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(UNIS) Signs 15-Year Commercial Supply Agreement for Wearable Injectors with Sanofi

Unilife to be the sole provider of wearable injectors for all of Sanofi’s applicable large dose volume drugs

YORK, Pa., Oct. 6, 2014  — Unilife Corporation (NASDAQ: UNIS and ASX: UNS), a developer and supplier of injectable drug delivery systems, announced today the signing of a worldwide Master Services and Commercial Supply Agreement with Sanofi to be the sole provider of cartridge based wearable injectors for all of Sanofi’s applicable large dose volume drugs, excluding insulins, for a minimum 15 years. Additionally the agreement will allow Sanofi to make Unilife’s wearable injectors available to its partners for use with applicable molecules under joint collaborations.

Unilife has granted Sanofi non-exclusive access to its wearable injector technology during the agreement. Unilife maintains the right to enter into supply agreements with other pharmaceutical companies for the use of its wearable injectors, so long as Sanofi’s non-exclusive access is preserved. Sanofi also has the option to extend the agreement for additional periods. In addition to an upfront payment and device sales, Unilife anticipates it will receive approximately $50 million from customization programs relating to Sanofi molecules and indications. Additional revenue is also expected from customization programs conducted under joint collaborations with Sanofi partners. Unilife will begin to generate revenue from Sanofi this fiscal year from an upfront payment, customization programs and initial commercial sales of the devices to Sanofi. Unilife and Sanofi will also collaborate in the development of other new technologies that address additional unmet or emerging needs for the delivery of large dose volume biologics. Additional information will remain confidential at this time.

Mr. Alan Shortall, Chairman and Chief Executive Officer of Unilife said: “Unilife continues to advance our lead position in the fast-growing market for wearable injectors, a market which is expected to generate $8 billion in sales at an average $25 per unit by 2025. Based upon public information and industry forecasts, Unilife estimates that Sanofi has between 5 to 10 molecules that will be delivered in wearable injectors. With many pharmaceutical companies having up to a dozen large dose volume biologics that will each require an average of five million units per drug per year, our wearable injectors are poised to generate substantial revenue and growth moving forward. Additionally, we anticipate substantial incremental revenue will be generated from customization programs conducted under joint collaborations with Sanofi partners that choose to participate,” Mr. Shortall concluded.

Unilife Platform of Wearable Injectors

The Precision-Therapy™ platform of disposable wearable injectors can be worn on the body of a patient during the subcutaneous administration of a large dose volume drug. Unilife’s wearable injectors can be prefilled, pre-assembled and ready to use, with only three intuitive steps for a patient to peel off the label, stick the product onto the body and click a button to commence the injection of a drug (Peel, Stick and Click™). Unilife wearable injectors require no terminal sterilization, utilize standard materials in the primary drug container and are supplied for seamless integration with standard filling and packaging systems. Products can be pre-configured to administer a measured dose volume over a designated period of time, typically ranging between one and thirty minutes. Unilife wearable injectors utilize a Flexwear™ comfort catheter for patient comfort, and an on-body safety lock that prevents unintentional activation.

The Global Market for Wearable Injectors

Wearable injectors are prefilled, disposable devices that are worn on the body of a patient during the subcutaneous administration of a large volume dose of medication. The market for wearable injectors is poised to experience rapid growth over the coming decade due to a convergence of market trends including accelerating pharmaceutical investment in biologics requiring large volume doses, and the shift of healthcare treatment from healthcare facilities to safe, simple and convenient self-injection by patients. According to the independent market research report Large Volume Wearable Injectors published by Roots Analysis in September 2014, it is estimated that the market for wearable injectors will generate up to $8 billion in sales by 2025, with 181 biologics across 14 disease areas identified for use with wearable injectors. The average selling price for a wearable injector is estimated to be on average between $25 and $35 per unit.

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 portfolio of innovative, differentiated products includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel systems. Products within each platform are customizable to address specific customer, drug and patient requirements. Unilife’s global headquarters and manufacturing facilities are located in York, PA. For more information, visit or download the Unilife IRapp on your iPhone, iPad or Android device.

General: UNIS-G

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.

Investor / PR Contacts (US): Analyst Enquiries Investor Contacts (Australia)
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Monday, October 6th, 2014 Uncategorized