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March 25, 2013

Approval for manufacturing and marketing of NOURIAST® tablets 20 mg, a novel antiparkinsonian agent

Tokyo, Japan, March 25, 2013 - Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin"), announced today that NOURIAST® tablets 20 mg (nonproprietary name: istradefylline; referred to below as "NOURIAST®"), a novel antiparkinsonian agent, has been approved for manufacturing and marketing in Japan.

NOURIAST® is a selective adenosine A2A receptor1 antagonist for Parkinson's disease2 of which action site is clearly distinct from the existing agents acting on dopamine receptors or dopamine metabolism. In clinical trials in Japan, NOURIAST® improved wearing-off phenomena and was well tolerated in Parkinson's disease patients treated with levodopa3. Based on the clinical outcomes, Kyowa Hakko Kirin submitted an application for manufacturing and marketing approval on March 30, 2012. NOURIAST® is authorized as the world's first antiparkinsonian agent of a first-in-class adenosine A2A receptor antagonist.

Kyowa Hakko Kirin has four strategic categories4 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: About 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: About 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: About Levodopa
Since dopamine deficiency causes Parkinson's disease, the symptoms can be improved by increasing dopamine levels in the brain. However, because dopamine cannot cross the blood-brain barrier, levodopa (L-dopa), which does cross the blood-brain barrier, is administered instead. Levodopa converts to dopamine in the brain, resulting in improving the dopamine deficiency.

4: About 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.
Date of approval March 25, 2013

Contact:

Kyowa Hakko Kirin
Media Contact:
+81-3-3282-1903
or
Investors:
+81-3-3282-0009



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