EX-99.19 22 exhibit99-19.htm MATERIAL CHANGE REPORT DATED DECEMBER 23, 2003 Filed by Automated Filing Services Inc. (604) 609-0244 - Cardiome Pharma Corp. - Exhibit 99.19

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.
 
3650 Wesbrook Mall
 
Vancouver, BC V6S 2L2
   
Item 2.
DATE OF MATERIAL CHANGE
   
 
December 23, 2003
   
Item 3.
PRESS RELEASE
   
 
December 23, 2003 - Vancouver, British Columbia
   
Item 4.
SUMMARY OF MATERIAL CHANGE
   
 
Cardiome has submitted a New Drug Application (“NDA”) to the United States Food and Drug Administration (“FDA”) seeking marketing approval for oxypurinol (proposed tradename: Oxyprim™), for the treatment of allopurinol-intolerant hyperuricemia (gout).
   
Item 5.
FULL DESCRIPTION OF MATERIAL CHANGE
   
 

Cardiome has submitted an NDA to the FDA seeking marketing approval for oxypurinol (proposed tradename: Oxyprim™), for the treatment of allopurinol-intolerant hyperuricemia (gout). The NDA application was submitted under the provisions of the Orphan Drug Act and under Subpart H of the Food and Drug Act in the U.S.

The treatment of allopurinol-intolerant hyperuremic gout patients with oxypurinol has been designated an orphan drug program by the FDA. Orphan drug status is typically granted to drug development programs for “rare diseases” (high-need patient population in the U.S. of up to 200,000 patients). Orphan drug designation provides at least seven years of mandated market exclusivity in the US market. In addition, such orphan drug programs often qualify for expedited review by the FDA and are exempt from the FDA user fees ordinarily charged to submit an NDA.

Submission of the NDA application starts an initial review period of the application by the FDA to ensure the sufficiency of the NDA package. About 30% of NDA applications fail such review, and are returned to the sponsor for further work. The remaining NDA applications are then given full review.

Cardiome is currently in discussions with various companies regarding arrangements to distribute Oxyprim™, if approved. No final decision has yet been made as to whether Cardiome will sell Oxyprim™ directly or enter into other marketing arrangements.



2

 

Gout is a chronic and potentially debilitating disease characterized by painful arthritis attacks that afflicts more than two million patients in the U.S. Allopurinol is an effective treatment for hyperuricemia, accounting for approximately 70% of all gout prescriptions. While allopurinol is well tolerated by most patients, 2-4% of patients develop allergic reactions that require immediate discontinuation of the drug. Some of those patients (estimated at between 2,000 and 10,000 patients) have severe gout-related hyperuricemia and no disease-modifying treatment alternatives. These patients currently suffer painful arthritis attacks, uric acid crystal deposits in joints and skin, and in some cases kidney stones or even kidney failure. Oxyprim™ has the potential to successfully treat approximately 70% of this allopurinol-intolerant patient population.

Oxypurinol, the therapeutic agent in Oxyprim™, is a xanthine oxidase inhibitor (XOI) that is the active metabolite of allopurinol. Allopurinol and oxypurinol are both inhibitors of xanthine oxidase, the enzyme that is responsible for the conversion of hypoxanthine and xanthine to uric acid. By inhibiting the formation of uric acid, oxypurinol lowers uric acid levels in the blood and urine. Allopurinol has been used as an agent in the suppression of uric acid for patients with gout since the early 1960's.

   
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: Christina Yip
  Title: Vice President, Finance and Administration
  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 31st day of December, 2003.

    CARDIOME PHARMA CORP.
     
  Per:
   
   
   
   
    Christina Yip,
    Vice President, Finance and Administration


3

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.