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 June, 2013
COMMISSION FILE NO. 000-29338
CARDIOME PHARMA CORP.
(formerly NORTRAN PHARMACEUTICALS INC.)
____________________________________________
(Translation of Registrant’s name into English)
Suite 405, 6190 Agronomy Rd
Vancouver, British Columbia, V6T 1Z3, 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
Form 20-F T | 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): *
Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange act of 1934.
Yes * | No T |
This Form 6-K is hereby filed and incorporated by reference in the registrant’s Registration Statements on Form F-10 (File No. 333-137935), Form F-3 (File No. 333-131912), Form S-8 (333-136696) and Form S-8 (333-125860).
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. | ||
Date:June 27, 2013 | /s/ JENNIFER ARCHIBALD | |
Jennifer Archibald | ||
Chief Financial Officer |
EXHIBIT INDEX
EXHIBIT | DESCRIPTION OF EXHIBIT | |
99.1 | Material Change Report | |
99.2 | News Release Dated June 27, 2013 - Cardiome Announces the Transfer of European Marketing Authorization from Merck | |
Exhibit 99.1
FORM 51-102F3
MATERIAL CHANGE REPORT
1. | Name and Address of Company |
Cardiome Pharma Corp. | |
6190 Agronomy Rd, Suite 405 | |
Vancouver, BC V6T 1Z3 | |
2. | Date of Material Change |
June 27, 2013 | |
3. | News Release |
June 27, 2013 - Vancouver, Canada | |
4. | Summary of Material Change |
Cardiome Pharma Corp. announced adoption of the decision by the European Commission of the transfer of the centrally-approved marketing authorisation (MA) for BRINAVESS™ (vernakalant intravenous) from Merck Sharp & Dohme Limited to Cardiome. The decision marks Cardiome’s assumption of responsibilities as the new marketing authorization holder (MAH) for BRINAVESS™ in the member states of the European Union. Cardiome and Merck will continue to work together until September 15, 2013 to finalize the organizational arrangement for transfer of all responsibilities, including batch release, and operational management of SPECTRUM, the post-approval safety study. | |
5. | Full Description of Material Change |
See attached press release | |
6. | Reliance on Subsection 7.1(2) or (3) of National Instrument 51-102 |
Not Applicable. | |
7. | Omitted Information |
Not Applicable. | |
8. | Executive Officer |
Name: Jennifer Archibald | |
Title: Chief Financial Officer | |
Phone No.:604-677-6905 | |
9. | Date of Report |
June 27, 2013 |
Per: ____“Jennifer Archibald”____
Jennifer Archibald,
Chief Financial Officer
Cardiome announces the transfer of European marketing authorization from merck
Vancouver, Canada, June 27, 2013 Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced adoption of the decision by the European Commission of the transfer of the centrally-approved marketing authorisation (MA) for BRINAVESS™ (vernakalant intravenous) from Merck Sharp & Dohme Limited to Cardiome. The decision marks Cardiome’s assumption of responsibilities as the new marketing authorization holder (MAH) for BRINAVESS™ in the member states of the European Union. Cardiome and Merck will continue to work together until September 15, 2013 to finalize the organizational arrangement for transfer of all responsibilities, including batch release, and operational management of SPECTRUM, the post-approval safety study.
“The transfer of the European marketing authorization to Cardiome marks an important milestone in the company’s history,” said William Hunter, M.D., Cardiome’s president and CEO. “Cardiome now assumes full control of all key commercialization activities for BRINAVESS™ in the European Union and as of July 1st, will begin realizing the benefit from worldwide product revenues.”
A transfer of marketing authorization is the procedure by which the MA is transferred from the currently approved marketing authorization holder to a new MAH which is a different person/legal entity.1 The MAH is allowed to market medicines and make it available to patients and healthcare professionals throughout the European Union when the product is registered via the centralized procedure.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESS™ (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.
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. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000045.jsp&mid=WC0b01ac0580023e80, accessed June 26, 2013
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 2013 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.
For Further Information:
Cardiome Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email: ir@cardiome.com
###
Exhibit 99.2
Cardiome Announces the Transfer of European Marketing Authorization from Merck
NASDAQ: CRME TSX: COM
VANCOUVER, June 27, 2013 /CNW/ - Cardiome Pharma Corp. (NASDAQ: CRME) (TSX: COM) today announced adoption of the decision by the European Commission of the transfer of the centrally-approved marketing authorisation (MA) for BRINAVESS™ (vernakalant intravenous) from Merck Sharp & Dohme Limited to Cardiome. The decision marks Cardiome's assumption of responsibilities as the new marketing authorization holder (MAH) for BRINAVESS™ in the member states of the European Union. Cardiome and Merck will continue to work together until September 15, 2013 to finalize the organizational arrangement for transfer of all responsibilities, including batch release, and operational management of SPECTRUM, the post-approval safety study.
"The transfer of the European marketing authorization to Cardiome marks an important milestone in the company's history," said William Hunter, M.D., Cardiome's president and CEO. "Cardiome now assumes full control of all key commercialization activities for BRINAVESS™ in the European Union and as of July 1st, will begin realizing the benefit from worldwide product revenues."
A transfer of marketing authorization is the procedure by which the MA is transferred from the currently approved marketing authorization holder to a new MAH which is a different person/legal entity.1 The MAH is allowed to market medicines and make it available to patients and healthcare professionals throughout the European Union when the product is registered via the centralized procedure.
About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a biopharmaceutical company dedicated to the discovery, development and commercialization of new therapies
that will improve the health of patients around the world. Cardiome has one marketed product, BRINAVESS™ (vernakalant IV),
approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults.
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. | http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000045.jsp&mid=WC0b01ac0580023e80, accessed June 26, 2013 |
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 2013 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.
%CIK: 0001036141
For further information:
Cardiome Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email: ir@cardiome.com
CO: Cardiome Pharma Corp.
CNW 09:00e 27-JUN-13
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