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May 29, 2013

Launch of NOURIAST® tablets 20 mg, in Japan, a novel antiparkinsonian agent

Tokyo, Japan, May 29, 2013---Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin"), announced today that it has launched NOURIAST® tablets 20 mg (nonproprietary name: istradefylline; referred to below as "NOURIAST®") that is a novel antiparkinsonian agent in Japan on May 30.

NOURIAST®, which is the world's first antiparkinsonian agent of a first-in-class adenosine A2A receptor1 antagonist, was listed on the National Health Insurance Drug Price List on May 24, 2013 after the manufacturing and marketing approval in Japan on March 25, 2013. In clinical trials in Japan, NOURIAST® improved wearing-off phenomena and was well tolerated in Parkinson's disease2 patients.

Kyowa Hakko Kirin has four strategic categories3 including the central nervous system (CNS) area, and will contribute to the treatment of patients suffering from Parkinson's disease and other CNS diseases.


1: Adenosine A2A receptor: Adenosine A2A receptors are a G protein-coupled receptor (GPCR), and also one of the receptors of adenosine, a substance widely distributed in the human body. In the brain, adenosine A2A receptors are considered to be present specifically in the basal ganglia, of which degeneration or abnormality is noted in Parkinson's disease. The basal ganglia are known to play an important role in motor control.

2: Parkinson's disease: A progressive, neurodegenerative disease characterized by motor symptoms such as tremors, rigidity, slow movement, and postural reflex disorders. It is thought to be caused by progressive degeneration associated with decreased levels of dopamine in certain parts of the brain, i.e., the substantia nigra and striatum. The number of patients in Japan is estimated to be 150,000 to 200,000.

3: Four categories: These are the following four disease areas: Nephrology, Oncology, Immunology, and Central Nervous System, as presented in Kyowa Hakko Kirin's FY 2013-2015 medium-term business plan.





Product summary for NOURIAST®

Brand name NOURIAST® tablets 20 mg
Nonproprietary name Istradefylline
Indications Improvement of wearing-off phenomena in patients with Parkinson's disease on concomitant treatment with levodopa-containing products
Dosage and administration To be administered concomitantly with levodopa-containing products.
The usual adult dosage of istradefylline is 20 mg orally administered once daily. According to symptoms, 40 mg of istradefylline can be orally administered once daily.
Approval date March 25, 2013
Package 30 tablets, 100 tablets
Drug price ¥760.7/tablet



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