Unilife Commences Initial Production of Unifill Prefilled Syringe
YORK, Pa., March 29, 2011 /PRNewswire/ -- 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.
The Unifill® Syringe
The Unifill syringe is the world's first prefilled syringe with safety features fully integrated within the glass barrel. It is designed for integration into fill-finish systems used by pharmaceutical manufacturers to load a measure dose of an injectable drug or vaccine into equivalent standard prefilled syringes, and features USP compliant materials inside the fluid path. An automatic (passive) needle retraction mechanism is activated in the Unifill syringe upon full dose delivery, allowing operators to control the speed of needle retraction directly from the body into the barrel to virtually eliminate the risk of infection from potential transmission modes such as needlestick injuries or splatter. The Unifill syringe is designed for compact handling and convenient disposal by either healthcare workers or patients that self-administer prescription medication. As a unique primary drug container offering optimal protection to healthcare workers and their patients, the Unifill syringe is strongly positioned to help pharmaceutical companies generate powerful brand differentiation within competitive therapeutic drug classes, and optimize product lifecycles.
Pharmaceutical Market for Prefilled Syringes
Prefilled syringes serve as a primary drug container for approximately 50 injectable drugs and vaccines currently marketed by more than 20 pharmaceutical companies. More than 2.4 billion prefilled syringes are used every year according to Greystone Associates, with the market growing at approximately 12% per year. Unilife considers the pharmaceutical market for prefilled syringes to be the fastest-growing, least congested and most profitable sector of the global syringe industry. To comply with legislation across international markets, such as the U.S. and Europe which mandate the use products that can protect healthcare workers from needlestick injuries, pharmaceutical companies currently attach ancillary safety products onto standard prefilled syringes. These ancillary safety products can increase pharmaceutical packaging, transport and disposal volumes by up to 70%.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic, operator-controlled needle retraction features which are fully integrated within the barrel, and are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485-certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.