Under the guidance provided by the Therapeutics Goods Agency in Australia, the average review time for applications is twelve months from the date of submission. Photocure will receive a milestone payment of €250,000 upon approval of Hexvix in Australia, estimated to occur in the second half of 2016.
Kjetil Hestdal, President & CEO of Photocure, said: "The partnership with Juno Pharmaceuticals is progressing well and we are pleased that they have reached this significant milestone with the filing of the MAA. We continue to expand Hexvix into new territories to ensure patients and urologists have access to the most optimal treatment for the diagnosis and management of bladder cancer.”
During the review process, Juno Pharmaceuticals will begin to prepare for the commercial launch of Hexvix in Australia. The market potential in the territory is estimated to be similar to the potential in the Nordics, where Photocure commercializes Hexvix with its own sales team.
For further information, please contact:
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: firstname.lastname@example.org
CFO Erik Dahl
Tel: +47 50 55 000, Email: email@example.com