NASDAQ: CRME TSX: COM
VANCOUVER, March 14, 2017 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ: CRME / TSX: COM) announced today that it received a
Notice of Compliance for BRINAVESS® (vernakalant
hydrochloride, IV) from Health Canada, which enables Cardiome to
begin commercializing BRINAVESS® in Canada. BRINAVESS® is indicated for
the rapid conversion of recent onset atrial fibrillation ("AF") to
sinus rhythm for: non-surgery patients with AF ≤ 7 days; and
post-cardiac surgery patients with duration of AF ≤ 3 days.
BRINAVESS® is not recommended for conversion of atrial
flutter to sinus rhythm.
"We are pleased and excited to have received the Notice of
Compliance for BRINAVESS® from Health Canada," said
William Hunter, MD, CEO and
President of Cardiome. "This is a very proud moment for the company
since BRINAVESS® was discovered in Canada by Canadian researchers who had the
goal of making this drug available in their own backyard. We have
built a pharmaceutical company focused on bringing compelling
medicines to acute care physicians in hospitals around the world,
and we can finally say that BRINAVESS® will be made
available to Canadian hospitals to treat patients who suffer from
acute onset atrial fibrillation. It has been a long road for us to
get to this point but we are very gratified now that we are
here."
Commenting on the Notice of Compliance for
BRINAVESS®, Jonathan
Mather, Director and Global Head of Regulatory Affairs of
Cardiome said, "This is an exciting moment for Cardiome as the
Canadian market was one of the few remaining major markets in the
world where BRINAVESS® was not yet approved for sale. We
are pleased that Health Canada believed, as we do, that
BRINAVESS® provides an attractive alternative to the
currently available treatment options of recent onset atrial
fibrillation. Our commercial team expects to begin detailing
BRINAVESS® to our hospital customers during the second
quarter, positioning us for commercial sales beginning in the third
quarter."
Atrial Fibrillation affects approximately 350,000 persons in
Canada.1
Cardiome would also like to provide an update on ongoing
vernakalant IV discussions with the U.S. Food and Drug Agency. A
Type A meeting is now scheduled during April and Cardiome's
management expects feedback from that meeting during its second
quarter of 2017. Vernakalant IV has been on clinical hold in
the United States since 2010.
References:
- Heart and Stroke Foundation of Canada.
http://www.heartandstroke.ca/heart/conditions/atrial-fibrillation
About BRINAVESS®
BRINAVESS®
(vernakalant HCl) 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 Cardiome Pharma Corp.
Cardiome Pharma Corp. is a
specialty pharmaceutical company dedicated to the development and
commercialization of innovative therapies that will improve the
quality of life and health of patients suffering from disease.
Cardiome has two marketed, in-hospital, cardiology products,
BRINAVESS® (vernakalant IV), approved in Europe, Canada, and other territories for the rapid
conversion of recent onset atrial fibrillation to sinus rhythm in
adults, and AGGRASTAT® (tirofiban HCl) a reversible GP
IIb/IIIa inhibitor indicated for use in patients with acute
coronary syndrome. Cardiome also commercializes
ESMOCARD® and ESMOCARD LYO® (esmolol
hydrochloride), a short-acting beta-blocker used to control rapid
heart rate in a number of cardiovascular indications, on behalf of
their partner Amomed in select European markets. Cardiome has also
licensed: XYDALBA™ (dalbavancin hydrochloride), a second
generation, semi-synthetic lipoglycopeptide approved in the EU for
the treatment of acute bacterial skin and skin structure infections
(ABSSSI) in adults for select European and Middle Eastern nations
and Canada from Allergan; and
TREVYENT®, a development stage drug device combination
that is under development for Pulmonary Arterial Hypertension for
Europe, the Middle East and for Canadian markets from
SteadyMed Therapeutics.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the
Toronto Stock Exchange (COM). For more information, please visit
our web site at www.cardiome.com.
Forward-Looking Statement Disclaimer
Certain statements in this news release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 or forward-looking information under applicable
Canadian securities legislation 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.
Forward- looking statements may involve, but are not limited to,
comments with respect to our objectives and priorities for the
remainder of 2017 and beyond, our strategies or future actions, our
targets, expectations for our financial condition and the results
of, or outlook for, our operations, research and development and
product and drug development. 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. Many such known risks, uncertainties and other factors
are taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the
following: general economic and business conditions in the United States, Canada, Europe, and the other regions in which we
operate; market demand; technological changes that could impact our
existing products or our ability to develop and commercialize
future products; competition; existing governmental legislation and
regulations and changes in, or the failure to comply with,
governmental legislation and regulations; availability of financial
reimbursement coverage from governmental and third-party payers for
products and related treatments; adverse results or unexpected
delays in pre-clinical and clinical product development processes;
adverse findings related to the safety and/or efficacy of our
products or products; decisions, and the timing of decisions, made
by health regulatory agencies regarding approval of our technology
and products; the requirement for substantial funding to expand
commercialization activities; and any other factors that may affect
our performance. In addition, our business is subject to certain
operating risks that may cause any results expressed or implied by
the forward-looking statements in this presentation to differ
materially from our actual results. These operating risks include:
our ability to attract and retain qualified personnel; our ability
to successfully complete pre-clinical and clinical development of
our products; changes in our business strategy or development
plans; intellectual property matters, including the
unenforceability or loss of patent protection resulting from
third-party challenges to our patents; market acceptance of our
technology and products; our ability to successfully manufacture,
market and sell our products; the availability of capital to
finance our activities; and any other factors described in detail
in our filings with the Securities and Exchange Commission
available at www.sec.gov and the Canadian securities regulatory
authorities at www.sedar.com. Given these risks, uncertainties and
factors, you are cautioned not to place undue reliance on such
forward-looking statements and information, which are qualified in
their entirety by this cautionary statement. All forward-looking
statements and information made herein are based on our current
expectations and we undertake no obligation to revise or update
such forward-looking statements and information to reflect
subsequent events or circumstances, except as required by law.
SOURCE Cardiome Pharma Corp.