Phase I trials of QDose have just been completed and the product is now beginning the first Phase II trials, with large-scale Phase II trials tipped for 2007.
QDose is an electronic, dry powder, multi-unit dose device based on the de-agglomeration of insulin powder, which is achieved through the dispersion if pizo crystals that vibrate within the device upon breath activation of an internal microphone.
The device technology was developed by Microdose Technologies, who owns the rights to QDose in an equal partnership with Innovata, who developed the dry powder formulation.
The market for pulmonary insulin, fuelled by Exubera, is tipped to reach $3.6bn (€2.9bn) by 2010, however, Innovata CEO Kieran Murphy told In-PharmaTechnologist that he expects QDose to give Exubera a run for its money when it is released, hopefully in 2011.
"I believe our dry powder insulin formulation is superior to the one used in Exubera," he said during an interview at the recent inaugural Piper Jaffray Health Care Conference in London.
Details of the actual formulation technology are, however, still undisclosed until a partnership deal is firmly in place, said Murphy.
"Our partnering discussions are progressing well and we hope to have a six figure partnership deal with a big pharma company finalised by the end of the year," he said.
Designed by Danish firm Bang & Olufsen Medicom to mimic the shape of a mobile phone, the QDose device is also much more discreet and user-friendly than the Exubera device, said Murphy.
Innovata has been working with an undisclosed plastics moulding firm to make the device, but the firm is planning to hand control of the manufacturing over to its new big pharma partner from Phase II onwards.
"It will be up to our partner to decide who they contract to manufacture and fill the device from Phase II onwards," said Murphy.
"We will continue to formulate the powder during the clinical stage but after commercialisation of the drug we plan to do a technology transfer to our partner and they will handle it from there."