Xceleron and Otsuka Sign META-ID Deal
News Nov 18, 2008
Xceleron has 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 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.”
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