Optimer's Dificid Cleared Down Under - Analyst Blog
May 01 2013 - 1:28PM
Zacks
Optimer Pharmaceuticals (OPTR) 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
Zealand.
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 ViroPharma Inc.’s (VPHM)
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 Astellas
Pharma (ALPMY), 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 Incyte
Corp. (INCY) currently look better positioned carrying a
Zacks Rank #1 (Strong Buy).
ASTELLAS PHARMA (ALPMY): Get Free Report
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