Unit 2, 22nd Floor, Tower 6789, 6789 Ayala Avenue, Makati City

+63 28887 5160

HCP Portal Login
a

METOJECT® SUBCUTANEOUS INJECTION PEN (METHOTREXATE) PEN-TYPE AUTOINJECTOR APPROVED IN JAPAN

For Print (PDF)

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:

Eisai Co., Ltd.

 nippon medac Co., Ltd.

Public Relations Department
TEL：+81-(0)3-3817-5120

Tatsuya Otsuki
TEL：+81-(0)3-6661-6270

[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

Our Values

Values are an integral part of our foundation. With every decision, we ensure that we follow:

Integrity

Integrity is the living up to legal, moral and ethical principles in the conduct of HI-Eisai Pharmaceutical Inc. business. It means that each employee embodies the value of integrity, and therefore represents the company in honesty and rectitude in all the ways they do their work.

It is expected that each employee would make decisions guided by good judgement, not just for one‘s self, but for HI-Eisai as the company. An employee who acts with integrity ensures that he has understanding of the principles by which the company operates, and in situations where he lacks clarity, will actively seek guidance.

Respect

The company is committed to ensure that it maintains a safe, inclusive, and healthy working environment that promotes productivity among employees. All employees are expected to show respect to fellow employees, customers, and patients, regardless of differences in gender, culture, backgrounds, and beliefs. Leaders in the organization are likewise expected to promote inclusivity with their teams, and shall not tolerate any discriminatory and offensive actions.

Accountability

Accountability at work means assuming responsibility for the business outcome and how that is achieved. It means that every employee, in whichever position, are equally responsible for the decisions and actions they make for the company. It is likewise, the responsibility of each employee to report, any knowledge of misconduct or potential violation to the company‘s rules and regulations.

Patient-Centric

At the heart of the company‘s operation are the patients. This means that every decision to be made, considers the potential impact and benefit to the patients. As such, the company commits itself in ensuring that business objectives align with its principle of human health care or hhc. The programs created and implemented are based on how well they could contribute to improving patients‘ lives.

For field-based employees, being patient-centric means that the focus of engagements with customers are on understanding patient needs as well as providing these stakeholders with comprehensive information on how HI-Eisai‘s products can support their patients goals.

For each employee, being patient-centric means taking on their responsibilities with care and consideration on how it impacts the patients experience, be it by making relevant information readily available for the doctors; or by ensuring access and availability to the medicines we offer.

Excellence

As a patient-centric company, we define Excellence by the outstanding quality of our work to improve patients‘ lives. Each employee is expected to consistently demonstrate work ethics that align to our values, policies, and our desire to provide above standard service. The company is committed in ensuring that all actions are in compliance with legal requirements.

Being excellent means that every employee passionately strives to be better and participates in the company‘s initiatives to develop their members in terms of knowledge, skills, and behavior, which will support a continuously improving, responsible and performance-driven workforce.

Our Vision

To be a successful and sustainable business in the Philippines by driving innovation and providing solutions to address unmet healthcare needs fueled by high-performing employees who deliver meaningful value and experience to patients and their families.

Our Mission

We give first thought to patients and their families, and to increasing the benefits health care provides.

Unit 2, 22nd Floor, Tower 6789, 6789 Ayala Avenue, Makati City

+63 28887 5160