Takeda Presents Vedolizumab Data at European Crohn's and Colitis Organisation Congress

- 18 abstract presentations including vedolizumab safety and efficacy data

ZURICH, Feb. 20, 2015 /PRNewswire/ --Takeda Pharmaceuticals International GmbH ("Takeda") today announced the presentation of data further demonstrating the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn's disease (CD). Findings from the Phase 3 pivotal GEMINI 1 (ulcerative colitis) and GEMINI 2 (Crohn's disease) studies, as well as interim data from the ongoing, open-label extension study GEMINI LTS (long-term safety) were presented as oral digital presentations and poster presentations during the 10th Congress of European Crohn's and Colitis Organisation (ECCO) in Barcelona, Spain. A total of 18 Takeda-sponsored abstracts were accepted for presentation at the meeting.

"As ulcerative colitis and Crohn's disease are so complex to treat, ongoing scientific study and exchange are important to further understand the clinical benefits of vedolizumab," said Prof. Dr. Severine Vermeire, University Hospitals Leuven, Belgium. "These findings signify its promise as an important treatment option for patients."

The GEMINI 1 and 2 studies are two randomized double-blind, placebo-controlled induction and maintenance studies examining the efficacy and safety of vedolizumab for induction and maintenance in adult patients with moderately to severely active UC and CD, respectively. GEMINI LTS is a Phase 3, ongoing, open-label extension study examining the long-term safety and efficacy of vedolizumab for the treatment of adults with moderately to severely active UC and CD.

Key data presentations include:

Vedolizumab is a gut-selective humanized monoclonal antibody available in the United States and the European Union, under the trade name Entyvio (vedolizumab). It is the first and only biologic therapy to be approved in the European Union simultaneously for the treatment of adults with moderately to severely active UC or CD who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha antagonist.

"Ulcerative colitis and Crohn's disease can seriously impact those affected, and we are committed to supporting patients with an effective treatment option," said Dr. Michael Smyth, Global Brand Medical Director, General Medicine, Takeda Pharmaceuticals. "We are very pleased to have the opportunity to present this breadth of data at ECCO, further demonstrating that vedolizumab is a potential treatment option for this patient population and the healthcare professionals who treat them."

About ulcerative colitis and Crohn's disease Ulcerative colitis (UC) and Crohn's disease (CD) are marked by inflammation in the GI tract. UC impacts the large intestine only, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.

About Entyvio(vedolizumab)Vedolizumab, developed for the treatment of UC and CD, is a humanized monoclonal antibody that is designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1) and fibronectin, but not vascular cell adhesion molecule 1 (VCAM-1).MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

About Takeda Pharmaceuticals International GmbHHeadquartered in Zurich as a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Osaka, Japan, the Company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of R&D focus include central nervous system, cardiovascular and metabolic, gastroenterology, oncology, and vaccines.

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Takeda Presents Vedolizumab Data at European Crohn's and Colitis Organisation Congress