- For Print
- March 2, 2023
Biogen Japan Ltd.
Eisai Co., Ltd.
Biogen Japan Ltd. (Headquarters: Tokyo, President and Representative Director: Takatsugu Den, “Biogen Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today the termination of the co-promotion agreement that has been in place since January 2018 for Biogen Japan's multiple sclerosis (MS) treatments TECFIDERA® (dimethyl fumarate), TYSABRI® (natalizumab, genetic recombinant) and AVONEX® (interferon beta 1a, genetic recombinant) in Japan as of March 31, 2023.
The two companies have been jointly engaged in promotional activities for MS treatments in Japan. However, since a certain objective has been achieved regarding penetration of the products into the Japanese market, the two companies decided to terminate this co-promotion agreement. As a result, Biogen Japan will have full responsibility for all operations related to the products after a transition period between the two companies. Upon termination of this agreement, Biogen will pay Eisai 31 million USD.
The termination of this co-promotion agreement does not impact any of the other agreements between Biogen and Eisai.
Biogen Japan Ltd.
Public Relations & CSR Department
Eisai Co., Ltd.
Public Relations Department
[Notes to editors]
1. About Multiple Sclerosis Treatments TECFIDERA, TYSABRI and AVONEX
TECFIDERA (dimethyl fumarate) is an orally-administered medicine for the treatment of relapsing forms of multiple sclerosis, including relapse-remitting multiple sclerosis, the most common type of multiple sclerosis. TECFIDERA was approved in Japan for the prevention of relapse and for delaying the accumulation of physical disability in multiple sclerosis in December 2016, and was launched in February 2017. First approved in 2013 in the United States, TECFIDERA has been approved in over 54 countries. TECFIDERA is widely used in the United States and countries in Europe as a first-line treatment, and the number of patients who have been treated with TECFIDERA worldwide to date reached 250,000.
TYSABRI (natalizumab, genetic recombinant) is a humanized monoclonal anti-α4 integrin antibody and a disease modifying drug. TYSABRI was approved in Japan for the prevention of relapse and delaying the accumulation of physical disability in multiple sclerosis in March 2014, and was launched in June of the same year. TYSABRI has been approved in over 77 countries worldwide including the United States and countries in Europe, and the number of patients who have been treated with TYSABRI worldwide reached 167,000.
AVONEX (interferon beta 1a, genetic recombinant) was approved in Japan for relapse prevention of multiple sclerosis in July 2006, and was launched in November of the same year. In December 2013 a pen formulation was approved and subsequently launched in June 2014.
2. About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer’s disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable and equitable world.
Biogen Japan is a subsidiary of Biogen in the U.S. Biogen Japan, as the Japanese affiliate of one of the oldest independent biotechnology companies, started its operation in Japan in 2000. To learn more about Biogen Japan, please visit https://www.biogen.co.jp/.
3. 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 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, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), with working on various activities together with global partners.
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about Biogen Japan’s promotional activities in Japan with respect to MS products; the anticipated benefits and potential of Biogen’s termination of the co-promotion; collaboration arrangements with Eisai; the potential of Biogen’s commercial business and pipeline programs; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from transition of co-promotion to Biogen Japan; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.