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

Osaka, Japan, October 19, 2015 – Takeda Pharmaceuticals Company Limited [TSE: 4502], (“Takeda”) today announced that data highlighting 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 study investigating indicators of suboptimal therapy among UC and CD patients treated with tumor necrosis factor antagonists (TNF-α).

“At Takeda we strongly believe in the importance of supporting patients around the world with innovative treatment options, and this is why we remain committed to excellence in our scientific exploration of vedolizumab,” said Dr. Michael Smyth, Global Brand Medical Director, Gastroenterology, Takeda Pharmaceuticals. “The extensive study results being presented at these congresses demonstrate that vedolizumab is an important addition to the therapeutic options available for patients living with ulcerative colitis and Crohn’s disease.”

Vedolizumab was approved as a gut-selective humanized monoclonal antibody available 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. It is the first and only biologic therapy to be approved in the European Union, as well as in the U.S., 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.

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.

INDICATIONS: ENTYVIO™ (vedolizumab)

Adult Ulcerative Colitis (UC)
Adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids (it says “conventional” therapy in the SmPC):

• inducing and maintaining clinical response
• inducing and maintaining clinical remission 
• improving endoscopic appearance of the mucosa 
• achieving corticosteroid-free remission

Adult Crohn's Disease (CD)
Adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids (it says “conventional” therapy in the SmPC): 

• achieving clinical response 
• achieving clinical remission 
• achieving corticosteroid-free remission

IMPORTANT SAFETY INFORMATION

Contraindications

• ENTYVIO (vedolizumab) is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.

Warnings and Precautions

• Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
• Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. 
• Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.

The risk of malignancy is increased in patients with Ulcerative colitis and Crohn’s disease. (from SmPC)

• There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
• Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks. 

Adverse Reactions

• USPI version: Most common adverse reactions (incidence greater than or equal to 3% and greater than or equal to 1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.

USPI/SmPC version  - includes “Very Common” and “Common” AEs from SmPC: Most common adverse reactions include: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, Gastroenteritis, Pharyngitis, nasal congestion, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, paraesthesia, hypertension, anal abscess, anal fissure, dyspepsia, constipation, abdominal distension, flatulence, haemorrhoids, eczema, erythema, night sweats, acne, muscle spasms, muscular weakness, oropharyngeal pain, and pain in extremities.

Please consult with your local regulatory agency for approved labeling in your country.

For U.S. Audiences, please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.

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:

For ACG:

Roseanne Durril
TEL: (224) 554-1474
[email protected]

For UEGW:

Danny Stepto
TEL: +41-44-555-1504
[email protected]

For Japanese media

Kazumi Kobayashi
TEL: +81-3-3278-2095
[email protected]

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