Optimer Pharmaceuticals' DIFICID Featured in Presentations at 49th Annual Meeting of IDSA

SAN DIEGO, Oct. 13, 2011 /PRNewswire/ -- Optimer Pharmaceuticals (NASDAQ: OPTR)  today announced that new research findings for DIFICID™ (fidaxomicin) tablets will be featured in presentations at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) occurring October 20-23 in Boston. The presentations include one late-breaker highlighting a new analysis of combined results from Optimer's two large clinical studies of DIFICID for the treatment of Clostridium difficile-associated diarrhea (CDAD), as well as additional research that further explores the safety and efficacy of DIFICID in the treatment of CDAD.

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"We look forward to presenting new research findings at IDSA that will help contribute to the medical community's understanding of DIFICID's role in treating patients with CDAD," said Glenn Tillotson, Ph.D. FIDSA , Senior Vice President, Medical Affairs for Optimer. "With positive reception from the medical community to date, DIFICID is emerging as an important addition to the available treatment options for this serious disease."

Optimer Pharmaceuticals representatives will provide information about DIFICID and its role in the treatment of CDAD during IDSA at Booth #309. Information about DIFICID research presentations at IDSA appear below and full abstracts can also be accessed at the IDSA conference website.

Late-Breaking Poster Presentation

  • LB-4 – "Fidaxomicin Shows Early Superiority over Vancomycin on Intention-To-Treat Analyses of Pivotal Randomized Controlled Trials in Clostridium difficile Infection" – Saturday, October 22 from 11:45 AM to 1:45 PM Eastern Time in Poster Hall B1

Oral Presentations

  • 759 – "Renal Impairment and Responses to Fidaxomicin versus Vancomycin in Patients with Clostridium difficile Infection" – Friday, October 21, 3:45 PM Eastern Time, in Room 151AB
  • 870 – "Factors Influencing Time to Resolution of Diarrhea in Patients with Clostridium difficile Infection Treated with Fidaxomicin or Vancomycin" – Saturday, October 22, 10:15 AM Eastern Time in Room 151AB

Poster Presentations

  • 346 – "Economic Burden of Clostridium difficile Infection Among Elderly Patients in the United States:  An Analysis Using Medicare Claims Data" – Friday, October 21 from 12:15 PM to 2:15 PM Eastern Time in Poster Hall B1
  • 276 – "Comparative clinical effectiveness of fidaxomicin for the treatment of Clostridium difficile infection" – Friday, October 21 from 12:15 PM to 2:15 PM Eastern Time in Poster Hall B1

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'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.

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