On September 20, 2020, the “2020 ADS Summit” (ADS: Advance Dementia Science) hosted by Eisai China Inc. was successfully held. Featuring the theme of “Run into the next decade”, the summit was made up of one main venue (online) and four sub-venues (offline) in Beijing, Shanghai, Guangzhou and Chengdu. Famous experts from China, Japan and South Korea and nearly 1,000 guests online and offline made exchanges on the frontier progress of dementia and cognitive disorders. The ADS Summit is another doctor information exchange platform built by Eisai China Inc, and is in the third session since it was first held in 2018.

At the beginning of the summit, Ms. Yanhui Feng, senior Vice President of Eisai Global and President of Eisai China Inc., delivered a speech at the main venue. Ms. Feng gave a warm welcome to all the experts and guests to the 2020 ADS Summit and sincerely thanked them for their strong support to the summit. Eisai China Inc. will devote itself to building an academic exchange platform for cognitive disorders and continue to increase research and development of new drugs in this field. At the same time, adhering to its business philosophy of?hhc?(human health care), it will work hand in hand with all walks of life to make contributions in disease cognition, prevention and control, patient care and other aspects.

Feng Yanhui delivered a speech at the main venue (online)?

At this summit, Prof. Jianping Jia from Xuanwu Hospital of Capital Medical University was invited as the chairman of the summit. Prof. Jia expressed thanks to Eisai China Inc. for setting up such an academic exchange platform that allows Chinese, Japanese and Korean experts and participants to share academic frontier progress and clinical practice, and wished the summit a complete success.

After that, Prof. Yeon-Sil Moon from the Affiliated Hospital of Konkuk University in South Korea and Prof. Kenjiro Ono from the Affiliated Hospital of Showa University in Japan brought the topics of “The Most ‘IN’ AD Biomarkers and Applications” and “New drugs for AD are braving the wind and wave” respectively, sharing their professional and in-depth insights with online and offline audiences.

At the sub-venues in Beijing, Shanghai, Guangzhou and Chengdu, the hot issues and key topics about dementia and cognitive disorders, such as “2020 AAIC Hot Issues” and “AD Whole-Process Management”, were set. In the “Expert Sofa Show”, a number of experts in the field also made wonderful and valuable comments and hot discussions on topics such as “AD Risk Factors and Prevention Guidelines”, “Prospects and Future of AD Treatment”, and “How to Conduct Whole-Process Management of AD”. The atmosphere at the scene was warm.

Prof. Jianping Jia Chairman of the Summit (left), and Mr. Jianzhong Zhang, Vice President of Eisai China Inc. delivered speeches

This summit showed warmly online and offline interaction, and experts and scholars in this field from various regions gathered together, sharing the latest academic frontier progress and clinical practice experience.

Sub-venues in Beijing, Shanghai, Guangzhou and Chengdu (offline)?

The statistics of the Alzheimer’s Disease International (ADI) in 2019 show that the number of dementia patients in the world has exceeded 50 million, and it is estimated that the number of dementia patients will increase to 152 million by 2050, with one new patient every 3 seconds. In China, the number of dementia patients has exceeded 10 million, and the average survival time of patients is only 5.9 years. However, despite the huge demand for clinical treatment, the pathogenesis of AD is not clear at present, and most of the existing drugs on the market can only relieve symptoms. There is no effective drug to reverse or prevent the progression of the disease so far. Moreover, many international clinical trials on AD drugs have failed. Therefore, it is still necessary to increase efforts in the research and development of AD therapeutic drugs.

Alzheimer’s disease is a disease that Eisai has been paying close attention to for a long time. Eisai not only introduced donepezil into China and facilitated its inclusion into the medical reimbursement system, but also invested in the research and development of new drugs on a long-term basis. Eisai China has always adhered to its business philosophy of?hhc?(human health care), and has brought rich experience that it has gained in other markets around the world to the Chinese market. During the 20 years of its development in China, it has joined forces with all walks of life and enhanced people’s attention to and correct understanding of Alzheimer’s disease in the whole Chinese society, and benefited patients and their families by carrying out science popularization activities, such as the “Remember I Love You” Alzheimer’s disease philanthropy campaign, “Yellow Bracelet Campaign”, “Memory Clinic”, and “Cognitive College”, etc..

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a series of abstracts will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from September 19 to 21, 2020. The abstracts highlight updates regarding Eisai’s in-house discovered LENVIMA^??(lenvatinib mesylate, the orally available kinase inhibitor, “lenvatinib”), Halaven^??(eribulin mesylate, halichondrin class microtubule dynamics inhibitor, “eribulin”) and its liposomal formulation.

There will be two oral presentations regarding the combination therapy of lenvatinib and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside of the United States and Canada)’s anti-PD-1 antibody, KEYTRUDA^??(pembrolizumab). Both of these presentations have been selected as Late-Breaking Abstracts. The interim results of the phase 2 study (LEAP-004) in advanced melanoma which had been treated with an anti-PD-1 or PD-L1 antibody (Abstract No: LBA44), as well as the interim results of the basket-type phase 2 study (LEAP-005) for 6 types (triple-negative breast cancer, ovarian cancer, gastric cancer, colorectal cancer, glioblastoma, and biliary tract cancer) of previously treated, advanced solid tumors (Abstract No: LBA41) will be presented.

There will also be an e-poster presentation (Abstract No: 346P) on the expansion cohort of HER2-negative breast cancer in a phase 1 study evaluating the eribulin liposomal formulation (E7389-LF) which aims to realize the efficient delivery to tumors.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, 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.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.

 

Oral Presentations*:

*Late Breaking Abstracts will be available on demand via ESMO’s website on September 19.

 

E-poster Presentations**:

**Abstracts and e-posters will be available on demand via ESMO’s website on September 14 and 17 respectively.

 

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

 

[Notes to editors]

1. About the Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Strategic Collaboration
In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., known as MSD outside the United States and Canada, through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of LENVIMA. Under the agreement, the companies will jointly develop, manufacture and commercialize LENVIMA, both as monotherapy and in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.’s anti-PD-1 therapy KEYTRUDA.

In addition to ongoing clinical studies evaluating the LENVIMA plus KEYTRUDA combination across several different tumor types, the companies have jointly initiated new clinical studies through the LEAP (Lenvatinib And Pembrolizumab) clinical program and are evaluating the combination in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer) across 19 clinical trials.

 

2. Eisai’s Focus on Cancer
Eisai focuses on the development of anticancer drugs, targeting the tumor microenvironment with experience and knowledge from Halaven and Lenvima and the driver gene mutation and aberrant splicing leveraging RNA Splicing Platform as areas (Ricchi) where real patient needs are still unmet, and where Eisai can become a frontrunner in oncology area. Eisai will discover innovative new drugs with new targets and mechanisms of action from these Ricchi, and aims to contribute to curing cancers.

KEYTRUDA^??is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

The 7th “Award Ceremony for 2020 Greater Suzhou Best Employer and Employer Brand Forum” was grandly held in the Studio of Suzhou Radio and Television General Station recently. Eisai China Inc. stood out among thousands of participating enterprises with its good employer brand image, excellent performance of employer social responsibilities and excellent employee engagement, and has been awarded the “Greater Suzhou Best Employer” award for four consecutive years.

Eisai China Inc. wins “Greater Suzhou Best Employer” award for four consecutive years

The “Greater Suzhou Best Employer” project has been held for 7 consecutive years since 2013. The selection of the best employers in 2020 underwent four processes: expert review, employee survey, public voting and brand diagnosis, which lasted for three months. More than 200 entrepreneurs and human resources professionals in Suzhou witnessed the birth of the “2020 Greater Suzhou Best Employer”. The “Greater Suzhou Best Employer” project is the most influential and appealing employer brand and selection activity in Suzhou at present, and has become the annual employer brand display ceremony in Suzhou. It has won this heavyweight trophy for four consecutive years, which represents the great recognition and affirmation of its years of devotion to its employer brand by the expert jury, society and employees.

Photo of Eisai China Inc. at scene of award ceremony

 

Since its entry into Suzhou Industrial Park in 1996, Eisai China Inc. promotes tens of pharmaceutical brands in China, specializing in neurology, oncology and gastrointestinal areas, and has been rooted in Suzhou Industrial Park for 24 years. It has always adhered to its business philosophy of?hhc?(human health care), provided Chinese doctors with medical treatment support, and provided patients and their families with high-quality, environmentally friendly, safe and satisfactory products and services. It requires every employee to devote 1% of their working time to?hhc?activities every year, walk into communities together, approach patients, listen to the voices of patients and their families, and understand their sufferings, so as to better meet their needs.

It always regards the improvement of employees’ ability as one of its long-term strategies. In order to enhance the sense of belonging of employees and strengthen the corporate cohesiveness, the “Honorary Staff Award” has been set up for employees who have served the company for 5, 10, 15 and 20 years respectively. The enhancement of employees’ ability and loyalty is the greatest reward and affirmation for an enterprise. It attaches importance to the personal value of each employee, and through the skill development system, it gives employees systematic training paths and clear development channels, and encourages everyone to solve problems with innovative thinking. Meanwhile, it offers competitive remuneration and welfare, and provides employees with comprehensive care and protection. It is committed to providing a healthy and happy working environment for its employees and hopes to work with them to build itself into a respectable?hhc?company.

On August 30, 2020, “the 37^th?China Pharmaceutical Industry Information Annual Conference2020″ hosted by China Pharmaceutical Industry Information Center was held in Zhuhai, Guangdong Province, and the conference released the list of the Top 100 Pharmaceutical Enterprises in China in 2019, which attracted much attention from the industry. Eisai China Holdings Ltd. (hereinafter referred to as “Eisai China”) ranked the 71st, being on this list for five consecutive years. The ranking has risen from the 97th in 2015 to the 71st in 2019, manifesting the strong development of Eisai China in recent years.

Eisai China ranks 71st in list of Top 100 Pharmaceutical Enterprises in China

With the theme of “innovation power”, this conference focused on the thoughts and explorations of new paths of innovation and development of Chinese medicine in the post-Covid19 period. The list of Top 100 Pharmaceutical Enterprises in China reflects the economic operation of China’s pharmaceutical industry, in which enterprises are ranked according to the annual Chinese pharmaceutical statistics report published by the Ministry of Industry and Information Technology. The entry threshold of the Top 100 in 2019 was increased from 2.61 billion yuan in 2018 to 2.86 billion yuan. According to the statistics and analysis of China Pharmaceutical Industry Information Center, the top 100 enterprises in 2019 continued their consistent strong growth momentum, with their main business income reaching 929.64 billion yuan, up by 10.7%. Driven by the leading role of the top 100 enterprises, the pharmaceutical industry enterprises have maintained strong revenue capacity and sufficient development momentum. The list of Top 100 Pharmaceutical Enterprises in China can stimulate the innovative impetus of more enterprises, drive more enterprises to transform and upgrade, and promote the high-quality development of China’s pharmaceutical industry.

Ms. Rao Ying from Access Management Division of Eisai China received the award on behalf of the Company

Eisai China has been developing smoothly since it entered the Chinese market in the early 1990s. It has set up Shenyang Eisai Pharmaceutical Co., Ltd and Eisai (Suzhou) Pharmaceutical Co., Ltd. since 1991, and was officially renamed Eisai China Inc. in 2002. With the business development in China, Eisai (Suzhou) Trade Co., Ltd. was established in 2010, Eisai Holdings Ltd. was established in 2014, and Eisai (Liaoning) Pharmaceutical Co., Ltd. was officially established in 2015 through full acquisition of local generic pharmaceutical enterprises. So far, a development mode has been formed, consisting of Eisai China Holdings Ltd. for capital control and management, while Eisai China Inc., Eisai (Liaoning) Pharmaceutical Co., Ltd. and Eisai (Suzhou) Trading Co., Ltd. for business support. In November 2018, the new factory in Suzhou of Eisai China was opened for business. It is one of the main factories of the group, and the products it produces will not only meet the demand of the Chinese market, but also be supplied to 23 countries and regions such as East Asia, Southeast Asia, Middle East, Central and South America and Europe. Eisai China’s sales have been among the highest among the Japanese-funded pharmaceutical companies in China for more than 10 consecutive years.

Eisai China will always uphold its business philosophy of?hhc?(human health care) and provide patients and their families with high-quality, environmentally friendly, safe and satisfactory products and services. Hopefully Eisai China can work with all its employees to build itself into a respectable?hhc?company.?

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a total of 10 presentations including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGOTM CIV) will be given at the 34th annual meeting of the Associated Professional Sleep Societies (SLEEP 2020), to be held virtually from August 27 to 30, 2020.

The main presentations from Eisai at this conference include presentations relating to the SUNRISE 2 Phase III clinical trial conducted globally, including sites in Japan: long-term efficacy and safety results of lemborexant in elderly adults with insomnia (oral presentation, presentation number O-01, 474), responder profiles on treatment with lemborexant (poster number 479), efficacy and safety results of lemborexant in perimenopausal female subjects with insomnia (poster number 480), and others.

Lemborexant is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). Lemborexant acts on the orexin neurotransmitter system and is believed to facilitate sleep onset, sleep maintenance, and wake by regulating sleep-wake rhythms. Lemborexant was approved in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, and was approved in Japan for the treatment of insomnia. The clinical development of lemborexant in patients with Irregular Sleep Wake Rhythm Disorder (ISWRD) associated with mild-to-moderate Alzheimer’s dementia is ongoing.

Insomnia is characterized by difficulty falling asleep, staying asleep, or both, despite an adequate opportunity to sleep, that can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.^1,2?Insomnia is one of the most common sleep-wake disorders. Approximately 30% of adults worldwide have symptoms of insomnia.^3,4?In particular, older adults tend to have a higher prevalence rate with many experiencing insomnia symptoms for months to years. As a result, insomnia causes various social losses, such as long absences and reduced productivity.

Eisai positions neurology as a key therapeutic area, and it will continue to create innovation in the development of new drugs based on cutting-edge neurology research as it seeks to contribute further to improving the benefits of patients and their families in diseases with high unmet needs, such as insomnia.

 

■?Virtual Oral Presentation:

? ??

■ Virtual Poster Presentation:

 

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120

 

[Notes to editors]

1. About Lemborexant

Lemborexant is Eisai’s in-house discovered and developed small molecule that binds to orexin receptors, OX1R and OX2R, and acts as a competitive antagonist (IC50 values of 6.1 nM and 2.6 nM, respectively). The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin to receptors OX1R and OX2R is thought to suppress wake drive (Ki values of 8.1 nM and 0.48 nM, respectively). Higher affinity and faster on/off receptor kinetics of lemborexant to orexin receptor 2, which also suppresses non-REM sleep, indicates its potential to facilitate non-sedative onset and maintenance of sleep. In June 2020, DAYVIGO was launched in the U.S. for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance; and in July 2020, DAYVIGO was launched in Japan for the treatment of insomnia. In addition, Eisai has submitted new drug applications seeking approval of DAYVIGO in Canada, Australia and HKSA. In addition, a Phase II clinical study of lemborexant in patients with Irregular Sleep Wake Rhythm Disorder (ISWRD) associated with mild-to-moderate Alzheimer’s dementia is underway.

 

2. About SUNRISE 2（Study 303）

SUNRISE 2 is a 12-month multicenter, global (Japan, North America, South America, Europe, Asia, and Oceania), randomized, placebo-controlled, double-blind, parallel group Phase III study of 949 male or female adult participants (18 to 88 years of age) with insomnia disorder. SUNRISE 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of only active treatment, and a two-week period without treatment prior to the end-of-study-visit. Lemborexant 5 mg, 10 mg or matching placebo was taken orally in tablet form at home each night immediately before the patient intended to try to sleep for the first six months of study. Patients who received placebo during the first six-month period were administered lemborexant 5 mg or 10 mg for the second six-month period. Patients who received active treatment during the first period continued on the treatment to which they were originally randomized.

The primary outcome measure was mean change from baseline in subjective sleep onset latency after six months of placebo-controlled treatment. Key secondary outcome measures were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset after six months of placebo-controlled treatment.

From the results, the primary endpoint and all secondary endpoints for efficacy were achieved for lemborexant arms, and statistically significant improvements in sleep onset and sleep maintenance were confirmed for lemborexant? arms compared to placebo during the six-month treatment period. The common adverse events in the lemborexant arms were somnolence, nasopharyngitis, headache and influenza.

 

¹?Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
²?Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
³?Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.
⁴?Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10.