Sanofi-aventis has secured exclusivity for the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines until June 30, 2014 (period of exclusivity). The 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.

As per the exclusive agreement, Sanofi-aventis will receive a 10 year extension (additional period) on its period of exclusivity within a designated therapeutic class should Sanofi-aventis purchase commercial quantities of the product prior to July 1, 2014.

The extension will be reduced on a per therapeutic class basis to five 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 five 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 and the company should 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.

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