-----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, HRA/0U9vPiF1sF7JgwbgQ65KjVJPmLvUHbRpULk0lbCFIt9m2W2UtpchyNDNkxvY oR8bUwFsaqoqVm8WgMJkXg== 0001062993-06-001978.txt : 20060711 0001062993-06-001978.hdr.sgml : 20060711 20060711151055 ACCESSION NUMBER: 0001062993-06-001978 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20060630 FILED AS OF DATE: 20060711 DATE AS OF CHANGE: 20060711 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: 06956117 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 form6k.htm REPORT OF FOREIGN PRIVATE ISSUER Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - 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
UNDER THE SECURITIES EXCHANGE ACT OF 1934

For June 30, 2006 – July 10, 2006

Commission File Number: 0-29338

CARDIOME PHARMA CORP.
(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   x 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 by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ¨ No x

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _________


For June 30, 2006 – July 10, 2006

CARDIOME PHARMA CORP.
(formerly NORTRAN PHARMACEUTICALS INC.)

TABLE OF CONTENTS

Exhibits

  99.1 Press Release – July 7, 2006 (Cardiome Provides Clinical Update)
     
  99.2 Material Change Report – Cardiome Provides Clinical Update
     
  99.3 Press Release – July 10, 2006 (Cardiome and Astellas Amend Agreement)
     
  99.4 Material Change Report – Cardiome and Astellas Amend Agreement

 


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.
  (Registrant)
     
Date: July 10, 2006 By: “Curtis Sikorsky”
    Curtis Sikorsky
    Chief Financial Officer

 


EX-99.1 2 exhibit99-1.htm PRESS RELEASE ??? JULY 7, 2006 (CARDIOME PROVIDES CLINICAL UPDATE) Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Exhibit 99.1
 

6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA
 
Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE       NASDAQ: CRME       TSX: COM

CARDIOME PROVIDES CLINICAL UPDATE

Vancouver, Canada, July 7, 2006 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that representatives from its co-development partner Astellas Pharma US, Inc. and Cardiome have met with the U.S. Food & Drug Administration (FDA) to discuss the “refusal to file” (RTF) letter received on May 30, 2006 for the New Drug Application (NDA) for RSD1235 (iv), an investigational new drug for the acute conversion of atrial fibrillation.

The meeting was requested by Astellas and Cardiome in order to explore the issues referenced by the FDA within the RTF letter, and to discuss appropriate measures which can be taken to resolve those issues. Astellas and Cardiome have dedicated substantial resources within their clinical and regulatory groups to conducting a comprehensive re-review and audit of the NDA documents and associated databases. The amended NDA will be re-submitted following completion of this process.

“We are pleased with how the meeting went with the FDA,” said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. “Astellas and Cardiome will reflect on the discussion and, following consultation with our partner, expect to be in a position to provide further guidance to investors in the near term regarding the timely and accurate re-submission of the NDA for RSD1235 (iv).”

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), and a pre-clinical program directed at improving cardiovascular function.

RSD1235 (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 RSD1235 (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.

RSD1235 (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. A Phase 2a pilot study for RSD1235 (oral) was initiated in December 2005.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:  
Don Graham Peter K. Hofman
Director of Corporate Communication Director of Investor Relations
(604) 676-6963 or Toll Free: 1-800-330-9928 (604) 676-6993 or Toll Free: 1-800-330-9928
Email: dgraham@cardiome.com 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 RSD 1235 (iv) 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 RSD 1235 (iv) and RSD (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.


EX-99.2 3 exhibit99-2.htm MATERIAL CHANGE REPORT ??? CARDIOME PROVIDES CLINICAL UPDATE Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Exhibit 99.2

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

 

 

 

July 7, 2006

 

 

Item 3.

PRESS RELEASE

 

 

 

July 7, 2006 - Vancouver, British Columbia

 

 

Item 4.

SUMMARY OF MATERIAL CHANGE

 

 

Cardiome Pharma Corp. announced that representatives from its co-development partner Astellas Pharma US, Inc. and Cardiome have met with the U.S. Food & Drug Administration (FDA) to discuss the “refusal to file” (RTF) letter received on May 30, 2006 for the New Drug Application (NDA) for RSD1235 (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 10th day of July, 2006.

  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-99.3 4 exhibit99-3.htm PRESS RELEASE ??? JULY 10, 2006 (CARDIOME AND ASTELLAS AMEND AGREEMENT) Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Exhibit 99.3

6190 Agronomy Rd.
6th Floor
Vancouver, BC
V6T 1Z3 CANADA
 
Tel: 604-677-6905
Fax: 604-677-6915
Website: www.cardiome.com

FOR IMMEDIATE RELEASE       NASDAQ: CRME       TSX: COM

CARDIOME AND ASTELLAS AMEND AGREEMENT

Vancouver, Canada, July 10, 2006 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced amendments to its co-development agreement with Astellas Pharma US, Inc., related to the planned re-submission of the New Drug Application (NDA) for RSD1235 (iv), an investigational new drug for acute conversion of atrial fibrillation.

Under terms of the amended agreement, Astellas has agreed to fund 100% of the costs associated with re-submission of the NDA, including engagement of any external consultants. Astellas has also agreed to modify the timing of the US$10 million NDA milestone, which will now be payable on the date of re-submission. Prior to this amendment, the milestone was conditional on acceptance of the NDA for review.

“This action by our partner Astellas is a clear demonstration of their confidence in the RSD1235 (iv) program,” said Bob Rieder, Chief Executive Officer of Cardiome. “The integrity and commitment embodied in this Astellas action demonstrates again that they are an outstanding partner company.”

In October 2003, Cardiome granted Astellas’ predecessor Fujisawa Healthcare, Inc. an exclusive license to develop and commercialize the intravenous formulation of RSD1235 in North America. Cardiome has retained all rights to the intravenous formulations outside of Canada, U.S. and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of atrial fibrillation.

About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug development company with two clinical drug programs focused on atrial arrhythmia (intravenous and oral dosing), and a pre-clinical program directed at improving cardiovascular function.

RSD1235 (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 RSD1235 (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.

RSD1235 (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. A Phase 2a pilot study for RSD1235 (oral) was initiated in December 2005.

Cardiome is traded on the Toronto Stock Exchange (COM) and the NASDAQ National Market (CRME). Further information about Cardiome can be found at www.cardiome.com.

For Further Information:  
Don Graham Peter K. Hofman
Director of Corporate Communication Director of Investor Relations
(604) 676-6963 or Toll Free: 1-800-330-9928 (604) 676-6993 or Toll Free: 1-800-330-9928
Email: dgraham@cardiome.com 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 RSD 1235 (iv) 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 RSD 1235 (iv) and RSD (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.


EX-99.4 5 exhibit99-4.htm MATERIAL CHANGE REPORT ??? CARDIOME AND ASTELLAS AMEND AGREEMENT Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Exhibit 99.4

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

 

 

 

July 10, 2006

 

 

Item 3.

PRESS RELEASE

 

 

 

July 10, 2006 - Vancouver, British Columbia

 

 

Item 4.

SUMMARY OF MATERIAL CHANGE

 

 

Cardiome Pharma Corp. announced amendments to its co-development agreement with Astellas Pharma US, Inc., related to the planned re-submission of the New Drug Application (NDA) for RSD1235 (iv), an investigational new drug for 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 10th day of July, 2006.

  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.


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