Optimer Pharmaceuticals, Inc. announced the commercial launch of DIFICID (fidaxomicin) tablets for the treatment of Clostridium Difficile-Associated Diarrhoea (CDAD) in patients 18 years of age and older. In two large phase III 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 Programme 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 US, 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 US, 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.”

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.

DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal haemorrhage (4%), anaemia (2%) and neutropenia (2%).

Clostridium Difficile-Associated Diarrhoea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. It 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 diarrhoea 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 US each year, though the incidence may be higher as many cases are believed to be undiagnosed, untreated and under reported. The disease adds significant costs and burden to the US healthcare system with estimates for medical treatment and hospital stays associated with CDAD reaching as much as $ 3.8 billion every year. Historically, approximately 20% to 30% of CDAD patients who initially respond to treatment experience a clinical recurrence.

DIFICID is the first antibacterial drug indicated for 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 III clinical studies DIFICID had a clinical response rate at the end of the 10-day treatment period that was non-inferior to oral vancomycin. 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.

DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal haemorrhage (4%), anaemia (2%), and neutropenia (2%).

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society.