As we put this edition of FierceBiotech to bed, there was still no word from the FDA on potential approval of Optimer Pharmaceuticals' antibiotic fidaxomicin (Dificid). The PDUFA date of May 30 falls on Memorial Day, a federal holiday, and some were wondering whether this timing would prompt the agency to hand the developer its key decision today.
Folks at San Diego-based Optimer ($OPTR) could have something big to celebrate over the holiday weekend if the FDA approves the antibiotic for C. diff infections today. While the drug has been a favorite to gain approval after an advisory panel unanimously endorsed its safety and efficacy last month, perhaps the bigger question is what the exact label of the drug will be, given that some on the panel argued over whether the antibiotic prevented recurrence of C. diff infections. That could impact how doctors prescribe the treatment if it's approved.
Still, Optimer has come a long way to get to this point. Dificid could become the developer's first approved product and the first new antibiotic for C. diff infections--which can be fatal and cause diarrhea--in a quarter of a century. The company is already building up its sales force in anticipation of a potential approval to market the drug to hospitals, where the nasty bugs are typically found. An approval would also be a bit of good news for Lexington, MA-based Cubist Pharmaceuticals ($CBST), which inked a two-year deal with Optimer last month to co-promote the antibiotic.
"For us, it's a dream come true. There are hundreds or even thousands of biotech companies that never see their product all the way through to the market," Optimer CEO Pedro Lichtinger, told Xconomy's Luke Timmerman. "For us to get the product to this stage and carry it to the commercial stage, it's fantastic."