Back to Archived News
Optimer Pharmaceuticals Announces Issuance of Key Patent Covering Fidaxomicin Methods of Use as a Treatment of Clostridium Difficile Infection
Tuesday, March 15, 2011
San Diego, CA -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent 7,906,489 which covers methods of Clostridium difficile infection (CDI) treatment with fidaxomicin. The patent, which is eligible for listing in the U.S. Food and Drug Administration's Orange Book, also received a term adjustment of an additional 762 days for the USPTO's delay in the examination process which extends the patent term to March 2027.
"The issuance of this patent provides strong intellectual property protection for fidaxomicin, enhancing our drug candidate's present value," said Pedro Lichtinger, President and CEO of Optimer. "Fidaxomicin is now protected by four issued patents and we are continuing our efforts to expand our patent portfolio for this important medical innovation."
Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment CDI. In two Phase 3 trials, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI. Most importantly, fidaxomicin reduced the risk of recurrence by 47% compared to vancomycin. Optimer has filed marketing applications in the United States and the European Union for fidaxomicin for the treatment of CDI and for reducing the risk of recurrence when used for treatment of initial CDI.
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 anti-infective product candidates in development, fidaxomicin and Pruvel™ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company's request for six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for fidaxomicin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.
Back to Archived News