YORK, Pa., June 29, 2011 /PRNewswire/ -- Unilife Corporation (“Unilife” or the “Company”) (NASDAQ: UNIS; ASX: UNS) today announced that it has successfully completed the validation phase of the Unifill® ready-to-fill (prefilled) syringe. This key industrial milestone represents the final step in the industrialization process for the Unifill syringe.
Mr. Alan Shortall, CEO of Unilife, said: “The completion of all validation tests associated with the Unifill syringe signals that the device is fully compliant with all key regulatory requirements and conforms to our own stringent specifications for device reliability and quality assurance. This is a testament to our unparalleled capacity for device innovation, the robustness of our Quality Management System and the commitment of our team to achieve what others within the industry had considered impossible.
“We are extremely pleased with how the Unifill syringe has performed across an extensive array of stringent validation tests. Production of the Unifill syringe is continuing at our FDA-registered facility in York, Pennsylvania to support expected initial sales to many of the 20 pharmaceutical companies we are currently in discussions with. Having already had our Quality Management System successfully audited by customers and certified to ISO 13485 by two notified regulatory bodies, we look forward to commencing initial sales of the Unifill syringe in the near future.”
Dr. Ramin Mojdeh, COO of Unilife, said: “The Unifill syringe is the world’s first and only prefilled syringe with safety features fully integrated within the primary drug container. It is a primary drug container, a safety device and a sharps container all rolled into one. I believe this game-changing technology is poised to revolutionize the fast-growing $2.7 billion device market for prefilled syringes, as it is light years ahead of the commoditized prefilled syringes currently being marketed by incumbent device manufacturers. Our Unifill technology platform can deliver a unique competitive edge to pharmaceutical companies that are marketing their injectable drugs within increasingly crowded therapeutic markets.”
Over the past eighteen months, Unilife has executed an extensive and rigorous verification and validation plan, a required step in the industrialization of medical devices, to ensure that the Unifill syringe is ready for commercialization. The verification and validation processes are designed to meet the requirements of Unilife’s Quality Management System (QMS), which sets a high standard in the medical device industry. The successful completion of these verification and validation steps by Unilife clears the path for the Unifill syringe to be shipped to pharmaceutical customers.
Upon the receipt of the Unifill syringe, pharmaceutical companies will typically conduct drug compatibility and stability studies in which their injectable drugs or vaccines are tested in combination with the device. The resulting data is filed as the last step in completing the regulatory process for the drug-device combination product. This step is typically followed by the pharmaceutical company building up inventory of the drug-device combination in anticipation of commercial launch.
One of the key components of Unilife’s strategy is product quality. Unilife has developed and implemented a best-practice QMS that adheres to the highest industry standards, including the FDA’s Quality System Regulations and ISO 13485:2003. Unilife’s QMS governs all product development and manufacturing activities to ensure the quality, reliability and functionality of its products. The QMS is further enhanced by full integration with Unilife’s SAP Enterprise Resource Planning [ERP] system, ensuring the highest level of quality and accuracy across its entire supply chain.
About Unilife Corporation
Unilife Corporation (NASDAQ: UNIS / ASX: UNS) is a U.S. based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world’s first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. For more information on Unilife, please visit www.unilife.com.
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.
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