Unilife Develops Breakthrough Device Technologies

Unilife Corporationrecently 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 in which 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-size doses to the eye. By significantly reducing the risk of over-dosing or under-dosing, Ocu-Ject devices can help maximize clinical outcomes, minimize patient pain, and enhance compliance with drug labeling.

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.”

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.

The Unilife Ocu-Ject platform enables the accurate delivery of microliter-size 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-microliter dose with a standard deviation of only 0.2 microliters (2% standard deviation) compared to a 1-mL tuberculin syringe of 2.9 microliters (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 info@unilife.com, (717) 805 8607, or visit www.unilife.com.