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 inter-individual 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.