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 December 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: December 10, 2019 |
By: |
/s/
Justin Renz |
|
|
Name: Justin Renz |
|
|
Title: President and Chief Financial
Officer |
Exhibit 99.1
Correvio Announces Outcome Of FDA Advisory
Committee Meeting Reviewing Brinavess™ For The Treatment Of Recent Onset Atrial Fibrillation
NASDAQ: CORV
TSX: CORV
VANCOUVER, Dec. 10, 2019 /CNW/ - Correvio
Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today announced
that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) met to review the Company's
New Drug Application (NDA) seeking approval for Brinavess. The Committee jointly voted that the benefit-risk profile was
not adequate to support approval (Vote: 2 Yes to 11 No). Brinavess is Correvio's anti-arrhythmic drug that is currently under
review by the FDA for the rapid conversion of recent onset atrial fibrillation (AF) in adult patients. While the FDA is not
required to follow the committee's vote, the agency considers the committee's recommendations when making its decision. Correvio's
NDA seeking approval for Brinavess is under review by the FDA with a target action date of December 24, 2019 under the Prescription
Drug User-Fee Act (PDUFA).
"We are disappointed with today's outcome
because we believe in the strength of the data we presented today for Brinavess," said Mark H.N. Corrigan, MD, Chief Executive
Officer of Correvio. "The treatment landscape is currently missing a rapid, efficacious and well tolerated option to
treat patients with recent onset atrial fibrillation and we believe Brinavess has the potential to fill that unmet medical need.
We remain confident in the safety and efficacy of the agent in the countries where it is approved and currently marketed."
The CRDAC is an independent panel of experts
that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cardiovascular
and renal diseases and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of
the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel
are non-binding.
The Brinavess NDA is supported by data from
SPECTRUM, a post-authorization 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 those treated AF patients into normal sinus rhythm. In addition, treatment with Brinavess
showed a median time to conversion of 12 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) was reported in less than 1% of patients. Twenty-eight serious adverse events were reported in 26 of the
1,778 patients, with no deaths and no torsades de pointes reported in the study. In addition to SPECTRUM, the Brinavess NDA
is supported by nine Phase 3 and Phase 2 clinical trials and over eight years of post-marketing experience in approximately 50,000
treatment patients worldwide. Brinavess has received marketing authorizations in 41 countries outside the U.S.
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 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 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. 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.
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. | Benjamin EJ et al. Heart Disease and Stroke Statistics-2019
Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. |
| 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. |
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 approval of Brinavess by the FDA and the
timing of any such approval. In particular, no statement herein should be understood to mean: (i) that the FDA will find our underlying
clinical trial data to be acceptable; (ii) that the FDA will find our manufacturing sites acceptable and validate them; or (iii)
that, in the event the FDA approves the Company's NDA, it will require substantive Risk Evaluation and Mitigation Strategies (REMS)
and/or substantively limit the product label. 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 miss its own required deadlines (including the target action date assigned
under the Prescription Drug User-Fee Act, or "PDUFA"); and (ii) the FDA may require further information or additional
clinical studies. Finally, no statement provided herein should be understood to provide an estimate of 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 and its quarterly
report filed November 14, 2019 for the third quarter of 2019. 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.
Trevyent® is a trademark of SteadyMed Ltd., a subsidiary of United Therapeutics Corporation 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-outcome-of-fda-advisory-committee-meeting-reviewing-brinavess-for-the-treatment-of-recent-onset-atrial-fibrillation-300972723.html
SOURCE Correvio Pharma Corp
View original content: http://www.newswire.ca/en/releases/archive/December2019/10/c3495.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, michelle@argotpartners.com, claudia@argotpartners.com
CO: Correvio Pharma Corp
CNW 16:38e 10-DEC-19
This regulatory filing also includes additional resources:
ex991.pdf
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