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.
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SOURCE Correvio Pharma Corp