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Press Release |
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Accium BioSciences and CMIC Announce Strategic Alliance to Provide Exploratory IND and Low-Radiation PK/ADME Services to the Japanese Pharmaceutical Industry Seattle and Tokyo (BUSINESS WIRE) – October 19, 2006 - Accium BioSciences, Inc., (Accium) the first U.S. provider of commercial Accelerator Mass Spectrometry (AMS) services, and CMIC Co., Ltd. (CMIC) Japan’s premier pharmaceutical contract research organization, today announced a partnership to offer Exploratory-IND (microdosing) and low-radiation PK/ADME Phase I clinical trials services to pharmaceutical developers in Japan. Accium has combined its ultra-sensitive AMS bioanalytical facility with U.S.-based clinical trial and regulatory teams to help reduce the time and cost of developing new drugs. Under the terms of this agreement, CMIC will offer Accium’s integrated service package to its Japanese clients. “This partnership leverages Accium’s unique bioanalytical and clinical trials capabilities with CMIC’s proven value creating clinical development processes. CMIC is recognized as the trusted source for clinical trials development services in Japan. Together our companies can now provide seamless access to the new tools described in FDA’s recent Exploratory-IND Guidance,” stated Michael Chansler, Director of Business Development for Accium. “Clinical studies conducted within the CMIC/Accium framework will give our clients the benefits of conducting trials to U.S. FDA standards while preserving Japanese drug development requirements.” “There is a growing interest among Japanese pharmaceutical researchers to implement time and cost saving strategies in drug development. The Exploratory IND Guidance recently issued by the U.S. FDA under their ‘Critical Path Initiative’ combined with recently developed Accelerator Mass Spectrometry techniques offered by Accium open new opportunities for cost saving to the Japanese drug developers,” said Kazuo Nakamura, President & CEO of CMIC. “Accium and CMIC have been in discussion for some time to develop an effective partnering plan that will help our clients take advantage of these new tools for drug development. We are pleased to offer Accium’s services and partner network to the Japan pharmaceutical industry.” About Accium BioSciences Accium BioSciences (http://www.acciumbio.com) operates the first commercial Accelerator Mass Spectrometry (AMS) facility in the U.S. Accium provides a full range of services for preclinical ADME testing, Exploratory IND/Microdosing studies and low-radiation Phase 1 PK/ADME clinical trials. About CMIC Since its founding in 1985, CMIC Co., Ltd. (http://www.cmic.co.jp/e), Japan’s leading clinical research organization (CRO), has rapidly expanded its pharmaceutical development business to service the booming pharma-medical industry in Japan. With more than 1,500 employees throughout Japan, CMIC provides a portfolio of comprehensive clinical development solutions including planning regulatory strategies, conducting feasibility studies, and bridging assessments, reviewing pre-clinical and clinical data to comply with Japanese regulations, developing Japanese Protocol, Investigator Brochures, Case Report Forms, Informed Consent and Clinical Study Reports, and providing clinical development services including site selection, document management, site management, investigator contracts, monitoring, data management, etc. Furthermore, CMIC offers clinical research coordinators (CRC) and a patient recruitment center. In addition to its Japanese operations, CMIC has operations in Korea, China and most recently in Brazil. As of September 1, 2005, CMIC was listed on the first section of the Tokyo Stock Exchange Market.
Inquiries
Accium BioSciences (206) 281-3915
CMIC Co. Ltd. Mitsunobu Hara +81-3-5745-7033
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