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Pre-filled syringe in production


March 31, 2011
By PR Newswire

NEWS HIGHLIGHT

Pre-filled syringe in production
Unilife Corporation has announced it has commenced initial production of the
Unifill ready-to-fill (pre-filled) syringe at its FDA-registered
manufacturing facility in York, Penn.

March 30, 2011 – Unilife Corporation has announced it has commenced initial production of the
Unifill ready-to-fill (pre-filled) syringe at its FDA-registered
manufacturing facility in York, Penn. The initial
production of the Unifill syringe, the world's first pre-filled syringe
with safety features fully integrated within the glass barrel, will
enable Unilife to further accelerate discussions with more than 20
pharmaceutical companies.

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These pharmaceutical companies are at various
stages of review in the potential use of the Unifill syringe with a
number of approved and pipeline injectable drugs and vaccines across
more than a dozen therapeutic classes.

Once Unilife
completes final product validation activities for the Unifill syringe
during the second quarter of 2011, the company can begin to fulfill
initial sales orders to its existing pharmaceutical partner. The supply
and sale of the Unifill syringe to other interested pharmaceutical
companies is expected to commence shortly afterwards.

Initial
production batches are expected to be utilized by pharmaceutical
companies and contract manufacturing organizations (which fill pre-filled
syringes with injectable drugs on behalf of their pharmaceutical
clients) for a number of activities. This will include the initiation
of drug stability studies, market evaluations, and validating the
integration of the product into fill-finish systems currently used to
load a measured dose of an injectable drug or vaccine into equivalent
standard pre-filled syringes.

Mr. Alan Shortall,
CEO of Unilife, said, "We look forward to being in a position to begin
fulfilling initial sales orders for the Unifill syringe towards the end
of June, and consolidating relationships with a number of interested
pharmaceutical companies during the rest of the year. We are proud to be
commencing initial production of the Unifill syringe nine months ahead
of our original schedule, having successfully met every quarterly
milestone since the industrialization program began in July, 2008."

The Unifill syringe

The Unifill
syringe is the world's first pre-filled syringe with safety features
fully integrated within the glass barrel. It is designed for integration
into fill-finish systems used by pharmaceutical manufacturers to load a
measure dose of an injectable drug or vaccine into equivalent standard
pre-filled syringes, and features USP compliant materials inside the
fluid path. An automatic (passive) needle retraction mechanism is
activated in the Unifill syringe upon full dose delivery, allowing
operators to control the speed of needle retraction directly from the
body into the barrel to virtually eliminate the risk of infection from
potential transmission modes such as needlestick injuries or splatter.
The Unifill syringe is designed for compact handling and convenient
disposal by either healthcare workers or patients that self-administer
prescription medication. As a unique primary drug container offering
optimal protection to healthcare workers and their patients, the Unifill
syringe is strongly positioned to help pharmaceutical companies
generate powerful brand differentiation within competitive therapeutic
drug classes, and optimize product lifecycles.

Pharmaceutical market for pre-filled syringes

Pre-filled
syringes serve as a primary drug container for approximately 50
injectable drugs and vaccines currently marketed by more than 20
pharmaceutical companies. More than 2.4 billion pre-filled syringes are
used every year according to Greystone Associates, with the market
growing at approximately 12 per cent, per year. Unilife considers the
pharmaceutical market for pre-filled syringes to be the fastest-growing,
least congested and most profitable sector of the global syringe
industry. To comply with legislation across international markets, such
as the U.S. and Europe which mandate
the use products that can protect healthcare workers from needlestick
injuries, pharmaceutical companies currently attach ancillary safety
products onto standard pre-filled syringes. These ancillary safety
products can increase pharmaceutical packaging, transport and disposal
volumes by up to 70 per cent.


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