The new drug application (NDA) of Optimer Pharmaceuticals Inc.’s (OPTR) lead pipeline candidate, fidaxomicin, is due to be reviewed by a US Food and Drug Administration (FDA) Advisory Committee on April 5, 2011. Fidaxomicin is an antibiotic for the treatment of clostridium difficile infection (CDI), the most common nosocomial or hospital-acquired diarrhea.
The FDA decision on fidaxomicin is expected in May 2011. Optimer expects to launch the antibiotic in August 2011. We believe fidaxomicin will receive a positive recommendation from the FDA panel and will be eventually approved. The candidate is also under review in the EU.
The FDA has granted fast track status to fidaxomicin for the treatment of CDI. In December 2010, fidaxomicin was grated orphan drug status by the FDA for the treatment of pediatric CDI.
Optimer is developing an oral suspension formulation of fidaxomicin for use in pediatric CDI patients. It is also evaluating development of an oral formulation of fidaxomicin for elderly patients who find it difficult to swallow tablets. Optimer also plans to conduct a proof-of-concept trial in high-risk patients as it believes fidaxomicin could also be effective in preventing CDI.
Optimer has an exclusive collaboration and license agreement with Astellas Pharma Europe Ltd. for the development and commercialization of fidaxomicin in Europe and certain other countries in the Middle East, Africa and Commonwealth of Independent States (CIS). We believe Astellas is an ideal partner for Optimer in Europe because of prior experience in commercializing anti-infective drugs like Mycamine, Avelox and Vivotif.
CDI is a serious illness caused by 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 33% 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.
Another pipeline candidate at Optimer is Pruvel indicated for the treatment of infectious diarrhea, including travelers’ diarrhea. Optimer reported positive top-line results from two late stage studies of the antibiotic. However, the timing of NDA filing of the candidate is uncertain due to occurrence of mild or moderately severe cutaneous rash in a drug interaction study.
Our Recommendation
Although we are quite optimistic regarding the approval of fidaxomicin, we remain concerned about the competitive scenario. We are particularly concerned about the presence of generics in the market.
Several pharmaceutical and biotechnology companies have already established themselves in the market for the treatment of CDI and/or infectious diarrhea and many other companies are currently developing products which will compete with fidaxomicin and Pruvel. The market includes players like Pfizer (PFE), Bayer (BAYRY), Sanofi-Aventis (SNY), Roche (RHHBY), Johnson & Johnson (JNJ), ViroPharma (VPHM) and Salix Pharmaceuticals (SLXP).
However, we are pleased to note that fidaxomicin scores better than the current available treatment options on many parameters. The uncertainty surrounding the regulatory filing of Pruvel is nevertheless an area of concern.
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