Xceleron, the pioneering service provider of ultra-sensitive analysis techniques for the acceleration of drug development, announces a new multimillion dollar investment to create its first pharmaceutical testing facilities in the US. The investment follows the successful establishment of its North American base in 2005 since when the company has experienced very significant demand for its services with substantial growth forecast from what is already estimated to be a $1bn market.
With up to 50 per cent of global demand for drug and metabolite analysis coming from the US. 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.
Professor Colin Garner, CEO of Xceleron commented: "The purchase of a second AMS instrument and the creation of a new U.S. AMS centre is a further step in ensuring that Xceleron remains the world's leading provider of AMS services to pharmaceutical and biotechnology companies. The publication of the Exploratory IND by the FDA1 in January this year has significantly increased Xceleron's business from the US, the world's largest pharmaceutical market and we have been quick to respond to this challenge."
Xceleron is the only good laboratory practice (GLP) accredited biomedical facility in the world with unique expertise in the field of zeptobiology (ultra-sensitive drug and metabolite analysis) using AMS. The company has a proven track record having worked on over 100 molecules including numerous marketed compounds seeking regulatory approval.
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 bio-availability studies which measure drug levels of simultaneously administered IV and oral doses in the same patient.