Asia PR News

TOKYO, April 27/Kyodo JBN - AsiaNet/–

Kyowa Hakko Kogyo Co., Ltd. (President: Dr. Yuzuru Matsuda) announced that
Kyowa Pharmaceutical, Inc. (New Jersey, United States, President: Shigeru
Kobayashi), its wholly owned U.S subsidiary, submitted on April 25, 2007 a new
drug application (NDA) to the U.S. Food and Drug Administration (FDA) for
Istradefylline(KW-6002), its investigational drug for Parkinson’s disease.

Parkinson’s disease is a progressive neurodegenerative disorder which is
characterized by motor symptoms such as slowness of movement, rigidity, tremor
and postural instability. The symptoms of this disease result from the
progressive degeneration of certain nerve cells located in a specific area in
the brain leading to a shortage of the neurotransmitter dopamine. This results
in decreased activation of dopamine receptors in the brain which is thought to
cause the motor symptoms. The symptoms of Parkinson’s disease are treated
primarily by dopamine replacement therapy with Levodopa or dopamine agonists.
Long term therapy with Levodopa is associated with motor complications such as
the development of a shortening response to each dose, which is called
"wearing-off phenomenon", and involuntary movements.

Phase II and III clinical studies were conducted with Istradefylline (KW-6002)
in Parkinson’s disease patients experiencing "wearing-off phenomenon" on
treatment with Levodopa alone or Levodopa administered concomitantly with other
Parkinson’s disease medications. Based on the clinical efficacy and safety data
obtained, the company submitted a NDA for Istradefylline(KW-6002) as adjunctive
therapy to levodopa/carbidopa for the treatment of idiopathic Parkinson’s
disease to improve motor function in patients who experience motor response
complications.

Istradefylline(KW-6002) is a novel investigational anti-Parkinson’s drug that
has a specific antagonistic action on the Adenosine A2A receptor in the brain
and is expected to provide benefit to patients with Parkinson’s disease.

Source: Kyowa Hakko Kogyo Co., Ltd.

Contact:
TETSURO KUGA, Public Relations
Kyowa Hakko Kogyo Co., Ltd.
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan 100-8185
TEL: +81-3-3282-1903
Fax: +81-3-3282-0990
e-Mail: info@kyowa.co.jp
URL: http://www.kyowa.co.jp/eng/index.htm