0001279569-13-001318.txt : 20130930 0001279569-13-001318.hdr.sgml : 20130930 20130930154733 ACCESSION NUMBER: 0001279569-13-001318 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20130930 FILED AS OF DATE: 20130930 DATE AS OF CHANGE: 20130930 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cardiome Pharma Corp CENTRAL INDEX KEY: 0001036141 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A1 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29338 FILM NUMBER: 131123221 BUSINESS ADDRESS: STREET 1: 6TH FLOOR STREET 2: 6190 AGRONOMY RD. CITY: VANCOUVER STATE: A1 ZIP: V6T 1Z3 BUSINESS PHONE: 1-604-677-6905 MAIL ADDRESS: STREET 1: 6TH FLOOR STREET 2: 6190 AGRONOMY RD. CITY: VANCOUVER STATE: A1 ZIP: V6T 1Z3 FORMER COMPANY: FORMER CONFORMED NAME: CARDIOME PHARMA CORP DATE OF NAME CHANGE: 20000407 6-K 1 cardiome6k.htm FORM 6-K

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, 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: September 30, 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 September 30, 2013 - Cardiome Receives Approval For BRINAVESS™ In South Africa

EX-99.1 2 ex991.htm MATERIAL CHANGE REPORT

Exhibit 99.1

FORM 51-102F3

MATERIAL CHANGE REPORT

Name and Address of Company

Cardiome Pharma Corp.

6190 Agronomy Rd, Suite 405

Vancouver, BC V6T 1Z3

Date of Material Change

September 30, 2013

News Release

September 30, 2013 - Vancouver, Canada

Summary of Material Change

Cardiome Pharma Corp. announced that BRINAVESS™ (vernakalant intravenous) has been approved in South Africa by the Medicines Control Council (MCC) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. The MCC oversees the regulation of medicines in South Africa.

Full Description of Material Change

See attached press release

Reliance on Subsection 7.1(2) or (3) of National Instrument 51-102

Not Applicable.

Omitted Information

Not Applicable.

Executive Officer

Name: Jennifer Archibald

Title: Chief Financial Officer

Phone No.: 604-677-6905

Date of Report

September 30, 2013

Per: ____“Jennifer Archibald”____

Jennifer Archibald,

Chief Financial Officer

SCHEDULE “A” - PRESS RELEASE

Cardiome RECEIVES approval FOR brinavess™ in south africa

Vancouver, Canada, September 30, 2013 - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that BRINAVESS™ (vernakalant intravenous) has been approved in South Africa by the Medicines Control Council (MCC) for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults. The MCC oversees the regulation of medicines in South Africa.

“Cardiome is pleased with the approval of BRINAVESS in South Africa,” said Karim Lalji, Cardiome’s Chief Commercial Officer. “We are committed to partnering BRINAVESS in this important pharmaceutical market as we continue to focus Cardiome's direct sales efforts on key countries in Europe.”

South Africa is one of the largest countries in Africa in terms of established pharmaceutical markets with total pharmaceutical sales reaching $3.7B USD in 2011, according to research conducted by IMS Health.¹

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^TM (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 website at www.cardiome.com.

References:

IMS Health Inc. Africa: A ripe opportunity. Understanding the pharmaceutical market opportunity and developing sustainable business models in Africa.

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

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