Unilife's Bolus Injector Platform Targeted by Global...

Unilife's Bolus Injector Platform Targeted by Global Pharmaceutical Company for Use in Multi-Drug Program

Cumulative device revenues expected to exceed $300MM for the first of five or more target drugs

YORK, Pa., Nov. 8, 2012 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS) today announced that its Precision-Therapy™ platform of bolus injection systems has been selected by a global pharmaceutical company to enter the next stage of collaboration as its preferred choice for long-duration subcutaneous drug delivery.

Unilife has been advised that the global pharmaceutical company (the "Customer") is targeting more than five pipeline injectable drugs for use with the Precision-Therapy platform of bolus injectors (wearable, disposable pumps). The first of these target drugs identified by the Customer is in Phase III clinical trials.

Unilife has recently commenced the initial supply of its Precision-Therapy devices to the Customer. Initial revenues will be generated by Unilife during the current fiscal year as it supports the immediate needs of the Customer under this partnership program.

Unilife expects to enter into a development agreement with the Customer during the current fiscal year to customize Precision-Therapy devices for use in the first target drug's upcoming human clinical trials. Unilife expects the first of these development agreements to generate in excess of $10 million in revenue over an 18 to 24 month period. Â Unilife expects to successively enter into a series of additional development agreements with similar terms relating to the other target drugs.

Unilife further expects that it will begin commercial supply of Precision-Therapy bolus injectors to the Customer in 2015 to support the anticipated market launch of the first target drug. Commercial supply contracts for each targeted drug under the program are expected to have an initial term of seven years. Based upon indicated customer requirements for the first drug candidate, Unilife expects to generate commercial revenues of approximately $50 million per year under an initial supply contract.

Unilife expects that it will enter into separate commercial supply contracts for each target drug brought to market by the Customer. Across the full portfolio of target drugs identified by the Customer, Unilife expects that commercial supply revenues per drug will range between $30 million and $70 million a year.

For commercial purposes and due to confidentiality clauses within the agreement, additional terms of the contract and the identity of the pharmaceutical company are to remain confidential at this time.

Mr. Alan Shortall, CEO of Unilife, said, "Our Precision-Therapy™ platform of bolus injectors and Flex-Therapy™ platform of infusion pumps are consistently being identified by pharmaceutical companies as the preferred technology for the long-duration subcutaneous delivery of injectable drugs.

"It is important to note that today's announcement regarding the selection of our bolus injection platform by a global pharmaceutical company follows an extensive evaluation process involving many of our device competitors. The customer has advised that their rationale for the selection of Unilife was our deep industry expertise, advanced operational capabilities, strong patent position and ability to consistently exceed program requirements. They believe our superior device technology will represent a major part of the value proposition to support the successful commercial launch of a series of injectable therapies that currently reside within their clinical pipeline.

"The platform-based approach we have utilized in the development of our Precision-Therapy bolus injectors means that we will play an integral role in the clinical development, regulatory approval and commercial success of a broad portfolio of injectable therapies under a long-term collaboration with this customer.

"We look forward to the signing of an initial development agreement this fiscal year to customize a device from our Precision-Therapy platform that will address the specific needs of this customer for the first of their target drugs. I expect each commercial supply contract that we sign under this program can ultimately generate hundreds of millions of dollars in cumulative revenues during its full term. Such long-term collaborations underpin the strength of the strategic relationships that we continue to build with a number of pharmaceutical companies for drug-device combination products.

"This marks the start of a multi-stage, multi-drug long-term partnership with this global pharmaceutical company. However it is just one of many exciting opportunities that now reside within our fast-expanding commercial pipeline. We look forward to entering into similar partnerships with other pharmaceutical companies that are now at various stages in the evaluation and selection of devices from our broad portfolio of technology platforms that will enable and enhance their target pipeline and approved drugs," Mr. Shortall concluded.

Precision-Therapy™ Bolus Injector Platform and Flex-Therapy™ Infusion Pump Platform

Unilife has developed the Precision-Therapy platform of bolus injectors and Flex-Therapy platform of infusion pumps to help enable and enhance bolus or rate-based injectable therapies that require the long-duration subcutaneous delivery of doses between 1mL and 30mL in volume. Featuring a primary container with standard materials in the fluid path, they are designed for integration into existing fill-finish lines and can be customized to address specific customer or patient needs including dose volume, delivery rate and duration, drug viscosity, and ergonomic design. Compact in size and highly intuitive for use, they can be comfortably worn on or off the body of a patient during the designated dose duration. Patients simply push a button to commence the automatic delivery of the dose via a soft, indwelling catheter. Visual and audible electronic indicators communicate with the patient during each stage of use. Upon the delivery of the full dose, the device can be removed from the body for convenient disposal.