Optimer Pharmaceuticals' Fidaxomicin Marketing Authorization Application Accepted for Review by European Medicines Agency

SAN DIEGO, Aug. 19 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that the European Medicines Agency (EMA) has accepted for review Optimer's Marketing Authorization Application (MAA) for fidaxomicin for the treatment of patients with Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI in the European Union (EU).  Optimer announced the submission of its MAA for fidaxomicin to the EMA on August 2, 2010.

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"An independent survey recently conducted by Decision Resources indicates that CDI is on the rise and that nearly 70% of surveyed infectious disease specialists and internists would use fidaxomicin in first- and second-line treatment of CDI, if approved," said Pedro Lichtinger, President and CEO of Optimer. "We believe the potential demand for a narrow spectrum antibiotic with lower recurrence rates for the treatment of CDI is significant. The acceptance for review of the fidaxomicin marketing application by the EMA is an important step in bringing this much needed therapy to Europe, where treatment options are limited.  With the validation of this MAA, we believe we have significantly improved the risk profile of our European program that when combined with our growing excitement and understanding of CDI incidence, access and prescribing intentions across the region, present an enhanced value proposition for fidaxomicin."  

Given these developments, the Company is increasing its focus on its European partnering process for fidaxomicin. J.P. Morgan has been engaged to advise and assist Optimer in this process.  

Optimer also plans to submit a new drug application to the FDA in 2010 for marketing approval of fidaxomicin in the U.S.

About Fidaxomicin

Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile. The narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics to treat CDI, metronidazole and vancomycin, disrupt the flora. Fidaxomicin may facilitate the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence.

About Clostridium difficile Infection (CDI)

CDI has become a significant medical problem in hospitals, long-term care facilities, and in the community.  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 late-stage anti-infective product candidates under development. Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI).  In two Phase 3 trials completed by Optimer to study the safety and efficacy of fidaxomicin for the treatment of CDI, fidaxomicin was statistically superior to vancomycin in global cure rate (defined as cure with no recurrence within four weeks of completing therapy) and reduced recurrences of CDI by up to 50% when compared with vancomycin, the only FDA approved product for CDI. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea.  Optimer has also successfully completed two Phase 3 trials with Pruvel.  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, 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, the timing of an NDA filing for fidaxomicin, the impact of the validation of Optimer's fidaxomicin MAA on the value of fidaxomicin or Optimer's partnership efforts, Optimer's plans to commercialize fidaxomicin, if approved, the likelihood that healthcare professionals would use fidaxomicin, if approved, 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 represent Optimer's judgment as of the time of this release and 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, the timing of any marketing approvals, Optimer 's ability to enter into a collaboration with respect to fidaxomicin on favorable terms or at all, Optimer's ability to complete its NDA submission 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.  Optimer disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

SOURCE Optimer Pharmaceuticals, Inc.

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