Recently, Optimer Pharmaceuticals (OPTR) entered into a long-term supply agreement with India based Biocon Limited. The agreement is aimed at manufacturing the active pharmaceutical ingredient of fidaxomicin, Optimer’s lead candidate.
Fidaxomicin is being developed to treat Clostridium difficile infection (CDI), the most common nosocomial or hospital-acquired, diarrhea. Following positive results from the second phase III trial of the drug in February 2010, Optimer is preparing to submit a new drug application in the second half of 2010. We believe the agreement with Biocon is a step towards the preparatory groundwork.
While Optimer currently holds worldwide rights to fidaxomicin, it is on the lookout for a suitable partnership for the commercialization of fidaxomicin outside North America. Optimer also plans to submit a Marketing Authorization Application (MAA) for fidaxomicin with the European Medicines Agency (EMEA).
Fidaxomicin may have some advantages over oral vancomycin and metronidazole–the two standard therapies used to treat CDI. It has a low C. difficile resistance, minimal systemic exposure resulting in a favorable safety profile, limited disruption of normal gut flora resulting in a lower likelihood of inducement of CDI and a convenient twice daily dosing regimen.
CDI is a serious illness caused by the infection of the inner lining of the colon by C. difficile bacteria that produce toxins resulting in inflammation, severe diarrhea and sometimes death. CDI accounts for approximately 20% of antibiotic-associated diarrhea incidences as well as many cases of antibiotic-associated colitis. The anti-infective market is one of the largest therapeutic categories worldwide. However, the market includes players like Pfizer (PFE), Bayer (BAYRY), Sanofi-Aventis (SNY), Salix Pharmaceuticals (SLXP) and ViroPharma (VPHM).
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