Unilife is a US-based company that designs, develops, manufactures and supplies injectable drug delivery systems.

Under the 15-year global agreement, Unilife will supply Hikma with customized prefillable delivery systems from its Unifill platform, including the Unifill syringe and the Unifill Nexus. Unifill pre-filled syringes have automatic and fully integrated needle retraction, eliminating the risk of needlestick injuries or the aerosolization (splatter) of blood or tissue residues. The Unifill Nexus is a glass pre-filled syringe that can be universally attached to ISO standard needleless luer access devices (used for intravenous administration of drugs).

Hikma has chosen 20 of its generic injectable products to be used with Unifill products. Hikma will have exclusive global rights to these Unifill products for use with the specific generic injectable products and has an option to add more to this list. Unilife will commence product sales to Hikma in early 2014.

In addition to product sales, Hikma will pay Unilife US$40 million in upfront and milestone payments. An initial upfront payment of US$5 million will be paid to Unilife immediately, with an additional US$15 million in payments expected during 2014. The final US$20 million in milestone-based payments will be paid during 2015.

Market demand for generic injectables is rapidly shifting from vials to pre-filled syringes, with safety issues driving this change. However, conventional pre-filled devices prevent universal attachment with any ISO standard needle hub or intravenous connector and are also associated with patient safety risks, including spontaneous disconnection and the leakage or occlusion of medication. The design of Unilife’s Unifill Nexus addresses these issues and is expected to rapidly become the preferred choice to deliver generic injectable drugs.

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