Unilife Signs Long-Term Supply Agreement with Hikma to Enhance Delivery of Generic Injectables

YORK, Pa., Nov. 20, 2013 /PRNewswire/ -- Unilife Corporation ("Unilife") (NASDAQ: UNIS, ASX: UNS) today announced the signing of a long-term commercial supply contract with Hikma Pharmaceuticals PLC ("Hikma") (LSE: HIK) for the use of Unifill^® prefilled syringes with a range of generic injectable drugs.

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 products"). 

Hikma has selected an initial list of 20 of its generic injectable products to be used with Unifill products. Unilife has granted Hikma exclusive global rights to its Unifill products for use with these specific generic injectable products. Additional injectable drugs may also be added to the exclusivity list subject to agreement by both parties.

Unilife will commence product sales to Hikma in early 2014. Under the terms of the contract, Unilife will supply Hikma a minimum volume of 175MM units per year following a rapid high-volume ramp up period.

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

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

Mr. Said Darwazah, Chief Executive Officer of Hikma, stated: "This agreement supports our strategy of developing higher value products and we are extremely pleased to be partnering with Unilife to develop our generic injectables capabilities.  We look forward to leveraging Unilife's innovative platform of Unifill syringes to differentiate our injectable products and to increase our market share."

Mr. Alan Shortall, Chief Executive Officer of Unilife, stated: "Unilife has developed a full range of innovative and highly differentiated syringes under our Unifill platform to accommodate the needs of all prefilled biologics, drugs and vaccines. This strategic partnership with Hikma enables us to rapidly penetrate the large and fast-growing market for generic injectables. Hikma is one of the world's fastest growing pharmaceutical companies, and a top three supplier by volume in the $7 billion U.S. market for generic injectables. Together with our recently announced long term supply contract with Sanofi, this partnership with Hikma instantly positions Unilife to become one of the largest suppliers of prefilled syringes in the world."

The Unifill^® Platform

Unilife has developed an extensive proprietary platform of prefilled syringes under its Unifill^® brand. Unifill is the world's first and only known platform of prefilled syringes with automatic and fully integrated needle retraction.  Designed for intuitive use by healthcare workers or self-injecting patients, an audible, tactile click signals the injection of the full dose and the automatic activation of the needle retraction mechanism. Users can control the speed of needle retraction directly from the body into the syringe barrel by relieving thumb or finger pressure on the plunger to eliminate the risk of needlestick injuries or the aerosolization (splatter) of blood or tissue residue.  Unifill syringes are compatible with standard filling and packaging processes, with USP compliant materials in the primary drug container.

The Unifill Nexus™

The Unifill Nexus is a glass prefilled syringe that can be universally attached to ISO standard needless luer access devices (NLADs). The Unifill Nexus is designed to address patient safety concerns relating to the reported malfunction, breaking or clogging of some conventional glass prefilled syringes when attached to NLADs. Unlike some other needleless prefilled syringes, it features an ISO standard luer lock tip that is designed for universal attachment onto standard needle hubs and IV connectors and prevents the risk of spontaneous disconnection or leakage of medication. Like other syringes within the Unifill platform, the Unifill Nexus is compatible with standard filling and packaging processes and has USP compliant materials in the primary drug container.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife's broad portfolio includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, intraocular delivery systems and novel devices. Each of these innovative, differentiated technology platforms can be customized to address specific customer, drug and patient requirements. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

About Hikma

Hikma Pharmaceuticals is a fast growing multinational group focused on developing, manufacturing and marketing a broad range of both branded and non branded generic and in-licensed products. Hikma's operations are conducted through three businesses: "Branded", "Injectable" and "Generics" based principally in the Middle East and North Africa (MENA) region, where it is a market leader, the United States and Europe. In 2012, Hikma achieved revenue of US$1,108.7 million and profit attributable to shareholders of US$100.3 million.

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 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, those 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. 

General: UNIS-G

SOURCE Unilife Corporation