Optimer Pharmaceuticals, Inc. announced the approval of Dificid (fidaxomicin) tablets in Canada for the treatment of clostridium difficile 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 post treatment.
Dificid is approved and marketed in the US for treating patients suffering from clostridium difficile-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 candidate.
Currently, we have a Neutral long-term stance on Optimer. The stock carries a Zacks #3 Rank (Hold rating) in the short run.