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Biogen Receives Favorable Decision from Court of Justice of the European Union Relating to TECFIDERA® (dimethyl fumarate) Regulatory Data and Marketing Protection
CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in
About this update from Biogen Inc.
[{"type":"text","content":"CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced that the Court of Justice of the European Union decided in favor of Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of TECFIDERA® (dimethyl fumarate) because of TECFIDERA’s regulatory data and marketing protection. With this favorable decision, Biogen believes that TECFIDERA is entitled to regulatory marketing protection in the European Union until at least February 4, 2024. Biogen will seek to enforce this protection and continue to enforce its EP 2 653 873 patent related to TECFIDERA, which expires in 2028. Biogen’s Full Year 2023 Financial Guidance issued on February 15, 2023, assumed a favorable decision such as this in this case. About BiogenFounded 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. We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Twitter, LinkedIn, Facebook, YouTube. Biogen Safe Harbor This press release contains forward-looking statements, relating to: our regulatory data and marketing protection, our patent protection; our 2023 financial guidance; strategy and plans; potential of, and expectations for, and our commercial business and pipeline programs; These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “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...