Saskatchewan government provides ULORIC® reimbursement for people suffering with gout

Patients to have access to first new treatment option in more than 40 years

MISSISSAUGA, ON, Sept. 8, 2011 /CNW/ - The Saskatchewan government, through recommendations by the Common Drug Review (CDR) and the Drug Advisory Committee of Saskatchewan (DACS), announced that ULORIC® (febuxostat), an innovative oral urate-lowering therapy to lower serum uric acid levels in patients with gout, is now covered on the Saskatchewan formulary for the treatment of symptomatic gout in patients with hypersensitivity to allopurinol, effective July 1, 2011.

"Takeda Canada is pleased with the Saskatchewan government's decision to list ULORIC on its provincial formulary as it demonstrates the province's commitment to ensuring all Saskatchewan patients who meet the criteria have access to optimal treatment," said Laurene Redding, Director, Government & Economic Affairs, Takeda Canada, Inc.  "By providing access for these patients, the province leads the way in improving quality of life for sufferers and halting the symptoms of this chronic and debilitating disease."

ULORIC (febuxostat, tablet, 80mg), is listed for the treatment of symptomatic gout in patients with hypersensitivity to allopurinol.  Hypersensitivity to allopurinol is a rare condition that is characterized by a major skin manifestation, fever, multi-organ involvement, lymphadenopathy and hematological abnormalities (eosinophilia, atypical lymphocytes).

Takeda Canada, Inc. continues to work with officials in each of the other provinces to ensure that people suffering from gout who rely on provincial drug plans will have access to ULORIC. Quebec's Conseil du médicament was the first in Canada to reimburse ULORIC under public drug plans, effective June 6, 2011.

Gout, a form of arthritis, is caused by above normal levels of serum uric acid in the blood.1 Uric acid is a natural waste product that when it accumulates, forms crystals and deposits in the joints.  These deposits result in inflammation causing pain, swelling, redness and tenderness of the area.  In many people, gout initially attacks the joint of the big toe and often affects people during the night while sleeping.  Over time, attacks become more frequent and severe and can move into other joints, such as the ankle, knee, foot, hand, wrist, and elbow.2

The underlying cause of gout is hyperuricemia, a condition of high levels of uric acid in the blood, and the key target in the treatment and management of gout. ULORIC lowers the level of serum uric acid in the blood by stopping the body from turning purines into uric acid.  In clinical trials, ULORIC 80 mg was superior to allopurinol 300/200 mg at achieving the primary end point of sUA (serum uric acid) levels less than 360 µmol/L at the final visit (both p<0.001).

Health Canada's approval of ULORIC was based on multiple phase III clinical trials. A diverse patient population of more than 4,000 subjects was studied, and in some cases for up to five years. ULORIC has a proven efficacy profile that makes it an appropriate option for patients who have elevated sUA levels, have mild-to-moderate renal or hepatic impairment, or are unresponsive to other treatment options.

ULORIC has an established safety profile with no dose adjustments required in patients with mild-to-moderate renal or hepatic impairment. As with all medications, ULORIC has an established risk to benefit profile and so patients should speak to their physician to determine if ULORIC is right for them. The possible side effects that can occur in people who use ULORIC include liver problems, diarrhea, nausea, dizziness, joint pain, gout flares, and rash. Also, a small number of heart attacks, strokes and heart-related deaths were seen in clinical studies. It is not certain that ULORIC caused these events. ULORIC is not indicated for the treatment of high uric acid without a history of gout.

ULORIC was approved for use in Canada in September 2010.  ULORIC is indicated to lower serum uric acid levels in patients with gout.

About Takeda Canada, Inc.
Takeda Canada, Inc. is a division of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The Canadian headquarters were established in Mississauga, Ontario, in 2009. Takeda Canada, Inc. currently distributes Actos® for the treatment of type 2 diabetes and DEXILANT for the treatment of gastroesophageal reflux disease. The company seeks to enhance the lives of Canadians by providing innovative new products for metabolic, cardiovascular, oncology, central nervous system, and other related conditions. Takeda is committed to striving toward better health for individuals and progress in medicine. To learn more about Takeda Canada, Inc. visit www.takedacanada.com.

ULORIC® is a registered trademark of Teijin Pharma Limited and used under license by Takeda Pharmaceuticals America, Inc.

DEXILANT is a trademark of Takeda Pharmaceuticals North America Inc. and used under license by Takeda Canada, Inc.

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1 Public Health Agency of Canada. Arthritis in Canada - An Ongoing Challenge. http://www.phac-aspc.gc.ca/publicat/ac/ac_2e-eng.php. Accessed July 2011.

2 The Arthritis Society. http://www.arthritis.ca/types%20of%20arthritis/gout/default.asp?s=1&province=ca Accessed July 2011.


SOURCE Takeda Canada, Inc.

For further information:

Laurene Redding
Takeda Canada
(905) 814-2329
laurene.redding@takedacanada.com

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Takeda Canada, Inc.

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