-----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, AEbEEPpi8k2ey2xblOpqRTalLwMOmYMiZZb2+CK6QdRA+8Gao1EdeWI69P0s4G20 RUDFLrbaCo4q54qFXXkEIA== 0001279569-08-000332.txt : 20080317 0001279569-08-000332.hdr.sgml : 20080317 20080317120548 ACCESSION NUMBER: 0001279569-08-000332 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080317 FILED AS OF DATE: 20080317 DATE AS OF CHANGE: 20080317 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: 08691796 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 cardiome6k.htm
 


 
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 March 2008

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: March 17, 2008
/S/ CURTIS SIKORSKY
 
Curtis Sikorsky
 
Chief Financial Officer




EXHIBIT INDEX

EXHIBIT
 
DESCRIPTION OF EXHIBIT
     
99.1
  Material Change Report - CARDIOME ANNOUNCES POSITIVE INTERIM PHASE 2B RESULTS FOR ORAL VERNAKALANT AND ENGAGES MERRILL LYNCH AS STRATEGIC ADVISOR
     
99.2
  Press Release - (CARDIOME ANNOUNCES POSITIVE INTERIM PHASE 2B RESULTS FOR ORAL VERNAKALANT AND ENGAGES MERRILL LYNCH AS STRATEGIC ADVISOR)

EX-99.1 2 ex991.htm MATERIAL CHANGE REPORT ex991.htm
Exhibit 99.1
FORM 51-102F3

MATERIAL CHANGE REPORT


1.  
Name and Address of Company
Cardiome Pharma Corp.
6190 Agronomy Rd, 6th Floor
Vancouver, BC V6T 1Z3

2.  
Date of Material Change
March 17, 2008

3.  
News Release
March 17, 2008 - Vancouver, Canada

4.  
Summary of Material Change
Cardiome Pharma Corp. today announced positive interim clinical results from its 90-day Phase 2b study of vernakalant (oral).  The interim analysis demonstrated statistically significant efficacy for the patient group receiving 500mg b.i.d. of vernakalant (oral) as compared to placebo.  The safety data from the interim analysis also suggests that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied during the dosing period under analysis.

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:
Curtis Sikorsky
  Title:    Chief Financial Officer
  Phone No.: 604-677-6905
                          
9.  
Date of Report
March 17, 2008



Per:      Curtis Sikorsky”           
Curtis Sikorsky,
Chief Financial Officer

EX-99.2 3 ex992.htm NEWS RELEASE DATED MARCH 17, 2008 ex992.htm
 
Exhibit 99.2
 
cardiome 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 POSITIVE INTERIM PHASE 2B
RESULTS FOR ORAL VERNAKALANT AND ENGAGES
MERRILL LYNCH AS STRATEGIC ADVISOR

Vancouver, Canada, March 17, 2008 - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced positive interim clinical results from its 90-day Phase 2b study of vernakalant (oral).  The interim analysis demonstrated statistically significant efficacy for the patient group receiving 500mg b.i.d. of vernakalant (oral) as compared to placebo.  The safety data from the interim analysis also suggests that vernakalant (oral) was well-tolerated in the atrial fibrillation population studied during the dosing period under analysis.

A Kaplan-Meier analysis of the 446 patients included in the interim dataset demonstrated a significant efficacy benefit for the 500mg dosing group as compared to placebo (two-sided, p<0.05).  Median time to recurrence of atrial fibrillation was greater than 90 days for the 500mg dosing group, compared to 39 days for the placebo group.  52% of patients in the 500mg dosing group (n=110) completed the study in normal heart rhythm compared to 39% of patients receiving placebo (n=118).  The interim efficacy analysis for the 150mg (n=110) and 300mg (n=108) dosing groups had not achieved statistical significance at the interim timepoint.

“This larger-scale, longer-term study of vernakalant (oral) was designed to find the appropriate dose to take into Phase 3, and to confirm our assumptions regarding safety,” said Dr. Charles Fisher, Executive Vice President and Chief Medical Officer of Cardiome.  “While the study is ongoing and we must await the final data before drawing conclusions, these statistically significant and clinically significant efficacy results as well as the attractive safety profile observed in this interim analysis strongly support our belief in the exciting potential of vernakalant (oral) as a therapy for atrial fibrillation.”

The safety data for all dosing groups suggests that vernakalant (oral) was well-tolerated within the interim safety population (n=537), which includes patients randomized who did not enter the maintenance phase of the study.  During the dosing period under analysis, there was no difference in the incidence of serious adverse events between treatment groups.  Potentially drug-related serious adverse events occurred in 1% of placebo patients, 2% of patients in the 150mg dosing group, 0% of patients in the 300mg dosing group and 1% of patients in the 500mg dosing group.  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.  There were 2 deaths during this period, both unrelated to vernakalant (oral), comprising a patient in the 150mg dosing group who died of cervical cancer at day 79, and a patient in the placebo group who died at day 86 after suffering an ischemic stroke.

“Our strategic intent with this study was to pave the way to Phase 3 and provide efficacy and safety data to support business discussions,” said Bob Rieder, Chairman and Chief Executive Officer of Cardiome.  “This strong interim data set clearly enables us to move forward in planning the Phase 3 program and continue our discussions with interested parties.”

The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral) over 90 days of dosing in patients at risk of recurrent atrial fibrillation.  Patients received a 150mg, 300mg or 500mg dose of vernakalant (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 vernakalant (oral) or placebo for the remainder of the 90-day trial and were monitored throughout the dosing period.

 
 

 
Cardiome initiated the Phase 2b in the first quarter of 2007.  Enrollment has completed, with a total of 735 patients randomized of which approximately 590 patients are expected to enter the maintenance phase and be measured for efficacy.  Final results from the study are expected in the third quarter of 2008.

Cardiome also announced that it has received detailed expressions of interest from global and regional pharmaceutical companies in pursuit of partnership opportunities for vernakalant. Cardiome’s Board of Directors has engaged Merrill Lynch & Co. as its financial advisor to assist in evaluating these partnership opportunities as well as alternative strategies beyond partnerships to maximize shareholder value, including acquisitions, divestitures and the sale of all or part of the Company.

“We began a partnership cycle in the second half of 2007 in anticipation of the U.S. approval of vernakalant (iv) and results from the vernakalant (oral) Phase 2b trial,” said Doug Janzen, President and Chief Business Officer of Cardiome. “In light of today’s positive results, we look forward to furthering our partnership discussions with those companies who have expressed interest to date, and welcome Merrill Lynch’s assistance in ensuring shareholder value is maximized.  Obviously, there can be no assurance that Cardiome's review of partnership opportunities and other strategic alternatives will result in any specific transaction, and while this review is about to be initiated, no timetable has been set for its completion.”

Cardiome will hold a teleconference and webcast on Monday, March 17, 2008 at 9:00am Eastern  (6:00am Pacific).  To access the conference call, please dial 416-340-8010 or 866-540-8136.  There will be a separate dial-in line for analysts on which we will respond to questions at the end of the call.  The webcast can be accessed through Cardiome’s website at www.cardiome.com.

Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through April 17, 2008.  Please dial 416-695-5800 or 800-408-3053 and enter code 3255778# to access the replay.

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.  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.  Cardiome’s co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006.  Positive top-line results from an additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007.  An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed.

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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