OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") today issued the following statement with regard to its discussions with the European Commission ("EC") as part of its Phase 1 review of the proposed acquisition of Shire plc ("Shire") announced on May 8, 2018 (the "Acquisition"):
Takeda confirms that it is in discussions with the EC in relation to the future potential overlap in the area of inflammatory bowel disease between Takeda's marketed product Entyvio (vedolizumab) and Shire's pipeline compound SHP647, which is currently in Phase III clinical trials, and has proposed a remedy of a potential divestment of SHP647 and certain associated rights.
The company remains committed to Entyvio, which has been granted marketing authorization in more than 60 countries and is the cornerstone of Takeda's diverse specialty gastrointestinal portfolio.
Takeda confirms that there are no discussions with the EC regarding any other marketed products or assets in the pipeline.
Takeda does not anticipate that its discussions with the EC will result in a delay to its previously announced timetable for completion of the transaction. A further announcement will be made as appropriate.
The Acquisition remains subject to certain other conditions, including receipt of the remaining regulatory clearances and approval by the shareholders of both companies.
About Entyvio® (vedolizumab)
Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation.1 It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).2 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.3 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.14 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn's disease (CD).4 5 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.
Vedolizumab IV is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. Vedolizumab IV has been granted marketing authorization in over 60 countries, including the United States and European Union, with over 200,000 patient years of exposure to date. 6
Therapeutic Indications
Ulcerative colitis
Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.
Crohn's disease
Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.
Important Safety Information
Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and special precautions for use
Vedolizumab should be administered by a healthcare professional equipped to manage hypersensitivity reactions, including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab. Observe all patients during infusion and until the infusion is complete.
Infusion-related reactions
In clinical studies, infusion-related reactions (IRR) and hypersensitivit...
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