-----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, LyJo6td2eScX6FWcSEIJjHqewz6+GamlC/PPXNla3DMJ9PdfUH9zMh78+yiBjMaJ OFWGB4hNqMcadRD5LUskYw== 0001279569-06-000822.txt : 20060724 0001279569-06-000822.hdr.sgml : 20060724 20060724155330 ACCESSION NUMBER: 0001279569-06-000822 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20060724 FILED AS OF DATE: 20060724 DATE AS OF CHANGE: 20060724 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: 06976634 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 REPORT OF FOREIGN PRIVATE ISSUER 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 the month of July
 
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    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 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    o
No    x
 
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82- _________
 
 


 

 
 
 
CARDIOME PHARMA CORP.
(formerly NORTRAN PHARMACEUTICALS INC.)
 
TABLE OF CONTENTS
 
Exhibit
Number
  Description
     
99.1
 
Material Change Report - Cardiome Announces Interim Phase 2A Results for Oral RSD1235
     
99.2
  Press Release  July 24, 2006 (Cardiome Announces Interim Phase 2A Results for Oral RSD1235)
 
 

 
 
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 24, 2006 By: “Curtis Sikorsky”
    Curtis Sikorsky
    Chief Financial Officer
EX-99.1 2 ex991.htm MATERIAL CHANGE REPORT - CARDIOME ANNOUNCES INTERIM PHASE 2A RESULTS FOR ORAL RSD1235 Material Change Report - Cardiome Announces Interim Phase 2A Results for Oral RSD1235
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
 
July 24, 2006
 
Item 3.  PRESS RELEASE
 
July 24, 2006 - Vancouver, British Columbia
 
Item 4.  SUMMARY OF MATERIAL CHANGE
 
Cardiome Pharma Corp. announced interim clinical results from the 300mg dosing group for its Phase 2a pilot study of RSD1235 (oral). The safety data for this first of two dosing groups suggests that RSD1235 (oral) appears well-tolerated within the target population. The interim analysis further demonstrated a clear positive trend toward efficacy, with 61% (33 of 54) of patients receiving RSD1235 (oral) completing the study in normal heart rhythm, as compared to 37% (10 of 27) of patients receiving placebo.
 
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 24th 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-99.2 3 ex992.htm PRESS RELEASE - JULY 24, 2006 Press Release dated July 24, 2006
Exhibit 99.2
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 ANNOUNCES INTERIM PHASE 2A RESULTS FOR ORAL RSD1235

Vancouver, Canada, July 24, 2006 -- Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced interim clinical results from the 300mg dosing group for its Phase 2a pilot study of RSD1235 (oral). The safety data for this first of two dosing groups suggests that RSD1235 (oral) appears well-tolerated within the target population. The interim analysis further demonstrated a clear positive trend toward efficacy, with 61% (33 of 54) of patients receiving RSD1235 (oral) completing the study in normal heart rhythm, as compared to 37% (10 of 27) of patients receiving placebo.

A total of 83 patients were successfully cardioverted after the initial 3 days of dosing and continued in the study, of which 81 reached an endpoint of the study (completion of dosing or relapse to atrial fibrillation). The remainder of the patients were discontinued from the study for reasons unrelated to atrial fibrillation.  

During the 28 days of oral dosing, serious adverse events occurred in 9% of placebo patients and 10% of patients receiving RSD1235 (oral). Potentially drug-related serious adverse events occurred in 3% of placebo patients and 4% of patients receiving RSD1235 (oral). There were no cases of drug-related “Torsades de Pointes”, a well-characterized arrhythmia which is an occasional side effect of some current anti-arrhythmic drugs.

“We are very pleased with these results and are enthusiastic about the prospects of RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation,” said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome. “The 300mg dose is well below the maximum tolerated dose indicated by our Phase 1 studies, and to see a positive safety profile coupled with a clear trend toward efficacy at these levels is very encouraging. We await the outcome for the 600mg dosing group and remaining placebo patients for final determination of the statistical significance of both active doses utilized in this trial.”

The double-blind, placebo-controlled, randomized, dose-ranging study is designed to explore safety and tolerability, pharmacokinetics and preliminary efficacy of RSD1235 (oral) over 28 days of dosing in patients at risk of recurrent atrial fibrillation. The majority of patients enrolled had experienced atrial fibrillation for greater than 30 days and less than 180 days in duration. Patients in the first stage of the study received a 300mg dose of RSD1235 (oral) or placebo twice per day. After the first 3 days, patients still in atrial fibrillation were electrically cardioverted. Successfully cardioverted patients continued to receive RSD1235 (oral) or placebo for the remaining 25 days and were monitored throughout the dosing period. Cardiome initiated the Phase 2a pilot study of RSD1235 (oral) in December 2005. The study is being conducted across 72 centres in Canada, U.S. and Europe.

“This patient population suffers significant disease burden including substantial risk of stroke, impaired cardiac function and decreased quality of life,” said Bob Rieder, Chief Executive Officer of Cardiome. “Worldwide, more than 4 million patients could benefit from a safe and effective oral drug to prevent atrial fibrillation. These interim trial results move RSD1235 (oral) an important step closer to meeting this critical unmet medical need.”

Enrollment and dosing for the second stage of this study, evaluating patients receiving a 600mg dose of RSD1235 (oral) or placebo twice per day, has now been completed. Results from this dosing group, and the complete study, are expected later in the 3rd quarter of this year. Initiation of a larger Phase 2b clinical study will follow analysis of these final results.


Cardiome will hold a teleconference and webcast on Monday, July 24, 2006 at 9:00am EST (6:00am PST) to discuss these results. Please dial 800-814-4941 or 416-644-3432 to access the call. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the presentation. The webcast can also be accessed through Cardiome’s website at www.cardiome.com.

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.  Cardiome and its co-development partner Astellas are working toward re-submitting a New Drug Application for RSD1235 (iv) following receipt of a Refusal to File letter from the FDA in May 2006.

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 RSD1235 (iv) or RSD1235 (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 RSD1235 (iv) and RSD1235 (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-----