FDA panel readies pivotal review of Optimer's fidaxomicin

Optimer Pharmaceuticals is going into today's expert panel meeting on the antibiotic fidaxomicin armed with some positive remarks from regulators and high hopes for what could become its first marketed product. Shares of Optimer ($OPTR) have been headed up in anticipation of a positive reception by the panel. Trading was halted this morning as the expert group prepared to deliberate on the data.

Just weeks ago Optimer landed a $224 million European licensing deal with Japan's Astellas, with a $68 million upfront and $156 million in milestones. TheStreet's Adam Feuerstein is live blogging the event here. And early reports from the panel session indicated that the review appears to be going smoothly for Optimer, raising hopes of a thumbs up this afternoon.

Fidaxomicin has a lot going in its favor. It's an oral macrocyclic antibiotic for Clostridium difficile with a more convenient dosing schedule than the current standard treatment, vancomycin. In two late-stage trials researchers said that the antibiotic worked significantly better than vancomycin in combating a relapse of Clostridium difficile.

In a 629-patient study investigators reported that fidaxomicin reduced the rate of recurrence by 45 percent when compared to vancomycin. Both antibiotics had a similar cure rate, but researchers hailed fidaxomicin's ability to target C. diff while leaving healthy bacteria in the gut untouched. And regulators have been anxious to encourage more antibiotic development after Big Pharma largely dropped out of the game.

- read the Optimer release
- here's the Reuters story

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