SAN DIEGO, April 2, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) announced today the presentation of information from insurance claims and survey databases highlighting the unmet need for targeted therapies to treat subpopulations at high risk of recurrence of Clostridium difficile infection (CDI). The research also presented the substantial mortality and frequent complications associated with CDI. Investigator Erik R. Dubberke, M.D., M.S.P.H., of the Washington University School of Medicine, St. Louis, Missouri, presented data at the 21st Annual Scientific Meeting of The Society for Healthcare Epidemiology of America (SHEA) in Dallas, Texas. Data for this research were obtained from the 2008 Nationwide Inpatient Sample, 2009 Medicare Provider Analysis and Review file, Florida fiscal year 2006-2007 Medicaid claims and 2007-2008 Medicare 5% Standard Analytical Files.
Dr. Dubberke presented the demographic and clinical characteristics of hospital inpatient CDI cases showing that the average CDI patient was 68 years old, more than half were female, and in total, 83% of CDI cases surveyed were from at least one of the following subpopulations: patients with renal impairment (36%), patients aged greater than age 80 (34%), patients aged 65-79 (33%), cancer patients (16%), inflammatory bowel disease patients (5%), organ transplant patients (2%), human immunodeficiency virus (HIV) patients (1%), or bone marrow transplant patients (0.4%). Each of these subpopulations are considered to be at high risk of recurrence or mortality from CDI.
Dr. Dubberke also presented data showing that Medicare was the largest payer in the CDI cases surveyed (68%), followed by private insurance (19%), and Medicaid (8%). Almost a third (31%) of the Medicare CDI hospital stays (initial or re-hospitalizations) included services in the intensive care unit (ICU) with an average length of stay in the ICU of 8.2 days. Almost two-thirds (62%) of the Medicare CDI hospital stays (initial or re-hospitalizations) included services in semi-private rooms with an average length of stay in semi-private rooms of 9.5 days. We believe the study highlights the substantial economic burden of both acute and recurrent CDI. The dreaded outcomes – recurrence and death – are seen more commonly in the elderly and those with serious underlying diseases.
Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). In two Phase 3 trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. Fidaxomicin also demonstrated statistically significant reduction in recurrences and an increase in global cure rate, defined as cure without recurrence. Importantly, fidaxomicin reduced the risk of recurrence by 47% compared to vancomycin. TheNew England Journal of Medicine has published results from the first Phase 3 trial in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection," which appeared in the February 3, 2011 issue.
About Clostridium difficile Infection (CDI)
Clostridium difficile infection (CDI), commonly referred to as "C. difficile" or "c-diff", has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S. It 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. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.
Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment. However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.
Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The rise in incidence of CDI, along with high rates of both treatment failures and recurrences with current therapies have resulted in greater awareness and concern about CDI among medical professionals and public health officials. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel™ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company's request for six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for fidaxomicin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Optimer Pharmaceuticals, Inc. Christina Donaghy, Corporate Communications Manager John D. Prunty, Chief Financial Officer & VP Finance 858-909-0736
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