Unilife Commences Initial Production of Unifill Prefilled Syringe
Unilife Corporation (“Unilife” or the “Company”) (NASDAQ: UNIS; ASX: UNS) today announced it has commenced initial production of the Unifill® ready-to-fill (prefilled) syringe at its FDA-registered manufacturing facility in York, Pennsylvania.
The initial production of the Unifill syringe, the world’s first prefilled syringe with safety features fully integrated within the glass barrel, will enable Unilife to further accelerate discussions with more than 20 pharmaceutical companies. These pharmaceutical companies are at various stages of review in the potential use of the Unifill syringe with a number of approved and pipeline injectable drugs and vaccines across more than a dozen therapeutic classes.
Once Unilife completes final product validation activities for the Unifill syringe during the second quarter of 2011, the Company can begin to fulfill initial sales orders to its existing pharmaceutical partner. The supply and sale of the Unifill syringe to other interested pharmaceutical companies is expected to commence shortly afterwards.
Initial production batches are expected to be utilized by pharmaceutical companies and contract manufacturing organizations (which fill prefilled syringes with injectable drugs on behalf of their pharmaceutical clients) for a number of activities. This will include the initiation of drug stability studies, market evaluations, and validating the integration of the product into fill-finish systems currently used to load a measured dose of an injectable drug or vaccine into equivalent standard prefilled syringes.
Mr. Alan Shortall, CEO of Unilife, said, “We look forward to being in a position to begin fulfilling initial sales orders for the Unifill syringe towards the end of June, and consolidating relationships with a number of interested pharmaceutical companies during the rest of the year. We are proud to be commencing initial production of the Unifill syringe nine months ahead of our original schedule, having successfully met every quarterly milestone since the industrialization program began in July 2008.
“We are now entering an exciting new chapter in Unilife’s emergence as a global leader for innovative drug delivery devices. Unilife has built the operational capabilities to serve as a full-service partner to pharmaceutical companies in the delivery of innovative device solutions that can generate powerful brand differentiation, protect healthcare workers and enhance patient care.
“We believe our capacity for developing market-driven and customized devices, our agility in satisfying customer requirements, and our reliability in delivering on project milestones can serve as a unique competitive advantage to which pharmaceutical partners will gravitate. The commercial supply of the Unifill syringe, and the commercialization of other products within our expanding pipeline should be just the start of us forging a strong industry reputation as a preferred pharmaceutical partner for device innovation,” concluded Mr. Shortall.
Download this document
