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FOR IMMEDIATE RELEASE
OPTIMER PHARMACEUTICALS CANADA LEVERAGES CANADIAN PHARMACEUTICAL
DISTRIBUTION NETWORK (CPDN)
Oakville, Ontario - July 9, 2012 - The Canadian Pharmaceutical Distribution Network (CPDN) is pleased to announce that Optimer
Pharmaceuticals Canada, Inc. (Optimer Canada) has joined Canada’s leading, cost-efficient delivery network.
Optimer Canada is an indirect wholly owned subsidiary of Optimer Pharmaceuticals, Inc., a biopharmaceutical company focused on
discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society.
Optimer Canada announced on July 5, 2012 the approval of DIFICID™ (fidaxomicin) by Health Canada for the treatment of
i
Clostridium difficile infection (CDI) in patients 18 years of age and older . DIFICID was approved by the FDA in May 2011, and by the
European Medicines Agency (EMA) in December 2011.
“This is yet another measure of CPDN’s leadership in assisting independent drug manufacturers with distributing important
medicines in the Canadian marketplace”, says J. Greg Gauthier, President and CEO, CPDN.
"We are very pleased to bring this first in class antibiotic to Canada, a country where CDI represents a significant burden on the
healthcare system and on the lives of patients and their families suffering from this disease," said Paulash Mohsen, Country Manager
of Optimer Canada. "Canada represents Optimer’s first direct entry into an international market, supporting wider DIFICID access to
patients in need and advancing the treatment of hospital acquired infections,"
About DIFICID
DIFICID is the first in a new class of antibiotics called macrocycles. DIFICID targets C. difficile with a high degree of specificity, and
has been shown to preserve the normal gut flora, suppress the production of C. difficile toxins A and B, and inhibit the production of
i
C. difficile spores .
DIFICID was studied in two large double-blind, comparative, randomized clinical studies with results published in two leading
medical journals, The New England Journal of Medicine and The Lancet Infectious Diseases. Over 400 Canadian patients participated
in the trials, representing over one third of patients studied. DIFICID was superior to oral vancomycin in reducing CDI recurrence by
i,ii.
46% and shown to be superior in sustaining clinical response for 28 days after treatment
About CDI in Canada
iii,vi,x
CDI is one of the leading causes of hospital-acquired infections
and mortality has been reported to be as high as 17% during
viii
outbreaks in Canada . C. difficile is a virulent, toxin and spore-producing pathogen. Infection from this pathogen is a serious and
life-threatening condition which can result in severe and debilitating diarrhea, removal of the colon and, in the most serious cases,
iv,v,vii,xi
v,vii,viii,ix
death
. CDI predominantly affects hospital inpatients
and has been associated with numerous outbreaks across the
viii
country . The risk of CDI increases with age, an impaired immune system, co-morbid disease and previous exposure to antibiotics
v,ix,xii,xiii
which disrupt the patient’s normal gut flora
.
About CPDN
Since 1994, CPDN is dedicated to providing the health care industry with a lower-priced delivery solution. As an industry funded
service provider, CPDN is a leading distribution channel to Canadian hospitals looking for alternatives to traditional, higher priced
intermediaries. All products are sold by their respective manufacturers/distributors. The CPDN Program enables the consolidated
ordering and delivery of pharmaceutical products, from a number of independent drug manufacturers, with the streamlined ability
to issue one, convenient payment for those products. Additional information about CPDN is available through its corporate website
www.cpdn.ca.
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If you would like more information on this topic, or the CPDN program, please call Judy Radan on 905.847.1273 ext. 227 or email
Judy at [email protected].
i
DIFICID Product Monograph. June 2012, Optimer Pharmaceuticals Canada, Inc.
ii
Based on a pooled analysis of the two pivotal Phase 3 clinical studies: 1) Cornely, O et al. “Fidaxomicin versus vancomycin for
infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial.” The
Lancet Infectious Diseases 2012: 12(4):281-289. 2) Louie, T et al. “Fidaxomicin versus Vancomycin for Clostridium difficile Infection.”
N Engl J Med 2011;364:422-31.
iii
Ghantoji, SS et al. Economic healthcare costs of Clostridium difficile infection: a systematic review. J Hosp Infect. 2010 Apr: 74(4):
309-18.
iv
McFarland LV et al. Recurrent Clostridium difficile disease: epidemiology and clinical characteristics. ICHE. 1999: 20(1): 43-50.
v
O’Brien JA et al. The emerging infectious challenge of Clostridium difficile-associated disease in Massachusetts hospitals: clinical
and economic consequences. ICHE. 2007: 28(11): 1219-1227.
vi
Miller MA, Hyland M, Ofner-Agostini M, Gourdeau M, Ishak M. Morbidity, mortality, and healthcare burden of
nosocomial Clostridium difficile-associated diarrhea in Canadian hospitals. Infect Control Hosp Epidemiol 2002;23:137-40.
vii
Gravel et al. Health Care-Associated Clostridium difficile Infection in Adults Admitted to Acute Care Hospitals in Canada: A
Canadian Nosocomial Infection Surveillance Program Study. Clin Infect Dis 2009; 46:568-76
viii
Pepin et al. Mortality Attributable to Nosocomial Clostridium difficile–associated Disease During an Epidemic Caused By a
Hypervirulent Strain in Quebec. CMAJ. 2005;173(9):1-6.
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Kelly et al. Clostriodium difficile—More Difficult than Ever. N Engl J Med. 2008;359(18):1932-1940
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Health Canada. It’s Your Health. June 2006. Catalogue # H13-7/13-2006E-PDF, ISBN # 0-662-43588-5. http://www.hc-sc.gc.ca/hlvs/iyh-vsv/diseases-maladies/cdifficile-eng.php accessed May 31 2012.
xi
Louie, T et al. N Engl J Med 2011;364:422-31.
xii
Bignardi GE. Risk factors for Clostridium difficile infection. J Hosp Infect 1998; 40:1-15.
xiii
Barbut F, Petit JC. Epidemiology of Clostridium difficile-associated infections. Clin Microbiol Infect 2001;7:405-10.
DIFICID™(fidaxomicin) is a trademark of Optimer Pharmaceuticals, Inc.
©2012 Optimer Pharmaceuticals, Inc. All rights reserved.