Navigation Links
Kyowa Hakko Kirin Announces Development Policy for Anti-Parkinson's Disease Drug KW-6002 (Istradefylline)
Date:1/14/2009

TOKYO, Jan. 15 /PRNewswire/ -- Kyowa Hakko Kirin Co., Ltd. (Chiyoda-ku, Tokyo Japan; President, Dr. Yuzuru Matsuda) announced on January 15 (Tokyo Time) that it has decided to continue the domestic development of its proprietary anti-Parkinson's disease drug KW-6002 (generic name: Istradefylline) and move it forward with a Phase 3 clinical trial in Japan.

KW-6002 has a novel mechanism of action that specifically antagonizes the adenosine A2A receptor. Kyowa Hakko Kirin initiated the clinical evaluation of KW-6002 in 1996, and conducted Phase 2 and 3 studies in the US and Europe to assess its efficacy and safety in Parkinson's disease patients who were experiencing wearing-off phenomenon*, a motor complication, while receiving Levodopa therapy alone or in combination with other anti-Parkinson's disease drugs. Based on the results of these studies, the new drug application (NDA) for registration of KW-6002 in the US was submitted to the Food and Drug Administration (FDA) in April 2007. On February 25, 2008, Kyowa received an action letter from the FDA. Subsequent to discussions with FDA, Kyowa decided to await the results of the ongoing Japanese phase 2b study of KW-6002 as adjunctive therapy to Levodopa, and then comprehensively examine and determine a path forward for KW-6002.

The results of the Phase 2b study in Japan have recently become available and demonstrate the efficacy of KW-6002 compared with placebo, warranting further clinical investigation in Japan.

For the development and commercialization of KW-6002 in overseas markets, is pursuing out-licensing opportunities.

We believe that KW-6002 will offer a new therapeutic option for Parkinson's disease and provide clinical benefit to patients suffering from wearing-off phenomenon and other symptoms.

* 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.

    Contact:
    TETSURO KUGA
    Public Relations
    Kyowa Hakko Kirin Co., Ltd.
    1-6-1, Ohtemachi, Chiyoda-ku, Tokyo, Japan 100-8185
    Phone:  +81-3-3282-1903
    Fax: +81-3-3282-0990
    E-mail:  info@kyowa-kirin.co.jp
    URL:http://www.kyowa-kirin.co.jp/english/index.html


'/>"/>
SOURCE Kyowa Hakko Kirin Co., Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Intra-Cellular Therapies Announces Successful Outcome of a Phase II Clinical Trial with ITI-007 in Patients with Sleep Maintenance Insomnia
2. Beactica Announces Fragment-Based Drug Discovery Research Collaboration With GE Healthcare and Uppsala University
3. Amicus Therapeutics Announces Positive Progress of Three Lead Clinical Programs and General Outlook for 2009
4. NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by The Lancet Neurology
5. Pulmo BioTech Inc. Announces Dual Listing on Frankfurt Borse
6. Human Genome Sciences Reports Substantial Progress Toward Commercialization and Announces 2009 Goals at JPMorgan Healthcare Conference
7. Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
8. ProUroCare Medical Inc. Announces Pricing of Equity Offering
9. Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function
10. Neurobiological Technologies Announces Viprinex(TM) Does Not Pass Interim Futility Analysis
11. Celtic Pharma Announces Update on Status of XERECEPT(R) Program Sale Planned in 2009
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016  MedSource announced ... as its e-clinical software solution of choice.  This ... best possible value to their clients by offering ... The preferred relationship establishes nowEDC as the EDC ... for MedSource,s full-service clients.  "nowEDC has long been ...
(Date:6/23/2016)... Research and Markets has announced the addition ... Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality (Filler, Binder, ... Forecast to 2021" report to their offering. ... excipients market is projected to reach USD 8.1 Billion ... forecast period 2016 to 2021. The ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
Breaking Medicine Technology:
(Date:6/26/2016)... NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and ... to be personalized through a fitness app. The fitness app plans to fix the two ... currently only offer a one size fits all type program , They don’t ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... , ... June 25, 2016 , ... On Friday, June ... a Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments ... of the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events ... turn to unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. ... tools for healthy coping following a traumatic event. , Trauma sufferers tend to feel ...
Breaking Medicine News(10 mins):