Unilife on Schedule to Fill Initial Orders for Unifill Syringe

Video of preparations to start production of the Unifill prefilled syringe available at www.unilife.com

Mar 15, 2011, 08:00 ET from Unilife Corporation

YORK, Pa., March 15, 2011 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (Nasdaq: UNIS; ASX: UNS) today announced that it remains on schedule to commence initial production of the Unifill® prefilled syringes later this month, and commence sales to pharmaceutical customers by the end of June 2011.  

Last week the Company successfully commissioned the cleanrooms at its state-of-the-art production facility in York, PA. Following the completion of this essential regulatory milestone, Unilife has now moved toward the final steps required to commence production of its Unifill and Unitract® safety syringe products at its new site. This includes the installation and final qualification of production systems utilized in the assembly of the Unifill syringe. As part of its planning to commence production, Unilife has begun to build up its inventory of components and other materials to be utilized in the assembly of the Unifill syringe.

Once initial production has commenced, Unilife will be able to complete final product qualification activities in the second quarter of the 2011 calendar year.  Accordingly, the Company expects to start filling initial sales orders it has received from existing pharmaceutical customers for the Unifill syringe by late-June 2011.

Unilife has also received requests from a number of other interested pharmaceutical companies for the Unifill syringe as part of ongoing discussions. It is expected that these pharmaceutical companies will purchase the initial production batches to undertake formal evaluations of the device prior to the signing of any commercial agreements with Unilife.

Dr. Ramin Mojdeh, Chief Operating Officer of Unilife, stated, "This is a truly exciting time for everyone associated with Unilife. Having now established the operational capabilities and human expertise necessary to begin to meet projected demand, we are now preparing to enter into the next phase of our expansion.

"Unilife is deeply committed to delivering upon our key business milestones. As such, I am very proud to report that the industrialization program for the Unifill syringe remains fully on-schedule. Our cleanrooms have now been commissioned and key sections of our assembly line for the Unifill prefilled syringe have already been installed and qualified. By the end of March, initial production of the Unifill syringe will commence.  As a result, we expect to be in a position to commence product sales to pharmaceutical customers towards the end of June 2011."  

A video of preparations to commence production of the Unifill prefilled syringe at Unilife's York facility is now available online at www.unilife.com.  

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. 

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