February 15, 2024
Eisai Co., Ltd.
nippon medac Co., Ltd.

METOJECT® SUBCUTANEOUS INJECTION PEN (METHOTREXATE)PEN-TYPE AUTOINJECTOR APPROVED IN JAPANEisai 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 fürklinische Spezialpräparate mbH (Headquarters: Germany, “medac GmbH”) announced today that they
have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour andWelfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumaticagent, 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 andimprove safety during self-injection. The drug can be self-injected in two steps (1- removing the cap, 2pressing the pen against the skin). The built-in needle cover prevents the needle from being seen prior toadministration 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 andmethotrexate 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
Public Relations Department
Eisai Co., Ltd.
TEL: +81-(0)3-3817-5120

Tatsuya Otsuki
nippon medac Co., Ltd.
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 isbelieved that MTX regulates cell growth by inhibiting folate metabolism in lymphocytes and other cells, and also hasan anti-inflammatory mechanism through the promotion of adenosine synthesis in vascular endothelial cells and othercells 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 countriesin 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 thebenefits 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 aglobal 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 workingto 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 ofpatients 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