SAN DIEGO, July 5, 2012 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today that DIFICID® (fidaxomicin) tablets were approved by Health Canada for the treatment of Clostridium difficile infection (CDI), in adults 18 years of age and older and that DIFICID is now available to treat patients in Canada. The approval was based on Health Canada's evaluation of two large, multi-national, Phase 3 clinical trials demonstrating that DIFICID was as effective as oral vancomycin in providing an initial clinical response and was superior in providing a sustained clinical response for 28 days post treatment. DIFICID is the first new treatment for CDI to be approved in Canada in over 20 years.
"Clostridium difficile infections have been an increasing challenge and burden for the Canadian health care system during the last decade and affect the elderly population in a disproportionate manner," said Dr. Karl Weiss Professor of Medicine Maisonneuve-Rosemont Hospital, Faculty of Medicine, Universite de Montreal. "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 over 60% after multiple recurrences."
The Health Canada product monograph for DIFICID highlights some of the important features of the product, including:
- Narrow spectrum activity that is bactericidal against C. difficile in vitro
- Mainly confined to the gastrointestinal tract
- Minimal effect on intestinal flora, with studies having demonstrated that fidaxomicin treatment did not affect Bacteroides concentrations or other major components of the microbiota in the feces of CDI patients
- Shown to inhibit C. difficile sporulation in vitro
- Suppresses the production of both toxin A and toxin B and inhibits toxin gene expression in vitro
"Awareness of the burden of CDI on the Canadian health care system is high with many health care providers, patients, and caregivers impacted by this devastating infection," said Paulash Mohsen, President and Country Manager for Optimer Canada. "This familiarity with CDI will help us as we make DIFICID available to Canadian patients in need."
CDI is the most frequent cause of health care-associated infectious diarrhea in industrialized countries. It is a significant medical problem in hospitals, long-term care facilities and in the community. CDI is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Clostridium difficile-associated diarrhea (CDAD) is the most common symptom of CDI. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDI, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDI patients are 65 years of age or older. Historically, approximately 20% to 30% of CDI patients who initially respond to treatment experience a clinical recurrence.
About DIFICID® (fidaxomicin) Tablets
DIFICID is the first antibacterial drug indicated for Clostridium difficile-associated diarrhea (CDAD) to be approved in more than 25 years in the U.S. It is indicated in the U.S. for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 mg tablets given orally twice daily.
Important Safety Information for DIFICID
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
Please visit www.DIFICID.com or call 855-DIFICID (343-4243) for full prescribing information for DIFICID.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a global biopharmaceutical company focused on developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer developed DIFICID® (fidaxomicin) tablets, an FDA-approved antibacterial drug for the treatment of adult patients with Clostridium difficile-associated diarrhea (CDAD) and is commercializing DIFICID in the US and Canada. Optimer also received marketing authorization for fidaxomicin tablets in the European Union where its partner, Astellas Pharma Europe, is commercializing fidaxomicin under the trade name DIFICLIR™. The company is exploring marketing authorization in other parts of the world where C. difficile has emerged as a serious health problem, including Asia. Additional information can be found at http://www.optimerpharma.com.
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to the commercial launch of DIFICID in Canada, Optimer's ability to quickly provide DIFICID to physicians and patients in Canada, and expected trends in the incidence of CDI. 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: Optimer's ability to commercialize DIFICID in Canada, 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, the ability of Optimer to adequately prepare for the launch of DIFICID in Canada, including its ability to hire, maintain and manage a sales force in Canada, the development of alternative treatments for or means of preventing CDI, whether healthcare professionals will prescribe DIFICID, whether DIFICID will receive reimbursement coverage and other risks detailed in Optimer's filings with the Securities and Exchange Commission
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
OPTIMER and DIFICID are trademarks of Optimer Pharmaceuticals, Inc. All other trademarks are the property of their respective owners.
SOURCE Optimer Pharmaceuticals, Inc.