|Friday, 10 May 2019, 12:34 HKT/SGT|
TOKYO, May 10, 2019 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has entered into a license agreement with medac Gesellschaft fur klinische Spezialpraparate mbH for the commercialization of its anti-rheumatic agent methotrexate (MTX) subcutaneous injection (pre-filled syringe) in Japan. Medac is marketing this product mainly in Europe and the United States.
Under the agreement, Eisai will obtain exclusive rights to market MTX subcutaneous injection in Japan. Medac will submit a manufacturing and marketing authorization application for the product after conducting a clinical study in Japan. Once approved, Eisai will distribute the product. In accordance with the agreement, Eisai will pay Medac an upfront payment as well as developmental and sales milestone payments.
MTX is used as the first-line option for the treatment of rheumatic arthritis. However, it is known that its bioavailability shows significant interindividual variability in oral administration.(1) MTX subcutaneous injection which Eisai is in-licensing from Medac, is administered once a week via subcutaneous injection and enables a high bioavailability to be maintained. Furthermore, MTX subcutaneous injection has been reported to have a lower intensity of some gastrointestinal side effects than the oral drug.(2),(3)
It is reported that there are approximately 700,000 - 800,000 rheumatoid arthritis patients in Japan.(4) Eisai markets the anti-rheumatic agents HUMIRA and Careram in Japan, and has a wealth of clinical data and experience in the field of rheumatoid arthritis. With the addition of MTX subcutaneous injection as the first choice for rheumatoid arthritis treatment to these existing products, it will be possible to make a major contribution to the patients in wider treatment stages for rheumatoid arthritis including the initial treatment.
By providing MTX subcutaneous injection as a new option for use in drug therapy for rheumatoid arthritis, Eisai will make further contributions to address the diversified needs of, and increase the benefits provided to, rheumatoid arthritis patients and their families.
About Methotrexate Subcutaneous Injection
Methotrexate (MTX) is positioned as the anchor drug for rheumatoid arthritis treatment.(5) 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. The subcutaneous formulation is administered once a week via subcutaneous injection, which enables a high bioavailability to be maintained. Furthermore, MTX subcutaneous injection has been reported to have a lower intensity of some gastrointestinal side effects than the oral drug.(2),(3)
Medac is a pharmaceutical company located in Wedel, Germany (suburbs of Hamburg), specialized in the treatment and diagnosis of oncological, urological and autoimmune diseases since 1970, and we are very much aware of the particular requirements of these fields. We take responsibility for our actions and all our expertise is geared to the provision of qualitatively perfect and reliable products for patients, doctors, laboratory personnel and hospitals.
For more information about Medac, please visit https://www.medac.de(New Window) (available in German only)
(1) Lebbe C, et al. Ann Rheum Dis 1994; 53(7) 475-477
(2) Rutkowska-Sak L, et al. Reumatologia 2009; 47 (4) 207-211
(3) Cipriani P, et al. Clin Ther 2014; 36(3) 427-435
(4) Report from Study Committee on Rheumatoid Arthritis and Allergy
(5) Japan College of Rheumatology, Clinical practice guideline of methotrexate for patients with rheumatoid arthritis: 2016 update version
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.
In its medium-term business plan EWAY2025, Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions), and is working on establishment of ecosystem platform business utilizing various data such as a large amount of clinical data, experiences, and know-how.
For more information about Eisai Co., Ltd., please visit https://www.eisai.co.jp.
Public Relations Department,
Eisai Co., Ltd.
May 10, 2019 12:34 HKT/SGT
Eisai (TSE: 4523)
Topic: Press release summary
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