Takeda’s ENTYVIO® (vedolizumab) receives positive reimbursement recommendation from Common Drug Review for treatment of Crohn's Disease

OAKVILLE, Ontario – November 24, 2016 – Canadians living with Crohn’s disease (CD), the most common form of inflammatory bowel disease,i may soon have access through provincial drug plans to the latest therapy, ENTYVIO® (vedolizumab), to treat the debilitating condition that affects more than 129,000 people in Canada.i The Canadian Drug Expert Committee (CDEC) of the Common Drug Review (CDR) issued a positive listing recommendation for the new Takeda biologic treatment ENTYVIO® for reimbursement by provincial drug plans for the treatment of adults with moderate to severely active CD. This is a key milestone in the process to secure public drug plan reimbursement for ENTYVIO® in Canada.

"Crohn’s disease is a real concern in Canada, where we have among the highest reported prevalence and incidence in the world. This incurable disease affects adults but can begin in early childhood. Effective treatments, such as the biologic medicine ENTYVIO®, are essential to keep this disease under control," said Gail Attara, Co-founder, President, and CEO, Gastrointestinal Society. "Our latest Inflammatory Bowel Disease (IBD) Report Card shows that there are gaps in the coverage of biologics across Canada. Crohn’s disease is a type of IBD. These patients need access to the right medication at the right time to live the fullest and most productive lives possible. We are pleased that the CDR listened to the complex patient experience with the disease and have recommended that our publicly-funded drug insurance plans cover ENTYVIO® for persons with Crohn’s disease, when prescribed by their doctor."

ENTYVIO® is the first and only gut-selective biologic therapy with no known systemic immunosuppressive effects and approved for use in adult moderately to severely active CD patients who have had an inadequate response with, loss of response to, or were intolerant to immunomodulators or a tumour necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.vii

The early discovery and development of ENTYVIO® can be traced back to London, Ontarioii and later Dr. Brian Feagan, Chief Scientific Officer of Robarts Clinical Trials Inc. at Western University, led international clinical trials that contributed to the Health Canada approval of vedolizumab.iii

"The recognition by CDR of the clinical value that ENTYVIO® brings to the treatment for Crohn’s disease is positive for patients," said Dr. Brian Feagan. "This treatment has the unique ability to specifically target the gut and the disease and we are seeing patients who don’t respond to other biologic therapies and otherwise likely would face life-changing colon surgery do well on ENTYVIO®. We are also seeing promising clinical results with it as an initial biologic treatment and this is encouraging."

Crohn’s disease can be very debilitating and significantly compromise a person’s quality of life.iv In Canada more than 5,700 cases of CD are diagnosed each year.i The exact cause for CD is not entirely understood, although many researchers believe that the interaction between genes, the body’s immune system, and environmental factors may play a role.v

"Crohn’s and Colitis Canada is excited that there is a new treatment available for Canadians living with Crohn’s disease. The ultimate goal for the many Canadians living with Crohn's disease or ulcerative colitis is finding the cures. In the meantime, effective treatments can lead to stability and allow patients to have active and healthy lives," said Mina Mawani, President & CEO of Crohn’s and Colitis Canada. "Whether you are newly diagnosed with inflammatory bowel disease or someone who has failed to respond to other treatments, you need to know that options not only exist, but that they are available. I have seen young people lose hope because they did not have access to a treatment that could potentially improve their quality of life. That’s why Crohn’s and Colitis Canada continues to advocate for improved coverage and timely access to new treatments on public and private drug plans."

ENTYVIO® works by targeting the gut, directly reaching inflammation that causes symptoms of CD and UC.iii In clinical studies, ENTYVIO® demonstrated statistically significant benefits versus placebo over a year-long trial in patients with CD who had failed previous treatments, including biologics (almost 50% had failed prior TNFα antagonist therapy and approximately 30% had failed two or more). After 52 weeks, of those on ENTYVIO® 39% achieved clinical remission (vs. 22% on placebo, p=0.0007), 44% had enhanced clinical response (vs. 30% on placebo, p=0.0132) and 32% achieved corticosteroid-free remission (vs.16% on placebo, p=0.0154).vi

Other than ENTYVIO®, biologic treatments for CD are all inhibitors of tumour necrosis factor (TNF)-alpha. While they have been an important treatment advance for a number of inflammatory conditions, there are a significant number of patients who are intolerant to anti-TNF-alpha treatment or for whom response is inadequate or is lost over time.

ENTYVIO® dosing, efficacy and safety

ENTYVIO® (vedolizumab) is 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 tumour necrosis factor-alpha (TNFα) antagonist; or have had an inadequate response, intolerance, or demonstrated dependence on corticosteroids.vii

The recommended dose regimen of ENTYVIO® is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.viii

The safety and efficacy of ENTYVIO® for the treatment of adult patients with moderately to severely active Crohn’s disease was demonstrated in GEMINI II, a randomized, double-blind, placebo-controlled trial. Patients enrolled in the trial had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or TNFα antagonists. TNFα antagonist failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant to a TNFα antagonist. Almost 50% of the overall population in GEMINI II CD Trial had failed prior TNFα antagonist therapy and approximately 30% had failed two or more prior TNFα antagonist therapies. After 52 weeks, of those on ENTYVIO® 39% achieved clinical remission (vs. 22% on placebo, p=0.0007), 44% had enhanced clinical response (vs. 30% on placebo, p=0.0132) and 32% achieved corticosteroid-free remission (vs. 16% on placebo, p=0.0154).ix

The ENTYVIO® tolerability profile was demonstrated in the 52-week GEMINI trials, with a low rate of discontinuations due to adverse events: 9% for those on ENTYVIO® vs. 10% for those on placebo.x

About Takeda Canada

Takeda Canada, located in Oakville, Ontario, is the Canadian sales and marketing organization of Takeda Pharmaceutical Company Limited, Osaka, Japan. The company has a commercial presence covering more than 70 countries, with particular strength in Asia, North America, Europe and fast-growing emerging markets including Latin America, Russia-CIS and China. Areas of focus include cardiovascular and metabolic, oncology, respiratory and immunology, central nervous system, general medicine, and vaccines. 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. Through strategic acquisitions, Takeda has been transforming itself, broadening its therapeutic expertise and geographic outreach.

Additional information about Takeda Canada is available at www.takedacanada.com.

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i Crohn’s and Colitis Canada, Fast Facts: Impact of IBD in Canada 2012, accessed at: http://www.isupportibd.ca/pdf/ccfc.ca-impact-report-fast-facts.pdf
ii Sher J, Approval being sought for new treatment for Crohn’s and colitis, The London Free Press, Aug. 21, 2013, accessed at: http://www.lfpress.com/2013/08/21/approval-being-sought-for-new-treatment-for-crohns-and-colitis
iii 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 at: http://www.nejm.org/doi/full/10.1056/NEJMoa1215734
iv Crohn’s and Colitis Canada, The impact of inflammatory bowel disease in Canada, 2012 final report, p.17; p. 21 accessed at: http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf
v Crohn’s and Colitis Foundation of America, The Facts about Inflammatory Bowel Disease, page 5, at: http://www.ccfa.org/assets/pdfs/updatedibdfactbook.pdf
vi Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 25.
vii Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 3.
viii Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 13.
ix Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 25.
x Takeda Canada Inc., ENTYVIO® (vedolizumab) Product Monograph, November 11, 2016, p. 7.

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