NASDAQ: CORV
TSX: CORV
Zero Deaths Reported, Safety Outcomes of
Interest Observed in 0.8% Cases
>70% of AF Episodes Successfully Converted
to Sinus Rhythm in a Median Time of 11 Minutes
VANCOUVER, Sept. 5, 2018 /CNW/ - 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 reported preliminary data from SPECTRUM, a
post-authorization safety study evaluating Brinavess (vernakalant
hydrochloride, IV), its antiarrhythmic drug for the rapid
conversion of recent onset atrial fibrillation (AF), conducted in
the European Union (EU).
SPECTRUM was conducted as part of the follow-up measures agreed
to with the European Medicines Agency in 2010. In this prospective
and retrospective, observational registry, 1,778 unique patients
with 2,009 treatment episodes were enrolled to describe patients
receiving Brinavess and characterize and quantify normal conditions
of use, dosing and safety following administration of
Brinavess. The data for SPECTRUM was provided by 53
participating hospitals in the EU and demonstrated that
treatment with Brinavess successfully converted 70.2% (95%
confidence interval [CI] 68.1 – 72.2) of all treated
patients. Treatment with Brinavess also showed a median time
to conversion of 11 minutes from start of first infusion among
patients who converted.
In the safety results, a total of 19 health outcomes of interest
("HOIs", defined as significant hypotension, ventricular
arrhythmia, atrial flutter, or bradycardia) were reported in 17
patients. The cumulative incidence of HOIs at study completion was
0.8% (95% CI: 0.5%-1.4%). Twenty-eight (28) serious adverse events
(SAEs) were reported for 26 patients and no deaths were reported in
the study.
"This large European registry provides important data on the
safety, efficacy and use of Brinavess in 1,778 patients in a
real-world setting," said Kiran Bhirangi, M.D., Correvio's Vice
President, Clinical Development and Medical Affairs. "In SPECTRUM,
normal heart rhythm was restored in over 70% of patients at a
median time of 11 minutes, HOIs were observed in 0.8% of patients,
and there were no deaths. SPECTRUM efficacy and safety
results compare well with what has been observed from a literature
review of 18 Brinavess studies from 20 centers in 9 different
countries. Collectively, these studies reported on an
additional 1,361 patients treated with Brinavess and demonstrated a
median rate of cardioversion of approximately 74% (range 52.2% –
95%), a median time to cardioversion of 11.8 minutes (range 8-62
minutes), and there were no deaths reported. We are
encouraged by the consistency of the efficacy and safety data
observed in the clinical setting and we thank the SPECTRUM study
investigators and the hospital site staff for their hard work and
commitment to this valuable registry."
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
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 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. 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
- 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.
- 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.
- 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" 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.
These forward-looking statements may include, but are not
limited to: possible future meetings with the FDA, including the
timing of any such meetings, and any possible regulatory path
forward with respect to BRINAVESS®; any potential cost
savings or efficiency improvements for hospitals attributable to
the emergency room treatment of acute AF with Brinavess; our plans
to develop and commercialize product candidates in various
countries and the timing of development and commercialization;
whether we or our partners will receive, and the timing and costs
of obtaining, regulatory approvals for our products in various
countries; clinical development of our product candidates,
including the results of current and future clinical trials and the
timing associated with the receipt of clinical trial results; the
ability to enroll and to maintain enrollment of patients in our
clinical trials; our estimates of the size of the markets and
potential markets for our products; our estimates of revenues and
anticipated revenues for the commercialization of products and
product candidates; the range and degree of market acceptance of
our products; the pricing of our products; and whether we will
receive, and the timing of, reimbursement for our products in
various countries.
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. A detailed
discussion of the risks and uncertainties facing Correvio are
discussed in the recent annual and quarterly reports of our former
parent company Cardiome Pharma Corp., the Short Form Base Shelf
Prospectus filed on July 5, 2018 by
Correvio, the Prospectus Supplement filed July 10, 2018 by Correvio and those risks and
uncertainties 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 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 presentation. 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