At Optimer®, we are focused on the development and commercialization of hospital products that have a positive impact on society. Our team led the preclinical and clinical development program that resulted in regulatory approvals of fidaxomicin in the United States, the European Union and Canada. Our current product development efforts are focused on studying DIFICID® (fidaxomicin) tablets in new patient populations, in previously studied populations of special interest and by pursuing new indications for DIFICID to further help address patient needs.
We have initiated a program to explore the safety and effectiveness of DIFICID in prevention of CDAD in patient populations at high risk of this disease. We have initiated a Phase 3b study in the fourth quarter of 2012 to evaluate the use of DIFICID for prophylaxis of CDAD in patients undergoing hematopoietic stem cell transplant (HSCT), often referred to as bone marrow transplantation.
Further, as required by the FDA, we are committed to studying DIFICID in pediatric patients. We have initiated our first pediatric trial of DIFICID, a pharmacokinetic/safety study, and are committed to undertaking a Phase 3 efficacy/safety study after our first study is complete.
We intend to also start a clinical trial, as per a commitment to the FDA, evaluating the effectiveness and safety of DIFICID as a treatment for patients with multiple recurrences of CDAD.
In addition to DIFICID, we have out-licensed two product candidates being developed by licensees.
Solithromycin is a next-generation investigational macrolide antibiotic licensed to and being developed by Cempra. Solithromycin retains activity against drug-resistant strains of Streptococcus pneumonia and Streptococcus pyogenes, common respiratory tract infection pathogens. The compound is currently being studied in a Phase 3 clinical trial.
OPT-822/821 is a novel investigational carbohydrate-based cancer immunotherapy out-licensed to, and being developed by, OBI, a Taiwanese company that was formerly a subsidiary of Optimer. It is currently in Phase 2/3 clinical trials in patients with breast cancer.