NASDAQ: CRME TSX: COM
VANCOUVER, July 17, 2017 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ:CRME / TSX:COM) today announced that the Therapeutic
Products Directorate (TPD) of Health Canada has approved the
AGGRASTAT® (tirofiban hydrochloride) 25 mcg/kg (high)
dose bolus ("HDB") regimen, as requested under the Company's
supplemental New Drug Submission (sNDS). The 25 mcg/kg AGGRASTAT
HDB regimen (25 mcg/kg over three minutes, followed by a
maintenance infusion of 0.15 mcg/kg/min) will now become the
recommended dose to reduce the rate of refractory ischemic
conditions, new myocardial infarction and death in high-risk
patients with non-ST-elevation acute coronary syndrome (NSTE-ACS)
who undergo early percutaneous coronary intervention (PCI).
Health Canada approved the
AGGRASTAT HDB regimen based on evidence from a number of
independent studies that indicated that a higher degree of platelet
inhibition was beneficial for patients in need of an urgent PCI and
thus at a high risk for ischemic events. The approval was
also informed by investigator-initiated clinical studies where the
clinical benefit of the AGGRASTAT HDB regimen was demonstrated in
patients with NSTE-ACS who undergo early PCI.
"The approval of the sNDS for a high dose bolus regimen of
AGGRASTAT for this higher risk patient population is an important
accomplishment as it better aligns the Canadian, United States and European labels and best
reflects current clinical practice," said Kiran Bhirangi, M.D.,
Cardiome's Head of Medical Affairs. "We expect that the label
expansion in Canada will offer
physicians the opportunity to treat even more patients suffering
from NSTE-ACS."
About Acute Coronary Syndromes
Acute Coronary Syndromes (ACS) is a term that refers to a
variety of conditions consistent with acute myocardial ischemia
and/or infarction that are usually due to an abrupt reduction in
coronary blood flow1. The ACS spectrum includes patients
with ST-elevation myocardial infarction (STEMI) and
non-ST-elevation ACS (NSTE-ACS), which is comprised of non-STEMI
(NSTEMI) and unstable angina. The thrombus (i.e. blood clot that
forms inside a blood vessel or chamber of the heart) formation
reduces blood flow in the affected coronary artery and causes
ischemic chest pain1. Research from Datamonitor
estimates that in 2013, >880,000 persons in the US experienced
an ACS event, while in the major five EU markets, this figure was
>650,0002. Furthermore, the number of ACS incidences
is expected to grow nearly 40% by 20332. Approximately
70,000 acute myocardial infarctions occur each year in Canada and some 19,000 Canadians die from this
condition3.
More About AGGRASTAT®
AGGRASTAT® (tirofiban hydrochloride, or HCl) is an
intravenous (IV) non-peptidal antagonist of the glycoprotein (GP)
IIb/IIIa receptor, an important platelet surface receptor involved
in platelet aggregation. AGGRASTAT, in combination with
heparin and acetylsalicylic acid (ASA), is currently approved in
Canada for the management of
patients with unstable angina or non-Q-wave myocardial infarction,
including patients who may subsequently undergo PCI to decrease the
rate of refractory ischemic conditions, new myocardial infarction
and death. By blocking fibrinogen from binding to the GP
IIb/IIIa receptor, AGGRASTAT prevents the crosslinking of
platelets, which is the basis for platelet aggregation.
AGGRASTAT is commercialized in 60 countries worldwide, either by
Cardiome or via its extensive distributor and partner network.
Cardiome acquired Canadian AGGRASTAT commercialization rights
through its acquisition of Correvio LLC in November 2013.
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 hydrochloride) 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.
References
- Amsterdam EA et al. 2014 AHA/ACC guideline for the management
of patients with non–ST-elevation acute coronary syndromes: a
report of the American College of Cardiology/American Heart
Association Task Force on Practice Guidelines. J Am Coll Cardiol.
2014;64:e139–228.
- Datamonitor. Acute Coronary Syndrome: Epidemiology.
October 2014.
- Fitchett DH et al. Assessment and Management of Acute Coronary
Syndromes (ACS): A Canadian Perspective on Current
Guideline-Recommended Treatment – Part 1: Non-ST–Segment Elevation
ACS Can J Cardiol 2011; 27:S387–S401.
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 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 or 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. These and
other risks are described in the Form 40F and associated documents
filed March 29, 2017 (see for
example, "Risk Factors" in the Annual Information Form for the year
ended December 31, 2016), in the Form
6-K filed May 15, 2017, and 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. 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.