LEWISBERRY, PA--(Marketwire - November 25, 2009) - Unilife Medical Solutions Limited ("Unilife"
or "the Company") (ASX: UNI) (PINKSHEETS: UNIFF) today announced the filing
of patent applications in the United States ("US") for a new ready-to-fill
syringe product to be marketed as the Unifill™ Select. Unilife is
confident that this new pipeline product, which is to be primarily targeted
for use with vaccines, can further expand the Company's ability to
penetrate the pharmaceutical market for prefilled syringes. Unilife has
recently commenced discussions with a number of interested pharmaceutical
parties regarding the Unifill™ Select.
Virtually all injectable drugs and vaccines known to Unilife that are
available for use in a prefilled syringe format are either indicated for
administration by subcutaneous (beneath the skin) or intramuscular ("IM" --
into the muscle) injection.
The Unifill™ Select is a new product line that will complement the
Unifill™ syringe which Unilife is currently bringing to market with its
major pharmaceutical customer. The Unifill™ syringe features a
fixed-length retractable needle, and is primarily targeted for use with
drugs such as anti-coagulants, multiple sclerosis and some vaccines where
prefilled syringes with a standard
fixed-length needle are used to administer a dose via subcutaneous
Introducing the Unifill™ Select
The newly filed patent application for the Unifill™ Select product is
designed to address the prefilled requirements of pharmaceutical companies
that manufacture injectable drugs and vaccines indicated for administration
via IM injection.
Standard clinical procedures for IM injections require healthcare workers
to select the gauge and length of a needle based upon the age, gender, and
size of the patient, as well as the location of the muscle into which the
drug will be administered. A needle length of between 5/8th of an inch and
1 1/2 inches is typically used for IM injections to ensure the dose is
administered at the correct depth into the target muscle of the patient.
Prefilled syringes containing drugs and vaccines indicated for the
administration of drugs via IM injection are typically supplied in a format
whereby healthcare operators can attach a needle of a suitable length to
accommodate the patient's clinical needs.
The Unifill™ Select syringes will allow healthcare workers to attach
needles of up to 1 1/2 inches in length and inject the dose into the
patient as per routine procedures for IM administration. Upon full dose
delivery, the needle retraction mechanism is activated automatically with
the operator being able to control the speed of needle withdrawal directly
from the body into the glass barrel. Pharmaceutical companies may elect to
supply the Unifill™ Select to healthcare facilities in a compact and
convenient kit format which is ready-for-injection by healthcare workers.
Like its companion product the Unifill™ syringe, the Unifill™ Select
would also be compatible with the drug filling systems now utilized by
pharmaceutical companies for comparable standard prefilled syringes.
Unilife believes that the Unifill™ Select would be the world's first
known prefilled syringe with automatic and fully integrated safety features
that allows healthcare workers to select and attach a suitably sized
needle. Furthermore, Unilife is not aware of any ancillary safety product
currently purchased by pharmaceutical companies for attachment onto
standard prefilled syringes which can accommodate needles of 1 1/2 inches
Market Opportunity for the Unifill™ Select
Unilife believes the Unifill™ Select is well positioned to cater to the
needs of pharmaceutical companies that manufacture vaccines. While
prescription-drug sales are forecast to rise by a third in five years,
vaccine sales should double, from US$19 billion last year to US$39 billion
in 2013, according to market-research firm Kalorama Information. Of more
than 50 injectable drugs monitored by Unilife that are available in a
prefilled syringe format, approximately half are indicated for IM injection
with the majority of these being vaccines. Greystone Associates estimates
that approximately three-quarters of vaccine doses will be administered in
a prefilled syringe format by 2012, with influenza vaccines being the
single largest application for the delivery of a therapeutic substance via
a prefilled syringe.
Other therapeutic drug sectors where drugs are indicated for administration
via IM injection and available in a prefilled syringe format include the
anti-viral, human growth hormone and anti-inflammatory (arthritis) sectors.
Unilife has received written legal opinion that the Unifill™ Select is
not subject to any agreements the Company has previously signed relating to
the Unifill™ syringe. The commercialization program to be undertaken for
the Unifill™ Select is expected to be run in conjunction with interested
Comments by CEO Alan Shortall
"Unilife is committed to developing a best-in-class range of safety
syringes that can meet the safety and functionality requirements of
pharmaceutical companies, healthcare workers and patients that
self-administer prescription medication. With the filing of patents for
this new pipeline product, we have taken another significant step towards
the achievement of this goal. We are particularly excited by emerging
commercial opportunities for the Unifill™ Select, which we believe will
help service the needs of pharmaceutical companies in fast-growing
therapeutic markets such as vaccines. Discussions with a number of
interested pharmaceutical parties have already commenced.
"The Unifill™ syringe that we are currently bringing to market with a
major pharmaceutical partner is very well positioned to become a preferred
delivery device for drugs and vaccines which are administered via
subcutaneous injection. By adding the Unifill™ Select to our proprietary
portfolio of ready-to-fill syringes, we look forward to expanding our
relationships with pharmaceutical companies and further establishing a
significant presence across therapeutic drug markets where prefilled safety
syringes are in strong demand.
"I believe that the addition of the Unifill™ Select to our product
portfolio can substantially increase our business opportunities and further
position us as a key participant in the drug delivery business. It is
another indication of our ability to develop innovative technologies which
meet market needs."
Unilife Medical Solutions Ltd is an ISO 13485 certified company that
designs, develops and supplies innovative safety medical devices. Listed on
the Australian Securities Exchange (ASX: UNI) since 2002, Unilife has
FDA-registered manufacturing facilities in the US State of Pennsylvania and
a proprietary portfolio of clinical and prefilled safety syringes designed
for use within healthcare and pharmaceutical markets.