Ocu-ject provides a tenfold improvement in the precision of delivering doses as small as 10 microliters
YORK, Pa., Dec. 16, 2013 /PRNewswire/ -- Unilife Corporation ("Unilife") (NASDAQ: UNIS, ASX: UNS) today announced the signing of an agreement with a global pharmaceutical company seeking to use the Unilife Ocu-ject™ ocular drug delivery system to deliver a target injectable therapy into the eye.
The identity of the global pharmaceutical company, one of the market leaders in ophthalmic therapies, as well as other terms of the agreement are not disclosed for commercial purposes and due to confidentiality requirements. Unilife will begin to generate revenue under the program in January 2014.
Unilife's Ocu-ject platform offers a breakthrough technology for the accurate and precise delivery of small dose volumes measured in microliters (uL) into the eye. Most ocular therapies for the treatment of conditions such as age-related macular degeneration, diabetic retinopathy, and diabetic macular edema are administered via intravitreal injection using a standard 1mL tuberculin syringe and needle. The potential for gross dosing inaccuracy is inherent with such conventional devices, which can compromise the ability of the drug to fully comply with its regulatory labeling requirements. Ocu-ject provides a tenfold improvement in the precision of delivering doses as small as 10 uL, which helps pharmaceutical customers ensure compliance with dose requirements on the drug label.
Mr. Alan Shortall, Chairman and CEO of Unilife said: "In tune with our commitment to address unmet needs within the pharmaceutical industry, we have created a new, significant drug delivery device category. Ocu-ject represents a game-changing delivery technology for ocular therapies, which is a large, fast-growing segment of the pharmaceutical market. We are pleased to have signed our first agreement for the Ocu-ject device platform, which is being pursued by a number of pharmaceutical companies seeking to maximize the clinical and commercial potential of approved and pipeline drugs that are targeted to treat a number of eye disorders. We look forward to serving these customers to address unmet market needs for the accurate, precise delivery of drugs to the eye."
The Ocu-ject device platform is designed to deliver drugs with small dose volume of between 10 microliters and 500 microliters for delivery into the eye with a level of accuracy and precision not possible with conventional syringes. It is designed for use with injectable therapies designed to treat diseases including Age-related Macular Degeneration (AMD), Diabetic Retinopathy, Diabetic Macular Edema and Uveitis. By minimizing over-dosing, the device platform has the potential to reduce the risk of increased intraocular pressure (IOP) and potentially minimize damage to the optic nerve. By further minimizing the risk of under-dosing, the platform has the potential to help avoid delivery of a drug outside its therapeutic window where its clinical efficacy may be compromised. The Ocu-ject platform also employs the highest grade drug contact materials unlike syringes currently used to inject into the eye.
To address specific customer, drug, and patient requirements, products from the Ocu-ject platform can be customized in a variety of configurations including prefilled, with either an attachable or integrated retractable needle, or for use with a drug vial. They are designed for intuitive use by clinicians, employ ergonomic features and have the potential to minimize patient pain and maximize safety.
About Unilife Corporation
Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife's broad portfolio includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, intraocular delivery systems and novel delivery systems. Each of these innovative, differentiated technology platforms can be customized to address specific customer, drug and patient requirements. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.
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.
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