Unilife Signs Long-Term Customization and Commercial Supply Agreement for EZMix Dual Chamber Syringe

15-Year Contract Expected to Generate up to $110 Million, with Revenue Starting Immediately

Unilife to Receive a Royalty of Net Drug Sales in Exchange for Exclusivity Rights

Apr 09, 2013, 08:00 ET from Unilife Corporation

YORK, Pa., April 9, 2013 /PRNewswire/ -- Unilife Corporation ("Unilife" or "Company") (NASDAQ: UNIS, ASX: UNS) today announced the signing of a Customization and Commercial Supply Agreement with a U.S. pharmaceutical company (the "Customer") for the EZMix dual-chamber syringe.

(Photo:  http://photos.prnewswire.com/prnh/20130409/NY91030 )

Unilife will supply the Customer with a customized device from its EZMix platform of dual-chamber delivery systems ("EZMix" or the "device") for use with a lyophilized drug (the "Drug") that requires mixing at the time of injection. The Drug, which is a proprietary version of an approved therapy, is entering late-stage clinical development with the Customer planning an accelerated pathway to U.S. regulatory approval.

Unilife expects to generate up to $110 million in revenue during the 15-year agreement based upon a customization and production scale-up program, commercial device sales and a royalty of net drug sales. Unilife will immediately begin to generate revenues under the program.

The Customer will pay Unilife approximately $3 million over a 12 to 24-month period for the customization and supply of prefilled EZMix devices for scheduled activities including human clinical drug trials and compatibility testing. Unilife will receive an additional $3 million from the Customer to fund the production scale-up of high-volume assembly equipment to manufacture the customized device at commercial volumes.

In exchange for the Customer securing worldwide exclusivity to EZMix for its target drug, Unilife will receive royalty payments on net annual commercial revenue of the Drug. These royalty payments are expected to represent approximately a third of the $110 million in cumulative revenues generated by Unilife during the contract period. The agreement includes a guaranteed minimum annual royalty payment that the Customer must provide to Unilife in order to maintain EZMix exclusivity for the target drug.

For commercial purposes and due to confidentiality provisions in the agreement, additional terms of the contract and the identity of the Customer are to remain confidential at this time.

Comments by Alan Shortall, CEO of Unilife

"As the world's only dual-chamber syringe with intuitive, ventless, orientation-free mixing and automatic needle retraction, EZMix is a game-changing technology for the delivery of liquid-liquid or liquid-dry drug combination therapies. Compared to conventional technologies which can take between five and a dozen complex steps to mix together the drug and diluent combination, EZMix can essentially achieve the same outcome with one easy, single-handed action. That makes EZMix an enabling technology for combination therapies targeted for use by healthcare workers or self-injecting patients," Mr. Shortall said.

"More than ten pharmaceutical companies are now pursuing EZMix in recognition of how it can enable or enhance the clinical development and lifecycle management of their injectable therapies. Given the significant competitive advantages of EZMix, many of these pharmaceutical companies are requesting worldwide exclusivity for the device. In this case, we will receive a royalty of the Drug's net commercial sales so that the customer can maintain exclusive access to EZMix for use with its target drug.  

"This agreement highlights the multitude of ways in which we can generate significant revenue not only from the customization, sale and exclusive use of our devices, but also by receiving a royalty from the commercial revenue of the injectable therapies they will deliver and differentiate. Many of the agreements that we are negotiating with various pharmaceutical companies are expected to include a combination of these sources of revenue," Mr. Shortall concluded. 

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 of proprietary device technologies includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors and targeted delivery systems. Each of these innovative and highly differentiated device platforms can be customized by Unilife 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 EZMix™ Syringes

EZMix is an innovative and highly differentiated platform of dual-chamber syringes that meet the needs of lyophilized, powder filled or liquid-liquid drug combinations. Proprietary features include orientation-free, ventless mixing to minimize drug loss and maintain sterility until time of injection, and the automatic, user-controlled retraction of the needle upon full dose delivery to virtually eliminate the risk of needlestick injuries. EZMix dual-chamber syringes are designed for intuitive use by healthcare workers or patients, with minimal steps required for reconstitution and injection of the therapy. EZMix syringes feature USP compliant materials in the drug fluid path and are supplied in a standard packaging format for integration into standard fill-finish systems. Device variants include the EZMix syringe with a staked retractable needle and the EZMix Select with attachable retractable needles. Multiple customization options are available. Pharmaceutical companies seeking additional information on EZMix are asked to contact Unilife. 

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. 

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