Takeda’s IBD Treatment ENTYVIO® (vedolizumab)Receives Prestigious Prix Galien Canada Innovative Product Award

OAKVILLE, Ontario – November 23, 2016 – Takeda Canada is pleased to announce that ENTYVIO® (vedolizumab), a gut-selective biologic treatment to treat the two most common types of inflammatory bowel disease (IBD), has been named the 2016 winner of the prestigious Prix Galien Canada Innovative Product Award.

The annual award, presented at a gala ceremony in Toronto on November 22, recognizes the new drug product judged by the jury to have made the most significant overall contribution to patient care in Canada in terms of efficacy, safety, benefits and innovation. ENTYVIO® was recognized for the innovative way that it tackles the disease, targeting the gut and directly reaching inflammation that causes symptoms of ulcerative colitis and Crohn’s disease.

ENTYVIO® is the first and only gut-selective biologic therapy with no known systemic immunosuppressive effects and the only biologic treatment approved for use in patients who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonist.i

"We are honoured that the value ENTYVIO® brings to IBD patients has been recognized with this prestigious award and are very much looking forward to the contribution it will make for the many Canadians who live with inflammatory bowel disease. To be able to help Canadians overcome the challenges of living with IBD is our greatest reward," said Chatrick Paul, General Manager of Takeda Canada Inc. "At Takeda we aspire to become an agile and innovative, best-in-class global pharmaceutical company and ENTYVIO® exemplifies the kind of innovations that we want to bring to the patients who count on us."

Tribute to Canadian research
Being awarded the Prix Galien for ENTYVIO® is also a tribute to the Canadian medical research community because of the pivotal role played by Canadian researchers in the treatment’s early discovery and development. Researcher Dr. Andrew Lazarovits of London, Ontario, developed a first potential molecule for this type of therapy while working in Boston but passed away in 1999 at age 44.

His work was taken up by others, resulting in the development of vedolizumab and eventually international clinical trials sponsored by Takeda which were led by Dr. Brian Feagan, Chief Scientific Officer of Robarts Clinical Trials Inc. at Western University in London, Ontario. The treatment was first used on an ulcerative colitis patient at University Hospital in London and Dr. Feagan was the lead author of the publication of the trial results in The New England Journal of Medicine in 2013. ENTYVIO® was approved by Health Canada for the treatment of ulcerative colitis in 2015 and for Crohn’s disease in 2016.

"The arrival of a biologic that really targets the inflammation within the gastrointestinal tract without systemic immunosuppressive effects represents a significant advance in how we manage IBD," said Dr. Feagan.

"While there have been big leaps and bounds over the last decade, we are very pleased that Canadian patients now have the opportunity to benefit from ENTYVIO®. It is indeed an important innovation and marks a historic change in the way this debilitating disease is treated."

About inflammatory bowel disease (IBD)
The two most common forms of IBD are ulcerative colitis (UC) and Crohn’s disease (CD). Nearly 250,000 Canadians are living with UC and CD and more than 10,000 new cases are diagnosed each year, typically in patients in their 20s, though it can be diagnosed at any age, including in children.ii UC causes the tissue of the large intestine (including the colon and rectum) to become inflamed, form sores and bleed easily. Along with symptoms of abdominal pain, cramping, diarrhea, nausea and vomiting, UC can cause severe complications including intestinal bleeding and bowel obstructions. CD may involve inflammation in different parts of the gastrointestinal (GI) tract in different people; however, it most commonly affects the lower part of the small intestine (the ileum) where it joins the beginning of the colon.iii Sometimes a portion of the bowel needs to be surgically removed to bring patients relief. The exact cause of IBD is not entirely understood, though it is believed to result from an interaction between genes and the body’s immune system, with environmental factors possibly playing a role.

About the Prix Galien Canada
The Prix Galien is the most prestigious award in the field of Canadian pharmaceutical research and innovation. Referred to as the Nobel Prize of pharmaceutical research, it recognizes the efforts and achievements of pharmaceutical research and development. The Prix Galien Canada is administered by Innovation Life Canada. www.prix-galien-canada.com.

About Takeda
Located in Osaka, Japan, 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. Additional information about Takeda is available at takeda.com.

Takeda Canada, located in Oakville, Ontario, is the Canadian sales and marketing organization of Takeda Pharmaceutical Company Limited. Takeda Canada is transforming to become an agile specialty pharmaceutical company, focusing on gastroenterology and oncology, while continuing to meet a number of important primary care needs. Additional information about Takeda Canada is available at takedacanada.com.

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i Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 3.
ii Crohn’s and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, page 7, accessed at: http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf
iii Crohn’s and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, page 17, accessed at: http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf

ENTYVIO® is a registered trademark of Millennium Pharmaceuticals, Inc. and used under licence by Takeda Canada Inc.
"While there have been big leaps and bounds over the last decade, we are very pleased that Canadian patients now have the opportunity to benefit from ENTYVIO®. It is indeed an important innovation and marks a historic change in the way this debilitating disease is treated."