Unilife Signs Exclusive Agreement with Global Prefilled
Manufacturer for the Unitract Prefilled Syringe
Unilife Medical Solutions Limited (“Unilife”) (ASX: UNI) is pleased to announce the signing of a
Business Development Agreement (“Agreement”) with Gerresheimer Buende GmbH (“Buende”), a
wholly owned subsidiary of Gerresheimer AG (“Gerresheimer”) which is the world’s second largest
manufacturer of prefilled syringe systems.
Buende is a leading supplier of prefilled glass barrel syringe assemblies to many of the world’s major
pharmaceutical companies, including the pharmaceutical group that Unilife has an exclusive
agreement with for the development of the Unitract Ready to Fill Syringe (“Unitract Prefilled
Syringe”).
In recognition of this exclusive relationship with the pharmaceutical company, the market potential of
the Unitract Prefilled Syringe and the technical feasibility of the design, Buende have entered into this
exclusive Agreement with Unilife. The Agreement sets out the principles on which the parties intend
to develop a collaborative commercial relationship with a view to negotiating and entering into a
formal Supply Agreement or Joint Venture.
The Agreement follows on from more than one year of collaboration between the parties. Buende
recently provided Unilife with 10,000 custom-manufactured glass barrels that are currently being used
for the pilot production of Unitract Prefilled Syringes for evaluation by its pharmaceutical partner.
Under the Agreement, Unilife and Buende have agreed to share relevant commercial and technical
information in relation to the development of a manufacturing strategy designed to support the
production of 400 million units of the Unitract Prefilled Syringe per annum, which Unilife anticipates
to be the minimum annual volume requirement.
The Agreement restricts Unilife and Buende (for itself and on behalf of the Gerresheimer group) for a
period of one year from continuing or initiating any enquiries or proposals from, or entering into any
arrangements or agreements with, other entities regarding the production of a similar prefilled safety
syringe.
Gerresheimer is a leading manufacturer of specialty products made of glass and plastic for the
pharmaceutical and life science industry, operating 37 manufacturing plants in the US, Europe and
Asia, employing 10,000 people worldwide with reported pro-forma sales of EUR 893 million in
CY2006. Gerresheimer was listed on the Frankfurt Stock Exchange in June 2007, by the Blackstone
Group, a US$91 billion US-based private equity group. The Blackstone Group is the major
controlling shareholder in Gerresheimer, having already invested in excess of US$ 700 million.
Comments by Mr. John Kelly, COO of Unilife
“I believe that this exclusive agreement with Buende is a further validation of the technical feasibility
of the Unitract Prefilled Syringe. Buende has entered into this agreement following the successful
pilot production of our custom-designed glass syringe barrel at their main manufacturing facility in
Germany. This successful production milestone and subsequent agreement further de-risks the
commercialisation of the Unitract Prefilled Syringe.
“Buende is a major supplier of prefilled syringes to our pharmaceutical partner and many other
global leaders within the pharmaceutical industry. By signing an exclusive agreement with Unilife to
assist us in the development of the Unitract Prefilled Syringe, Buende is able to strengthen its overall
competitive position in a global market currently growing in excess of 20 per cent per annum.
“We look forward to continuing to work closely with both Buende and our pharmaceutical partner to
implement a high volume production strategy capable of meeting the growing demand for this
product”.
Comments by Mr Alan Shortall, CEO of Unilife
“Unilife has now secured exclusive relationships with a pharmaceutical company which is one of the
world’s largest consumers of prefilled syringes and the world’s second largest manufacturer.
“The exclusive agreement with our pharmaceutical partner has helped to validate the significant
commercial potential of the Unitract Prefilled Syringe to become the drug delivery device of choice
for the US$100 billion market for injectable drugs. This new partnership with Buende means we now
have an exclusive arrangement with the world’s second largest prefilled syringe manufacturer to help
move this project forward towards full industrialisation.
“The rapid transition from vials to the use of prefilled syringes is irrefutable, with annual demand
expected to exceed 2.5 billion units by 2010. With legislation requiring the mandatory use of sharps
safety products in the US, and many other countries now in the process of implementing similar
legislation, Unilife believes that the Unitract Prefilled Syringe will become the product of choice in
this market. To our knowledge, there is no prefilled product other than the Unitract Prefilled Syringe
where automatic needle retraction is fully integrated into the actual syringe.”
“Unilife anticipates that its relationship with the Gerresheimer group, of which Buende is a key
member, is likely to create a number of additional corporate and operational opportunities for our
company moving forward. Through the acquisition of IBS, the expansion of our US production
activities into other sharps safety markets, our exclusive relationship with one of the world’s largest
consumers of prefilled syringes and this agreement with the world’s second largest prefilled syringe
manufacturer, Unilife has now attained a highly competitive position. Indeed, all the pieces of the
jigsaw puzzle are coming together nicely. Unilife intends to continue to move towards its goal of
becoming a multinational leader in the supply of innovative sharps safety devices for global
healthcare and pharmaceutical markets.”
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