press release
June 18, 2012, 11:49 a.m. EDT
Unilife Signs Long-Term Supply Contract for the Unifill Prefilled Syringe
--Unifill Chosen for Upcoming Launch of Generic Equivalent of Auto-Immune Therapy --7-Year Contract to Generate Annual Revenue of up to $15MM for Initial E.U. Geography --Exclusivity Fee for Initial E.U. Geography and Indication, Other Territories Reserved
YORK, Pa., June 18, 2012 /PRNewswire via COMTEX/ -- Unilife Corporation ("Unilife" or "Company") UNIS +5.43% (asx:UNS) today announced the signing of a seven-year commercial supply contract with a pharmaceutical company for the Unifill ® ready-to-fill (prefilled) syringe.
Target Drug and Market This supply contract for the Unifill syringe relates to the planned launch of a generic equivalent of an approved auto-immune therapy that is currently available in a standard prefilled syringe format for use across several indications.
The auto-immune therapeutic space includes disease states such as rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus and Crohn's disease. The cumulative U.S. patient population affected by auto-immune diseases is greater than seven million people and approximately twice that worldwide. The drug has also been shown to be effective for the treatment of several cancers including breast, head and neck, leukemia, lymphoma, lung, osteosarcoma, bladder and trophoblastic neoplasms.
Currently, the majority of injections within the auto-immune therapeutic class are self-administered by patients using either a standard prefilled syringe or a conventional auto-injector. The release of the generic drug utilizing the Unifill syringe will mark the first time an auto-immune therapy is supplied in a prefilled syringe with safety features that can prevent needlestick injuries and encourage more convenient, safer disposal.
Exclusivity of Supply An exclusivity fee will be added onto the negotiated unit price of the Unifill syringe when agreed exclusivity conditions are met. Unilife will grant to the pharmaceutical customer an exclusivity of supply right for the Unifill syringe for a specific indication and Western European geography.
The Unifill syringe was selected by the pharmaceutical customer because of its capacity to differentiate its drug from brand name or generic competitors. The implementation next year of a legally binding E.U directive mandating the use of needlestick prevention products within European healthcare facilities also played a significant role in the selection of the Unifill syringe. Exclusive access to the Unifill syringe further strengthens the pharmaceutical customer's competitive strategy.
Other international geographies have also been reserved for exclusivity by the pharmaceutical customer, and will be added subject to the agreement of terms by both parties.
Projected Revenue Initial sales of the Unifill syringe to the pharmaceutical customer will commence in July 2012. Sales are expected to progressively increase in anticipation of the scheduled commercial launch of the pharmaceutical customer's drug within international geographies after regulatory approvals are granted during Fiscal Year 2013. Annual unit volumes for the Unifill syringe within the initial European geography are expected to reach up to 10 million units during the contract period, generating up to $15 million in revenue per year.
The unit volumes for the Unifill syringe can increase as other reserved international geographies are added by the pharmaceutical customer.
For commercial purposes and due to confidentiality clauses within agreements, additional terms of the contract and the identity of the pharmaceutical company are to remain confidential at this time.
Comments by Unilife CEO Alan Shortall Mr. Alan Shortall, CEO of Unilife, said, "Pharmaceutical companies are actively seeking access to innovative, differentiated devices for delivery of their brand name, generic and biosimilar drugs. The long-term supply contract that we have signed today underscores this growing trend and demonstrates how our proprietary portfolio of innovative device technologies can enable and enhance their commercial strategies for injectable drugs.
"Through the pairing of the Unifill syringe with their drug, this pharmaceutical customer can set a new benchmark for safety and functionality within this high-value therapeutic class, and turn compliance with needlestick prevention laws into a competitive market advantage. We look forward to building a strong relationship with this pharmaceutical customer to help them generate powerful differentiation and market demand for their drug.
"While full terms of this long-term contract cannot be fully disclosed for commercial purposes, I am pleased that it contains multiple revenue-generating components, including exclusivity fees, an attractive unit price and significant commercial upside moving forward as other reserved international territories are added."
"This is just one of many supply contracts that we expect to be generated for the Unifill syringe moving forward. We expect the Unifill syringe will be selected for a number of brand name and generic drugs targeted for use across a wide variety of therapeutic indications that are either approved and at various stages in their commercial lifecycle, or in clinical development. To best align ourselves with the commercial strategies of these pharmaceutical customers, and to drive shareholder value for Unilife, I expect these upcoming contracts will all vary in terms of size, scope and structure."
About Unilife Corporation Unilife Corporation is a U.S. based developer and commercial supplier of advanced drug delivery systems. Unilife collaborates with pharmaceutical and biotechnology companies seeking innovative, differentiated devices that can enable or enhance the delivery of injectable drugs and vaccines supplied in either a liquid stable or lyophilized form. The Unifill syringe, the world's first and only prefilled syringe with fully integrated safety features, sits at the leading edge of this diversified portfolio. In addition to prefilled and hypodermic safety syringes with automatic, user-controlled needle retraction, Unilife has other proprietary technology platforms including drug reconstitution delivery systems, auto-injectors, auto-infusion pump systems and specialized devices for targeted organ delivery. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. 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, including statements relating to anticipated sales and revenues pursuant to the supply agreement, expected future supply contracts for the Unifill syringe, and potential geographical exclusivity additions under the supply agreement, 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, the risk that projected sales under the supply agreement will not be achieved, the risk that delays in regulatory approvals or commercial launch, and those risks and uncertainties 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.
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