Healthcare Industry News:  biosimilar 

Devices Drug Delivery

 News Release - August 23, 2011

Unilife Develops Unifill(R) EZMix Multiple-Chamber Prefilled Syringes

First Prefilled Safety Syringe for Lyophilized Drugs Requiring Reconstitution

YORK, Pa., Aug. 23, 2011 -- (Healthcare Sales & Marketing Network) -- Unilife Corporation ("Unilife" or the "Company") (NASDAQ:UNIS ) today announced the development and patenting of the Unifill® EZMix multiple-chamber ready-to-fill (prefilled) syringes.

Unifill EZMix syringes have been developed in direct response to the unmet needs of pharmaceutical companies seeking an innovative and convenient delivery system for the reconstitution and administration of lyophilized drugs and vaccines. Unifill EZMix syringes feature two or more primary drug containers within a single glass barrel to store a combination of liquid stable or lyophilized drugs along with up to 1mL of diluent for reconstitution.

In addition to being the world's first and only dual or multi-chamber prefilled syringes with automatic (passive) safety features fully integrated within the glass barrel, the Unifill EZMix syringe offers minimal steps of use for healthcare workers and patients alike. The end-user simply advances the plunger to mix the lyophilized powder with the diluent, before swirling the device to complete reconstitution. An audible, tactile click signals the injection of the full dose and the activation of a passive safety system that allows operators to control the speed of needle retraction directly from the body into the barrel.

The Unifill EZMix syringe will be available with either a fixed (staked) needle for drugs indicated for subcutaneous injections, or with attachable needles of up to 1.5 inches in length.

Unilife CEO, Alan Shortall, said, "Unifill EZMix syringes are designed to address the unmet needs of pharmaceutical and biotechnology companies active within the large, fast-growing market for lyophilized drugs and vaccines. Nearly a third of all novel drugs approved by the FDA in the last three years were lyophilized either because a drug's large molecular composition made it unsuitable for liquid stable form or a pharmaceutical company wanted to fast-track the time to market.

"With the development pipelines of many pharmaceutical companies teeming with complex biologics that must be reconstituted at the point of delivery, we expect the market for lyophilized drugs and vaccines to experience double-digit growth for the foreseeable future. In addition, there are dozens of approved drugs requiring reconstitution that are approaching patent expiration and coming under increased pressure from brand-name, biosimilar or generic competition.

"Pharmaceutical companies recognize that innovative, convenient devices can help enhance therapy compliance, improve patient care and generate powerful brand differentiation within competitive therapeutic classes, therefore enabling them to increase market share and revenue. However, until now, there has never been a fully integrated delivery system that combines convenient drug reconstitution, intuitive use by the operator and optimal protection from needlestick injuries. Our Unifill EZMix syringes bring these distinct market needs together in one elegant and highly effective drug delivery system," concluded Mr. Shortall.

During its development program, Unifill EZMix syringes were referred to by Unilife as "Project Liger."

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS ) is a U.S.-based developer, manufacturer and supplier of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in 2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated proprietary portfolio of its own injectable drug delivery products, including the Unifill® and Unitract® product lines of safety syringes with automatic, operator controlled needle retraction. Unifill represents the world's first prefilled syringe technology integrating safety within the primary drug container. The products are ideally positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and enhance patient care. Unifill syringes, together with other devices that are part of the Unilife technology platform, can either be supplied to pharmaceutical customers ready for use, or customized to address the specific requirements of targeted novel drugs. 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.


Source: Unilife

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