Aradigm rescued Intraject from now-defunct UK company Weston Medical. The company paid $2 million (€1.8m) for the injector, which hit problems in September 2002 after it emerged that the product was not meeting the specifications for reliability laid down by its commercial partners. The fault was eventually traced to the design of a valve in the device.
The process of selecting the final configuration was enabled through the correlation of in vitro data with the results of human clinical trials. A computer model, based on over 3,600 individual in vitro data points, and data from over 4,000 human injections utilising 30 different Intraject configurations, has been developed that accurately predicts clinical performance from laboratory testing.
"The model predicts the clinical performance of the configuration and these results now allow us to prepare for and schedule final clinical verification testing, which will then corroborate performance. These tests are scheduled to occur later this year," said Stephen Farr, Aradigm's chief scientific officer.
Aradigm has also moved closer to commercialisation of Intraject with the signing of interim clinical supply agreements with key suppliers responsible for drug capsule filling (Patheon), actuator assembly (Bespak) and drug capsule manufacturing (MGlas).
Aradigm's technology is interesting because it is suitable for the delivery of liquid drugs, in contrast to the powder-based delivery system pioneered by the UK's Powderject. Other companies looking at needle-free delivery of liquid drugs include Equidyne, Antares and Penjet.