FOR MEDICAL MEDIA

Takeda Presents Vedolizumab Data at the 2015 American College of Gastroenterology (ACG) Annual Meeting and United European Gastroenterology Week (UEGW)

Patient reported outcomes, vedolizumab efficacy and safety data and comparative cost-effectiveness studies are among 20 abstract presentations

Osaka, Japan, October 19, 2015 – Takeda Pharmaceuticals Company Limited [TSE: 4502],(“Takeda”) today announced that data on the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD), will be presented during the 2015 American College of Gastroenterology (ACG) Annual Scientific Meeting in Honolulu, Hawaii, held on October 16-21, and during the United European Gastroenterology Week (UEGW) annual meeting, which takes place in Barcelona, Spain from October 24-28.

Eleven Takeda-sponsored posters, as well as one oral presentation entitled ‘Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan, Siegel, Melmed, et al.), will be featured during the ACG meeting. Data presented during the UEGW meeting will highlight findings from an analysis of the cost-effectiveness of vedolizumab as a treatment for UC compared with conventional therapy in the United Kingdom, as well as results from a multinational survey investigating indicators of suboptimal therapy among UC and CD patients treated with tumor necrosis factor antagonists (TNF-α).

Vedolizumab was approved in the European Union on May 27, 2014, under the trade name Entyvio® (vedolizumab). Entyvio is also available in the United States (U.S.) following U.S. Food and Drug Administration (FDA) approval on May 20, 2014.

A full list of Takeda-sponsored abstracts presented at ACG is as follows:

On Sunday 18 October

Abstract # P378: Corticosteroid Dose Reduction in Ulcerative Colitis Patients Treated with Vedolizumab During the GEMINI 1 Trial (Loftus, Siegel, Panaccione, et al)
- This data is also being presented at UEGW 2015 (see abstract # P0372)
Abstract # P377: Corticosteroid Dose Reduction with Vedolizumab Treatment of Crohn’s Disease During the GEMINI 2 Trial (Loftus, Siegel, Panaccione, et al)
- This data is also being presented at UEGW 2015 (see abstract # P0371)
Abstract # P373: Characteristics of Patients with Ulcerative Colitis initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds, Alam, O’Hara, et al)
Abstract # P374: Characteristics Of Patients with Crohn’s Disease initiating Vedolizumab Therapy in Real-World Clinical Practice (Reynolds, Alam, O’Hara, et al)
Abstract # P379: Regional Variation in Quality of Care for Inflammatory Bowel Disease in the United States (Rubin, Patel, Shi, et al)
Abstract # P380: Epidemiology of Inflammatory Bowel Disease (IBD) and use of Biologic Therapy in the United States (US): A Retrospective Claims Database Study (Rubin, Patel, Shi, et al)
Abstract # P383: Indicators of Suboptimal Biologic Therapy in Patients with Ulcerative Colitis or Crohn’s Disease in the United States (Mody, Patel, Rubin)
Abstract # P382: Characteristics of Patients Treated with Vedolizumab for Inflammatory Bowel Disease in the United States (Chastek, Patel, Mody)

On Monday 19 October

Abstract # P1069: Defining Remission using Patient-Reported Outcome Components of the Crohn’s Disease Activity Index: Post Hoc analyses of Vedolizumab Data from the GEMINI 2 Study (Sandborn, Vermeire, Sands, et al)
- This data is also being presented at UEGW 2015 (see abstract # P1578)

On Tuesday 20 October

(Oral Presentation)Abstract # 021: Efficacy of Vedolizumab Maintenance Therapy with and without Continued Immunosuppressant Use in GEMINI 1 and GEMINI 2 (Feagan, Siegel, Melmed, et al)
- This data is also being presented at UEGW 2015 (see abstract # OP052)
Abstract # P1769: Vedolizumab Exposure in Pregnancy: Outcomes from Clinical Studies in Ulcerative Colitis and Crohn’s Disease (Mahadevan, Dubinsky, Vermeire, et al)
Abstract # P1764: Efficacy and Safety of Vedolizumab with Advancing Age in Patients with Crohn’s Disease: Results from the GEMINI 2 Study (Yajnik, Khan, Dubinsky, et al)

The following presentations will be held during UEGW:

On Monday 26 October

Abstract # P0346: Indicators of Suboptimal Therapy among Crohn’s Disease Patients treated with Tumor Necrosis Factor Antagonists: Results from a Multinational Study (Armuzzi, Lindsay, Mody, et al)

On Tuesday 27 October

Abstract # P0963: A Multinational Study to Determine Indicators of Suboptimal Therapy among Ulcerative Colitis Patients treated with Tumor Necrosis Factor Antagonists (Lindsay, Gisbert, Mody, et al)

On Wednesday 28 October

Abstract # P1589: Cost-Effectiveness of Vedolizumab Compared with Infliximab, Adalimumab, and Golimumab for treatment of Moderately-to-Severely Active Ulcerative Colitis in the United Kingdom (Wilson, Kerrigan, Smyth, et al)
Abstract # P1590: Cost-Effectiveness of Vedolizumab Compared with Conventional Therapy for Treatment Of Moderately-to-Severely Active Ulcerative Colitis in the United Kingdom (Wilson, Kerrigan, Smyth, et al)

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 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.

KÄYTTÖAIHEET: Entyvio (vedolitsumabi)

Haavainen paksusuolitulehdus

Entyvio on tarkoitettu keskivaikeaa tai vaikeaa aktiivista haavaista paksusuolitulehdusta sairastavien aikuispotilaiden hoitoon silloin, kun vaste tavanomaiseen hoitoon tai tuumorinekroositekijä-alfan (TNFα) estäjään on ollut riittämätön tai se on hävinnyt tai kun potilas ei ole sietänyt näitä hoitoja.

Crohnin tauti

Entyvio on tarkoitettu keskivaikeaa tai vaikeaa aktiivista Crohnin tautia sairastavien aikuispotilaiden hoitoon silloin, kun vaste tavanomaiseen hoitoon tai tuumorinekroositekijä-alfan (TNFα) estäjään on ollut riittämätön tai se on hävinnyt tai kun potilas ei ole sietänyt näitä hoitoja.

About Takeda Pharmaceuticals Company Limited

Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Contact:

Klaus Tamminen
Lääketieteellinen johtaja
+358 40 734 1212

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