Bio Screening Industry News

December 7, 2005

Xceleron and Servier Sign Collaborative Agreement to Accelerate Drug Development Using Microdosing

Filed under: Collaborations, Europe, Research Projects, Reports — admin @ 5:19 pm

YORK, Scotland, December 7, 2005 - Xceleron, the bioanalytical CRO who has pioneered human Phase 0 microdose studies and Servier, a French pharma company, announce today that they have signed a twelve-month rolling Collaborative Agreement. The Agreement covers the provision by Xceleron of accelerator mass spectrometry (AMS) services to assist Servier in taking candidate drugs into humans much earlier than conventional Phase 1 studies. This Agreement is the first of its kind whereby a pharma company is altering its traditional discovery/development processes to accommodate early human studies as part of the drug candidate selection processes.

Professor Colin Garner, Xceleron’s CEO commented “this collaborative Agreement is the result of Servier and Xceleron working together for a number of years to use the AMS technology to accelerate drug development. It shows the far-sightedness of Servier in introducing novel enabling technologies to change their paradigm of drug development”. Dr Bernard Marchand, Servier’s Director of Biopharmacy commented, “we are delighted to be working with Xceleron who have pioneered the human Phase 0 microdose approach. Our positive experience as one of the supporters of the CREAM trial has enabled us to see the potential utility of AMS in improving our drug selection procedures”.

-Ends-

Notes to Editors

About Xceleron Ltd Xceleron is the world’s leading commercial biomedical AMS Company. With two locations in the UK and one in the USA, Xceleron is a GLP accredited organisation with unique expertise in its field of ultrasensitive analysis of drugs and their metabolites. Xceleron’s technology has been used to assist 15 of the world’s top 20 pharma companies in their drug development activities.

As many as one in three drugs fail in Phase I (healthy volunteer) clinical testing despite extensive pre-clinical screening of potential clinical candidates with a wide variety of in silico, in vitro, ex-vivo and animal models. A high proportion of these failures can be attributed to sub-optimal pharmacokinetics (PK) leading to potential efficacy or safety issues in humans.

There is general recognition by the pharma industry that more clinical information needs to be gathered earlier than currently practiced. The AMS technology permits (1) Phase I / mass balance studies to be combined (2) absolute bioavailability studies to be conducted with less animal safety testing (3) early human metabolite profiling and (4) human microdosing (Phase 0 studies) as an aid in candidate selection. All these approaches allow earlier entry into humans of new drug compounds and hence assist in reducing attrition rates later down the clinical development path.

More information can be obtained on www.xceleron.com

About Servier Servier is a privately-owned company, established in 1954 by its founder and current Chairman, Jacques Servier, M.D. Servier allocates approximately 25% of its turnover to Research and Development. Its main therapeutic products used to treat diabetes, cardiovascular disease, neuropsychiatric disorders, cancer, and bone and joint diseases. In the past 18 months Servier has been able to file for registration three innovative pharmaceutical specialties in the field of osteoporosis, cardiovascular diseases and treatment of depression and two of them have already been accepted by EMEA.

For further information:

Xceleron Ltd Prof. Colin Garner, CEO Jeremy Hague, European Business Development Manager Tel: +44 (0) 1904 561561 or visit www.xceleron.com

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