Germantown, MD – Xceleron, a global leader in predictive clinical research, today announced they have signed an agreement with Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) to provide META-ID™ services to the company. The deal will enable OPDC to obtain detailed absorption, distribution, metabolism and excretion (ADME) data in Phase I. Normally this data is not obtained until Phase II or III. This earlier and insightful data can then be used to address recently announced FDA Guidance on safety testing of drug metabolites faster and more cost effectively than is possible with conventional methods.
“By working with Xceleron, we hope to obtain an early read of human drug metabolites instead of relying on animal models. This will allow us to make knowledge-based, strategic decisions that foster our cost-effective and prudent drug-development decisions,” said Jerry Brisson, OPDC’s Associate Director of Clinical Pharmacology.
The FDA Guidance Document entitled “Safety Testing of Drug Metabolites”, published in February 2008, encourages drug developers to study differences in drug metabolism between animals used in non-clinical safety assessments and humans as early as possible during the drug development process. META-ID™ is designed to help companies accomplish this goal and to do so early in the process and with lower doses of radioactivity.
META-ID™ works in three stages, each building on the previous:
• Stage one quantifies the extent of metabolism by comparing amounts of total drug to parent drug in plasma. The extent of metabolism is determined by comparing these values.
• Stage two quantitates metabolites in plasma at different time points.
• Stage three measures full absorption, distribution, metabolism and excretion (ADME). This Human Mass Balance study can be used as the regulatory Mass Balance normally carried out during Phase II studies.
“We are pleased to be able to offer services to OPDC, and trust that the information obtained is valuable” said Scott Tarrant, Executive Vice President Global Sales and Marketing for Xceleron. “Through META-ID™ we can offer both local and international companies our ultra-sensitive analytical services so that they can make crucial assessments of a candidate drug’s metabolism profile much earlier in the development cycle.”
Leveraging its proprietary methods and ultra-sensitive technology platform, Xceleron delivers the earliest possible, most relevant human insights to its clients enabling smarter and safer drug development decision-making in terms of productivity, pipeline value and profit. Xceleron maintains ongoing client engagements with 15 of the 20 largest pharmaceutical companies in the world and analyzed more than 200 molecules to date. For more information, log onto www.xceleron.com
About Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC)
Otsuka Pharmaceutical Development & Commercialization, Inc. is involved in conducting all phases of clinical research and development of innovative healthcare products to address unmet medical needs. OPDC is well established in the scientific community as a globally focused organization that plays a leadership role in the research and development of ethical healthcare products. The Company is dedicated to the improvement of the quality of human life and health of patients around the world with a strong commitment to research and development in the areas of cardiovascular, gastrointestinal, respiratory, renal and neuroscience systems, and to treat cancer and ophthalmic disorders. OPDC is part of the Otsuka Pharmaceutical Group, which is comprised of 106 companies and employs approximately 33,000 people in 18 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥928.4 billion (approx. US $9.2 billion) in annual revenues in fiscal 2007. For additional information, please visit www.otsuka-us.com.