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 June 2019
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: June 24, 2019 |
By: |
/s/
Justin Renz |
|
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Name: Justin Renz |
|
|
Title: President and Chief Financial
Officer |
Exhibit 99.1
Correvio Resubmits Brinavess (Vernakalant)
New Drug Application to U.S. FDA for the Treatment of Patients with Recent Onset Atrial Fibrillation
NASDAQ: CORV TSX: CORV
VANCOUVER, June 24, 2019 /CNW/ - Correvio Pharma
Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced
it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for Brinavess™
(vernakalant hydrochloride, IV), its antiarrhythmic drug for the rapid conversion of adult patients with recent onset atrial fibrillation
(AF).
"The resubmission of the Brinavess NDA
is a major milestone for Correvio and is the culmination of substantial effort by our employees and the investigators who have
dedicated themselves toward investigating this potential new treatment option for adult patients with recent onset AF," said
Mark H.N. Corrigan, MD, CEO of Correvio. "If approved, we believe that Brinavess will be an attractive addition to the AF
treatment landscape and will provide physicians with a well tolerated and effective pharmacologic treatment approach to cardioversion.
We greatly appreciate the FDA's willingness to work with us during the resubmission process and, assuming the refiling is
accepted as a complete resubmission, we look forward to working closely with the FDA as they review the new data supporting the
safety and efficacy of Brinavess."
The NDA is supported by data from SPECTRUM,
a post-approval safety study that was conducted in Europe which evaluated 1,778 unique patients across a total of 2,009 treatment
episodes following administration of Brinavess. The SPECTRUM data demonstrated that treatment with Brinavess successfully
converted 70.2% of all treated AF patients into normal sinus rhythm. In addition, treatment with Brinavess showed a median
time to conversion of 11 minutes from the start of the first infusion among patients who successfully converted. The cumulative
incidence of health outcomes of interest (defined as significant hypotension, ventricular arrhythmia, atrial flutter, or bradycardia)
were reported in 0.8% of patients. Twenty-eight serious adverse events were reported in 26 of the 1,778 patients and no deaths
were reported in the study. In addition to SPECTRUM, the Brinavess NDA is also supported by nine Phase 3 and Phase 2 clinical
trials and over eight years of real-world experience in approximately 50,000 treatment patients worldwide.
Brinavess has received marketing authorizations
in 41 countries outside the United States.
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. 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.
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.
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 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 our web site www.correvio.com.
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 (collectively, "forward-looking statements"). Forward-looking
statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance,
capital expenditures, financing needs and other information that may not be based on historical fact. Forward-looking statements
can often be identified by the use of terminology such as "believe", "may", "plan", "will",
"estimate", "continue", "anticipate", "intend", "expect", "look forward
to" and similar expressions. Forward-looking statements are necessarily based on estimates and assumptions made by us based
on our experience and perception of historical trends, current conditions and expected future developments, as well as other factors
we believe are appropriate.
By their very nature, 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. These
forward-looking statements include, but are not limited to, statements relating to the resubmission of a U.S. NDA for Brinavess,
the FDA's acceptance of the refiling as a complete resubmission and the FDA's continued willingness to work with the Company on
the resubmission. In particular, no statement herein should be understood to mean that: (i) the FDA will accept our resubmission
of the NDA; (ii) that out resubmission will be deemed to be complete by the FDA; (iii) that the FDA will find our underlying clinical
trial data to be acceptable; (iv) that the FDA will find our manufacturing sites acceptable and validate them; or (iv) that our
NDA will ultimately be approved by the FDA. Furthermore, the timing of any action by the FDA and possible regulatory paths
forward cannot be guaranteed, in that, for example: (i) the FDA may require an Advisory Committee meeting; (ii) the FDA may miss
its own required deadlines (including for example, the PDFUA date); and (iii) the FDA may require further information or additional
clinical studies. Finally, no statement provided herein should be understood to provide an estimate of the current or future
prevalence of atrial fibrillation or the market potential for Brinavess in the United States.
A detailed discussion of the risks and uncertainties
facing Correvio are discussed in the annual report 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.
In particular, we direct your attention to Correvio's Annual Report on Form 40-F for the year ended December 31, 2018. All of the
risks and certainties disclosed in those filings are hereby incorporated by reference in their entirety into this news release.
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. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly
investors are cautioned not to put undue reliance on forward-looking statements due to their inherent uncertainty.
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 Ltd. and used under license.
All other trademarks are the property of their respective owners.
View
original content:http://www.prnewswire.com/news-releases/correvio-resubmits-brinavess-vernakalant-new-drug-application-to-us-fda-for-the-treatment-of-patients-with-recent-onset-atrial-fibrillation-300873249.html
SOURCE Correvio Pharma Corp
View original content: http://www.newswire.ca/en/releases/archive/June2019/24/c5912.html
%CIK: 0001036141
For further information: Justin Renz, President & CFO,
Correvio Pharma Corp., 604.677.6905 ext. 128, 800.330.9928, jrenz@correvio.com; Argot Partners, Michelle Carroll/Claudia Styslinger,
212.600.1902, correvio@argotpartners.com
CO: Correvio Pharma Corp
CNW 07:00e 24-JUN-19
This regulatory filing also includes additional resources:
ex991.pdf
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