Recently, Optimer Pharmaceuticals (OPTR) presented positive data from a final stage trial of one of its lead candidates, fidaxomicin. The second phase III study was conducted in patients with Clostridium difficile infection (CDI). The data were presented at the 20th Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna, Austria. The phase III trial, conducted in two phases enrolled over 1,100 patients.
The second phase III trial, conducted in about 100 clinical sites in North America and Europe with 535 patients, was aimed at comparing the safety and effectiveness of fidaxomicin with that of Vancocin. It was observed that fidaxomicin met the primary endpoint of non-inferiority compared to Vancocin. Moreover, fidaxomicin scored better than Vancocin on both recurrence rates and global cure rates. We note that these data confirm results of the first phase III trial reported in November 2008.
While Optimer currently holds worldwide rights to fidaxomicin, it is on the lookout for a suitable partnership deal for the commercialization of fidaxomicin outside of North America. The company plans to file a New Drug Application (NDA) for fidaxomicin with the US Food and Drug Administration (FDA) in the second half of 2010.
Fidaxomicin has many advantages over oral vancomycin and metronidazole, two standard therapies used to treat CDI. Optimer is also looking at label expansions by introducing an oral suspension formulation of fidaxomicin for elderly patients who may find it difficult to swallow the pill.
Optimer has another candidate in final stages of development, Pruvel (prulifloxacin) for the treatment of travelers’ diarrhea, a form of infectious diarrhea.
Although the antibacterial drugs market is huge, it is crowded and competition is fierce. Optimer will face significant competition from Pfizer (PFE), Sanofi-Aventis (SNY) and ViroPharma (VPHM). We are Neutral on the stock.
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