Optimer Pharmaceuticals, Inc. (OPTR) and partner Astellas Pharma recently announced that their antibiotic Dificlir received a positive recommendation for approval in the European Union (EU). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approving Dificlir in the EU for the treatment of clostridium difficile-associated diarrhea (CDAD) also known as clostridium difficile infection (CDI). CDAD is the most common nosocomial or hospital-acquired diarrhea and is a significant malaise in hospitals and nursing home facilities.
Dificlir is already marketed as Dificid in the US for CDAD. The positive opinion of CHMP was based on data from two late stage studies which showed that Dificlir was non-inferior to ViroPharma’s (VPHM) Vancocin (the only other approved antibiotic for the treatment of CDI). The studies showed that Dificlir achieved clinical cure in similar proportion of patients as Vancocin at the end of 10 days of treatment. The EMA, which usually follows the CHMP’s recommendation, is due to give its decision within the next three months.
Optimer has an exclusive collaboration and license agreement with Astellas Pharma for the development and commercialization of Dificid in Europe and certain other countries in the Middle East, Africa and Commonwealth of Independent States (CIS). We remind investors that Optimer is entitled to receive upto 115 million euros as regulatory and commercial milestones and high-teens to low-20% royalties on ex-US sales from Astellas which could result in increased cash flows for the company.
Our Recommendation
We currently have an Outperform recommendation on Optimer. The stock carries a Zacks #3 Rank (short-term “Hold” rating).
We are highly encouraged by the positive EU recommendation for Dificlir. Dificid/Dificlir scores better than currently available treatment options on many parameters. Particularly, we believe the inclusion of superior recurrence benefits over Vancocin in the product label will provide valuable benefit and help Dificid sales. Dificid is the first drug to be approved in almost 25 years for the treatment of CDAD and thus targets a market with significant unmet need. Further, the deals with Cubist Pharmaceuticals (CBST) and Astellas are positive for Optimer as it will benefit from their experience in marketing hospital based antibiotics. Moreover, these partnerships should maximize the impact of Dificid’s commercial launch.
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