Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)

Feb 27, 2008, 00:00 ET from Kyowa Hakko Kogyo Co., Ltd.

    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.) and in the U.K. (Kyowa Hakko
 U.K. Ltd.). In the U.S., U.K., and China, they are pushing ahead with the
 clinical development of new drug candidates as well as the therapeutic
 antibody business based on Kyowa Hakko's proprietary technology
 (POTELLIGENT) that enhances the activity of antibodies.
     Last autumn, Kyowa Hakko announced that the Kyowa Hakko group and the
 Kirin group entered into an agreement to form a strategic business/capital
 alliance. Through this tie-up, the two groups will endeavor to build a
 global leader in the research and development-driven life sciences business
 based in Japan, which is centered on pharmaceutical operations with
 strengths in biotechnology. The new company "Kyowa Hakko Kirin Co., Ltd."
 will start operating on October 1, 2008.
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: URL:

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