Xceleron moves in on $1bn US testing market
in the US after regulations recently introduced by the Food and
Drug Administration (FDA) are setting this industry sector ablaze.
The FDA's new investigational drug application process, called the "Exploratory IND", was introduced in January in order to limit animal testing by simplifying toxicology requirements for pre-Phase I human trials.
Under the regulations, drug developers no longer have to depend solely on preclinical data for Phase I candidate selection, meaning that labs can test "microdoses" of drugs in humans to help identify pharmacokinetic properties before beginning formal Phase I studies.
As a result, more and more US companies are seeking testing services from firms such as Xceleron for early human drug testing; up to 50 per cent of global demand for drug and metabolite analysis is now coming from the US.
"The publication of the Exploratory IND by the FDA has significantly increased Xceleron's business from the US, the world's largest pharmaceutical market," Professor Colin Garner, CEO of Xceleron, told Labtechnologist.com.
"Early identification of human metabolism of drugs and therefore microdosing is an area that has now more interest for American pharmaceutical companies."
Obtaining human data prior to final candidate selection reduces the risk of failure in later clinical trials and decreases the overall cost of the drug development process.
As many as one in three drugs fail in Phase I clinical studies, despite extensive preclinical screening of potential candidates with a wide variety of in silico, in vitro, and animal models.
However, even without the FDA's recent regulation, Xceleron's US business is booming, as the company has expertise in the field of zeptobiology and is one of only three companies worldwide who use it.
The technology, combined with the use of an accelerator mass spectrometer (AMS), enables the pharmacokinetic measurement of absorption, distribution, metabolism and excretion of drugs administered to humans at very low levels.
As the demand for its services shows no sign of slowing, Xceleron is investing $7.5m (€5.9m) to create the new testing laboratories in Maryland and also for the purchase of a new AMS.
The new facilities will come on stream in late 2007 and will significantly increase the company's testing capacity, said Garner.
The firm is expecting its revenues to exceed $20m by 2011.
