-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, BSY2fFCxyjlakJMmT1IDeQfzPpf1NBjf4jAxqtz4ALYzCQV8eRp3brkN10awzpXZ /u8zCT77ah9bJXu4h+XCFA== 0001279569-07-000792.txt : 20070530 0001279569-07-000792.hdr.sgml : 20070530 20070530153155 ACCESSION NUMBER: 0001279569-07-000792 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070530 FILED AS OF DATE: 20070530 DATE AS OF CHANGE: 20070530 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: 07887336 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 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 May 2007

COMMISSION FILE NO. 000-29338
 
CARDIOME PHARMA CORP. 
(formerly NORTRAN PHARMACEUTICALS INC.)  

(Translation of Registrant’s name into English)
 
6190 Agronomy Road, 6th Floor
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 o    Form 40-F x
 
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): o

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): o
 
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 o    No x   
 
 





 
 
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: May 30, 2007
/S/ CURTIS SIKORSKY
  Curtis Sikorsky
  Chief Financial Officer 




EXHIBIT INDEX

EXHIBIT
 
DESCRIPTION OF EXHIBIT
     
99.1
 
Material Change Report - Cardiome Announces Filing of New Drug Submission in Canada
99.2
 
Press Release - May 30, 2007 (Cardiome Announces Filing of New Drug Submission in Canada)

EX-99.1 2 ex991.htm MATERIAL CHANGE REPORT - CARDIOME ANNOUNCES FILING OF NEW DRUG SUBMISSION IN CANADA MATERIAL CHANGE REPORT - CARDIOME ANNOUNCES FILING OF NEW DRUG SUBMISSION IN CANADA
 
Exhibit 99.1


FORM 53-901F
 
SECURITIES ACT
 
MATERIAL CHANGE REPORT UNDER
SECTION 85(1) OF THE SECURITIES ACT (BRITISH COLUMBIA)
AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Item 1.
REPORTING ISSUER
 
Cardiome Pharma Corp.
6190 Agronomy Road, 6th Floor
Vancouver, BC V6T 1Z3
 
Item 2.
DATE OF MATERIAL CHANGE
 
May 30, 2007
 
Item 3.
PRESS RELEASE
 
May 30, 2007 - Vancouver, British Columbia
 
Item 4.
SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp. today announced that Astellas Pharma Canada, Inc., an affiliate of its co-development partner, Astellas Pharma US, Inc., has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada seeking Canadian approval to market the intravenous formulation of vernakalant hydrochloride (vernakalant (iv)), an investigational new drug for the acute conversion of atrial fibrillation.

Item 5.
FULL DESCRIPTION OF MATERIAL CHANGE

See attached press release

Item 6.
RELIANCE ON SECTION 85(2) OF THE SECURITIES ACT (BRITISH COLUMBIA) AND EQUIVALENT LEGISLATION OF OTHER JURISDICTIONS
 
Not Applicable.
 
Item 7.
OMITTED INFORMATION
 
Not Applicable.
 
Item 8.
SENIOR OFFICER
 
 
Name:
 
Curtis Sikorsky
Title:
Chief Financial Officer
Phone No.:
604-677-6905
 
Item 9.
STATEMENT OF SENIOR OFFICER
 
The foregoing accurately discloses the material change referred to herein.
 

 
 

 
 
 
Dated at Vancouver, British Columbia, this 30th day of May, 2007.
 
   
CARDIOME PHARMA CORP.
     
   Per:   “Curtis Sikorsky”
     
   
Curtis Sikorsky, 
Chief Financial Officer
 
  
IT IS AN OFFENCE FOR A PERSON TO MAKE A STATEMENT IN A DOCUMENT REQUIRED TO BE FILED OR FURNISHED UNDER THE ACT OR THIS REGULATION THAT, AT THE TIME AND IN THE LIGHT OF THE CIRCUMSTANCES UNDER WHICH IT IS MADE, IS A MISREPRESENTATION.
 

 

EX-99.2 3 ex992.htm PRESS RELEASE - MAY 30, 2007 PRESS RELEASE - MAY 30, 2007
Exhibit 99.2
 
 Cardiome Pharma logo
6190 Agronomy Road, 6th Floor
Vancouver, B.C.
V6T 1Z3
Tel: 604-677-6905
Fax: 604-677-6915
 
 
FOR IMMEDIATE RELEASE NASDAQ: CRME TSX: COM
 
CARDIOME ANNOUNCES FILING OF NEW DRUG
SUBMISSION IN CANADA

Vancouver, Canada, May 30, 2007 - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that Astellas Pharma Canada, Inc., an affiliate of its co-development partner, Astellas Pharma US, Inc., has filed a New Drug Submission (NDS) with the Therapeutic Products Directorate of Health Canada seeking Canadian approval to market the intravenous formulation of vernakalant hydrochloride (vernakalant (iv)), an investigational new drug for the acute conversion of atrial fibrillation.

This filing follows the December 2006 submission of a New Drug Application (NDA) for vernakalant (iv) with the United States Food & Drug Administration (FDA), which is currently under review. Based on typical review periods, Cardiome expects to receive a decision from the FDA in October of 2007, and expects a decision from Health Canada in mid-2008.

In October 2003, Cardiome granted Astellas Pharma US, Inc. an exclusive license to develop and commercialize vernakalant (iv) in North America. The companies have co-developed vernakalant (iv) to NDA, with Astellas responsible for 75% of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two late-stage clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), a Phase 1 program for GED-aPC, an engineered analog of recombinant human activated Protein C, and a pre-clinical program directed at improving cardiovascular function.

Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. An additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, and an open-label safety study evaluating recent-onset AF patients, called ACT 4, are ongoing. Cardiome’s co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006.

Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for vernakalant (oral) in September 2006. A Phase 2b study for vernakalant (oral) is ongoing.

In April 2007 Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME).

 
 

 

For Further Information:
Peter K. Hofman
Senior Director, Investor Relations
(604) 676-6993 or Toll Free: 1-800-330-9928
Email: phofman@cardiome.com
 
Forward-Looking Statement Disclaimer
Certain statements in this press 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. Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments, or industry results, to be materially different from any future results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, our stage of development, lack of product revenues, additional capital requirements, risk associated with the completion of clinical trials and obtaining regulatory approval to market our products, the ability to protect our intellectual property, dependence on collaborative partners and the prospects for negotiating additional corporate collaborations or licensing arrangements and their timing. Specifically, certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties that: we may not be able to successfully develop and obtain regulatory approval for vernakalant (iv) or vernakalant (oral) in the treatment of atrial fibrillation or any other current or future products in our targeted indications; our future operating results are uncertain and likely to fluctuate; we may not be able to raise additional capital; we may not be successful in establishing additional corporate collaborations or licensing arrangements; we may not be able to establish marketing and sales capabilities and the costs of launching our products may be greater than anticipated; we rely on third parties for the continued supply and manufacture of vernakalant (iv) and vernakalant (oral) and we have no experience in commercial manufacturing; we may face unknown risks related to intellectual property matters; we face increased competition from pharmaceutical and biotechnology companies; and other factors as 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 and uncertainties, 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.


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-----END PRIVACY-ENHANCED MESSAGE-----