Now Available in Canada: First-ever treatment for adults living with a life-threatening kidney disease (ADPKD)

  • On February 25, 2015, Health Canada approved JINARC™ (tolvaptan) as the first pharmaceutical treatment available in Canada for patients with autosomal dominant polycystic kidney disease (ADPKD). JINARC™ was discovered in Japan by Otsuka Pharmaceutical and was first approved there for the treatment of ADPKD in 2014.
  • Effective today, JINARC™ is now commercially available for use in Canada.
  • JINARC™ slows the progression of kidney enlargement in patients with ADPKD, which should help protect the kidneys from damage and failure.

MONTREAL, QC, June 3, 2015 /CNW/ - Today, Otsuka Canada Pharmaceutical Inc. announced that JINARC™ (tolvaptan), is now commercially available for use in Canada. JINARC™ is indicated to slow the progression of kidney enlargement in adults with autosomal dominant polycystic kidney disease (ADPKD).

"ADPKD can have a significant impact on a person's health and quality of life, and often afflicts many individuals in a family across the generations. Ultimately it leads to kidney failure and the need for kidney transplant or dialysis in most people affected by the disease," says Dr. Phil McFarlane, nephrologist from Toronto. "With the availability of JINARC™, Canadians living with ADPKD and the clinicians who care for them now have an option that can potentially slow cyst growth, delay disease progression, and improve symptom control."

Approximately, half of polycystic kidney disease (PKD) patients reach end stage renal disease (ESRD) and require renal replacement therapy in the form of dialysis or a kidney transplant by age 54.1 According to a recent Canadian survey, the majority of ADPKD patients say the disease has impacted their ability to: complete everyday activities, such as working or spending time with family (66 per cent); travel and go on vacation (58 per cent); and lead a healthy and active lifestyle (56 per cent).2 Furthermore, on average, two-thirds (67 per cent) of ADPKD patients have other family members who have been diagnosed with the disease.* 

"When I was first diagnosed with ADPKD 14 years ago, it was hard for me to accept that there weren't any treatment options that could slow the progression of my disease," says Cheri Barton, Ottawa, ON. "With the availability of JINARC™, there's finally hope for our family and for the PKD community."

Health Canada's approval was based on the results of the pivotal Phase 3 randomized, double-blind and placebo-controlled TEMPO 3:4 Trial, which is the largest, Phase 3 study conducted to date in adults with ADPKD.3

About JINARC (tolvaptan)

JINARC™ was developed over a period of 26 years through the persevering efforts of researchers in Otsuka's Japanese pharmaceutical research center. Upon discovering a cell signaling pathway that causes renal cysts to proliferate and enlarge,4 Otsuka launched an effort in 2004 to develop a drug for the disease in conjunction with the world's leading ADPKD medical specialists. JINARC™ is a selective vasopressin V2-receptor antagonist and is indicated to slow the progression of kidney enlargement in patients with ADPKD. Vasopressin is a hormone normally responsible for maintaining water balance by stimulating water re-absorption in the kidney. Vasopressin levels are higher than normal in people with ADPKD. The high level of vasopressin promotes cyst growth, which increases the size of the kidneys.5 JINARC™ works by blocking the effects of vasopressin, which can slow down the rate at which cysts – and therefore kidneys – grow. This should help protect kidneys from damage and failure.6 JINARC™, a twice-daily, oral medication,7 is now available for eligible patients in Canada as of May 2015. JINARC™ is only available through a hepatic safety monitoring and distribution program conducted and maintained by Otsuka Canada Pharmaceutical Inc. (OCPI) and managed in conjunction with patients' treating physicians. In addition, OCPI is funding a Canadian JINARC™ ADPKD patient outcomes registry available to all patients on the treatment.

About ADPKD

ADPKD impacts approximately 35,000 Canadians8 and affects people regardless of gender, age, race or ethnic origin.9 ADPKD is the most common, inherited kidney disease and is primarily characterized by the development and expansion of multiple fluid-filled cysts in the kidney, leading to an increase in total kidney volume. As a result of cyst growth, kidneys become significantly enlarged and, over time, kidney function deteriorates and can result in complications that include chronic and acute pain, hypertension and kidney failure.10 The genetic mutation that causes ADPKD is a dominant trait meaning only one parent needs to be affected for their child to have a 50 per cent chance of inheriting the disease.11

About Otsuka Canada Pharmaceutical Inc.

Otsuka Canada Pharmaceutical Inc. (OCPI) is an innovative, fast-growing healthcare company that commercializes Otsuka medicines in Canada, with a focus on neuroscience, nephrology, oncology and cardiovascular health. OCPI is dedicated to improving patients' health and the quality of human life. OCPI was established in 2010, with headquarters in Saint-Laurent, Québec.

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creating new products for better health worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leading firm in the challenging area of mental health and also has research programs for several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate more powerfully than words how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

*Given the low incidence population and the small sample size for this hard to reach group, survey results should be interpreted directionally and with caution.

References
___________________
1 Alam, Ashan and Perrone, Ronald D.,Management of ESRD in patients with autosomal dominant polycystic kidney disease. Advances in Chronic Kidney Disease, Vol 17, No 2. March 2010: pp 164-172.
2 The "ADPKD – Quality of life patient study" was conducted through an online survey by Vision Critical between November 21, 2014 and February 9, 2015, with 58 Canadian adults who currently have ADPKD. A probability sample of ADPKD patients of the same size would yield a margin of error of +/- 13%.
3 JINARC™ Canadian product monograph. Otsuka Canada Pharmaceutical Inc. Updated: February 23, 2015.
4 Gattone, VH et al. Inhibition of renal cystic disease development and progression by a vasopressin V2 receptor antagonist. Nature Medicine. 2003: 9 (10): 1323-1326
5 Ibid.
6 Ibid.
7 Ibid.
8 The Kidney Foundation of Canada. Polycystic kidney disease (PKD). Accessed January 2015. http://www.kidney.ca/page.aspx?pid=329  
9 The PKD Foundation of Canada. Just diagnosed. Accessed 2015. http://endpkd.ca/learn/learn-about-adpkd/just-diagnosed/
10 Grantham, Jared J. Does extended-release somatostatin slow the growth of renal cysts in autosomal-dominant polycystic kidney disease? Nature Clinical Practice Nephrology. 2006: 66-67.
11 The Kidney Foundation of Canada. Polycystic kidney disease (PKD). Accessed January 2015. http://www.kidney.ca/page.aspx?pid=329  

SOURCE Otsuka Pharmaceutical Co., Ltd.

Image with caption: "Otsuka Pharmaceutical Co., Ltd. (CNW Group/Otsuka Pharmaceutical Co., Ltd.)". Image available at: http://photos.newswire.ca/images/download/20150603_C8325_PHOTO_EN_17463.jpg

For further information: Allison Rosenthal, Otsuka Canada Pharmaceutical Inc., (514) 332-3099, Allison.Rosenthal@otsuka.com; Erin Collett, (416) 849-8911, Erin.Collett@edelman.com

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