Addition of High-Risk STEMI Patients
Significantly Expands the Number of Patients in Which Aggrastat Can
Be Used
NASDAQ:CRME TSX:COM
VANCOUVER, Jan. 23, 2018 /PRNewswire/ - Cardiome Pharma
Corp. (NASDAQ:CRME / TSX:COM), a revenue-generating, specialty
pharmaceutical company focused on commercializing patent-protected
hospital drugs, today announced that the Chinese Center for Drug
Evaluation (CDE) has approved an expansion of the indications for
Aggrastat (tirofiban hydrochloride) to now, in addition to acute
coronary syndromes without ST elevation (NSTE-ACS) include patients
with ST-segment elevation myocardial infarction (STEMI), who are
intended for primary percutaneous coronary intervention
(PCI). In addition to the expanded indications, the CDE also
approved an Aggrastat high dose bolus (HDB) regimen (25 mcg/kg over
a 3-minute period, followed by continuous infusion of 0.15
mcg/kg/min for 12-24 hours and up to 48 hours) to be used on both
indicated patient populations.
"This label expansion in China
is a highly positive development for the Aggrastat franchise
because it significantly expands the number of patients in which
the drug can be used to now include both NSTE-ACS and STEMI
patients," commented Kiran Bhirangi, M.D., Cardiome's Vice
President, Clinical Development and Medical Affairs. "Identifying
STEMI patients is done via a standard 12-lead ECG, so is therefore
a fast, easy and cost-effective means to capturing these additional
high-risk patients who stand to benefit from treatment with
Aggrastat. The inclusion of the HDB regimen is also important
because it aligns the Chinese posology with that used in the U.S.,
Europe and Canada and better reflects current clinical
practice."
In China, Aggrastat was
previously indicated for use in patients with NSTE-ACS, as well as
to prevent ischemic complications as a result of coronary
angioplasty procedures. The new expanded label will include
both STEMI and NSTE-ACS. Aggrastat is currently marketed by
Cardiome in over 60 countries worldwide.
The Aggrastat HDB regimen will now become the recommended dose
regimen to reduce the rate of refractory ischemic conditions, new
myocardial infarction and death in both STEMI patients set to
undergo PCI and NSTE-ACS patients who undergo early PCI. The CDE's
approval of the Aggrastat label expansion is based on results from
several clinical trials demonstrating the tolerability, and
risk reduction of myocardial infarction and death by Aggrastat when
compared to placebo and other agents. These studies 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, and that clinical benefit of the Aggrastat HDB was
demonstrated in patients with NSTE-ACS who undergo early PCI, as
well as in STEMI patients undergoing primary PCI. Cardiome's
partner, Eddingpharm, markets and distributes Aggrastat in
China and executes regulatory
initiatives such as this label expansion.
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
>650,000.2 Furthermore, the number of ACS incidences
is expected to grow nearly 40% by 2033.2 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
anticoagulants (e.g. heparin) and other antiplatelet therapies,
including acetylsalicylic acid (ASA), is currently approved in
Canada for the management of adult
patients with non-ST-elevation acute coronary syndrome (NSTE-ACS),
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 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, Cardiome 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), excluding
ventilator-associated pneumonia (VAP) ; 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 beta-blocker used to control rapid
heart rate in a number of cardiovascular indications.
Cardiome's pipeline of product candidates includes
Trevyent®, a drug device combination that is designed to
deliver Remodulin® (treprostinil) the world's leading
treatment for pulmonary arterial hypertension.
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 U.S. Private Securities
Litigation Reform Act of 1995 or forward-looking information under
applicable Canadian securities legislation ("forward-looking
statements") 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. Such forward-looking
statements, including statements with respect to the potential
impact of a product label expansion in China 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 discussion of the risks and
uncertainties facing Cardiome are discussed in our most recent
annual and quarterly reports 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. All of the risks and
certainties disclosed in these filings are hereby incorporated by
reference in their entirety. While Cardiome 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.
Cardiome® and the Cardiome Logo are the proprietary
trademarks of Cardiome Pharma Corp.
Aggrastat® and Brinavess® are trademarks
owned by Cardiome and its affiliates worldwide.
Xydalba® is a trademark of Durata Therapeutics Holding
C.V., 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 and used under
license.
All other trademarks are the property of their respective
owners.
SOURCE Cardiome Pharma Corp.