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:2/9/2016)... N.J. , Feb. 9, 2016  Bluestar Silicones ... (LSR) product line for long-term implant applications and ... Medical Design & Manufacturing (MD&M) West Conference (Booth ... --> --> ... Silbione® Biomedical LSRs offer outstanding physical properties enabling ...
(Date:2/8/2016)... Respiratory Devices - Medical Devices Pipeline ... sector report, " Respiratory Devices - Medical Devices ... Respiratory Devices currently in pipeline stage. The ... with comparative analysis of the products at various ... involved in the pipeline product development. It also ...
(Date:2/8/2016)... 8, 2016 CBG Technologies, a U.S. ... Solvent Recycling Systems, specifically designed for precision parts ... new and existing vapor degreasers, parts washers and ... through continuous recycling and recovers 100% of the ... --> Precision parts manufacturers benefit from ...
Breaking Medicine Technology:
(Date:2/9/2016)... ... February 09, 2016 , ... Cirracore Enterprise ... enterprises move workloads to the cloud. Cirracore provides a secure VMware® vCloud ... traversing the Internet. Transformation Solutions (TSL Partners) provides a full range of ...
(Date:2/9/2016)... (PRWEB) , ... February 09, 2016 , ... ... specialty pharmacies, announces today the continuation of the ‘Pay It Forward’ program into ... prescription referral received at our specialty pharmacy. , “Since our Pay It ...
(Date:2/9/2016)... ... February 09, 2016 , ... On January 12, 2016 Paul ... appointment after they noticed their furnace not producing any heat. Shortly after entering the ... cracked heat exchanger was leaking dangerous levels of carbon monoxide into the home, at ...
(Date:2/9/2016)... ... February 09, 2016 , ... The ... Herberger’s and Younkers department stores, announced it has raised $176,000 to benefit the ... Holden Comprehensive Cancer Center at the University of Iowa, The Lynn Sage Cancer ...
(Date:2/9/2016)... ... 09, 2016 , ... ZipHearing.com is proud to ... hearing aids , increase industry transparency, and promote awareness of hearing solutions ... “For the average consumer, the hearing aid industry is esoteric and difficult to ...
Breaking Medicine News(10 mins):