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Optimer Pharmaceuticals 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 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 - Analyst Report) currently look better positioned carrying a Zacks Rank #1 (Strong Buy).

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