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VIDEOForest Faces a Positive-Leaning Panel
Briefing documents from the FDA seem to indicate that Forest's antibiotic, ceftaroline, will face a relatively painless advisory meeting next week.
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On Thursday, the FDA released briefing documents with its opinion of Forest's antibiotic ceftaroline ahead of the Advisory Committee meeting that is set to take place next Tuesday. The documents are almost always released two business days prior to the panel and have been posted on the FDA website currently due to the upcoming Labor Day holiday. The panel will vote on two questions regarding whether they believe the safety and efficacy of the drug in two separate indications -- skin infections (cSSSI) and community-acquired pneumonia (CABP).
Analysts had worried that the company would face a tough panel due to the ever-changing guidelines of the FDA in regards to these types of hospital-based infections.
"FDA posed only two questions to the panel. Both are very broad/open-ended, with no mention of evaluating narrowly against its preferred new design/primary endpoints," wrote R.W. Baird analyst Tom Russo in a note on Thursday to investors.
Forest's antibiotic could become an important drug in the hospital setting. Analysts estimate it could have revenues of $361 million by 2014 due to the growing problem of treatment-resistant bacteria spreading through hospitals. The biotech's antibiotic has shown that it doesn’t have a high propensity to develop a resistance. Physicians typically see this as an unmet medical need -- ultimately, a huge positive for Forest.
The briefing documents from the FDA seem relatively positive; analysts believe that the stock could swing $2 to $3 in either direction depending on the outcome of the panel. "Study P903-08 and Study P903-09 each met pre-specified efficacy endpoints, and showed trends favoring ceftaroline over ceftriaxone for the treatment of CABP," said the documents. Overall, findings of non-inferiority of ceftaroline to vancomycin + aztreonam based on key sensitivity analyses of Day 3 responder rates in FDA-MITT subjects appeared to be robust."
Analysts are still a little worried that the FDA didn't include a list of the participants on the panel (as is customary), but see this as only a small negative. "September 7 panel should be positive; panel participants are the only major wild card left in our opinion," write Leerink Swann analyst Seamus Fernandez. "We see little reason for a negative panel outcome since FDA documents appear supportive of approval; ceftaroline looks very safe and is a member of what is believed to be one of the safest drug classes."
Lastly, the FDA seems to have no major concerns when it comes to safety for the drug. This will help speed the panel along.Twitter: @biowriterchik
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