Cardiome’s Chinese development and commercialisation partner, Eddingpharm, plans to initiate a phase 1 study for Brinavess to support regulatory approval in China. The study will be conducted in healthy volunteers. Other details of the study were not disclosed. If Brinavess successfully completes phase 1, Eddingpharm anticipates initiating a pivotal phase 3 study by year end.
“We are pleased that Eddingpharm is taking the first steps necessary to gain approval of Brinavess in China,” said William Hunter, chief executive officer and director of Cardiome. “The Chinese market is an important growth driver for Brinavess given the region’s size and demand for innovative medicines, and Eddingpharm is the perfect partner for Cardiome. Cardiome remains committed to have Brinavess available for all patients suffering from atrial fibrillation worldwide.”
Cardiome and Eddingpharm entered into a Brinavess development and commercialisation agreement in China, Taiwan, Macau and Hong Kong in December 2014. Under the terms of the agreement, Eddingpharm made an upfront payment of US$1m to Cardiome and agreed to specific annual commercial goals for Brinavess. Cardiome is also eligible to receive regulatory milestone payments of up to US$3m. Other financial details have not been disclosed.