Optimer Pharmaceuticals, Inc.
) announced the approval of Dificid (fidaxomicin) tablets in Canada
for the treatment of
infection (CDI). Approval was based on data from two large
multi-national, phase III clinical trials conducted in adults of 18
years and older.
This is the first drug to be approved in Canada for the
treatment of CDI in the last 20 years. Dificid was as effective as
oral vancomycin in providing an initial clinical response and was
superior in providing a sustained clinical response for 28 days
Dificid is approved and marketed in the US for treating patients
-associated diarrhea (CDAD). In the first quarter of 2012, Optimer
recorded Dificid sales of $14.4 million.
The product was approved in Europe in December 2011 for the
treatment of adults with CDI under the trade name, Dificlir.
Optimer has an agreement with Specialised Therapeutics Australia
Pty, Ltd. to register and commercialize fidaxomicin tablets in
Australia and New Zealand.
In March 2012, Optimer entered into another collaboration and
license agreement for Dificlir. Under this deal, the company
granted exclusive, royalty-bearing license and intellectual
property to Astellas Japan for the development and
commercialization of Dificlir in that country.
The sole marketed product at Optimer is Dificid. Even though the
European and Canadian approval of the drug should aid sales, we
remain concerned about Optimer's dependence on a single product for
growth. We believe the company lacks a decent pipeline
Currently, we have a Neutral long-term stance on Optimer. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.
OPTIMER PHARMAC (OPTR): Free Stock Analysis
To read this article on Zacks.com click here.