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Optimer Launches DIFICID™ (fidaxomicin) Tablets for Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) in Patients 18 Years of Age and Older
Date:7/18/2011

m 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 CDAD 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 CDAD, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDAD patients are 65 years of age or older.

Current estimates suggest CDAD may affect more than 700,000 people in the U.S. each year, though the incidence may be higher as many cases are believed to be undiagnosed, untreated and underreported. The disease adds significant costs and burden to the U.S. healthcare system with estimates for medical treatment and hospital stays associated with CDAD reaching as much as $3.8 billion every year. Historically, approximately 20% to 30% of CDAD patients who initially respond to treatment experience a clinical recurrence.

About DIFICID™ (fidaxomicin) Tablets

DIFICID is the first antibacterial drug indicated for CDAD to be approved in more than 25 years. It is indicated for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 mg tablets given orally twice daily. In two large Phase 3 clinical studies DIFICID had a clinical response rate at the end of the 10-day treatment period that was non-inferior to oral vancomycin. DIFICID demonstrated superior sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment, compared to oral vancomycin. This difference was due to lower rates of proven or suspected CDAD during the follow-up period in DIFICID-treated patients. Similar rates of clinical respo
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6. Optimer Pharmaceuticals and Cubist Pharmaceuticals Announce Collaboration to Co-Promote DIFICID™ (Fidaxomicin) for Clostridium difficile Infection in the United States
7. Optimer Announces that the U.S. Food and Drug Administrations Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificid™ for Treatment of Patients with Clostridium difficile infection (CDI)
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9. Optimer Pharmaceuticals Announces Presentation at SHEA of Data Highlighting the Burden of Clostridium difficile Infection (CDI) in Hospital Patients
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11. Optimer Pharmaceuticals Announces Issuance of Key Patent Covering Fidaxomicin Methods of Use as a Treatment of Clostridium difficile infection
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