Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a revenue-generating, specialty pharmaceutical company focused on providing innovative, high-quality brands that meet the needs of acute care physicians and patients, today announced that Brinavess^®  (vernakalant hydrochloride, IV), its antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation, was selected by the China Food and Drug Administration’s Center for Drug Evaluation as potentially eligible for priority review.  In the list published last week by the CDE, Brinavess was named one of 48 therapies assessed as “clinically urgently needed new drugs”, and therefore eligible under the priority review pathway.

In addition to clinical trial data supporting Brinavess’ ex-China regulatory approvals, Correvio will also be expected to provide evidence that there are no differences in Brinavess’ efficacy or safety across ethnicities. The Brinavess clinical data package includes positive results from a Phase 3 trial evaluating Brinavess in AF patients (n=123) which was conducted in Korea, Taiwan, Hong Kong and India.  In addition to this trial, Correvio’s partner Eddingpharm (Asia) Macao Commercial Offshore Limited recently initiated a randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating Brinavess versus placebo in patients with recent onset AF.  Approximately 240 patients are expected to be enrolled at an estimated 30 clinical trial sites in China.  If a New Drug Application (NDA) is accepted for priority review in China, the average length of time to approval is approximately 60 business days.

“With a population of approximately 1.4 billion, China is the world’s largest drug market after the U.S. and demand for new therapies has been surging there due to an aging population and rising incidence of chronic diseases such as cardiovascular disease, diabetes and cancer,” said William Hunter, MD, Chief Executive Officer and President of Correvio.

For more information about the CDE’s list of “clinically urgently needed new drugs,” please visit: http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314651

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 The prevalence of AF in Chinese adults age 35 and above is estimated to be 0.74% in males and 0.72% in females, but the prevalence rises significantly for adults age 60 and above with the prevalence estimated to be 1.8% in males and 1.9% in females.  With a population of greater than one billion, this translates to a significant market opportunity in China.³

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.^1,4  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.

References

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 Jan 26;133(4):e38-60.
3. Zhang S et al. Atrial fibrillation in mainland China: epidemiology and current management. BMJ Heart. 2009;95:1052–1055. doi:10.1136/hrt.2008.146589
4. 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.