Quebec makes new inflammatory bowel disease treatment ENTYVIO® (vedolizumab) available through public drug plan

OAKVILLE, Ontario – May 10, 2017 – Takeda Canada Inc. is pleased to announce that Quebec’s public drug plan has agreed to fund ENTYVIO® (vedolizumab), the first and only gut-selective biologic therapy for inflammatory bowel disease (IBD).

ENTYVIO® has been added to the Régie de l'assurance maladie du Québec (RAMQ) Liste des medicaments for adults with moderate or severe ulcerative colitis (UC) regardless of whether they were previously on biologic treatment. For people living with Crohn’s disease (CD), ENTYVIO® is available after failure on all funded anti-TNF therapies or for those contraindicated to receive or unable to tolerate anti-TNF therapies.

“This is good news for Quebecers living with IBD because it gives patients access to a new treatment option. ENTYVIO® has a unique gut-selective mode of action which directly targets the disease, leaving less potential for side effects,” said Dr. Edmond-Jean Bernard, a gastroenterologist at the CHUM-Hôtel-Dieu in Montreal. “We have seen positive results in patients using this new treatment option and are very pleased we will now be able to use it with patients covered under the public drug plan.”

In addition to Quebec, ENTYVIO® is now available through public drug plans in Ontario, British Columbia, Saskatchewan, Nova Scotia and Yukon, subject to certain varying criteria in different jurisdictions. The listings follow the successful conclusion of negotiations between Takeda Canada Inc. and the pan-Canadian Pharmaceutical Alliance (pCPA), the body set up by all the provinces and territories to jointly negotiate terms of public drug plan listings with pharmaceutical companies.[1] ENTYVIO® is already covered by almost all private insurers in Quebec, but many Quebecers with IBD rely on the public provincial plan for their treatments.

"Canadians living with Crohn's and/or colitis need access to drugs and treatments that could alleviate their symptoms and help them achieve remission which has a huge impact on quality of life,” said Mina Mawani, President and CEO, Crohn’s and Colitis Canada. “This news is very encouraging and we are pleased that patients in Quebec will have access to ENTYVIO® through their public drug plan.”

ENTYVIO® is Takeda Canada’s innovative biologic treatment to treat the two most common types of IBD, CD and UC.[2] ENTYVIO® was the 2016 winner of the prestigious Prix Galien Canada - Innovative Product Award, recognizing its unique mode of action and ability to offer an efficacious gut-selective treatment option for patients living with moderate to severe UC or CD.[3]

Patients who are prescribed ENTYVIO® are fully supported with information, reimbursement assistance and convenient infusion clinics through Takeda’s patient support program YOURVANTAGE™.

“We are very pleased that Quebec has recognized the need for additional IBD treatment options and has added ENTYVIO® to the treatments covered by its public drug plan,” said Chatrick Paul, General Manager of Takeda Canada. “ENTYVIO® has been enthusiastically received by physicians and patients since it was first approved in Canada in 2015 and we know it is anxiously awaited by those who depend on public drug plans.”

About inflammatory bowel disease (IBD)
The two most common forms of IBD are ulcerative colitis (UC) and Crohn’s disease (CD).[4] Approximately 233,000 Canadians are living with UC and CD. 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.[5] IBD has been labelled Canada’s “national disease” due to Canada having among the highest rates in the world.[6] 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.[7] Sometimes a portion of the bowel needs to be surgically removed to bring patients relief.[8] 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.[9]

About ENTYVIO®
ENTYVIO® is the first and only gut-selective biologic therapy with no known systemic immunosuppressive effects[10] and works by targeting the gut, directly reaching inflammation that causes symptoms of ulcerative colitis and Crohn’s disease.[11] ENTYVIO® is approved by Health Canada for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, loss of response to, or were intolerant to either conventional therapy or infliximab, a TNFα antagonist.[12] ENTYVIO® is also indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to immunomodulators or a tumor necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.[13]

Canadian researchers played a pivotal role 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.[14] His work was taken up by others, resulting in the development of vedolizumab and eventually international clinical trials financed by Takeda which were led by Dr. Feagan in London, Ontario. The treatment was first used on an ulcerative colitis patient at University Hospital in London[15] and Dr. Feagan was the lead author of the publication of the trial results in The New England Journal of Medicine in 2013.[16]

Takeda’s Commitment to Gastroenterology
More than 70 million people worldwide are impacted by gastrointestinal (GI) diseases, which can be complex, debilitating and life-changing.[17] Takeda is driven to improving the lives of patients with GI diseases through innovative medicines, dedicated patient disease management support and the evolution of the healthcare environment. Takeda is leading in gastroenterology through the delivery of innovative medicines in areas associated with high unmet needs, such as inflammatory bowel disease, GI acid-related diseases and GI motility disorders. Our GI research & development team is also exploring solutions in celiac disease and nonalcoholic steatohepatitis (NASH), as well as scientific advancements through microbiome therapies. With more than 25 years of experience in this area, our broad approach to treating many diseases that impact the GI system and our global network of collaborators, Takeda aims to advance how patients manage their disease.

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.

                      *****
ENTYVIO® is a registered trademark of Millennium Pharmaceuticals, Inc. and used under licence by Takeda Canada Inc.
YOURVANTAGE™ is a trademark of Takeda Canada Inc.

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[1] Benefits Canada, How the pan-Canadian Pharmaceutical Alliance works; accessed March 13, 2017, at: http://www.benefitscanada.com/benefits/health-benefits/how-the-pan-canadian-pharmaceutical-alliance-works-81307

[2] Crohn’s and Colitis Canada, Newly Diagnosed; accessed April 25, 2017, at: http://www.crohnsandcolitis.ca/Living-with-Crohn-s-Colitis/Diagnostic-recent

[3] Prix Galien Canada, 2016 Laureates; accessed March 13, 2017 at: http://eng.prix-galien-canada.com/2016-laureates.html

[4] Crohn’s and Colitis Canada, Newly Diagnosed; accessed April 25, 2017, at: http://www.crohnsandcolitis.ca/Living-with-Crohn-s-Colitis/Diagnostic-recent

[5] Crohn’s and Colitis Canada, The Impact of IBD Report, Who is affected; accessed April 25, 2017, at: http://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report

[6] Media Planet, Digestive Wellness Supplement, Tackling the burden of ulcerative colitis, March 2015, accessed March 13, 2017, at: http://www.personalhealthnews.ca/prevention-and-treatment/tackling-the-burden-of-ulcerative-colitis

[7] Crohn’s and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, page 17, accessed April 25, 2017, at: http://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report

[8] Crohn’s and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, page 20 and 22, accessed April 25, 2017, at: http://crohnsandcolitis.ca/About-Us/Resources-Publications/Impact-of-IBD-Report

[9] Crohn’s and Colitis Foundation of America, The Facts about Inflammatory Bowel Disease, page 5, accessed March 13, 2017, at: http://www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf

[10] Feagan BG et al, Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis, N Engl J Med 2013; 369:699-710, August 22, 2013, page 700, accessed March 13, 2017, at: http://www.nejm.org/doi/full/10.1056/NEJMoa1215734

[11] Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 3.

[12] Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 3., and Health Canada Notice of Compliance information. Available at: https://health-products.canada.ca/noc-ac/info.do?lang=en&no=16576 Accessed May 4, 2017.

[13] Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 3., and Health Canada Notice of Compliance information. Available at: https://health-products.canada.ca/noc-ac/info.do?lang=en&no=17908 Accessed May 4, 2017.

[14] Feagan BG et al, Treatment of Active Crohn's Disease With MLN0002, a Humanized Antibody to the α4β7 Integrin, Clinical Gastroenterology and Hepatology, 2008; 6:12, 1370–1377 accessed March 13, 2017, at: http://www.cghjournal.org/article/S1542-3565%2808%2900617-4/abstract and Sher J, Approval being sought for new treatment for Crohn’s and colitis, The London Free Press, Aug. 21, 2013, accessed March 13, 2017, at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis

[15] Sher J, Approval being sought for new treatment for Crohn’s and colitis, The London Free Press, Aug. 21, 2013, accessed March 13, 2017, at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis

[16] Feagan BG et al, Vedolizumab as Induction and Maintenance Therapy for Ulcerative Colitis, N Engl J Med 2013; 369:699-710, August 22, 2013, accessed March 13, 2017, at: http://www.nejm.org/doi/full/10.1056/NEJMoa1215734

[17] Digestive Health. University of Miami Hospital. http://umiamihospital.com/service-lines/digestive-health. Accessed April 24, 2017.