SAN DIEGO, Sept. 9, 2011 /PRNewswire/ -- Optimer Pharmaceuticals (NASDAQ: OPTR) today announced that 11 abstracts reporting new research findings for DIFICID (fidaxomicin) tablets will be presented at the 2011 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) taking place September 17-20 in Chicago. DIFICID was approved by the U.S. Food and Drug Administration (FDA) in May of 2011 for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and DIFICID is the first antibacterial drug approved for the treatment of CDAD in 25 years.
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The 11 new data presentations provide additional insight on the safety and efficacy of DIFICID and further advance the medical community’s understanding of the potential role of DIFICID in treating CDAD.
In addition, Sherwood Gorbach, MD, Chief Scientific Officer at Optimer, will present a session titled “The Role of Narrow-Spectrum Agents and Novel Mechanisms of Action in Containing Antibiotic Resistance” during an ICAAC-sponsored symposium on Sunday, September 18 from 12:15 PM to 12:45 PM Central Time in room W179b.
“Our presence at ICAAC reinforces Optimer’s leadership in advancing C. difficile related research and medicine,” said Glenn Tillotson, Ph.D., Senior Vice President, Medical Affairs for Optimer. “We remain committed to engaging in research that will improve how the medical community treats patients with CDAD.”
Optimer Pharmaceuticals representatives will provide information about DIFICID and its role in the treatment of CDAD during ICAAC at booth #909. All presentations about research on DIFICID appear below and full abstracts can also be accessed at www.icaac.org.
Oral Presentation:
- “Multivariate Analysis of C. difficile Infection (CDI) Outcomes in Epidemic BI-associated Cases Treated with Fidaxomicin or Vancomycin” Tuesday, September 20, 2011 from 10:30 AM to 10:45 AM Central Time in room W181c
Poster Presentations:
- A2-044 - “Coadministration of Fidaxomicin Does Not Impact the Pharmacokinetics of CYP Substrates Omeprazole, Warfarin, or Midazolam” Saturday, September 17, 2011 from 11:30 AM to 1:30 PM Central Time
- A2-045 - “Effect of Cyclosporine on the Pharmacokinetics of Fidaxomicin” Saturday, September 17, 2011 from 11:30 AM to 1:30 PM Central Time
- A2-043 - “Minimal Effect of Fidaxomicin on Digoxin Pharmacokinetics” Saturday, September 17, 2011 from 11:30 AM to 1:30 PM Central Time
- A2-042 - “Minimal Impact of Food on the Pharmacokinetics of Oral Fidaxomicin” Saturday, September 17, 2011 from 11:30 AM to 1:30 PM Central Time
- C1-635 - “Fidaxomicin Inhibits Clostridium difficile Toxin Synthesis and Sporulation” Sunday, September 18, 2011 from 11:15 AM to 1:15 PM Central Time
- C1-634 - “Fidaxomicin Inhibits Production of Toxin A and Toxin B in Clostridium difficile” Sunday, September 18, 2011 from 11:15 AM to 1:15 PM Central Time
- C1-632 - “Fidaxomicin Inhibits Spore Production in Clostridium difficile” Sunday, September 18, 2011 from 11:15 AM to 1:15 PM Central Time
- C1-631 - “RNA Polymerase Target Modification in Clostridium difficile with Reduced Susceptibility to Fidaxomicin” Sunday, September 18, 2011 from 11:15 AM to 1:15 PM
- K-1476 - “Emergence of Fidaxomicin-resistant Vancomycin-resistant Enterococci in Mice Treated with Fidaxomicin” Monday, September 19, 2011 from 11:15 AM to 1:15 PM Central Time
- B-1190 - “Effect of antibiotics used for treatment of Clostridium difficile infection on intestinal colonization with vancomycin-resistant enterococci and Klebsiella pneumoniae in mice” Monday, September 19, 2011 from 11:15 AM to 1:15 PM Central Time
Important Safety Information for DIFICID
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).
About CDAD
Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDAD 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 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. Approximately 20% to 30% of CDAD patients who initially respond to treatment experience a clinical recurrence. CDAD recurrence typically takes place within 1 to 3 weeks after completion of therapy for the initial infection.
About DIFICID (fidaxomicin) Tablets
DIFICID is the first antibacterial drug indicated for Clostridium difficile-associated diarrhea (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 125 mg four times daily. 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 response at the end of treatment and proven or suspected CDAD during the follow-up period were seen in DIFICID-treated and vancomycin-treated patients infected with a BI isolate. However, DIFICID did not demonstrate superiority in sustained clinical response when compared with vancomycin in these patients.
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%).
For full prescribing information for DIFICID, please visit www.dificid.com or call 855-DIFICID (343-4243)
About 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 developed and is commercializing DIFICID (fidaxomicin) tablets, an FDA-approved antibacterial drug for the treatment of adult patients 18 years of age and older with Clostridium difficile-associated diarrhea (CDAD). Optimer has filed a marketing authorization application with the European Medicines Agency for fidaxomicin. Optimer’s clinical pipeline includes Pruvel, a product in the fluoroquinolone class of antibiotics that has completed Phase 3 trials as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Contacts:
Optimer Pharmaceuticals, Inc.
David Walsey, Vice President, Investor Relations and Corporate Communications
858-909-0736
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
619-849-6005
SOURCE Optimer Pharmaceuticals, Inc.
