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
Unilife to Receive a Royalty of Net Drug Sales in Exchange for Exclusivity
YORK, Pa., April 9, 2013
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
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.
Thispress 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 "Item1A.
Risk Factors" and elsewhere inourAnnual Report on Form 10-Kand those
described from time to time in other reports which we file with the Securities
and Exchange Commission.
Investor Contacts (US): Analyst Enquiries Investor Contacts Media Contact
Todd Fromer / Garth Lynn Pieper Jeff Carter Eve McGrath
KCSA Strategic Westwicke Partners Unilife Corporation Rubenstein PR
P: + 1 212-682-6300 P: + 1 P: + 61 2 8346 6500 P: + 1 212
SOURCE Unilife Corporation
Press spacebar to pause and continue. Press esc to stop.