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.
TETSURO KUGA, Public Relations
Kyowa Hakko Kogyo Co., Ltd.
1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan 100-8185
SOURCE Kyowa Hakko Kogyo Co., Ltd.