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Wednesday, May 23, 2018

XenoBiotic Laboratories and Eckert & Ziegler Vitalea Science Establish Strategic Partnership to Provide Enhanced Metabolism Services to Drug Development Programs requiring Accelerator Mass Spectrometry (AMS)

Plainsboro, NJ and Davis, CA, 12 August, 2013 - XenoBiotic Laboratories, Inc. (XBL) and Eckert & Ziegler Vitalea Science (EZVS) today announced the formation of a strategic partnership in which XBL and EZVS will jointly provide an integrated set of bioanalytical and consultation services to clients.  The immediate area the collaboration addresses is the relatively new concept of clinical AME (Absorption, Metabolism, and Elimination) studies using only trace levels (microtracer) of radiolabeled drug (< 1 µCi).

Under this partnership, the comprehensive radiolabel and cold metabolism services currently offered by XBL, at its facilities in New Jersey and China, will be presented to EZVS’s clients that are preparing or have conducted clinical AME and non-clinical ADME studies at trace levels of radiocarbon (14C).  These integrated research services will be made available to the pharmaceutical industry either through EZVS or XBL business contacts.

The partnership is paving new ground in CRO services to address the evolving landscape of drug development.  Radioactive AME studies are central to the elucidation of human metabolism, routes of excretion, and ultimately the safety profile of the drug.  The AMS method brings a thousand-fold improvement in detection sensitivity relative to traditional methodologies for radioactive counting, thus reducing radiation exposures to ambient levels.  In a traditional single dose human AME study, 100 µCi is typically administered.  By contrast, the sensitivity of AMS affords a reduction in the amount of radioactivity required to less than 1 µCi, and thus opens up this type of investigation to traditionally neglected subpopulations such as: women of child bearing years, specific patient populations, and children, and potentially, multi-dose studies.  In summary, AMS allows AME testing of drugs in the populations that are most relevant to the treatment.

EZVS (www.vitaleascience.com) is the first U.S. provider of AMS services, founded in 2003 as Vitalea Science.  The core scientists were trained at the University of California and Lawrence Livermore National Lab.  Recently, Vitalea Science was acquired by Berlin based Eckert & Ziegler, a premier global provider of isotopes for biomedical and industrial applications.  It now operates as a fully owned subsidiary of Eckert & Ziegler as Eckert & Ziegler Vitalea Science.

“We are pleased to be able to partner with Eckert & Ziegler Vitalea Science to provide a comprehensive set of metabolism services to clients that are conducing radiocarbon microtracer studies that require AMS”, commented  Dr. Jinn Wu, President and CEO of XenoBiotic Laboratories, Inc., and XBL-China.  “With the backing of Eckert & Ziegler, Vitalea Science (EZVS) currently has the resources of a large and supportive corporation.  This is key towards addressing the needs of large pharmaceutical companies that require scale and stability within GLP-compliant quality systems.”XBL, with global headquarters near Princeton, New Jersey, currently provides in vitro and in vivo non-labeled and radiolabel DMPK/ADME services that include radioprofiling and metabolite ID.  “The applications of AMS in clinical AME and non-clinical ADME studies continues to grow”, remarked Dr. Dennis Heller, Vice President of Pharmaceutical Development at XBL, “and partnering with EZVS is a natural progression for XBL to leverage its long standing expertise and capabilities in metabolism with EZVS’s expertise in AMS analysis”.

“XBL’s strong reputation for providing high quality science, expertise and services in drug metabolism for over 25 years made XBL an attractive partner for EZVS”, noted Stephen Dueker, co-founder of Vitalea Science and now Chief Scientific Officer of EZVS, “The core competencies of EZVS and XBL are truly complementary and our partnership will fulfill a need for both companies as AMS continues to expand into pharmaceutical drug development.  Our customers want expert analytical solutions from seasoned providers.  This partnership will deliver that expertise.”

Partnering with EZVS is reflective of XBL’s commitment to enhance its core services in the bioanalytical, non-clinical ADME and clinical AME, and metabolite profiling areas, as well as commitment to provide the best CRO services to the pharmaceutical, biotechnology, animal health and agrochemical industries.  XBL facilities in Plainsboro, NJ (www.xbl.com) and Nanjing, China (www.xbl-china.com) operate to GLP standards, are licensed for the use of radioisotopes, and are AAALAC accredited for animal research.

For further information, contact:

Dennis P. Heller, Ph.D., VP Pharmaceutical Development, dheller@xbl.com or inquire at www.xbl.com - XenoBiotic Laboratories, Inc., 609 799-2295 or 888 XENO-880 (936-6880)

Stephen R. Dueker, Ph.D., Chief Scientific Officer, stephen.dueker@ezag.com or inquire at www.vitaleascience.com - Eckert & Ziegler Vitalea Science, (530) 341-0200