Correvio Reports Preliminary Data Collected from >2,000 Brinavess® Treatment Episodes in EU Post-Authorization Safety Study

Correvio Pharma Corp., a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients, reported preliminary data from SPECTRUM, a post-authorization safety study evaluating Brinavess (vernakalant hydrochloride, IV), its antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF), conducted in the European Union (EU).

SPECTRUM was conducted as part of the follow-up measures agreed to with the European Medicines Agency in 2010. In this prospective and retrospective, observational registry, 1,778 unique patients with 2,009 treatment episodes were enrolled to describe patients receiving Brinavess and characterize and quantify normal conditions of use, dosing and safety following administration of Brinavess. The data for SPECTRUM was provided by 53 participating hospitals in the EU and  demonstrated that treatment with Brinavess successfully converted 70.2% (95% confidence interval [CI] 68.1 – 72.2) of all treated patients. Treatment with Brinavess also showed a median time to conversion of 11 minutes from start of first infusion among patients who converted.

In the safety results, a total of 19 health outcomes of interest ("HOIs", defined as significant hypotension, ventricular arrhythmia, atrial flutter, or bradycardia) were reported in 17 patients. The cumulative incidence of HOIs at study completion was 0.8% (95% CI: 0.5%-1.4%). Twenty-eight (28) serious adverse events (SAEs) were reported for 26 patients and no deaths were reported in the study.

"This large European registry provides important data on the safety, efficacy and use of Brinavess in 1,778 patients in a real-world setting," said Kiran Bhirangi, MD, Correvio's Vice President, Clinical Development and Medical Affairs. "In SPECTRUM, normal heart rhythm was restored in over 70% of patients at a median time of 11 minutes, HOIs were observed in 0.8% of patients, and there were no deaths. SPECTRUM efficacy and safety results compare well with what has been observed from a literature review of 18 Brinavess studies from 20 centers in 9 different countries. Collectively, these studies reported on an additional 1,361 patients treated with Brinavess and demonstrated a median rate of cardioversion of approximately 74% (range 52.2–95%), a median time to cardioversion of 11.8 minutes (range 8-62 minutes), and there were no deaths reported. We are encouraged by the consistency of the efficacy and safety data observed in the clinical setting and we thank the SPECTRUM study investigators and the hospital site staff for their hard work and commitment to this valuable registry."

About Atrial Fibrillation

Atrial Fibrillation (also known as AFib or AF) is a supraventricular tachyarrhythmia with uncoordinated atrial activation resulting in ineffective atrial contraction and if left untreated, structural and/or electrophysiological atrial tissue abnormalities.¹ AF is a common cardiac rhythm disturbance that increases in prevalence with advancing age.¹ According to the American Heart Association, estimates of the prevalence of AF in the U.S. ranged from 2.7 million to 6.1 million in 2010, and is expected to rise to between 5.6 million to 12 million in 2030.²

There are two strategies to manage AF, namely, rhythm- or rate-control. A rhythm-control strategy may be used in patients who are severely compromised, remain symptomatic despite adequate rate control, when adequate rate control is difficult to achieve, when long term rhythm control therapy is preferred, younger patient age, presence of tachycardia-mediated cardiomyopathy, and first episode of AF.^1,3 Early intervention with a rhythm-control strategy to prevent progression of AF may be particularly beneficial to the AF patient.¹

About Brinavess^®

Brinavess^® (vernakalant HCl, IV) is an antiarrhythmic drug that acts preferentially in the atria by prolonging atrial refractoriness and slowing impulse conduction in a rate-dependent fashion. Brinavess is approved for marketing in Europe, Canada and several other countries worldwide. In Europe, it is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults: 1) for non-surgery patients: atrial fibrillation < 7 days duration; and 2) for post-cardiac surgery patients: atrial fibrillation <3 days duration. Vernakalant IV is not approved for use in the United States.

About Correvio Pharma Corp.

Correvio Pharma Corp. is a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients. With a commercial presence and distribution network covering over 60 countries worldwide, Correvio develops, acquires and commercializes brands for the in-hospital, acute care market segment. The Company's portfolio of approved and marketed brands includes: Xydalba^™ (dalbavancin hydrochloride), for the treatment of acute bacterial skin and skin structure infections (ABSSSI); Zevtera^®/Mabelio^® (ceftobiprole medocaril sodium), a cephalosporin antibiotic for the treatment of community- and hospital-acquired pneumonia (CAP, HAP); Brinavess^® (vernakalant IV) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm; Aggrastat^® (tirofiban hydrochloride) for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome, and Esmocard^® and Esmocard Lyo^® (esmolol hydrochloride), a short-acting betablocker used to control rapid heart rate in a number of cardiovascular indications. Correvio's pipeline of product candidates includes Trevyent^®, a drug device combination that is designed to deliver treprostinil, the world's leading treatment for pulmonary arterial hypertension. Correvio is traded on the NASDAQ Capital Market (CORV) and the Toronto Stock Exchange (CORV). For more information, please visit www.correvio.com.

1. January CT, et al. 2014 AHA/ACC /HRS guideline for the management of patients with atrial fibrillation. J Am Coll Cardiol. 2014;34:e1-e76.
2. Mozaffarian D, et al. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016;133(4):e38-60.
3. Camm AJ, et al. Guidelines for the management of atrial fibrillation, The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010;31:2369-2429.