Unilife's Unitract 1mL Insulin Syringes receive 510(k) market clearance

Apr 6 2010

Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS; ASX: UNS) today announced it has received from the U.S. Food and Drug Administration (FDA) 510(k) market clearance for the  Unitract™ 1mL Insulin Syringes assembled at its Lewisberry, PA manufacturing facility.  

The Unitract™ range of 1mL syringes is the world's first and only known syringe that allows operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place. The products are well positioned to help prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication.

In August 2008, Unilife first secured U.S. FDA clearance for the Unitract™ 1mL Insulin Syringe assembled at the Shanghai facilities of a Chinese manufacturing partner. With Unilife's FDA-registered Lewisberry facility being considered as a new manufacturing site by the FDA, the Company was required to submit an additional 510(k) for U.S.-assembled stock.

Production of the Unitract™ 1mL Insulin Syringe at Unilife's Lewisberry facility is occurring on a fully automated assembly system that the Company designed, developed and built using in-house expertise. A video of this automated production system, which has an annual production capacity of approximately 40 million units per year, can be viewed at www.unilife.com.

Following FDA-clearance for US-assembled units of the Unitract™ 1mL Insulin Syringe, Unilife has immediately shifted manufacturing activities at Lewisberry to a four shift, 24 hour, 7 day per week (24/7) manufacturing cycle. This 24/7 manufacturing cycle is expected to maximize annual production capacities for the Unitract™ 1mL syringes and further improve manufacturing cost-efficiencies.

Unilife will now immediately file an additional 510(k) with the FDA seeking clearance for the Unitract™ 1mL Tuberculin (TB) Syringe. FDA clearance of the Unitract™ 1mL TB Syringe, which is a variant of the Insulin syringe product, will further expand the ability of the Company to market its range of safety syringes to U.S. healthcare facilities.

The Company recently announced the appointment of Stason Pharmaceuticals as a distribution partner for Asian countries including Japan, Taiwan and China.  As part of this agreement, Stason is coordinating local regulatory submissions, establishing business relationships with Asian pharmaceutical and healthcare companies, and has placed an initial order for one million units of the Unitract™ 1mL syringes assembled at Unilife's U.S. production facility.

Unilife is currently negotiating with a number of other interested healthcare and pharmaceutical companies in the U.S., Europe and Asia regarding its Unitract™ 1mL syringes, and will also continue to send shipments to Haiti to support ongoing humanitarian relief efforts.  

"With the FDA placing an increasingly stringent focus on approved medical devices, the receipt of clearance for our U.S. assembled syringes further underlines the strength of Unilife's quality management and production systems," stated Alan Shortall, CEO of Unilife Corporation.

"We have experienced significant progress with the international rollout of our Unitract™ 1mL safety syringe over the past year. We believe this most recent FDA clearance now allows Unilife to more aggressively target U.S. customers and further drive market awareness of our leading safety syringe technology. In addition, with the majority of those pharmaceutical and healthcare companies seeking to utilize product assembled at our U.S. facility, we can now further accelerate the rollout of this product."