by codm | Feb 20, 2024 | Newsletter
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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been selected for “Human Capital Leaders 2023” and “Human Capital Management Gold Quality” in the “Human Capital Survey 2023” jointly conducted by HR Technology Consortium, HR Research Institute (ProFuture Inc.) and MS&AD InterRisk Research & Consulting, Inc.
In the “Human Capital Survey 2023” (conducted between September and December 2023), 16 highly rated companies were selected for “Human Capital Management Gold Quality”, and 8 companies that were recognized by experts as having made particularly outstanding efforts were selected as “Human Capital Leaders 2023” out of approximately 500 participating companies and organizations. Eisai was highly evaluated for its unique initiatives, such as human capital management that is connected with its Articles of Incorporation, and straightforward communication on its social impact, as well as its proactive attitude on information disclosure including the use of its own performance indicators.
Eisai made a partial amendment to the Articles of Incorporation at an Ordinary General Meeting of Shareholders in 2022, adding “respecting human rights and diversity”, “providing full opportunities for growth to support self-fulfillment”, and “creating an employee-friendly environment” to “Ensuring stable employment”, which had previously been stipulated in it. The company has also reinforced its human resource initiatives, including the formulation of an “Integrated Human Resource Strategy”, with the pillars of “Wellbeing including health of employees”, “Diverse work style”, “Development and growth of employees”, and “Growth of the organization and businesses”, as well as introducing a compensation system based on employee roles in 2023, along with a personnel assessment system putting high value on employee actions with the aim of encouraging employees to grow autonomously and motivate them to serve in higher positions. Moreover, Eisai published the “Human Capital Report 2023” in July, 2023 that summarizes its human capital initiatives and KPI linked to its human resource strategies. Eisai promotes information disclosure regarding its initiatives on human capital management in its annual “Value Creation Report” and on its corporate website’s “Sustainability” section.
Eisai is seeking to provide impact to not only our shareholders, but various stakeholders throughout society including our customers and local communities by delivering new value to patients and the people in the daily living domain through the activities of our employees who are the only stakeholders who can directly contribute to our corporate concept, human health care.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
by codm | Feb 15, 2024 | Newsletter
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Eisai Co., Ltd.
nippon medac Co., Ltd.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and nippon medac Co., Ltd. (Headquarters: Tokyo, CEO: Hirohisa Iriyama, “nippon medac”), a subsidiary of medac Gesellschaft für klinische Spezialpräparate mbH (Headquarters: Germany, “medac GmbH”) announced today that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent, pen-type autoinjector “Metoject® Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL” (methotrexate). Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan.
This formulation incorporates the previously MHLW-approved Metoject Subcutaneous Injection pre-filled syringe formulation in a pen-type autoinjector and was developed to reduce the burden on patients and improve safety during self-injection. The drug can be self-injected in two steps (1- removing the cap, 2- pressing the pen against the skin). The built-in needle cover prevents the needle from being seen prior to administration and automatically locks after administration to prevent accidental skin puncture.
It is estimated that there are approximately 700,000 – 800,000 rheumatoid arthritis patients in Japan,1 and methotrexate is used as the first-line option for the treatment of rheumatic arthritis. Eisai and nippon medac are committed to delivering this treatment option to reduce the burden on patients with rheumatoid arthritis, and will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients.
Media Inquiries:
[Notes to editors]
1. About Metoject® Subcutaneous Injection Pen (methotrexate)
Methotrexate (MTX) is positioned as the anchor drug for rheumatoid arthritis treatment.2 For rheumatoid arthritis, it is believed that MTX regulates cell growth by inhibiting folate metabolism in lymphocytes and other cells, and also has an anti-inflammatory mechanism through the promotion of adenosine synthesis in vascular endothelial cells and other cells in synovial membranes. Metoject Subcutaneous Injection Pen will be the first self-administrable MTX subcutaneous injection pen-type autoinjector for rheumatoid arthritis in Japan. It is approved in more than 16 countries in Europe.
2. About Eisai
Eisai’s Corporate Concept is “to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides.” Under this Concept (also known as our human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, our continued commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), is demonstrated by our work on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai Co., Ltd.), and connect with us on X, LinkedIn and Facebook.
3. About nippon medac
nippon medac Co., Ltd. was established in April 2016 as the Japanese subsidiary of medac GmbH. We are working to develop new drugs that can expand treatment options for diseases for which therapeutic requirements have not yet been fully met. We will work diligently to deliver quality drugs as quickly as possible to improve the quality of life of patients and their families in areas with high medical need.
1 Report from Study Committee on Rheumatoid Arthritis and Allergy
http://www.mhlw.go.jp/stf/houdou/2r9852000001nfao-att/2r9852000001nfdx.pdf
2 Japan College of Rheumatology, Clinical practice guideline of methotrexate for patients with rheumatoid arthritis: 2016 updated version
by codm | Feb 1, 2024 | Newsletter
COMMENCEMENT OF DIRECT SALES OPERATIONS IN AFRICA, AND ESTABLISHMENT OF BRANCH OFFICE IN KENYA
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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that fully-fledged operations have begun at Eisai Pharmaceuticals Africa (Pty) Ltd (“Eisai South Africa”), a pharmaceutical sales subsidiary recently established in Johannesburg, South Africa, and direct sales operations and business activities have commenced in Africa. Eisai South Africa is a wholly-owned subsidiary of Eisai.
South Africa has a population of about 60 million, with the largest pharmaceutical market in Sub-Saharan Africa at 3.477 billion USD in 2022, exhibiting an average growth rate of 6% in local currency terms from 2018 to 2022.1 In 2017, Eisai started selling Eisai products in South Africa through local distribution partners, marketing anticancer drugs Halaven® and Lenvima®, and the antiepileptic drug Fycompa®. Eisai South Africa was established in May 2022, and took over the marketing authorization approvals for those products from the local distribution partners. Eisai South Africa has started sales and marketing activities directly for Lenvima and Fycompa from January 2024, as well as Halaven from February 2024. Additionally, the market launch of anti-insomnia drug Dayvigo® is planned for June 2024. Eisai South Africa plans to expand sales of these products to other Southern African Development Community (SADC) member states, such as Namibia, Botswana, Zambia, and Zimbabwe. Moreover, a regulatory filing for Alzheimer’s disease treatment LEQEMBI® in South Africa is scheduled in FY2023 ending March 31, 2024.
Kenya Branch, Eisai Pharmaceuticals Africa (Pty) Ltd (“Eisai Kenya”), established in October 2022 in Nairobi, Republic of Kenya, as a branch of Eisai South Africa, will expand access to new treatments such as Halaven and Fycompa in Kenya and other East African Community (EAC) countries, such as Tanzania and Uganda through local distribution partners. Eisai Kenya will also serve as a site for collaboration with research institutes, such as Drugs for Neglected Diseases initiative (DNDi), an important local partner in the global health field of Neglected Tropical Diseases (NTDs) and malaria, one of Eisai’s focus areas, and the Nagasaki University Institute of Tropical Medicine’s Kenya Research Station, to further expand networks of people and promote R&D and access to medicines.
With the rapid economic growth and improvement of the medical environment in Africa in recent years, the average life expectancy is increasing, and there is expected to be a growing demand for cancer and dementia treatments. Meanwhile, improving access to medicines for NTDs, which cause a vicious cycle of poverty and infectious diseases in endemic areas, potentially hindering economic growth, is also an imminent challenge. Seeking solutions to these challenges in Africa, Eisai will continue its initiatives to deliver necessary medicines to the patients who need them through Eisai South Africa and Eisai Kenya.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
[Notes to editors]
1. Outline of Eisai South Africa
1) Company Name: Eisai Pharmaceuticals Africa (Pty) Ltd
2) Location: Johannesburg, Republic of South Africa
3) Scope of Business: Import and marketing of pharmaceutical products
4) Charter Capital: 36.5 million rand (about 300 million JPY)
5) Shareholder: Eisai Co., Ltd.
6) Date of Establishment: May 18, 2022 (local time)
Outline of Eisai Kenya
1) Branch Name: Kenya Branch, Eisai Pharmaceuticals Africa (Pty) Ltd
2) Location: Nairobi, Republic of Kenya
3) Scope of Business: Import and marketing of pharmaceutical products, collaboration with partners and activities for SDGs (provisional)
4) Date of Establishment: October 3, 2022 (local time)
2. About the Pharmaceutical Market in South Africa
South Africa has a population of about 60 million and achieved a real GDP growth rate of 1.91% in 2022. The South Africa, the largest pharmaceutical market in Sub-Saharan Africa, was 3.477 billion USD in 2022 and has shown high average growth rate of 6% on its local currency basis from 2018 to 2022. 1 South Africa is assumed to have 15,491 newly diagnosed breast cancer patients, 2,435 liver cancer patients, and 1,305 thyroid cancer patients in 2020, 2 as well as almost 680,000 people affected by epilepsy. 3 The South African government is working to restructure its healthcare system, including the planned implementation of National Health Insurance (NHI) from 2012 to 2025, to ensure universal healthcare access to quality health services for all citizens.
3. About Eisai’s Commitment to Improving Global Access to Medicines
Eisai’s corporate concept is “to give first thought to patients and the people in the daily living domain, and to increase the benefits that health care provides to them”. Under this concept, Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. One social good that Eisai is focusing on is the elimination of NTDs, which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), with the aim of reducing healthcare disparities.
Since 2010, Eisai has been working on the elimination of lymphatic filariasis (LF), an NTD, through free provision of LF treatment and disease awareness with global partners such as the WHO and the Bill & Melinda Gates Foundation. Also, Eisai is moving ahead with new drug development projects targeting malaria and NTDs such as mycetoma and LF, based on partnerships with international non-profit organizations such as the Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV), as well as research organizations such as Liverpool School of Tropical Medicine, University of Kentucky, and the Broad Institute.
Furthermore, Eisai co-established the Global Health Innovative Technology Fund (GHIT Fund), Japan’s first public–private partnership to advance development of new health technologies for the developing world.
1 Created Based on IQVIA World Review Analyst 2023, Data Period 2018-2022 (Copyright ©2024 IQVIA.). Reprinted with permission.
2 Cancer Today (accessed on December 8, 2023)
3 Epilepsy & Behavior Volume 118, May 2021, 107910 “Epilepsy surgery in Africa: state of the art and challenges”
https://www.sciencedirect.com/science/article/pii/S152550502100144X
by codm | Jan 26, 2024 | Newsletter
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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has submitted a New Drug Application (NDA) for ultrahigh-dose mecobalamin (development code: E0302) for the indication of amyotrophic lateral sclerosis (ALS) to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan. In May 2022, ultrahigh-dose mecobalamin received orphan drug designation by the Ministry of Health, Labour and Welfare (MHLW).
This application is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), a Phase III trial to evaluate efficacy and safety of ultrahigh-dose methylcobalamin (mecobalamin) in early onset ALS patients, that was conducted as an investigator-initiated trial by a research team with Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University, and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, and Professor Satoshi Kuwabara (Coordinating Investigator), the Department of Neurology, Chiba University Graduate School of Medicine. The results of JETALS were published in the peer-reviewed journal JAMA Neurology
.
ALS is an intractable, progressive, neurodegenerative disease that results in severe muscle atrophy and weakness in the muscles due to motor neuron dysfunction. As the main cause of death is respiratory failure due to paralysis of the respiratory muscles, without the use of an artificial respirator, death occurs within approximately 3 to 6 years from the onset of the disease. The number of patients in Japan is estimated to be approximately 10,000. Currently, there is no curative treatment established for ALS, and since there are only limited number of medicines approved in Japan and abroad, this is a disease with significant unmet medical needs.
Eisai considers neurology a therapeutic area of focus. As a human healthcare company, Eisai is committed to fulfill unmet medical needs in neurology and further its contribution to improving the benefit of patients and the people in the daily living domain.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
[Notes to editors]
1. About Mecobalamin
Mecobalamin (generic name, development code: E0302) is approved and marketed as Methycobal®, a 500 µg injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency. Methycobal is also approved as a tablet formulation (250µg and 500 µg) as well as a fine granule formulation (0.1%) indicated for the treatment of peripheral neuropathies. While the mechanism of action of mecobalamin in amyotrophic lateral sclerosis (ALS) is not known, it has been suggested in non-clinical research that mecobalamin may have efficacy through a neuroprotective effect and regeneration of nerve axons. Since the 1990s, clinical research has been carried out on ultrahigh-dose mecobalamin in ALS by a study group on neurodegenerative disease, funded through the Ministry of Health, Labour and Welfare’s Specified Disease Treatment Research Program. Short- and long-term trials of intramuscular injection of mecobalamin at 25 mg and 50 mg per day, which is respectively 50 and 100 times the approved dosage of Methycobal, suggested that ultrahigh-dose mecobalamin could have a clinical effect in ALS. Therefore, Eisai had conducted the Phase II/III clinical trial (Study 761) since 2006 and submitted a new drug application for ultrahigh-dose mecobalamin as treatment for ALS in May 2015 but withdrew the application in March 2016 after the Pharmaceuticals and Medical Devices Agency (PMDA) indicated that additional clinical trials were necessary.
Following favorable clinical trial results in JETALS, Eisai prepared to file a new drug application for ALS in Japan.
by codm | Jan 18, 2024 | Newsletter
ADDRESSING MEDICAL NEEDS FOR TREATMENT THROUGH A NON-ORAL ADMINISTRATION ROUTE
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Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has obtained marketing authorization approval from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa® (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible.
Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation. Due to concern about the risks of seizures associated with interruption of administration when the drug cannot be taken orally temporarily, such as during surgery, it is suggested that epilepsy patients should continue treatment via routes other than oral administration.
Since Fycompa is the only AMPA receptor antagonist-based AED, Eisai developed this injection formulation to meet the needs of patients who are unable to use oral administration, and filed a supplementary new drug application as a new route of administration in August 2022, leading to this approval.
Eisai considers neurology, including epilepsy, a therapeutic area of focus. As a human health care company, Eisai pursues its mission to provide “seizure freedom” to a greater number of patients with epilepsy. Eisai remains committed to further addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
[Notes to editors]
1. About perampanel (product name: Fycompa)
Perampanel is a first-in-class anti-epileptic agent (AED) discovered and developed by Eisai. With epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Perampanel is currently approved in more than 75 countries and territories, including Japan, China, and other countries in Europe and in Asia as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. In addition, perampanel has been approved in more than 70 countries, including Japan, in Europe and in Asia for treatment as an adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In Japan and China, perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. In Europe the approved age range is 4 years of age and older for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) and 7 years of age and older for the treatment as an adjunctive therapy for primary generalized tonic-clonic seizure. A tablet, fine granule formulation and injection formulation have been approved in Japan. An oral suspension formulation and tablet have been approved in Europe and China. In January 2023, the commercial rights in the United States were transferred to Catalyst Pharmaceuticals, Inc.
2. About Epilepsy
Epilepsy is broadly categorized by seizure type, with partial-onset seizures accounting for approximately 60% of epilepsy cases and generalized seizures accounting for approximately 40%. In a partial-onset seizure, an abnormal electrical disturbance occurs in a limited area of the brain, and may subsequently spread throughout the brain, becoming a generalized seizure (known as a secondarily generalized seizure). In a generalized seizure, abnormal electrical disturbances occur throughout the brain, and can be followed by a loss of consciousness or physical symptoms manifested throughout the whole body.
Epilepsy affects approximately 1 million people in Japan, 3.4 million people in the United States, 6 million people in Europe, 9 million people in China, and approximately 60 million people worldwide. As 30-40% of patients with epilepsy are unable to control their seizures with currently available AEDs,* this is a disease with significant unmet medical needs. Although onset occurs at any age, onset is most common in people aged 18 and younger and the elderly. As causes and clinical symptoms of pediatric epilepsy are not uniform, and prognoses can range from very positive cases to obstinate cases, special consideration for each patient is required of treatments.
* “The Epilepsies and Seizures: Hope Through Research. What are the epilepsies?” National Institute of Neurological Disorders and Stroke, accessed September 2018,
https://catalog.ninds.nih.gov/sites/default/files/publications/epilepsies-seizures-hope-through-research.pdf
by codm | Jan 17, 2024 | Newsletter
HIGHEST RANKED GLOBAL PHARMACEUTICAL COMPANY
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. This marks Eisai’s eighth inclusion on the list. Ranked 35th, Eisai is the highest ranking company among global pharmaceutical companies. Also, Eisai became the highest ranking Japanese company among the three Japanese companies listed in the Global 100 (please visit here for the Global 100 ranking).
The Global 100 evaluates the sustainability of more than 6,700 of the world’s major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance). Since 2005, those companies ranking among the top 100 in the world have been announced each year. The Global 100 is based on up to 25 key performance indicators covering ESG initiatives, with the evaluations carried out based on data publicly disclosed in financial filings, integrated reports, or through other such channels. Eisai was highly evaluated, particularly in indicators for reducing greenhouse gas emissions, and enhancing employee value such as safe work environment, sick leave support system and employee retention rate.
Eisai’s corporate concept is to give first thought to patients and the people in the daily living domain, and increase the benefits that health care provides to them as well as meet their diversified healthcare needs worldwide. Based on this human health care (hhc) corporate concept, Eisai is striving to sustainably enhance corporate value by strengthening its ESG initiatives and increasing non-financial value.
Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120
