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 September 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 September 12, 2017 - Cardiome Announces Agreement with Basilea for Distribution of Zevtera®/Mabelio® (Ceftobiprole) in
Europe and Israel |
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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.
|
CARDIOME
PHARMA CORP. |
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(Registrant) |
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Date: September 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 Agreement with Basilea for Distribution
of Zevtera®/Mabelio® (Ceftobiprole) in Europe and Israel
VANCOUVER, Sept. 12, 2017 /CNW/ - Cardiome Pharma Corp. (NASDAQ:
CRME / TSX: COM) today announced that it has entered into a distribution and license agreement with Basilea for its antibiotic
Zevtera®/Mabelio®. Under the terms of the agreement, Basilea has granted Cardiome an exclusive license
to commercialize ceftobiprole in 34 European countries and Israel. Cardiome will provide Basilea with an upfront payment and additional
milestone payments based upon achievement of certain commercial and regulatory milestones. As a result of the agreement, Cardiome
will be responsible for the registration, promotion and commercialization of Zevtera®/Mabelio® in
the covered countries. The drug is currently marketed in Germany, Italy, the United Kingdom, France, Austria and Switzerland. Cardiome
plans to commercialize Zevtera®/Mabelio® in every European country where it currently has a direct
sales force, with the potential for further distribution and expansion. Zevtera®/Mabelio® has shown
sales growth since its launch.
"The addition of Zevtera®/Mabelio®
to our product portfolio is an important step in our Company's strategic growth as it fits well alongside our previous license
of Xydalba™ (dalbavancin hydrochloride), which was launched earlier this year. Ceftobiprole allows us to expand
our offering of differentiated hospital products to our European customers while increasing the operating leverage within our commercial
infrastructure" said Hugues Sachot, Cardiome's Chief Commercial Officer. "We expect to begin to recognize revenues from
Zevtera®/Mabelio® immediately and our sales force will be ready to accelerate commercialization of
this important antibiotic after the successful transition of Zevtera®/Mabelio® from Basilea to Cardiome
in the months to come."
"Zevtera addresses a significant medical need for patients
who are suffering from hospital- and community-acquired pneumonia. Cardiome has a strong presence in the specialty care market
in key European countries and we look forward to supporting Cardiome in bringing Zevtera to even more patients across Europe,"
said David Veitch, Basilea's Chief Commercial Officer.
About ceftobiprole
Ceftobiprole (ceftobiprole medocaril sodium) is a cephalosporin antibiotic for intravenous administration with rapid bactericidal
activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus
aureus (MSSA, MRSA) and susceptible Pseudomonas spp.1 Ceftobiprole is currently approved for sale in 13 European
countries and several non-European countries for the treatment of adult patients with community-acquired pneumonia (CAP) and hospital-acquired
pneumonia (HAP), excluding ventilator-associated pneumonia (VAP).1 Ceftobiprole is currently commercialized in Italy,
France, Germany, the U.K., Austria and Switzerland under the brand name Zevtera® or Mabelio®. Basilea
is preparing a clinical phase 3 program aiming at the regulatory approval of ceftobiprole in the United States. It consists of
two cross-supportive phase 3 studies, one in the treatment of Staphylococcus aureus bacteremia (bloodstream infections)
and the second one in acute bacterial skin and skin structure infections (ABSSSI). The program receives funding from the Biomedical
Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, Office of the Assistant
Secretary for Preparedness and Response, under contract number HHSO100201600002C. Subject of a successful outcome of these studies,
there may an option to apply for label extensions in Europe and other regions.
About hospital-acquired and community-acquired pneumonia
Hospital-acquired pneumonia (HAP) is one of the most common hospital-acquired infections and has been shown to have among the highest
mortality rates of all hospital-acquired infections.2 Methicillin-resistant Staphylococcus aureus (MRSA)
is one of the most frequent causes of hospital-acquired pneumonia.3 Community-acquired pneumonia (CAP) is a common
condition with up to 60% of the patients requiring hospital admission and intravenous antibiotics.4 Prompt empiric
intervention with an appropriate broad-spectrum antibiotic treatment is considered a best medical practice. The increasing incidence
of bacteria resistant to many established antibiotics is a major concern.
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. | UK Summary of Product Characteristics (SPC) Zevtera®:
http://www.mhra.gov.uk/ [Accessed: September 12, 2017] |
| 2. | C. Rotstein et al. Clinical practice guidelines for
hospital-acquired pneumonia and ventilator-associated pneumonia in adults. Canadian Journal of Infectious Diseases & Medical
Microbiology 2008 (19), 19-53 |
| 3. | R. N. Jones. Microbial etiologies of hospital-acquired
bacterial pneumonia and ventilator-associated bacterial pneumonia. Clinical Infectious Diseases 2010 (51), S81-S87 |
| 4. | W. I. Sligl et al. Severe community-acquired pneumonia.
Critical Care Clinics 2013 (29), 563-601 |
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 August 10, 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.
View original content: http://www.newswire.ca/en/releases/archive/September2017/12/c1182.html
%CIK: 0001036141
For further information: Justin Renz, CFO, Cardiome Pharma
Corp., 604.677.6905 ext. 128, 800.330.9928, jrenz@cardiome.com
CO: Cardiome Pharma Corp.
CNW 07:00e 12-SEP-17
This regulatory filing also includes additional resources:
ex991.pdf
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