The approval by Therapeutic Goods Administration (TGA) in Australia has triggered a $4m milestone payment to Curis, which is even eligible for sales based royalties of Roche’s Erivedge in Australia.
Curis chief executive officer Dan Passeri said the TGA’s decision to grant Erivedge approval in Australia is evidence of Roche’s efforts to expand patient access to the medication.
"We expect approval decisions in additional territories in 2013, including in the European Union after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on approvability," Passeri added.
"We also expect that Roche will continue making global submissions seeking marketing approval for Erivedge in several territories in the coming months."
Erivedge works by targetting the Hedgehog signaling pathway which plays a vital role in the development of certain types of cancers such as basal cell carcinoma.