SAN DIEGO, Jan. 4, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that fidaxomicin, the Company's lead product candidate, has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pediatric Clostridium difficile infection (CDI). This orphan drug designation applies to the active moiety and covers all formulations of fidaxomicin used to treat Clostridium difficile infection in children 16 years of age or younger.
Optimer has completed Phase 3 trials in adults and filed applications in the U.S. and the EU for marketing authorization for fidaxomicin for the treatment of CDI and for the prevention of recurrences.
The FDA Orphan Drug Designation is intended to support the clinical development of drugs for diseases and conditions that affect fewer than 200,000 people in the United States. Orphan Drug Designation gives seven years of market exclusivity for the designated indication in the U.S. from the date the product receives marketing approval for that indication. Orphan Drug Designation also provides access to regulatory support from the FDA throughout the development process, potential grant funding for clinical studies, potential FDA fee reductions, and tax credits related to development expenses. This designation does not imply that fidaxomicin has demonstrated the efficacy, safety and quality required for drug approval in the U.S.
Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the 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, have been shown to disrupt the gut flora. Fidaxomicin facilitates the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence. Optimer has filed applications in the U.S. and the EU for marketing authorization for fidaxomicin for the treatment of CDI and for the reduction of recurrences.
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). The Company has submitted an NDA to the FDA, and filed a 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.
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 the potential of fidaxomicin to lower CDI recurrences, lower the costs of treating additional CDI episodes and reduce the spread of CDI, the potential to lower the cost burden to the healthcare system by reducing the spread of CDI, the development of fidaxomicin, the timing of NDA submissions, the incidence and effects of CDI, the efficacy of current CDI treatments and 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 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.
Optimer Pharmaceuticals, Inc.
Christina Donaghy, Corporate Communications Manager
John D. Prunty, Chief Financial Officer & VP Finance