Optimer Pharmaceuticals, Inc. (OPTR) announced that it has recently launched its solely approved drug, antibiotic Dificid (fidaxomicin), for the treatment of clostridium difficile-associated diarrhea (CDAD) in adults. Optimer also plans to begin a Patient Assistance Program under which eligible patients in need will get easy access to Dificid.
Dificid was approved by the US Food and Drug Administration (FDA) in May 2011. CDAD is the most common nosocomial or hospital-acquired diarrhea and is a significant malaise in hospitals and nursing home facilities. Dificid (twice daily tablets) is the first drug to be approved in almost 25 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 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 superior recurrence benefits of Dificid over Vancocin will be included in the label, which we believe is of great importance for Dificid sales as it provides a clear differentiation from existing options.The candidate is currently under review in the EU.
Optimer has an exclusive two-year agreement with Cubist Pharmaceuticals (CBST) to co-promote Dificid in the US. Optimer plans to market the drug to physicians, hospitals, long-term care facilities and other healthcare institutions with the help of Cubist’s existing US hospital sales force and medical affairs team, which hold experience in marketing Cubist’s lead antibiotic Cubicin for the treatment of complicated skin infections.
Our Recommendation
We currently have a Neutral recommendation on Optimer. The stock carries a Zacks #3 Rank (short-term “Hold” rating).
We are highly encouraged by the FDA approval of Dificid. Further, the deal with Cubist should maximize the impact of Dificid’s commercial launch. We are, however, concerned about the competitive scenario. Dificid will have to compete with many established players. We are nevertheless pleased to note that Dificid scores better than currently available treatment options on many parameters. Particularly, we believe the inclusion of superior recurrence benefits over vancomycin in the product label will help Dificid sales. However, we remain concerned about the uncertainty surrounding the regulatory filing of a late-stage pipeline candidate, Pruvel (infectious diarrhea).
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