Unilife Corporation recently announced it has agreed to a list of therapeutic drug classes within which sanofi-aventis has the exclusive right to purchase the Unifill ready-to-fill syringe. Sanofi-aventis has secured exclusivity for the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines until June 30, 2014. These two therapeutic classes together represent the majority of all prefilled syringes consumed globally. Sanofi-aventis has also secured Product exclusivity in an additional six smaller sub-groups that fall within other therapeutic classes that Unilife believes represent new market opportunities in the pharmaceutical use of prefilled syringes.

The scope of the Exclusivity List allows Unilife to commence formal discussions with other pharmaceutical companies relating to the potential use of the Unifill syringe within a number of significant therapeutic classes that fall outside of those areas retained by sanofi-aventis. In accordance with the Exclusive Agreement, sanofi-aventis will receive a 10-year extension on its Period of Exclusivity within a designated therapeutic class should sanofi-aventis purchase commercial quantities of the product prior to July 1, 2014. This extension will be reduced on a per therapeutic class basis to 5 years in the event that sanofi-aventis does not sell a minimum of 20 million units of the Unifill syringe for use with an injectable drug product to be marketed for this therapeutic class in at least one of the first 5 years of the Additional Period.

During the Period of Exclusivity, sanofi-aventis may also nominate additional therapeutic sub-groups to be placed onto the Exclusivity List should the company not have already signed a commercial arrangement within this sub-group with a third party. Before an additional therapeutic class can be added to the Exclusivity List, both parties will need to be reasonably satisfied that a target drug suitable for use with the Unifill syringe is likely to generate a commercial order.

"The agreement of an exclusive list of therapeutic drug classes with sanofi-aventis for the purchase of the Unifill syringe is a significant business milestone for Unilife,” said Unilife CEO Alan Shortall. “The confined nature of the therapeutic sectors defined within the Exclusivity List considerably expands our commercial opportunities with additional pharmaceutical companies. In return, sanofi-aventis retains the opportunity to nominate the placement of additional therapeutic drugs onto the Exclusivity list provided they are commercially favorable and do not infringe upon any future agreements we may sign with other pharmaceutical companies. This is indicative of the strong collaborative relationship that has been established between both parties. We look forward to commencing supply of the Unifill syringe after the scheduled completion of the industrialization program.”

The Unifill syringe is targeted for use by pharmaceutical manufacturers who utilize prefilled (ready-to-fill) syringes as a preferred drug delivery device for injectable drugs and vaccines. More than 50 drug products used within healthcare facilities or by patients who self-administer prescription medication are currently available in a prefilled syringe format. Unilife has designed the Unifill syringe so that it is compatible with the drug validation and manufacturing systems currently used by target pharmaceutical customers to fill and package standard prefilled syringes. To Unilife's knowledge, the Unifill syringe is the only known product of its kind with automatic safety features that are integrated inside the glass barrel. The compact size, intuitive use, functionality, and automatic safety features of the Unifill syringe may help pharmaceutical companies extend product lifecycles, increase levels of market differentiation in competitive therapeutic areas, and expand the marketability of some drugs for convenient self-administration by patients outside of the healthcare setting.

Sanofi-aventis has paid Unilife a euro 10 million exclusivity fee and committed to pay the company up to an additional euro 17 million to fund the industrialization program for the Unifill syringe. Upon the scheduled completion of the industrialization program in late 2010, Unilife expects to commence the supply and sale of the Unifill syringe to sanofi-aventis.