SOURCE: Unilife Medical Solutions

Unilife Medical Solutions

November 25, 2009 09:21 ET

Unilife Files Patents for Additional Ready-to-Fill Safety Syringe

First Known Prefilled Safety Syringe With Attachable Needles Suited for Intramuscular Injection

Pipeline Product Not Constrained by Existing Agreements

Discussion With Interested Pharmaceutical Companies Underway

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 injection.

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 in length.

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 pharmaceutical parties.

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."

About Unilife

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.

Contact Information

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