Unilife Signs Long-Term Customization & Commercial Supply Agreement; $110-Million Potential

Unilife Corporation recently announced the signing of a Customization and Commercial Supply Agreement with a US pharmaceutical company for the EZMixTM dual-chamber syringe.

Unilife will supply the customer with a customized device from its EZMix platform of dual-chamber delivery systems for use with a lyophilized 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 US 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.

“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,” said Alan Shortall, CEO of Unilife.

“More than 10 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,” he continued. “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.”

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a US-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.

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