Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Unilife, focused on the design, development, manufacture and supply of a range of retractable syringes, 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 as a preferred drug delivery device for injectable drugs and vaccines.
Subscribe to our email newsletter
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.
Additionally, 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 agreement, Sanofi-aventis is expected to 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 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.
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. We look forward to commencing supply of the Unifill syringe after the scheduled completion of the industrialisation program.”