York, PA (April 18, 2013) – Unilife Corporation (“Unilife” or “Company”) (NASDAQ: UNIS, ASX: UNS), today announced the development of the Unifill Assure™, a customized device from its Unifill® platform of ready-to-fill (prefilled) syringes that is designed to address unmet market needs for the injection of high-viscosity biologic drugs by patient populations with reduced dexterity.
Mr. Michael Ratigan, Chief Commercial Officer of Unilife, said, “The Unifill Assure optimizes our ability to fully address the needs of all prefilled biologics, drugs and vaccines under one innovative and fully customizable platform. In addition to automatic, user-controlled needle retraction being integrated within the glass barrel, which is unique to our Unifill platform, the Unifill Assure features an extended finger flange with a soft, rubberized non-slip grip and an easy-to-press thumb button on a strengthened plunger. The unique combination of these proprietary features makes the Unifill Assure the most ergonomic, comfortable and intuitive prefilled syringe ever developed for the patient self-injection of biologics.
“We are pleased that the Unifill Assure, like other Unifill configurations, is now being actively pursued by pharmaceutical companies who recognize its unique potential to differentiate their biologic therapies against competing drugs supplied in prefilled syringes with needle sheath-based ancillary safety products, which our technology essentially replaces. The combination of the Unifill Assure with either of our disposable or electro-mechanical reusable auto-injectors can further allow pharmaceutical companies with biologic drugs to address the specific needs of all segments of a target patient population to further drive therapy compliance and maximize patient preference rates,” Mr. Ratigan concluded.
Initial supply of the Unifill Assure to interested pharmaceutical companies recently commenced to support drug compatibility programs and user studies with target patient groups involving prefilled syringes with needle sheath-based ancillary safety products, where the Unifill Assure excelled across all metrics including safety, aesthetics, ease-of-use and convenience. Competitive benefits of the Unifill Assure include:
Ergonomic Handling and Confident Self-Injection by Patients with Reduced Dexterity
All Unifill syringes feature a molded flange that can be customized in size and shape for optimal handling and intuitive use by the target patient population. For the Unifill Assure, Unilife has leveraged human factors findings to develop an extended finger flange with ergonomic features including a soft rubber non-slip grip coating. Together with a strengthened plunger with a large, customizable thumb press, the Unifill Assure provides unparalleled injection support and stability for patients with reduced dexterity. Unlike prefilled syringes with needle sheath-based ancillary safety products, patients also have a clear and unobstructed view of the drug from any angle during all stages of use.
Optimal Needlestick Protection
Unilife syringes provide operators with audible, tactile and visual indicators to simultaneously confirm full dose delivery and the automatic activation of the retraction mechanism. Unlike prefilled syringes with needle sheath-based ancillary safety products that require deployment of the safety mechanism in the open air after removal from the injection site, Unifill syringes allow patients to control the speed of needle withdrawal directly from the body back into the syringe. This combination of automatic, user-controlled and fully integrated needle retraction eliminates risks such as needlestick injuries or the aersolization (splatter) of blood or tissue residue, and is only available in Unifill syringes.
Automatic Reuse Prevention for Compact, Convenient Disposal
Unifill syringes represent the ultimate reuse prevention and needle containment system for compact and convenient disposal. Unlike prefilled syringes with needle sheath-based ancillary safety products that can potentially be disassembled after use and the intact syringe reused or tampered with, the plunger of Unifill syringes is automatically and permanently locked following retraction to prevent any risk of device reuse or needle re-exposure. The compact size of Unifill syringes compared to prefilled syringes with bulky needle sheath-based ancillary safety products can also help to minimize waste disposal volumes.
Visual Distinction and Strong Preference and Acceptance Rates to Differentiate Injectable Drugs
The visually distinctive design and strong user acceptance of syringes within the Unifill platform such as the Unifill Assure™, the Unifill Finesse™ or the Unifill Select™ can be leveraged by pharmaceutical companies to differentiate their injectable therapies against prefilled rivals supplied with ancillary safety products.
Unifill syringes feature a sleek, elegant and attractive design, with no unsightly springs or mechanisms visible during all stages of use. Independent human factor studies support 100% acceptance and strong preference rates for Unifill syringes by patients and healthcare workers in every aspect of use, with all participants finding the devices intuitive to use even on the first attempt. Unilife’s needle retraction technology was also deemed by participants as being safer and easier to utilize compared to prefilled syringes with needle sheath-based ancillary safety products.
Compatible with Standard Filling and Packaging Process
Designed for direct integration into standard fill-finish processes used for equivalent conventional prefilled syringes, Unifill syringes can eliminate costs and operational inefficiencies associated with the purchase, secondary attachment and excess packaging volume needle sheath-based ancillary safety products. Unifill syringes also utilize USP compliant materials in the drug container, with customization options including coated elastomers and silicone minimization available to support the compatibility needs of biologics.
Production of the Unifill platform of syringes is now underway at Unilife’s FDA-registered manufacturing facilities in York, PA. The Unifill Assure is available for evaluation by interested pharmaceutical companies. For further information, please visit the Unilife website at www.unilife.com or email [email protected].
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 of proprietary device technologies includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, bolus injection devices and targeted delivery systems. Each of these innovative and highly differentiated device platforms can be customized by Unilife to address specific customer, drug and patient requirements. Unilife’s global headquarters and state-of-the-art manufacturing facilities are located in York, PA.