Health & Fitness
Health and Fitness
Health and Fitness
Thu, February 26, 2009 Optimer Pharmaceuticals Announces Publication in Peer-Reviewed Journal about Prulifloxacin?s Antibacterial Activity against Inf
SAN DIEGO--([ BUSINESS WIRE ])--Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced the publication of in vitro data highlighting the antibacterial activity of prulifloxacin in the March 2009 edition of Antimicrobial Agents and Chemotherapy published by the American Society for Microbiology. The article is titled, "Antimicrobial Activity of Prulifloxacin Tested against a Worldwide Collection of Gastroenteritis-Producing Pathogens, Including Those Causing Traveler's Diarrhea" (AAC March 2009; v.53: 1221-1224). The results from these studies compared the in vitro antibacterial activity of prulifloxacin to that of other antimicrobial agents against 582 strains from global surveillance studies, including Escherichia coli, Salmonella spp., Shigella spp., Yersinia spp., Vibrio spp., Aeromonas spp., Plesiomonas spp., and Campylobacter spp. The study was conducted by JMI Laboratories and demonstrated that prulifloxacin is the most active of the antimicrobial agents tested against these gastroenteritis-causing pathogens.
Infectious diarrhea can be caused through infection by bacteria, viruses or parasites. Travelers' diarrhea is infectious diarrhea caused by the ingestion of contaminated food or water by travelers usually in a developing country. Symptoms include stomach cramps, vomiting, nausea, fever and headache. Approximately 85% of travelers' diarrhea cases are caused by bacteria, such as E. coli, Shigella, Salmonella, or Campylobacter. The limitations of currently available antibiotics used to treat infectious diarrhea include: limited spectrum of activity, antimicrobial resistance, certain side effects, and poor compliance.
Prulifloxacin Overview
Prulifloxacin is a broad-spectrum fluoroquinolone antibiotic approved in Japan, Korea and several European countries for the treatment of various bacterial diseases including respiratory and urinary tract infections, skin infections, infectious enteritis, cystitis, and prostatitis. It is a prodrug and is metabolized in the body to the active compound, [ ulifloxacin ]. Optimer acquired exclusive rights to develop and commercialize prulifloxacin in the U.S. from Nippon Shinyaku Co., Ltd., in June 2004. Optimer recently announced positive results from the second of two double-blind pivotal Phase 3 trials assessing the safety and efficacy of prulifloxacin as a once-daily (600 mg), three-day oral therapy for the treatment of infectious diarrhea, including travelers' diarrhea. This was the second Phase 3 clinical study performed in preparation for a NDA filing with the U.S. Food and Drug Administration. Positive data from the first Phase 3 study was announced in July 2008.
About Optimer Pharmaceuticals
Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative anti-infective products to treat serious infections and address unmet medical needs. Optimer has two late-stage anti-infective product candidates under development. Fidaxomicin, formerly known as OPT-80, is the only antibiotic therapy currently in Phase 3 worldwide clinical development for Clostridium difficile infection. Prulifloxacin is an antibiotic which has completed two Phase 3 clinical trials for the treatment of travelers' diarrhea, a form of 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 all statements related to incidence of infectious diarrhea or travelers' diarrhea, the development of prulifloxacin and any planned regulatory filings. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "goal" 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 timing, progress and likelihood of success of its product research and development programs, the timing and status of its preclinical and clinical development of potential drugs and other risks detailed in Optimer's filings with the Securities and Exchange Commission.
