SOURCE: Unilife Medical Solutions

Unilife Medical Solutions

November 19, 2009 09:12 ET

Unilife Appoints Unifill™ Automated Assembly Line Supplier

Successful Product Assembly During Proof-of-Principle Activities

LEWISBERRY, PA--(Marketwire - November 19, 2009) - Unilife Medical Solutions Limited ("Unilife" or "the Company") (ASX: UNI)(PINKSHEETS: UNIFF) today announced the appointment of Mikron Group ("Mikron") as its contracted supply partner for the development and supply of automated assembly systems to support the commercial production of the Unifill™ ready-to-fill syringe (Unifill™ syringe).

Mikron is a Swiss-based international leader for manufacturing technology and assembly automation. They employ 1,000 staff worldwide, and specialise in high-performance assembly and test solutions for the medical device, pharmaceutical, automotive supply and electronics markets.

During the past 30 years, the Mikron Assembly Technology Division has developed more than 2,000 assembly systems. Many of these were contracted for supply by pharmaceutical and healthcare equipment companies to manufacture medical devices that included inhalers, pen injectors, safety syringes and insulin pens. They also have extensive experience in the development of automated assembly systems for ready-to-fill glass barrels used in the production of prefilled syringes.

After an extensive due diligence process, Unilife has engaged Mikron to develop and supply the automated assembly lines that will be used in the production of the Unifill™ syringe. The first Unifill™ commercial line will have a target production capacity of approximately 60 million units per year, which is 50% greater than originally anticipated when the industrialisation program first commenced in July 2008.

The development of this commercial line is expected to commence next month, with its scheduled installation into Unilife's new production facility in Pennsylvania during the fourth quarter of 2010. This commercial line will support the completion of the Unifill™ industrialisation program which Unilife is currently undertaking in conjunction with its major pharmaceutical partner.

After the successful validation of the first commercial assembly line, Unilife expects to work with Mikron on the development of a high-volume line. This high-volume assembly line, which will have a target annual production capacity of 150 million units per year, is scheduled for installation at Unilife's new production facility towards the end of 2011.

Following the installation of both the commercial and high-volume assembly lines, Unilife would have a total production capacity for the Unifill™ syringe of more than 200 million units per year. Subject to the successful development and supply of these assembly lines to contract specifications by Mikron, Unilife expects that it will order additional high-volume lines to meet ongoing pharmaceutical demand for its ready-to-fill safety syringes.

To optimize production scalability and minimize operational risk, both lines will utilize a modular assembly platform which has been successfully applied by Mikron across several hundred previous projects. Prior to the appointment of Mikron as the contracted supplier of automated assembly systems for Unilife, they were required to undertake a number of proof-of-principle activities to validate that their modular assembly platform was capable of assembling the Unifill™ syringe at speeds equivalent to those targeted for the high-volume line. As part of proof-of-principle activities undertaken by Mikron, the Unifill syringe was successfully produced at desired speeds using the same assembly system station that will serve as the platform for the commercial and high-volume assembly lines. Multiple versions of these scalable, industry-accepted and highly flexible stations will be integrated into each commercial and high-volume assembly line to be developed by Mikron to attain Unilife's target production volumes. This process of replicating an already proven assembly system has helped to significantly de-risk the path towards high-volume commercial production of the Unifill™ Syringe.

Comments by CEO Alan Shortall

"It has been a key business priority for Unilife this year to select our contract partner for the development of automated systems to assemble our Unifill™ syringes at commercial levels. After carefully considering and evaluating several high quality potential suppliers, Mikron was chosen because it has a strong and proven background within the highly-specialized pharmaceutical market for injectable drug delivery devices.

"Mikron has direct experience with developing assembly systems for ready-to-fill syringes. As an established industry leader with strong relationships with a number of pharmaceutical companies, they also have sufficient resources to accommodate our aggressive production ramp plans. Most importantly, we have validated that our Unifill™ syringes can be assembled using their proven technology systems at commercially sustainable levels. From here, the path to high-volume commercial production is a scheduled process of replication rather than a complex technical challenge. We believe the appointment of Mikron to be a safe choice that will significantly de-risk the commercial feasibility and on-time delivery of this key Unilife project."

Comments by SVP Operations Bernhard Opitz

"Unilife undertook a comprehensive and highly detailed selection process spanning almost twelve months to identify the right partner to develop and supply the automated assembly systems that will manufacture our Unifill™ syringes. Following the successful completion of several critical proof-of-principle activities by Mikron, we believe we have selected the partner with the right level of industry experience and operational capabilities to deliver this key project on-time and according to contract specifications. We look forward to receiving Mikron's highly-efficient automated assembly lines to help support the manufacturing of our Unifill™ syringes for supply to international pharmaceutical customers."

Comments by President Mikron Corporation Denver, Paul Kuchay

"It is with great pleasure that Mikron Assembly Technology acknowledges the responsibility to partner with Unilife on this ambitious program. For over 30 years we have delivered innovative, reliable, efficient assembly solutions to the pharmaceutical and medical device industries. The robust design of the Unifill™ product strongly complements our proven automated assembly technology. Mikron Corporation Denver will be partnering with Mikron Assembly Technology division's headquarters in Boudry, Switzerland in order to deploy and fulfil our commitments to the customer's production schedule. We look forward to building a strong relationship with a dynamic company such as Unilife."

About Unilife

Unilife Medical Solutions Ltd is an ISO 13485 certified company that designs, develops and supplies innovative safety medical devices. Listed on the Australian Securities Exchange (ASX: UNI) since 2002, Unilife has FDA-registered manufacturing facilities in the US State of Pennsylvania and a proprietary portfolio of clinical and prefilled safety syringes designed for use within healthcare and pharmaceutical markets.

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