) received encouraging news recently when the Australian
regulatory body (Australian Therapeutic Goods Administration)
cleared its drug Dificid (fidaxomicin). Dificid tablets were
cleared for the treatment of confirmed clostridium difficile
infection (CDI) in adults.
The product will be available in Australia from May 14, 2013
from Specialised Therapeutics Australia Pty, Ltd. (STA). We note
that STA has the exclusive rights to Dificid in Australia and New
Dificid's Australian approval was based on positive results
from two phase III studies evaluating the safety and efficacy of
the drug in comparison to
) oral Vancocin in CDI patients.
We remind investors that Dificid, Optimer's sole marketed
product, was launched in the US in Jul 2011 for treating patients
suffering from clostridium difficile-associated diarrhoea (CDAD)
-- the most common symptom of CDI. Dificid was launched in Canada
in Jun 2012. Dificid is also approved in the EU under the trade
name, Dificlir, since Dec 2011.
Optimer has an exclusive agreement with
), under which Astellas has the rights to develop and
commercialize Dificid in Europe and certain other countries. In
Mar 2012, Optimer entered into another collaboration and license
agreement with Astellas Japan. Astellas was granted exclusive,
royalty-bearing license and intellectual property to develop and
commercialize Dificlir in Japan.
Optimer reported Dificid net product sales of $62.4 million in
the US in 2012 compared to $21.5 million in 2011.
While we are pleased with the company's effort to expand
Dificid's market globally, we remain concerned about Optimer's
dependence on a single product for growth.
Optimer, a biopharma company, currently carries a Zacks Rank
#3 (Hold). Meanwhile, other biopharma stocks such as
) currently look better positioned carrying a Zacks Rank #1
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