UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant to Rule 13A-16
or 15d-16 of
The
Securities Exchange Act of 1934
For
the month of December 2017
COMMISSION
FILE Number.
000-29338
CARDIOME
PHARMA CORP.
(Translation
of registrant’s name into English)
1441
Creekside Drive, 6th floor
Vancouver,
British Columbia, V6J 4S7, CANADA
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS REPORT
Exhibit |
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Description |
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99.1 |
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News Release dated December 12, 2017 - Cardiome Announces Strategic Licensing Agreement To Commercialize Aggrastat In Russia |
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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CARDIOME
PHARMA CORP. |
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(Registrant) |
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Date: December 12,
2017 |
By: |
/s/
Justin Renz |
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Name: Justin Renz |
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Title: Chief Financial Officer |
Exhibit 99.1
Cardiome Announces Strategic Licensing Agreement To Commercialize
Aggrastat In Russia
NASDAQ:CRME TSX:COM
VANCOUVER, Dec. 12, 2017 /CNW/ - Cardiome Pharma Corp.
(NASDAQ:CRME / TSX:COM), a revenue-generating, specialty pharmaceutical company focused on commercializing patent-protected hospital
drugs, today announced that its affiliate Correvio has entered into an exclusive license and distribution agreement with ZAO Firma
Euroservice that will advance Aggrastat® (tirofiban hydrochloride) toward commercialization in Russia. Aggrastat
is indicated for the reduction of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) and is currently
marketed in over 60 countries worldwide.
Under the terms of the license agreement, ZAO will be responsible
for obtaining regulatory approvals for Aggrastat from Russia's Ministry of Health, then executing the commercial launch and subsequent
sale and marketing of Aggrastat in the territory. Under the agreement, Cardiome and ZAO have agreed to certain minimum annual purchase
requirements. Additional terms of the agreement were not disclosed.
"ZAO Firma Euroservice has a solid track record of regulatory
and commercial expertise, obtaining necessary drug distribution approvals and the subsequent delivering of high-quality medications
to hospitals and customers throughout Russia," said Hugues Sachot, Cardiome's Chief Commercial Officer. "Aggrastat is
currently marketed in over 60 countries worldwide, and we're pleased to be adding Russia as a new territory for distribution of
this important medication."
Mikhail Lazarev, Director, Regulatory Affairs at ZAO Firma
Euroservice commented, "The addition of Aggrastat to our hospital products line underscores our commitment to bringing high-quality
products into the hands of the physicians and patients who need them. We look forward to filing a timely registration package
for Aggrastat in one year time, and obtaining the required authorizations to advance this high-value product toward the market."
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 reduce blood flow in the affected coronary artery and cause 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 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 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); 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
1. |
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. |
2. |
Datamonitor. Acute Coronary Syndrome: Epidemiology. October 2014. |
3. |
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 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; and 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 November 14, 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.
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.
View original content: http://www.newswire.ca/en/releases/archive/December2017/12/c4650.html
%CIK: 0001036141
For further information: Justin Renz, CFO, Cardiome Pharma
Corp., 604.677.6905 ext. 128, 800.330.9928, jrenz@cardiome.com; Argot Partners, Michelle Carroll/Sean Augustine-Obi, 212.600.1902,
michelle@argotpartners.com, sean@argotpartners.com
CO: Cardiome Pharma Corp.
CNW 08:00e 12-DEC-17
This regulatory filing also includes additional resources:
ex991.pdf
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