Optimer introduces DIFICID for treatment of C. difficile-associated diarrhea

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the commercial launch of DIFICID™ (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in patients 18 years of age and older. In two large Phase 3 clinical studies, DIFICID had clinical response rates at the end of the 10-day treatment period that were non-inferior to oral vancomycin. In addition, DIFICID was superior to vancomycin in 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. With the commercial availability of DIFICID, Optimer is initiating a Patient Assistance Program to help eligible uninsured and underinsured patients gain access to this important treatment option. DIFICID is the only FDA-approved treatment for CDAD that has demonstrated superiority to vancomycin in sustained clinical response and the first new drug approved for the treatment of CDAD in more than 25 years.

"Patient access to DIFICID is Optimer's highest priority. For eligible patients, the Patient Assistance Program will help expand access to DIFICID for those patients in need," said Pedro Lichtinger, President and Chief Executive Officer of Optimer. "We have assembled a world class hospital-based product launch team in the U.S., including expertise in access, reimbursement, health economics, medical education, sales and marketing that we believe when combined with Cubist, our co-promotion partner in the U.S., will make the DIFICID launch one of the most impactful in the hospital segment. This team will help bring to patients a new option proven to provide superior sustained clinical response."

More information on the Optimer Patient Assistance Program, including eligibility guidelines, can be accessed from Optimer's website at http://www.optimerpharma.com. Patients also can call (855) 841-4236 between the hours of 8 a.m. and 8 p.m. Eastern Daylight Time (EDT), Monday through Friday to complete the phone application process.

"CDAD can be devastating. The initial disease can be serious, even life-threatening, and about 20 to 30% may have a recurrence. In some cases, patients have many recurrences. Any treatment that can provide a sustained clinical response is an important advance," said John Bartlett, M.D., Stanhope Bayne Jones Professor of Medicine and Chief of the Division of Infectious Diseases at The Johns Hopkins University School of Medicine.

Optimer also has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for approval of fidaxomicin, and has entered into an exclusive collaboration and license agreement with Astellas Pharma Europe Ltd. to develop and commercialize the drug in Europe and certain other countries.