TORONTO, July 5, 2012 /CNW/ - Optimer Pharmaceuticals Canada, Inc. announced today the approval of DIFICID (fidaxomicin) by Health Canada for the treatment of Clostridium difficile infection (CDI) in patients 18 years of age and older. DIFICID was approved in Canada on a priority basis recognizing the critical need for new options to treat this disease and is the first new treatment for CDI in over 20 years.
Two large double-blind, comparative, randomized clinical studies were conducted 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 46% and shown to be superior in sustaining clinical response for 28 days after treatmenti,ii.
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 C. difficile sporesi. "Collectively, these novel effects may contribute to DIFICID's superior efficacy in reducing the risk of CDI recurrence," stated Dr. Wendy Arnott, Executive Director, Scientific Affairs, Optimer Canada.
CDI has a significant burden on the healthcare systemiii,iv,v,vi and on the lives of patients and their families suffering from this disease.
"Clostridium difficile infections (CDI) have been an increasing challenge and burden for the Canadian healthcare system during the last decadevii,viii,ix, and affect the elderly population in a disproportionate manner,iv,v,vii,x " said Dr. Karl Weiss, Professor of Medicine at Maisonneuve-Rosemont Hospital and a member of the Faculty of Medicine at Université de Montréal. "Reducing CDI recurrence is a major objective, knowing that 20 to 30% of affected Canadian patients will experience at least one relapse of the disease, escalating to over 60% after multiple recurrencesx."
"Today marks a significant advance in the fight against CDI. Awareness of the burden of CDI on the Canadian healthcare system is high with many healthcare providers, patients, and caregivers impacted by this devastating infection, but what is less commonly understood is that CDI is much more than an acute infection. In a significant proportion of patients it is a chronic disease given this high rate of recurrence," said Paulash Mohsen, President and Country Manager for Optimer Canada. "We are proud to have the opportunity to bring this first-in-class antibiotic to help Canadian patients in need."
"C. difficile can be a very serious condition with devastating impact on the lives of patients and their caregivers," said Gail Attara, President & Chief Executive Officer, Gastrointestinal Society. "Advances in CDI therapy are important if we want to win the ongoing battle against these types of infections."
About CDI in Canada
CDI is one of the leading causes of hospital-acquired infectionsiii,vi,xi, and mortality has been reported to be as high as 17% during outbreaks in Canadaix. 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, deathiv,v,viii,xii. CDI predominantly affects hospital inpatientsv,viii,ix,x and has been associated with numerous outbreaks across the countryix. The risk of CDI increases with age, an impaired immune system, co-morbid disease and previous exposure to antibiotics which disrupt the patient's normal gut florav,x,xiii,xiv.
CDI represents a major challenge to the Canadian healthcare systemiii,vi,ix. The detriment of this disease impacts the lives of the patients and the families of those who suffer from this virulent pathogen. In Canada, the infection has been associated with a median increase in length of stay in the hospital of 6 daysxv. The spore form of pathogen is resistant to gastric acidxvi,xvii,xviii, antibacterial soaps and alcohol based hand sanitizersxix, and can survive for months on surfacesxix. While not as well characterized, CDI is thought to be an increasing burden in long-term care facilitiesxx,xxi,xxii,xxiii, and the community setting as wellxii,xxiv.
Two pivotal, randomized, multi-center, double-blinded trials were conducted in a total of 1,164 adults with confirmed CDI. A non-inferiority design was utilized to demonstrate the efficacy of DIFICID (200 mg orally twice daily for 10 days) compared to vancomycin (125 mg orally four times daily for 10 days) for initial cure of the infection. Additional efficacy endpoints were recurrence of infection and sustained clinical response, defined as clinical response at the end of treatment and not having a recurrence of CDI at any time through 28 days beyond the end of treatment.
DIFICID was superior to oral vancomycin in reducing CDI recurrence by 46% (recurrence rates 14.1% and 26.0% for DIFICID and vancomycin respectively p<0.001). DIFICID was also shown to be superior to vancomycin in sustaining clinical response for 28 days after treatmenti,ii. For treatment of the acute initial episode DIFICID achieved the goal of noninferiority versus vancomycin [95%CI]i,ii.
DIFICID was approved by the FDA in May 2011, and by the European Medicines Agency (EMA) in December 2011.
Important Safety and Dosing Information about DIFICIDxxv
DIFICID should not be used for systemic infections. DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile.
The most common adverse drug reactions in patients receiving DIFICID were nausea (2.7%), constipation (1.2%), and vomiting (1.2%). The majority of adverse drug reactions were reported as mild or moderate in severity.
DIFICID is administered orally over a 10 day course at 200mg twice daily, and its activity is confined to the gastrointestinal tract, where CDI persists, allowing for maximum bactericidal activity.
Video footage of Dr. Karl Weiss, clinical investigator on the comparative trials published in NEJM and The Lancet Infectious Diseases is available for download at http://cnw.pathfireondemand.com/viewpackage.action?packageid=558
For complete Product Monograph for DIFICID, please call 1-855-DIFICID (1-855-343-4243).
Optimer Pharmaceuticals Canada Inc. is an indirect wholly-owned subsidiary of Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR), a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has developed and commercialized fidaxomicin tablets, an antibacterial drug authorized for sale as DIFICID® in the US and as DIFICLIRTM in Europe for the treatment of adult patients with Clostridium difficile infection (CDI). Additional information can be found at http://www.optimerpharma.com.
Forward Looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to Optimer's plans to commercialize DIFICID, the incidence of CDI, and Optimer's plans to conduct post-marketing research, a surveillance program and clinical trials of DIFICID. Words such as "believes", "would", "anticipates", "plans", "expects", "may", "intend", "will", and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. These forward-looking statements are based on management's expectations on the date of this release. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to:, the ability of Optimer and its third party contractors to manufacture and supply sufficient quantities of DIFICID in accordance with Good Manufacturing Practices to meet demand, whether healthcare professionals will prescribe DIFICID, whether DIFICID will receive reimbursement coverage from healthcare payors and government agencies, the extent to which DIFICID organization, Optimer's ability to initiate and complete planned post-marketing research, surveillance programs and clinical trials of DIFICID in a timely manner and the results of those efforts and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
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 Mulvey et al. Hypervirulent Clostridium difficile Strains in Hospitalized Patients, Canada. Emerg Infect Dis 2010; 16:678-81
viii 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
ix 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.
x Kelly et al. Clostriodium difficile—More Difficult than Ever. N Engl J Med. 2008;359(18):1932-1940
xi 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/hl-vs/iyh-vsv/diseases-maladies/cdifficile-eng.php accessed May 31 2012.
xii Louie, T et al. N Engl J Med 2011;364:422-31.
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xviii Jump RLP, Pultz MJ, Donskey CJ. Vegetative Clostridium difficile Survives in Room Air on Moist Surfaces and in Gastric Contents with Reduced Acidity: A Potential Mechanism to Explain the Association Between Proton Pump Inhibitors and C. difficile-associated Diarrhea? Antimicrob Agents Chemother. 2007:51(8):2883-7.
xix Cohen SH et al. Clinical Practice Guidelines for Clostridium difficile infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectous Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010:31(5):431-455
xx Simor A et al. Clostridium difficile in Long-Term-Care Facilities for the Elderly. Infection Control and Hospital Epidemiology. 2002:23(11):696-703.
xxi Walker KJ, Gilliland SS, Vance-Bryan K, Moody JA, Larsson AJ, Rotschafer JC, et al. Clostridium difficile colonization in residents of long-term care facilities: prevalence and risk factors. J Am Geriatr Soc 1993;41:940-6.
xxii Rivera EV, Woods S. Prevalence of asymptomatic Clostridium difficile colonization in a nursing home population: a cross-sectional study. J Gender-Specific Med 2003;6:27-30
xxiii Johnson S, Clabots CR, Linn FV, Olson MM, Peterson LR, Gerding DN. Nosocomial Clostridium difficile colonisation and disease. Lancet 1990;336:97-100
xxiv Kasper AM et al. A Multicenter Study of Clostridium difficile Infection-related Colectemy, 2000-2006. Infect Control Hosp Epidemiol. 2012 May;33(5):470-6
xxv Prescribing Information. May 2011, Optimer Pharmaceuticals, Inc.
SOURCE Optimer Pharmaceuticals Canada, Inc.