Xceleron plans major expansion of US operations

Xceleron, provider of ultrasensitive analysis techniques for the acceleration of drug development, has announced a new multimillion dollar investment to create its first pharmaceutical testing facilities in the US.

The investment follows the establishment of its North American base in 2005, following which the company has had significant demand for its services with substantial growth forecast from what is already estimated to be a US$1bn market.

Xceleron will invest up to $7.5m on the purchase of a new accelerator mass spectrometer (AMS) to carry out analysis on pharmaceutical drug candidates, new laboratories in Maryland and additional personnel.

The new facilities will come on stream in late 2007, considerably increasing the company's testing capacity. By 2011 employee numbers are planned to rise to at least 150 and North American revenues to exceed $20m, Xceleron says.

Xceleron is the only good laboratory practice (GLP) accredited biomedical facility in the world with expertise in the field of zeptobiology (ultra-sensitive drug and metabolite analysis) using AMS.

AMS enables the pharmacokinetic (PK) measurement of absorption, distribution, metabolism and excretion of drugs administered to humans in microdose quantities. The company's approach facilitates Phase 0 early human trials to identify the metabolic fate of a drug at the single molecule level.

To date, studies have consistently shown data linearity between Phase 0 microdosing and traditional Phase I PK measures.

Xceleron's technology offers streamlined clinical development with combined Phase I and mass balance studies, early detection of human specific metabolites, and absolute bioavailability studies which measure drug levels of simultaneously administered IV and oral doses in the same patient.