Cardiome and SteadyMed Announce Decision for Centralized Review of Trevyent® by the European Medicines Agency

Cardiome Pharma Corp.

and SteadyMed Ltd.

, today announced that the European Medicines Agency (EMA) has approved Cardiome's request to review Trevyent® (treprostinil PatchPump) under the Centralised Authorisation Procedure drug review process. This procedure results in a single marketing authorization that is valid in all 28 European Union (EU) countries as well as 3 European Economic Area (EEA) countries. Cardiome requested, and was granted, the centralized pathway on the basis that Trevyent® represents a significant technical innovation for the potential treatment of pulmonary arterial hypertension (PAH). "We are pleased that the EMA has agreed to review Trevyent through the centralized review process," said Jonathan Mather, Cardiome's Director of Regulatory Affairs. "This will enable us to streamline the process of gaining a license in all member states of Europe, with the opportunity of providing those living with PAH quicker access to Trevyent." "Registration through the Centralized Procedure is typically reserved for products with significant therapeutic, scientific or technical innovation and reflects positively on the innovative approach we are taking to the potential treatment of PAH and the patient-friendly design of Trevyent," stated Peter D. Noymer, Ph.D., Chief Technology Officer of SteadyMed. "I am very pleased with the EMA's decision and its potentially positive impact on the lives of patients with this devastating disease." Cardiome and its affiliate, Correvio International Sárl, entered into an exclusive license and supply agreement for Trevyent with SteadyMed Ltd. in June 2015 that includes the territories of Europe, Canada and the Middle East. Trevyent is a development stage drug product candidate that combines SteadyMed's PatchPump technology with treprostinil, a vasodilatory prostacyclin analogue, to treat PAH. SteadyMed intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration for Trevyent in the third quarter of 2016.