Eisai Co. Ltd.

Stock Exchange: XTKS • Ticker: 4523 • HQ: Tokyo, Japan • Employees: 9,877 (consolidated)

Ranking by technical area
Ranking by strategic pillar

Performance

Eisai remains 11th. It improves modestly across all areas, but is outperformed by peers. It is among the leaders in Market Influence & Compliance, with no settlements relating to unethical behaviour. It also improves in R&D, conducting a higher portion of relevant R&D through partnerships than any other. Many of these partnerships are based on terms for ensuring access. Eisai drops in pricing, however, as it makes no disease-specific commitment to registering new products in countries in scope, nor does it use intra-country equitable pricing for products in scope. Eisai has not licensed relevant products, nor published patent statuses. Eisai’s donations for lymphatic filariasis (LF) reach a significant number of beneficiaries. It continues to build capacity in all areas of the value chain, albeit through a relatively low number of activities.

Change since 2014

Maintains a comprehensive access-to-medicine strategy.

Takes a strong approach to stakeholder engagement, with a best-practice model for creating insight through stakeholder interaction.

Has received no negative judgements concerning unethical behaviour.

Has published its policy on clinical trial data transparency, and now provides researchers with access to anonymised patient-level data.

Has applied inter-country equitable pricing strategies to more products than in 2014.

Commits to not enforcing its patents in Least Developed Countries, low-income countries, or Low Human Development countries.

Continues to work toward the elimination of lymphatic filariasis through its donation programme.

Opportunities

Partner to build capacity in response to local needs. Eisai can build on its experience with partnerships in other areas (e.g., its best-practice approach to R&D collaborations) to expand and enhance its capacity building activities within the pharmaceutical value chain, by working with partners to understand and target local needs.

Set registration targets for key diseases. Eisai can set disease-level registration targets for low- and middle-income countries. This will help ensure people in those countries gain early access to high-need products. The company can also register existing products in more countries with high burdens of disease.

Expand and strengthen R&D in partnership. Eisai can expand its collaborative R&D activities to more disease areas, building upon the strong public health rationale already informing its R&D activities for neglected tropical diseases (NTDs), and recognising additional priorities set by global health stakeholders. The company can also ensure access-oriented terms are systematically included in its R&D partnership agreements.

Expand access approach to mental health products. Eisai can expand its approach for improving access to mental health products that are needed in low and middle income countries (e.g., escitalopram (Es.O.K.®), and amoxapine (Defanyl®)). The company can also implement intra-country equitable pricing strategies in countries with high inequality and/or high out-of-pocket spending (e.g., Afghanistan, Cambodia, Mexico, India).

Expand pro-access approach to filing for and enforcing patents. Eisai can expand its pro-access approach to filing for and enforcing patents in Least Developed Countries, low-income countries, or Low Human Development countries. Eisai can do this by publishing its approach to voluntary licensing and its use as a mechanism to support affordability and supply. To complement this approach, Eisai can publicly disclose the status of its patents, clearly showing where products are on and off patent, and when patents are due to expire.

Sales and operations

Eisai operates through two segments, with its pharmaceuticals business offering prescription pharmaceuticals, consumer healthcare and generic medicines. Eisai divested its diagnostics business in November 2015. The company’s focus areas are oncology and neuroscience, including neurodegenerative and neurological disorders.

Eisai currently has sales in 26 countries in the Index scope. However, sales are limited in countries outside Japan and the US.

Sales in countries in scope
Sales by division
Sales by region

Portfolio and pipeline

Eisai has a small portfolio of relevant products, of 12 medicines in total, and a mid-sized pipeline of projects that address the needs of people in countries in scope, with 14 R&D projects in total.

The majority of Eisai’s relevant medicines target non-communicable diseases (NCDs). These are mainly mental health conditions and neurological disorders: anxiety disorder; bipolar affective disorder; epilepsy; migraine; and unipolar depressive disorders.

Products per disease category

Eisai’s medicines target non-communicable diseases, mainly mental health conditions and neurological disorders, specifically epilepsy.

Compared with 2014, the company has a number of new medicines in development, targeting a wide range of diseases: epilepsy; malaria; lymphatic filariasis; onchocerciasis; Chagas disease; and leishmaniasis. It also has projects targeting influenza. Its projects for malaria and NTDs target high-priority product gaps with low commercial incentive.

Pipeline projects

Eisai has R&D partnerships in all its disease areas, except epilepsy. Many involve the Global Health Innovative Technology Fund (GHIT), which requires reasonable prices in low-income countries or royalty-free licences.

First-line treatments and essential medicines

Three medicines, all off-patent, are listed on the WHO EML and/or as first-line treatments: valproate (Val.O.K.®), escitalopram (ES.O.K.®) and diethylcarbamazine citrate (DEC).

Pipeline by stage of development
– Innovative medicines and vaccines

Eisai’s R&D focus is on innovative medicines. One of its medicines in clinical development is the oral anti-malarial candidate compound SJ733, a non-artemisinin-based therapy with the potential to cure in a single dose.

Pipeline by stage of development
– Adaptive medicines and vaccines

Eisai is collaborating to develop a fixed-dose combination (FDC) of benznidazole and E1224 for Chagas disease. This project involves multiple access plans, including a no-profit, no-loss policy.

Please refer to the pdf of the report card (that can be downloaded here) for information on Eisai’s performance per technical area.

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