Unilife Develops Breakthrough Device Technologies for Targeted Drug Delivery

Unilife Develops Breakthrough Device Technologies for Targeted Drug Delivery
Devices to enable and enhance delivery of injectable therapies to the eye

YORK, Pa., Oct. 16, 2012 /PRNewswire/ -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ: UNIS; ASX: UNS) today announced the development of two new breakthrough platform technologies for targeted drug delivery that can enable and enhance patient outcomes for many acute and chronic conditions where there are high rates of occurrence but limited treatment options available.

These proprietary device technologies for microliter doses and drug depot deployment have broad applicability for use across a number of important and fast-growing therapeutic areas, including targeted organ delivery to the eye, brain, ear or liver, as well as the delivery of novel therapies such as sirNA, microRNA and gene therapy.

Unilife is pleased to announce the development of two distinct brand platforms that are ideally suited to the delivery of injectable therapies to the eye:

    The Unilife Depot-Ject™ platform - enables a physician to precisely and intuitively implant a drug depot (solid or oil based substance) into a targeted region of the body, such as the eye, for the release of an active pharmaceutical compound in a consistent way over an extended duration of time.

    The Unilife Ocu-Ject™ platform - enables the accurate, precise and intuitive delivery of microliter sized doses to the eye. By significantly reducing the risk of over-dosing or under-dosing, Ocu-Ject devices can help to maximize clinical outcomes, minimize patient pain and enhance compliance with drug labeling.

Comments by Unilife CEO Alan Shortall

Mr. Alan Shortall, CEO of Unilife, said: "Since commencing an ongoing collaboration with a global pharmaceutical company to develop a specialized device for targeted organ delivery, we have identified many additional areas where we have been able to leverage our proprietary technologies to address other unmet customer needs. There are many acute and chronic diseases that have been recognized by pharmaceutical companies as attractive areas for investment where the absence of a suitable delivery system has impeded the commercialization and widespread clinical adoption of promising injectable therapies.

"Our innovative device solutions for drug depot deployment and microliter dosing offer a wide range of opportunities to improve patient comfort and safety, optimize clinician convenience, and enable or enhance the commercialization of drugs designed for targeted or localized delivery to many areas of the body, including the eye. Having developed and patented these breakthrough platform technologies, we are pleased to advise that active discussions have already commenced with a number of interested pharmaceutical companies where we can enter into collaborations to address many of these fast-growing, high-value markets," Mr. Shortall said.

Unilife Depot-Ject™ Platform

Currently available device technologies for depot drug delivery have several challenges for clinicians and patients. Significant training is required for a clinician to deploy the drug into the target region of the body in a surgical environment. Conventional device technologies can potentially reduce clinical efficacy by damaging the drug, or harm and discomfort the patient, due to factors such as their non-intuitive steps of use, the precise angle at which the needle must be inserted and withdrawn, and the rapid velocity at which the drug is propelled into the target region of the body.

Unilife's solution to these problems is the Unilife Depot-Ject™ platform, which leverages certain aspects of the Unifill™ system of automatic, user-controlled needle retraction technology. It allows pharmaceutical companies to supply their drug depot to clinicians in a ready-to-inject format, where they can intuitively and precisely implant the drug depot into the target region of the patient's body using a standard one-handed technique. The ability for a clinician to accurately and precisely implant the depot can help to minimize the risk for internal injury to a target organ, and also reduce the risk of damage to the drug itself.

A video of the Depot-Ject can be seen at www.unilife.com. Certain aspects of the device have been blurred in the video for commercial purposes.

Unilife Ocu-Ject™ Platform

The Unilife Ocu-Ject™ platform enables the accurate delivery of microliter-sized doses to the eye far more precisely than is currently possible with conventional devices. Under laboratory testing, the Ocu-Ject technology has been demonstrated to deliver a 10 uL dose with a standard deviation of only 0.2 uL (2% standard deviation) compared to a 1mL tuberculin syringe of 2.9 uL (31% standard deviation). This capacity to precisely delivery microliter doses can deliver a tenfold increase in compliance with drug labeling requirements.

To address specific customer, drug and patient requirements, each Ocu-Ject device can be customized in a variety of configurations including prefilled, with either an attachable or integrated retractable needle, or for filling at time of use. Unilife Ocu-Ject™ devices are designed for intuitive use by clinicians, employ ergonomic features and can help to minimize patient pain and safety.

Pharmaceutical and biotechnology companies seeking further information on the Unilife Ocu-Ject and Depot-Ject technology platforms are encouraged to contact Unilife at [email protected] or +1 717 805 8607.

Industry Background - Unmet Needs for Injectable Therapies

Many pharmaceutical companies have early-stage molecules in their clinical pipelines that can redefine treatment by enabling the targeted or localized delivery of the injectable therapy to a specific region of the human body. However, in many cases, due to the novel nature of the therapy, application or procedure, these novel molecules can require a specialized delivery system to enable their commercialization and approval. Without an effective delivery system, it is not commercially feasible for these pipeline drugs to make the transition from the laboratory to clinical trials and regulatory approval.

There are many approved drugs that utilize conventional commodity-type device technologies that limit a drug's clinical efficacy and generate sub-optimal clinical outcomes. An aging population and increasing prevalence of diabetes are especially driving demand for the development of therapies used in the treatment of eye disorders. Several pharmaceutical companies are actively involved in the development and refinement of new or existing therapies for diseases including age-related macular degeneration, diabetic retinopathy and diabetic macular edema that cost billions of dollars a year for current treatments.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of advanced drug delivery systems. Unilife collaborates with pharmaceutical and biotechnology companies seeking innovative, differentiated devices that can enable or enhance the delivery of injectable drugs and vaccines supplied in either a liquid stable or lyophilized form. The Unifill syringe, the world's first and only prefilled syringe with fully integrated safety features, sits at the leading edge of this diversified portfolio. In addition to prefilled and hypodermic safety syringes with automatic, user-controlled needle retraction, Unilife has other proprietary technology platforms including drug reconstitution delivery systems, auto-injectors, auto-infusion pump systems and specialized devices for targeted organ delivery. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information on Unilife, please visit www.unilife.com.  

Forward-Looking Statements

This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.

General: UNIS-G

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