Unilife Initiates Global Product Rollout Plan

SYDNEY, Australia, Nov. 10 /PRNewswire-FirstCall/ -- By E-Lodgement

Unilife Medical Solutions Limited is pleased to announce the signing of a Memorandum of Understanding (MOU) with Integrated BioSciences, Inc., ("IBS"), a US-based international leader in medical device contract manufacturing. Under the MOU, IBS will establish the first automated assembly line for the Unitract Clinical range of syringes, which are designed to meet the injection safety needs of hospitals and healthcare workers.

IBS is a US Food and Drug Administration ("FDA") registered and ISO 9001:2000 certified contract manufacturer of medical devices, with an international reputation for innovation in the development of assembly and automation systems for sophisticated devices.

IBS will develop and operate the new assembly line for the Unitract Clinical range in its certified 1,000sqm clean-room facility located in the US State of Pennsylvania. Upon the expected completion and validation of the assembly line in late 2006, Unilife will be ideally positioned to launch its Unitract Clinical range into the US$1 Billion North American market for these syringes, prior to obtaining required regulatory approval.

The Unitract Clinical Range

The Unitract Clinical range is designed to allow healthcare workers to conduct standard clinical injection procedures without the risk of needlestick injury, or harm to their patients. It features a unique automatic retraction mechanism which allows healthcare workers to control the speed of needle retraction directly from the patient. An interchangeable needlemount also allows for the use of commonly available luer-slip and luer-lock needle products. US legislation now requires healthcare employers to select safer needle devices and to involve staff in the identification of those devices suitable for this use.

The Unitract Clinical range is an important addition to the Unitract portfolio, which also includes the 1mL Unitract Safe Syringe(TM) to be manufactured in Sydney and designed for use by injecting drug users.

IBS MOU

As part of the MOU, IBS have agreed to contribute 50% of all capital expenditure associated with the development of the assembly line for the Unitract Clinical range in return for the exclusive right to manufacture the product in the US. Unilife considers this financial investment by IBS to be a strong endorsement of the commercial viability of the Unitract Clinical range to become the product of choice for the US healthcare market.

Several multinational medical device manufacturers have long-term supply agreements with IBS. In addition, IBS enjoys a strong pre-existing commercial relationship with West Pharmaceutical Services Inc ("West") , the world's premier manufacturer of components and systems for injectable drug delivery. West, which is headquartered in the US, is recognised as a global leader in the production of syringe components for some of the world's largest pharmaceutical, biotechnology, and medical device companies. Through their strategic relationship with IBS, West will also be engaged to assist with the development and commercial-scale production of the Unitract Clinical range.

Mr Ed Paukovits, President of IBS said:

"Having spent many years at the forefront of advanced automation systems for products such as medical devices, I am confident that the Unitract technology has significant potential to help revolutionise the global syringe market. There is no other syringe currently available within the US healthcare market that rivals the Unitract Clinical range in terms of functionality and safety. We see our association with Unilife as a unique opportunity to provide US healthcare workers with a range of Unitract safety syringes which are perfectly designed to meet their injection safety needs.

"The design and development of an automated assembly line to produce the Unitract Clinical range of syringes is an exciting business opportunity for IBS. After a comprehensive review of the Unilife production facility in Western Sydney and the R&D facility in Newcastle, my colleagues and I at IBS are highly impressed by the achievements of the Company to date. We look forward to building a long-term global relationship with Unilife."

Mr Alan Shortall, Chief Executive of Unilife said:

"This strategic partnership with IBS is a strong endorsement for Unilife and the commercial potential of our Unitract portfolio of safety syringes. It marks the initiation of our global rollout plan for the Unitract portfolio of safety syringe products. IBS is highly regarded by global healthcare leaders for its expertise in the design of innovative medical devices, and the development of automated assembly systems for their production. Unilife also recognises that the pre-existing relationship between IBS and West Pharmaceutical Services adds great value to our capacity to rapidly commercialise the Unitract portfolio of safety syringes."

"This alliance with IBS offers significant opportunities for Unilife to launch its Unitract Clinical range from within the heartland of the world's largest market for safety syringes. The agreement also adds great value to our ability to work with other key partners, such as KDL in China, to expand production capacities at sufficient rates to meet global demand. We look forward to a strong and prosperous partnership between Unilife and IBS."

Media Enquiries: Shareholder/Analyst Enquiries: Chris Savage Alan Shortall Savage & Horrigan Unilife Medical Solutions Limited +61-404-012-266 +612-8346-6500 Unilife Medical Solutions Limited (Unilife)

Unilife Medical Solutions Limited (Unilife) is an Australian public company , focused on the development and commercialisation of innovative healthcare safety products. The platform technology of the Company is a range of patented safety syringes, offering independent automatic needle retraction and reuse prevention features. Marketed under the Unitract(TM) brand, each product is custom-designed to reduce the transfer of blood borne viruses like HIV, as well as the incidence of needlestick injuries within the healthcare environment and the community. The 1mL Unitract Safe Syringe(TM) is designed for the harm reduction market in an effort to reduce syringe reuse and sharing. Unilife is concurrently developing Unitract safety syringes for the healthcare, vaccination and pharmaceutical markets. The global syringe market is estimated at USD 3 - 4 billion per annum.

Integrated BioSciences, Inc., (IBS)

Integrated BioSciences, Inc. (IBS) is an FDA registered, ISO 9001:2000 certified contract manufacturer of class I and II medical devices and disposables, with expertise in designing, building and running the automated equipment used in the production of such devices. Located in the US State of Pennsylvania, IBS is widely recognised for its experience in assisting medical device companies outsource or upscale the production of sophisticated products, automated equipment or entire manufacturing programs. Its skills and experience range from product design through to supporting the development of cost-effective automated systems for the assembly and packaging of medical devices including syringes. IBS clientele includes global market leaders in the medical device and pharmaceutical industries. http://www.ibiosci.com/