Eddingpharm to begin Phase I trial of Brinavess in China

If Brinavess successfully completes the Phase I trial, which will be conducted in healthy volunteers, Eddingpharm intends to start a pivotal Phase III study by year end.

Cardiome director and CEO William Hunter said: "We are pleased that Eddingpharm is taking the first steps necessary to gain approval of Brinavess in China.

"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."

Last December, Cardiome and Eddingpharm have entered into a Brinavess development and commercialzation agreement in China, Taiwan, Macau and Hong Kong.

As part of that deal, Eddingpharm made an upfront payment of $1m to Cardiome and agreed to specific annual commercial goals for Brinavess, while Cardiome is also eligible to receive regulatory milestone payments of up to $3m.

Currently, Cardiome has two marketed, in-hospital, cardiology products, Brinavess (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and Aggrastat (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome.