Unilife Develops Proprietary Portfolio of Wearable Subcutaneous...

Unilife Develops Proprietary Portfolio of Wearable Subcutaneous Infusion Devices for the Self-Administration of Large Volume Drugs by Patients

The world's first and only wearable, disposable automatic delivery system for self-administration of drugs with dose volumes 5mL or larger
Now available to pharmaceutical companies for use in drug clinical trials



YORK, Pa., Sept. 12, 2011 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS) today announced the development of its AutoInfusor? portfolio of subcutaneous infusion systems for the patient self-administration of drugs in 3mL, 5mL, 7mL, and 10mL volumes.

Unilife has developed its AutoInfusor technology to address the unmet needs of pharmaceutical and biotechnology companies with drugs that have complex formulations with higher viscosities and requiring large dose volumes. AutoInfusors are now available for supply to pharmaceutical companies for human clinical trials in either prefilled or fill-at-time-of-use formats.

AutoInfusors are compact, single-use drug delivery systems that are designed for simple, intuitive and convenient use by patients outside of healthcare facilities. Consisting of a primary drug container, fluid delivery path, and drive mechanism, AutoInfusors are modular in design and can be customized to address the specific requirement of the drug and its target patient. They can be pre-set for infusion periods that can span minutes or hours in duration, as specified by the pharmaceutical customer.

Once the patient attaches the device onto the injection site and pushes the activation button, the automatic infusion of the drug into the subcutaneous tissue commences. With the size, shape and functionality of the AutoInfusor being ergonomically designed for optimal wearability, the patient can continue to go about their normal daily routines during the period of dose delivery. A series of audible, tactile and visual indicators can signal to the patient when the full dose has been delivered, at which time the AutoInfusor can be removed from the body for convenient disposal.

Mr. Alan Shortall, CEO of Unilife said, "Our AutoInfusors represent the world's first and only subcutaneous infusion system ready for human clinical trials that can facilitate the patient self-administration of drugs between 3mL and 10mL in dose volume.

"Pharmaceutical companies are actively developing a significant number of pipeline drugs targeted for the treatment of acute, chronic and palliative diseases. Many of these emerging macro-molecule drugs, including a number of biologics, feature a complex formulation of proteins with higher viscosities that require large volume doses. The conventional patch pumps that have been developed for the delivery of drugs such as insulin are largely unsuitable for delivery of these drugs. Until now, pharmaceutical companies developing these complex drugs have lacked access to a single-use subcutaneous infusion system that can enable patients to easily self-administer doses greater than 3mL in volume.

"As the world's first and only known subcutaneous infusion systems available in a range of sizes including 3mL, 5mL, 7mL, and 10mL, our AutoInfusors represent breakthrough technology within this fast-growing and high-value sector for injectable drug delivery devices. For clinical trial purposes, the AutoInfusor can either be filled at the time of use for the convenience of pharmaceutical customers, or supplied in a prefilled format.

"With the development of our AutoInfusor technology platform, Unilife now has the most complete proprietary portfolio of injectable drug delivery devices. Our extensive and customer-focused portfolio of technology platforms includes our Unifill primary drug delivery systems with integrated safety features, patient self-injection devices including auto-injectors and subcutaneous infusion systems, as well as devices for targeted organ delivery. With Unilife, pharmaceutical and biotechnology companies now have the option of selecting a single partner in the development and commercial supply of innovative, differentiated devices that can help to enable, enhance and extend the commercial lifecycles of their injectable drugs and vaccines."

Pharmaceutical and biotechnology companies seeking additional information regarding the Unilife AutoInfusor can contact Unilife at [email protected].