial Park on the morning of May 31, 2016. The leaders of the Japanese Consulate General in Shanghai, Jiangsu Provincial Food and Drug Administration, Suzhou Municipal Government, Management Committee of Suzhou Industrial Park, Suzhou Municipal Food and Drug Administration, Eisai Co., Ltd., and Eisai China attended the groundbreaking ceremony.

OSD Facility Relocation Groundbreaking Ceremony of Eisai China Inc.

Dr. Haruo Naito, CEO of Eisai Co., Ltd.

Dr. Haruo Naito, CEO of Eisai Co., Ltd., said in his speech, “It has been 20 years since we entered Suzhou Industrial Park in 1996. We have witnessed the rapid and healthy development of Suzhou as well as China, and our business in China is growing constantly. It is estimated that our sales volume in China will reach 3 billion yuan this year. Eisai will uphold the operation concept of “hhc?(human health care)”, put the interests of patients and their families in the first place, and make contributions to the improvement of their well-being. Meanwhile, we will regard Compliance (compliance with laws, regulations and ethics) as the most fundamental code of conduct in our day-to-day business, and be devoted to the fulfillment of our social responsibilities”.

Design Sketch of the New Facility of Suzhou Plant of Eisai China

This solid preparation facility covers a floor area of 31,000 square meters, including a building area of 23,000 square meters, and its designed production capacity will reach 3 billion preparation tablets /year and 5 billion package tablets /year, according to sources. The facility design will place stress on energy saving, and the international plant will be designed and built according to Chinese GMP and internationally recognized GMP. In the future, the base will supply high-quality products produced by Suzhou Plant of Eisai China to other Asian countries and regions in addition to the Chinese market. It is estimated that the new facility will be completed in October 2017, and may be officially put into operation in June 2018. Currently, the Phase I logistics warehouse and injection production workshop have been completed and put into operation. After completion of the solid preparation facility, Suzhou Plant of Eisai China will be relocated to 168 Xingpu Road of Industrial Park from 32 Baiyu Road of Industrial Park.

Reference information：

1. Eisai Co., Ltd.

Eisai Co. Ltd. (Japanese name: エーザイ株式會(huì) 社, Chinese name: 衛(wèi)材株式會(huì)社, hereinafter referred to as “Eisai”) is a multinational company dedicated to the research and development of pharmaceuticals. Founded in 1941, it is headquartered in Tokyo, Japan, and has three major institutions, namely Tsukuba Institute in Japan, Boston Institute in the U.S., and London Institute in Britain. Its foreign branches, subsidiaries and plants are all over Europe, America, and Asian countries and regions.

By 2015, the Company had 10,183 employees worldwide, its sales volume reached 548.5 billion Japanese yen (about 5 billion U.S. dollars), and 20% of such sales volume was used for development investment. Eisai covers five major regions, namely Japan, America, Europe, Asia and China. It is dedicated to the research and development of neurology, gastroenterology and oncology.

2016 marks the 25th anniversary of Eisai’s entry into the Chinese market, as well as the 20th anniversary of the establishment of Eisai China. In addition to Japan, China alone is regarded as a target region. Currently, its companies in China include Eisai China Inc. and its branches, Eisai China Holdings Ltd., Eisai (Suzhou) Trading Co., Ltd., and Eisai (Liaoning) Pharmaceutical Co., Ltd.

2. Eisai China Inc.

Eisai China Inc. is a pharmaceutical company owned solely by Eisai Co., Ltd. Founded in March 1996 and with a gross investment of 230 million U.S. dollars, the Company is located at 32 Baiyu Road at Suzhou Industrial Park, and has set up 10 branches in big cities.

Currently, Eisai sells more than ten types of medicines in China, and such medicines are mainly used for the central nervous system, digestive and hepatic diseases, endocrinology and orthopaedics. All the products that it produces are for domestic sales. After 20 years of steady development, the number of employees of the Company has reached 1,849, the sales volume was 2.6 billion yuan, and the total tax payment was 592 million yuan by the end of 2015. Eisai China has always been a key tax-payer enterprise in Suzhou since 2001. The average growth rate of its yearly sales volume in the past 5 years reached 20%, and it is estimated that its sales volume in 2016 will reach 3 billion yuan.

As part of its global manufacturing system, Suzhou Plant of Eisai carries out in-situ production of solid preparations and subpackaged production of imported products. In the early stage of development, Suzhou Plant was located in Suzhou Industrial Park, covered an area of 25,000 square meters, and was equipped with the most advanced machines. In 2005, Eisai added investment of 55 million U.S. dollars for construction of the Phase-II facility in order to increase its production capacity. In order to maintain its business development in China, Eisai added investment of 120 million U.S. dollars in 2010, bought a piece of new land in Suzhou Industrial Park to build a new facility for development, production and logistics. This new facility will become a global innovation center of Eisai in the future. Currently, the logistics warehouse and injection production workshop in the new facility have been completed and put into operation.

3. Eisai China Holdings Ltd.

Eisai established Eisai China Holdings Ltd. at Suzhou Industrial Park in November 2014, with a registered capital of 108.54 million U.S. dollars. The company successfully bought a domestic pharmaceutical enterprise in December 2015, and established Eisai (Liaoning) Pharmaceutical Co., Ltd., with a registered capital of 50 million yuan.

4. Eisai (Suzhou) Trading Co., Ltd.

Eisai established Eisai (Suzhou) Trading Co., Ltd. at the comprehensive bonded zone of the park in 2010, with a registered capital of 70 million yuan and mainly for wholesale of medicines. The company carried out business successfully, and its sales volume reached 285 million yuan in 2015.

5. Eisai (Liaoning) Pharmaceutical Co., Ltd.

Eisai China Holdings Ltd. signed an agreement with Liaoning Tianyi Biological Pharmaceuticals Co., Ltd. in November 2015, and Eisai China Investment Co., Ltd. purchased 100% of the shares of Liaoning Tianyi Biological Pharmaceutical Co., Ltd. Through this acquisition, Eisai will enter the generic pharmaceutical business in China in addition to expanding its existing business focused on new medicines. By further strengthening its business platform foundation established over 25 years of doing business in China and providing a stable supply of high quality generic pharmaceuticals, Eisai will be able to fulfill an even wider range of medical needs in China.

Eisai China donates medicines worth 144,000 yuan to the “Health for Rural Areas” program for three consecutive years

On May 19, 2016, Eisai China Inc. (hereinafter referred to as “Eisai China”) attended on invitation the “Health for Rural Areas” program which was jointly held by the Committee of Education, Science, Culture, Health and Sports of Chinese People’s Political Consultative Conference (CPPCC) and Chinese Hospital Association in Yuanling County, Huaihua City, Hunan Province, and donated to this program the medicines which are worth about 500,000 yuan and will be used for medical treatment and health purposes at local hospitals.?Statistics show that Eisai China has always upheld the spirit of?“hhc?(human health care)”, fulfilled its corporate responsibility, and donated medicines worth 450,000yuan?and 490,000 yuan respectively through the “Health for Rural Areas” programs in 2014 and 2015.

Eisai China donates medicines worth about 500,000 yuan to?the?“Health for Rural Areas” program

The “Health for Rural Areas” program is an important activity organized by the Committee of Education, Science, Culture, Health and Sports of CPPCC every year, and is a traditional activity that implements the regulations of CPPCC. The activity not only sends medical services, medicines, concepts, technologies and management to the grassroots units, but also helps the committee members and experts approach the mass. This accords with Eisai China’s concept of “hhc”, namely human health care. Eisai China calls on each of its employees to spend 1% of their working time fulfilling “hhc” with patients, and believes that only after they experience the feelings and pain their patients do can they provide better services, provide patients with what they really need, and let patients and their families trust the products and services provided by Eisai China. Led by the Board Chairman, Mr. Kaneko Norio and the General Manager, Ms. Feng Yanhui, Eisai China will continuously to give its love to the “Health for Rural Areas” program, and make its due contributions to the medical care cause in the poverty-stricken areas.

Eisai China Inc. gets the Certificate of Donation

This activity was chaired by Hu Shijun, Deputy Secretary of the Party committee of Yuanling County. A total of more than 300 persons, including Huang Jiefu, member of the Standing Committee of the Chinese People’s Political Consultative Conference (CPPCC), Fan Li, Zhao Ping, Wen Jianmin, Niu Zhongying and Yang Jinsheng who are CPPCC members, Zhang Wujun, Deputy Director of the Committee of Education, Science, Culture, Health and Sports of CPPCC, Xue Xiaolin, Vice President of Chinese Hospital Association, Wang Ling, Deputy Secretary of Chinese Hospital Association, Ouyang Bin, Vice-Chairman of Provincial Political Consultative Conference of Hunan, Zhang Jian, Director of Hunan Provincial Health and Family Planning Commission, Zhao Yingyun, Mayor of Huaihua City, Qin Daishou, Secretary of the Party Committee of Yuanling County, experts from Beijing, Changsha, etc., representatives of the donating enterprises, and staff members of Yuanling County People’s Hospital, attended this activity.

After the donation ceremony was over, the experts for the “Health for Rural Areas” program carried out activities in groups. They went into the wards of Yuanling County People’s Hospital and Hospital of Traditional Chinese Medicine to give guidance on medical technologies, gave free clinic services to the public, held technical seminars on treatment of cardiovascular diseases for the key medical staff of the county and town, and conducted surveys on rural medical construction at Mingxikou Township Hospital and Huangyangping Community Clinic.

EISAI RECEIVES POSITIVE CHMP OPINION ON NEW INDICATION FOR ANTICANCER AGENT HALAVEN? FOR TREATMENT OF ADVANCED LIPOSARCOMA

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its European regional headquarters Eisai Europe Ltd. (Location: U.K.) has received a positive opinion from the European Medicines Agency‘s Committee for Medicinal Products for Human Use (CHMP) on anticancer agent Halaven? (eribulin mesylate) for treatment of adult patients with unresectable liposarcomas who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease. Halaven is the first and only single agent to demonstrate an overall survival (OS) benefit in a Phase III trial in patients with advanced, recurrent or metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma). Following approval for use in the treatment of metastatic breast cancer in the EU, this marks the second indication for which Halaven has received a positive CHMP opinion based on a statistically significant extension of OS.

The CHMP‘s positive opinion is based on the results from Phase III study (Study 309) comparing the efficacy and safety of Halaven versus dacarbazine in 452 patients (aged 18 or over) with locally advanced or recurrent and metastatic soft tissue sarcoma (liposarcoma or leiomyosarcoma) who had disease progression following standard therapies which must have included an anthracycline and at least one other additional regimen. Halaven demonstrated a statistically significant extension in the study‘s primary endpoint of OS over the comparator treatment dacarbazine (Halaven median OS: 13.5 months vs dacarbazine median OS: 11.5 months; Hazard Ratio (HR) 0.77 [95% CI=0.62-0.95], p=0.0169). For patients with liposarcoma, Halaven demonstrated a significant improvement in OS over dacarbazine (Halaven, median OS: 15.6 months vs dacarbazine, median OS: 8.4 months; HR 0.51 [95% CI=0.35-0.75]).
In this study, the most common treatment-emergent adverse events (incidence greater than or equal to 25%) in patients treated with Halaven were fatigue, neutropenia, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia, which was consistent with the known side-effect profile of Halaven.

Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. Recent non-clinical studies showed that Halaven is associated with increased vascular perfusion and permeability in tumor cores. Halaven promotes the epithelial state and decreases the capacity of breast cancer cells to migrate. Halaven is currently approved for use in the treatment of breast cancer in approximately 60 countries including Japan and countries in Europe and the Americas. Halaven was approved in the United States for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen in January 2016, and was approved in Japan for the treatment of soft tissue sarcoma in February 2016. Halaven has been designated as an orphan drug for soft-tissue sarcoma in the United States and Japan.

Soft tissue sarcoma is a collective term for a diverse group of malignant tumors that occur throughout the soft tissue (fat, muscle, nerves, fibrous tissues and blood vessels). Approximately 29,000 patients in Europe are diagnosed with soft tissue sarcoma each year or about 1% of all cancers diagnosed in Europe. Liposarcoma is one of the most common forms of soft tissue sarcoma. As outcomes are poor for patients with advanced disease, it remains a disease with significant unmet medical need.

Through obtaining this additional approval, Eisai aims to enhance the clinical value of Halaven to contribute further toward addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.