The trend shift towards drug delivery devices becoming a regular part of the FDA approval process took another step forward today as Unilife Corporation (NASDAQ:UNIS) announced one of its portfolio devices was selected by a leading global pharmaceutical company for clinical trials in conjunction with a pipeline biologic drug for targeted organ delivery. The clinical trial is planned to commence within the fourth quarter of 2011 to the first quarter of 2012.
An initial quantity of devices was delivered by Unilife to the pharmaceutical customer in April 2011 for clinical evaluation, based on an initial agreement that was signed with the pharmaceutical customer. The terms of that agreement and the pharmaceutical customer are confidential at this time. The follow-on clinical supply agreement for final development of the clinical device units and their delivery for the upcoming clinical trial is expected to occur shortly.
Unilife Chief Executive Officer, Alan Shortall, stated,
“Targeted organ delivery is one of the key technology platforms within Unilife’s rapidly expanding device portfolio. This initial agreement with another leading global pharmaceutical company signals the start of our expansion into other high-value segments in advanced drug delivery systems.
Our rapidly expanding platform of proprietary devices is being driven in direct response to the emerging and unmet needs of our pharmaceutical customers. The drug delivery market is now being driven by a new paradigm whereby pharmaceutical companies want innovative devices that are customized to meet the specific needs of highly specialized biologics and the target patient population. Pharmaceutical companies especially desire devices with superior safety and functionality features that can enable their drug products to generate powerful brand differentiation within competitive markets.
We are able to secure agreements like this because of the successful commercialization of the Unifill® syringe. Our entire business is now fully aligned around addressing the unmet needs of pharmaceutical customers with an unparalleled level of speed, innovation and performance.
“We are now replicating our success with the Unifill syringe on a grand scale, with the development of a rich and expansive portfolio of additional pipeline devices. Every one of these products has the potential to revolutionize the delivery of therapeutic drugs within its respective class. Because of our fortitude and foresight in aligning our business to fully serve the needs of our customers early in their clinical development pipeline, we anticipate significant returns as these products are commercialized a few years down the road.”