Optimer Pharmaceuticals, Inc.,a global biopharmaceutical company, and Specialised Therapeutics Australia Pty, Ltd. (STA) have entered into an exclusive agreement to register and commercialize fidaxomicin tablets in Australia and New Zealand for the treatment of Clostridium difficile Infection (CDI).
“CDI presents a serious bacterial health threat and current CDI treatment options are limited. Our license of fidaxomicin gives us a great opportunity to bring a highly differentiated and much-needed new therapy to patients in Australia and New Zealand,” said Carlo Montagner, chief executive officer of STA. “An application has already been filed with the Australian Therapeutic Goods Administration and pending approval, we are planning to launch fidaxomicin in mid 2013.”
Under the agreement Optimer is entitled to receive commercial milestone payments upon the achievement of cumulative net sales targets. In addition, Optimer will also receive payments for the supply of fidaxomicin tablets to STA for a return equivalent to approximately 30 per cent of expected fidaxomicin sales in Australia and New Zealand. STA is responsible for all costs associated with the registration and commercialization of fidaxomicin tablets in Australia and New Zealand.
“We are systematically executing on our plans to bring fidaxomicin to patients in need across the globe,” said Pedro Lichtinger, president and CEO of Optimer. “Agreements such as this one with STA will support our plans to commercialize fidaxomicin globally, and we will ensure that we are engaged with the companies best able to bring fidaxomicin to patients in their specific territories.”
Fidaxomicin is approved by the US Food and Drug Administration (FDA) for the treatment of Clostridium difficile-associated diarrhoea (CDAD) in adults 18 years of age or older in the United States under the trade name DIFICID. In addition, the European Commission granted Marketing Authorization to fidaxomicin for the treatment of adults with Clostridium difficile infection under the trade name DIFICLIR.
Clostridium difficile infection (CDI) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDI 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. Clostridium difficile-associated diarrhea (CDAD) is the most common symptom of CDI. Patients typically develop CDI 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 CDI, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDI patients are 65 years of age or older. Historically, approximately 20 per cent to 30 per cent of CDI patients who initially respond to treatment experience a clinical recurrence.
STA, a bio-pharmaceutical company dedicated to working with leading pharmaceutical companies worldwide to make acute care therapies for high unmet medical needs available to people living in Australia and New Zealand.