Optimer Pharmaceuticals, Inc.
) and partner Astellas Pharma recently announced that their
antibiotic Dificlir received approval in the European Union (
), not belying expectations. The European Medicines Agency (EMA)
cleared Dificlir for the treatment of clostridium
difficile-associated diarrhea (CDAD) also known as clostridium
difficile infection (
). CDAD is the most common nosocomial or hospital-acquired diarrhea
and is a significant malaise in hospitals and nursing home
facilities. The EU approval does not surprise us since in September
this year Dificlir received a positive opinion from the Committee
for Medicinal Products for Human Use (
) of the EMA.
Dificlir is already marketed as Dificid in the US for CDAD in
Cubist Pharmaceuticals, Inc.
). The European regulatory body's decision was based on data from
two late stage studies which showed that Dificlir was non-inferior
) Vancocin (the only other approved antibiotic for the treatment of
CDI). The studies showed that Dificlir achieved clinical cure in a
comparable number of patients as Vancocin at the end of 10 days of
treatment. In addition, data showed that Dificlir led to a
statistically lower CDI recurrence rate over Vancocin through 30
days post treatment. Similar to the US, the Dificlir label will
also include superior recurrence benefits than Vancocin. We
believe this will give a fillip to Dificlir sales marking a clear
differentiation from existing options.
Optimer has an exclusive collaboration and license agreement
with Astellas Pharma for the development and commercialization of
Dificlir in Europe and certain other countries in the Middle East,
Africa and Commonwealth of Independent States (
We remind investors that Optimer is entitled to receive 40
million euros on approval of Dificlir and another 10 million euros
on commercial launch of the drug which could result in increased
cash flows for the company. Optimer is also entitled to receive
other milestone payments as well as high-teens to low-20% royalties
on ex-US sales from Astellas.
We currently have a Neutral recommendation on Optimer. The stock
carries a Zacks #3 Rank (short-term "Hold" rating).
We are encouraged by the EU approval of Dificlir as well as the
strong launch of Dificid in the US. Dificid 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/Dificlir 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. However, we
prefer to stay on the sidelines until we gain more visibility on
the commercial launch of the drug. Moreover, Optimer is highly
dependent on Dificid for its success. Following termination of
development of Pruvel, the company hardly has anything in its
pipeline. Consequently, if Dificid fails to impress, the company
will have little to fall back on. Moreover, the huge up-tick in
SG&A expenses concerns us.
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