NASDAQ: CRME TSX: COM
VANCOUVER, Oct. 14, 2016 /CNW/ - Cardiome Pharma Corp.
(NASDAQ: CRME / TSX: COM) announced that it has initiated
commercial sales operations in Canada. The Canadian sales force will
immediately begin detailing AGGRASTAT® (tirofiban
hydrochloride) to Canadian hospitals but is expected to expand its
efforts to include the detailing of BRINAVESS®
(vernakalant hydrochloride), XYDALBA™ (dalbavancin hydrochloride)
and TREVYENT® (treprostinil sodium), if and when
marketing approval for each respective drug is granted by Health
Canada's Therapeutic Products Directorate.
Commenting on the initiation of commercial operations in
Canada, Hugues Sachot, SVP
Commercial of Cardiome said, "This is a proud day for Cardiome. We
have been a Canadian company for over two decades and we are
excited to finally expand our direct sales force beyond
Europe into Canada. The Canadian sales force's immediate
focus is to re-launch AGGRASTAT and we look forward to
commercializing our other exciting innovative products, especially
XYDALBA and BRINAVESS, in the near future." Further commenting,
William Hunter, MD, CEO and
President of Cardiome said, "Over the past few years we have seen
several specialty pharmaceutical companies achieve significant
success by focusing only upon the Canadian market. Canada represents an attractive pharmaceutical
market, but it is just one of many major markets that Cardiome now
maintains commercial operations within."
The Canadian sales force will re-launch AGGRASTAT under the
current label. Cardiome was recently notified by Health Canada that
it was unsuccessful at expanding the indication to include patients
with ST-elevation myocardial infarction (STEMI) undergoing primary
PCI and the option to administer AGGRASTAT as a High-Dose Bolus
regimen. The patient population currently approved for AGGRASTAT
use in the Canadian market is similar to the patient population
approved by the FDA for the US market. The Company does not believe
that the commercial opportunity in Canada will be negatively impacted as a result
and expects to continue to work with Health Canada on the
matter.
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 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 AOP Orphan Pharma 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 2016 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.