SAN DIEGO, Nov. 2, 2010 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that new research has been published in Microbiology, a peer-reviewed journal of the Society for General Microbiology, highlighting fidaxomicin's narrow spectrum of activity and minimal disruption of microflora in patients with Clostridium difficile infection (CDI) compared to the only FDA approved CDI therapy, vancomycin. The article titled, "A new macrocyclic antibiotic, Fidaxomicin (OPT-80), causes less alteration to the bowel microbiota of Clostridium difficile-infected patients than does vancomycin", was authored by Gerald W. Tannock, Ph.D., University of Otago, Dunedin, New Zealand and colleagues, and published online today in Microbiology. (doi: 10.1099/mic.0.042010-0).
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In this study, Dr. Tannock investigated the impact of fidaxomicin on the composition of microflora of patients compared to that of vancomycin, using advanced molecular techniques that are more sensitive than the traditional culture method. Fidaxomicin was shown to have a minimal effect on Bifidobacteria (gram-positive anaerobe in the colon) compared to the large impact of vancomycin. Previous studies found that fidaxomicin also has a minimal effect against gram-negative bacteria that make up the microflora in the gut. By way of contrast, treatment with vancomycin was shown to have devastating effects on broad segments of the microflora.
"This research is in line with what other experts have posited. Fidaxomicin's minimal disruption of microflora may explain the 47% lower recurrence rate of CDI versus vancomycin (p < 0.001) found in Optimer's Phase 3 trials," said Sherwood Gorbach, M.D., Chief Medical Officer of Optimer and Professor of Public Health and Medicine, Tufts University School of Medicine. "Antibiotics that produce a cure while having minimal effects on the composition of the microbiota are desirable. This will ensure that normal physiological processes are restored quickly with minimal consequences to the human-microbe balance that underpins the healthy bowel biome."
About Fidaxomicin
Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in rapid killing of C. difficile. The narrow-spectrum profile of fidaxomicin eradicates C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, seriously disrupt the flora. Fidaxomicin facilitates the early return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence. Optimer has filed an application in the EU for marketing authorization for fidaxomicin for the treatment of CDI and prevention of recurrences of CDI and has initiated a rolling submission in the U.S.
About Clostridium difficile Infection (CDI)
Clostridium difficile infection (CDI), commonly referred to as 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 caused by infection of the inner lining of the colon by C. difficile bacteria, which produces 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, and thus allowing C. difficile bacteria to flourish.
Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, 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 antibiotic administration.
Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), advanced age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. Increasing incidence, higher treatment failures and recurrence with current therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials. Learn more about CDI at www.cdiinfo.org.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. 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) and the Company recently initiated a rolling submission of its NDA filing to the FDA, and the EMA (Europe) has accepted its MAA filing for review. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea and we plan to have a NDA submitted to the FDA in the first quarter of 2011. 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 all statements related to the development of fidaxomicin and Pruvel, the timing of NDA submissions, anticipated timing of the FDA's review of Optimer's NDA submissions, the incidence and effects of CDI, the efficacy of current CDI treatments and the efficacy and potential benefits of fidaxomicin, potential regulatory approval of fidaxomicin and the awareness of CDI among healthcare professionals. 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. 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 development of alternative treatments for or means of preventing CDI, whether regulatory authorities will review or approve Optimer's applications for marketing approval within Optimer's anticipated timelines or at all, the timing of any marketing approvals, Optimer's ability to complete its NDA submissions in a timely manner, Optimer's ability to commercialize any products for which it receives marketing approval, whether healthcare professionals will prescribe fidaxomicin, if approved, whether fidaxomicin will receive reimbursement coverage from healthcare payors and government agencies and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
Contacts |
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Optimer Pharmaceuticals, Inc. |
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Christina Donaghy, Corporate Communications Manager |
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John D. Prunty, Chief Financial Officer & VP Finance |
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858-909-0736 |
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Canale Communications, Inc. |
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Jason I. Spark, Senior Vice President |
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619-849-6005 |
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SOURCE Optimer Pharmaceuticals, Inc.
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