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Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)
Date:2/27/2008

TOKYO, Feb. 27 /PRNewswire/ -- Kyowa Hakko Kogyo Co., Ltd. (President: Dr. Yuzuru Matsuda) announced that Kyowa Pharmaceutical, Inc. (New Jersey, United States), its wholly owned U.S. subsidiary, received on February 25, 2008 (local time) a Not approvable letter from the U.S. Food and Drug Administration (FDA) for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease.

In the not approvable letter FDA expressed concern if the efficacy findings support clinical utility of istradefylline (KW-6002). FDA requested an overall summary of nonclinical mineralization findings. Additionally, FDA asked for clinical pharmacology follow-up information as a Phase 4 commitment.

After closely examining the FDA's response, Kyowa Hakko will work closely with FDA and conduct a comprehensive discussion to determine a path forward for istradefylline (KW-6002).

Istradefylline (KW-6002) has a novel mechanism of action that antagonizes the adenosine A2A receptor. It has been under FDA review 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.

Kyowa Hakko is a biotechnology-based company focused on two businesses: pharmaceutical operations engaged in the research and development, manufacturing, and marketing of prescription drugs; and bio-chemical operations that handle a variety of products such as amino acids, nucleic acids, and nutritional supplements/healthcare products. Its pharmaceutical business places emphasis on research and development in the fields of oncology, allergy, and the central nervous system. In Japan, Kyowa Hakko is marketing medications for a wide range of diseases, including allergy, hypertension, angina pectoris, and cancer. With the aim of penetrating the global market, Kyowa Hakko has overseas development bases in the U.S. (Kyowa Pharmaceutical, Inc. and BioWa, Inc.) an
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SOURCE Kyowa Hakko Kogyo Co., Ltd.
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