Takeda to Highlight Compelling New Data and Portfolio Advances for Gastrointestinal (GI) Diseases at DDW 2019

LEXINGTON, Mass., May 16, 2019 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") today announced that it will present more than 25 company-sponsored abstracts and share an overview of innovative pipeline research across its expanding gastrointestinal (GI) portfolio at the 2019 Digestive Disease Week^® (DDW) annual scientific meeting, May 18-21 in San Diego, CA. Research highlights will include a Distinguished Abstract Plenary Lecture Presentation of further results from VARSITY, the first head-to-head ulcerative colitis (UC) biologic study, which evaluated the efficacy and safety of gut-selective Entyvio^® (vedolizumab) compared to adalimumab.

"Takeda's vision is to shape the future of gastroenterology so that people living with gastrointestinal diseases experience a meaningful difference in their lives," said Uthra Sundaram, Senior Vice President, GI Business Unit, Takeda Pharmaceuticals U.S.A., Inc. "We aim to deliver transformational medicines – first or best-in-class treatments – by taking a collaborative approach to working with partners and peers, focusing on targeted therapies for distinct populations, and remaining scientifically curious. This year at DDW, we look forward to sharing our work and engaging in productive scientific exchange that will continue to drive the development of solutions for patients in need."

In addition to the VARSITY data, Takeda-sponsored Entyvio research will feature long-term efficacy and safety data, and real-world safety and effectiveness findings in patients with UC and Crohn's disease (CD) naïve to biologic treatment. Research on the effects of an investigational subcutaneous formulation of vedolizumab on health-related quality of life and work productivity in patients with UC will also be presented.

Complementing Takeda's focus on inflammatory bowel disease (IBD) is investigational research into other inflammatory diseases of the GI tract, such as celiac disease and eosinophilic esophagitis (EoE); in addition, the company's research and development teams are addressing patient groups with higher-need motility disorders. Company-sponsored abstracts being presented at DDW include real-world evidence demonstrating the humanistic, economic and health care system burdens of celiac disease and gastroparesis, as well as the prevalence and characteristics of EoE in the community.

Full details of Entyvio oral presentations at DDW, including VARSITY, are as follows:

• Development and validation of a clinical scoring tool for predicting treatment outcomes with vedolizumab in patients with ulcerative colitis
• Presentation: 334
• Session: Predicting Outcomes in IBD: Biomarkers to Endoscopy (May 19 at 10:15-10:30 am PST)
• Vedolizumab shows superior efficacy versus adalimumab: Results of VARSITY – the first head-to-head study of biologic therapy for moderate-to-severe ulcerative colitis
• Presentation: 416a
• Session: IMIBD (May 19 at 5:16-5:30 pm PST)
• Long-term safety of vedolizumab in ulcerative colitis and Crohn's disease: Final results from the GEMINI LTS study
• Presentation: 835
• Session: Clinical Trials in IBD: Optimizing Current Therapies (May 21 at 9:00-9:15 am PST)

Details of additional research presentations can be found on DDW's website here.

About Ulcerative Colitis and Crohn's Disease

Ulcerative colitis (UC) and Crohn's disease (CD) are two of the most common forms of inflammatory bowel disease (IBD). Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal (GI) tract that are often progressive in nature. UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus. CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine. UC commonly presents with symptoms of abdominal discomfort, loose bowel movements, including blood or pus. CD commonly presents with symptoms of abdominal pain, diarrhea, and weight loss. The cause of UC or CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC or CD.

About Entyvio^® (vedolizumab)

Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation. 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). 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 ulcerative colitis (UC) and Crohn's disease (CD). 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 65 countries, including the United States and European Union, with more than 260,000 patient years of exposure to date.

INDICATIONS: ENTYVIO (vedolizumab)

Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in 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 for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.

Adult Crohn's Disease (CD)
ENTYVIO (vedolizumab) is indicated in 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 for achieving clinical response, achieving clinical remission, and achieving corticosteroid‐free remission.

IMPORTANT SAFETY INFORMATION

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

• Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. 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, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. 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. Consider screening for tuberculosis (TB) according to the local practice.

• 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. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.

• 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.

• Most common adverse reactions (incidence ≥3% and ≥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.

Please see the accompanying full Prescribing Information including Medication Guide for ENTYVIO.

More information is available at www.ENTYVIOHCP.com and www.ENTYVIO.com

Takeda's Commitment to Gastroenterology
Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.

About Digestive Disease Week® (DDW)
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18-21, 2019, at the San Diego Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience, and Rare Diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com

SOURCE Takeda Pharmaceuticals, U.S.A., Inc.

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