The needle-free injector technology originated by now-defunct UK company Weston Medical has passed a new series of feasibility testing at new owner Aradigm and looks back on track for commercialisation.
Aradigm paid $2 million (€1.8m) for the Intraject device, 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.
At the time analysts suggested that Aradigm had bought a bargain, if its hunch - that the design fault could be overcome - turned out to be correct. For just $2 million, the US firm got its hands on all the intellectual property for Intraject, as well as Weston's licensing partnerships with Roche for its Pegasys (peginterferon alpha-2a) for hepatitis C and GlaxoSmithKline for migraine drug Imitrex (sumatriptan), as well as an option agreement for undisclosed products with Abbott Laboratories, amongst others.
In the latest development, Aradigm today released the results of its Configuration Trial (C-Trial), in which 28 configurations of the Intraject device were tested in 300 individuals. Each volunteer received 12 injections at randomised sites to measure tolerability and quality. All 28 configurations passed mechanical reliability tests, including shelf life assessments and analyses of the injector's ability to handle bubbles in solution, and were well tolerated with no adverse events reported.
Aradigm now has three front-runner designs and says that at least one of these should lead to a commercial product. The 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.
Aradigm said that it will now conduct an in vivo/in vitro correlation study to select and test the final commercial configuration of Intraject. "This will then allow us to go forward to the final clinical performance verification trial that we anticipate will occur in 2004," said the firm in a statement.