Optimer Pharmaceuticals Inc. (OPTR) received a huge boost recently when it received approval from the US Food and Drug Administration (FDA) for its first drug, antibiotic Dificid, for the treatment of clostridium difficile-associated diarrhea (CDAD). CDAD is the most common nosocomial or hospital-acquired diarrhea and is a significant malaise in hospitals and nursing home facilities. Optimer's Dificid twice daily tablets are the first drug to be approved in almost 30 years for the treatment of CDAD.
The FDA approval was based on combined data from two of the largest late-stage studies ever conducted for the disease. Data revealed that Dificid was non-inferior to ViroPharma’s (VPHM) Vancocin (the only FDA approved antibiotic for the treatment of clostridium difficile infection) in achieving clinical response at the end of treatment. In addition, data further showed the superiority of Dificid over Vancocin in sustaining clinical response through 25 days post treatment. Dificid thus becomes the only drug which has shown superiority over Vancocin in sustained clinical response for CDAD. The drug is also under regulatory review in the EU.
CDAD has huge unmet clinical need with statistics showing that it affects more than an estimated 700,000 people in the US annually. CDAD is associated with disease recurrence in many patients (elderly patients, patients who are exposed to concomitant antibiotics and patients whose immune systems have been compromised), which usually occurs within the first few weeks after treatment. It is thus crucial to achieve a sustained clinical response in these patients. Dificid represents an important treatment option for such patients.
The FDA approval was expected as an advisory panel of the FDA, in April 2011, had unanimously recommended approval of Dificid. Optimer has an exclusive two-year agreement with Cubist Pharmaceuticals (CBST) to co-promote Dificid in the US. Astellas Pharma will commercialize Dificid in Europe and certain other countries in the Middle East, Africa and Commonwealth of Independent States (CIS).
Our Recommendation
Currently, we have a Neutral recommendation on Optimer. Optimer carries a Zacks #3 Rank (short-term “Hold” rating). We are highly encouraged by the FDA approval of Dificid. We are however concerned about the competitive scenario. On launch, Dificid will have to compete with many established pharma players. However, we are pleased to note that Dificid scores better than currently available treatment options on many parameters. We are also concerned about the uncertainty surrounding the regulatory filing of Pruvel.
CUBIST PHARM (CBST): Free Stock Analysis Report
OPTIMER PHARMAC (OPTR): Free Stock Analysis Report
Be the first to comment