Unilife Gets PFS Contract

Unilife has entered of a seven-year commercial supply contract with an undisclosed pharmaceutical company for its Unifill prefilled syringe. The deal is for 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 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, according to Unilife.

An exclusivity fee will be added onto the negotiated unit price of the Unifill syringe when agreed exclusivity conditions are met. Unilife will grant the client an exclusivity of supply right for the Unifill syringe for a specific indication and western European geography. 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.

According to Unilife, the Unifill syringe was selected by the client to differentiate its drug from brand name or generic competitors. The implementation next year of a legally binding EU directive mandating the use of needlestick prevention products within European healthcare facilities also played a significant role in the selection of the Unifill syringe.

Initial sales of the Unifill syringe to the pharmaceutical customer will begin in July 2012. Sales are expected to increase in anticipation of the scheduled commercial launch of the pharmaceutical customer’s drug within international geographies after regulatory approvals are granted during 2013. Annual unit volumes for the Unifill syringe within the initial European markets are expected to reach as much as 10 million units during the contract period, generating as much as $15 million in revenue per year. Unit volumes may increase as other reserved international geographies are added by the client.

Mr. Alan Shortall, chief executive officer 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 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.”

He 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.”