Takeda Pharmaceuticals North America, Inc

Deerfield, Ill., October 28, 2015 –Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”), today announced that Entyvio® (vedolizumab) has been nominated for the 2015 Prix Galien USA Award in the Best Biotechnology Product category. In May 2014, Entyvio was approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).

“Entyvio has been an important treatment option for patients living with UC and CD,” explained Asit Parikh, M.D., Ph.D., Head, Gastroenterology Therapeutic Area Unit, Takeda. “On behalf of Takeda, we are honored to receive this nomination for Entyvio, and this recognition is representative of our commitment to advancing research in gastroenterology.”

The Prix Galien USA Award recognizes the technical, scientific and clinical research skills and achievements necessary to develop innovative medicines and devices. It is considered the biomedical industry’s highest accolade.

Entyvio is a humanized monoclonal antibody that binds to the human alpha4beta7 integrin. It is the only approved biologic treatment developed and indicated specifically for UC and CD. A first in the biologic category, Entyvio also received simultaneous approval for both UC and CD in the U.S., and near simultaneous approval by the FDA and European Commission in May, 2014.

About Entyvio® (vedolizumab)
Entyvio, an integrin receptor antagonist, is a humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin and blocks the interaction of alpha4beta7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) and inhibits the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue. Entyvio does not bind to or inhibit function of the alpha4beta1 and alpha E beta 7 integrins and does not antagonize the interaction of alpha4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The alpha4beta7 integrin is expressed on the surface of a discrete subset of memory T-lymphocytes that preferentially migrate into the gastrointestinal tract. MAdCAM-1 is mainly expressed on gut endothelial cells and plays a critical role in the homing of T-lymphocytes to gut lymph tissue. The interaction of the alpha4beta7 integrin with MAdCAM-1 has been implicated as an important contributor to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease.

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 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.

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

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

About Ulcerative Colitis and Crohn’s Disease
Ulcerative colitis (UC) and Crohn’s disease (CD) are marked by inflammation in the lining of the gastrointestinal tract. UC impacts the large intestine only, which includes the colon and the rectum, while CD can impact any part of the digestive tract, and predominantly affects the ileum. There is no known cause for UC and CD, although many researchers believe that the interaction between genes, the body’s immune system, and environmental factors may play a role.

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

The company has a commercial presence covering around 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.

Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. marketing and sales organization of Takeda Pharmaceutical Company Limited.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.

About Takeda Pharmaceutical 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.

About the Galien Foundation
The Galien Foundation fosters, recognizes and rewards excellence in scientific innovation to improve the state of human health. The vision of the Galien Foundation is to be the catalyst for the development of the next generation of innovative treatment and technologies that will impact human health and save lives.

The Foundation oversees and directs activities in the USA for the Prix Galien, an international award that recognizes outstanding achievements in improving the human condition through the development of innovative therapies.14 The Prix Galien was created in France in 1970 in honor of Galen, the father of medical science and modern pharmacology. Worldwide, the Prix Galien is regarded as the equivalent of the Nobel Prize in biopharmaceutical and medical technology research.

For more information visit www.galienfoundation.org.

Contacts:

Roseanne Durril
Takeda Pharmaceuticals U.S.A., Inc.
(224) 554-1474
[email protected]
Takeda Pharmaceutical Company
Corporate Communications Dept. (PR/IR)
TEL: +81-3-3278-2037