UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant to Rule 13A-16
or 15d-16 of
The
Securities Exchange Act of 1934
For
the month of May 2018
COMMISSION
FILE Number.
000-29338
CORREVIO
PHARMA CORP.
(Translation
of registrant’s name into English)
1441
Creekside Drive, 6th floor
Vancouver,
British Columbia, V6J 4S7, CANADA
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS REPORT
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
|
CORREVIO
PHARMA CORP. |
|
(Registrant) |
|
|
|
Date: May 17, 2018 |
By: |
/s/
Justin Renz |
|
|
Name: Justin Renz |
|
|
Title: Chief Financial Officer |
Exhibit 99.1
Correvio Announces Enrollment of First Patient in Phase
3 Study Evaluating Brinavess® in China
NASDAQ: CRME TSX: COM
VANCOUVER, May 17, 2018 /CNW/ - Correvio Pharma Corp. (NASDAQ:
CRME / TSX: COM), formerly Cardiome Pharma Corp., today announced that its partner Eddingpharm has enrolled the first patient in
a randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating Brinavess® versus placebo in patients
with recent onset atrial fibrillation (AF). Approximately 240 patients are expected to be enrolled at an estimated 30 clinical
trial sites in China.
Patients will be randomized 1:1 to receive either Brinavess
intravenously or placebo. The primary objective of the study is to demonstrate the effectiveness of Brinavess in the conversion
of recent onset AF to sinus rhythm, compared to placebo. Secondary objectives include assessment of the safety and tolerability
of Brinavess, time to conversion of AF to sinus rhythm and pharmacokinetics, among others.
"Enrollment of the first patient in a Phase 3 clinical
trial in China is an important milestone for the global Brinavess program and underscores our commitment to expanding the geographic
footprint for Correvio's in-hospital acute care products in new territories worldwide," said Kiran Bhirangi, M.D., Vice President,
Clinical Development and Medical Affairs of Correvio. "We look forward to working with Eddingpharm to complete this clinical
study as rapidly as possible to obtain the requisite data to advance Brinavess toward approval in this key territory and into the
hands of the physicians and patients who need it."
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 beta-blocker
used to control rapid heart rate in a number of cardiovascular indications. Correvio's pipeline of product candidates also 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 (CRME) and
the Toronto Stock Exchange (COM). For more information, please visit our web site at www.correvio.com.
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. |
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking
statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation
("forward-looking statements") that may not be based on historical fact, including without limitation statements containing
the words "believe", "may", "plan", "will", "estimate", "continue",
"anticipate", "intend", "expect" and similar expressions. Such forward-looking statements involve
known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially
different from any future results, events or developments expressed or implied by such forward-looking statements. A discussion
of the risks and uncertainties facing Correvio are discussed in the most recent annual and quarterly reports of our former parent
company Cardiome Pharma Corp., and detailed from time to time in our other filings with the Securities and Exchange Commission
("SEC") available at www.sec.gov and the Canadian securities regulatory authorities at www.sedar.com. All of the risks
and certainties disclosed in these filings are hereby incorporated by reference in their entirety. While Correvio makes these forward-looking
statements in good faith, given these risks, uncertainties and factors, you are cautioned not to place undue reliance on any forward-looking
statements made in this press release. All forward-looking statements made herein are based on our current expectations and we
undertake no obligation to revise or update such forward-looking statements to reflect subsequent events or circumstances, except
as required by law.
Correvio® and the Correvio Logo are the proprietary
trademarks of Correvio Pharma Corp.
Aggrastat® and Brinavess® are trademarks owned by Correvio and its affiliates worldwide.
Xydalba™ is a trademark of Allergan Pharmaceuticals International Limited and used under license.
Zevtera® and Mabelio® are trademarks owned by Basilea Pharmaceutica International Ltd., and used
under license.
Esmocard® and Esmocard Lyo® are trademarks owned by Orpha-Devel Handels und Vertriebs GmbH, and used
under license.
Trevyent® is a trademark of SteadyMed and used under license.
All other trademarks are the property of their respective owners.
View original content:http://www.prnewswire.com/news-releases/correvio-announces-enrollment-of-first-patient-in-phase-3-study-evaluating-brinavess-in-china-300649976.html
SOURCE Correvio Pharma Corp
View original content: http://www.newswire.ca/en/releases/archive/May2018/17/c5860.html
%CIK: 0001036141
For further information: Justin Renz, CFO, Correvio Pharma
Corp., 604.677.6905 ext. 128, 800.330.9928, jrenz@correvio.com; Argot Partners, Michelle Carroll, 212.600.1902, michelle@argotpartners.com
CO: Correvio Pharma Corp
CNW 07:00e 17-MAY-18
This regulatory filing also includes additional resources:
ex991.pdf
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