Drug Development, Regulatory

Paratek clears one last big hurdle on the way to an FDA marketing decision for antibiotic

Paratek’s $PRTK antibiotic omadacycline went three for three in Phase III. And now it looks ready to move on to a near-term FDA approval.

An agency expert panel provided its blessing for a marketing approval on Wednesday, voting 17-to-1 to recommend it for acute bacterial skin and skin structure infections with a still-lopsided 14-to-4 vote favoring an OK for community-acquired bacterial pneumonia.

Michael Bigham

In every instance, Paratek was able to provide a solid set of supporting efficacy and safety data to back up its contention that their antibiotic matched up well with existing standards in the field. The biotech has been patiently hunting both US as well as European approval, taking measured steps in their approach.

On the efficacy side oral omadacycline came through in Phase III for acute bacterial skin and skin structure infections, proving noninferior to linezolid with an 87.5% response rate for their antibiotic against 82.5% for the industry standard.  Omadacycline matched up with moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia, with early clinical response rates scoring 81.1 % and 82.7% in new and old antibiotics.

That won’t qualify for blockbuster status, but analysts have given Paratek good odds at building a business worth some hundreds of millions of dollars.

Paratek’s stock is up about 9% on this latest advance.

It’s no easy task getting a new antibiotic through these hurdles. Big Pharma largely stepped out of development efforts over the years, capped by Novartis’ recent decision to abandon their own early-stage efforts. For bigger companies, the growing threat of drug resistance may create a significant unmet need, but not a significant market opportunity.

Several biotechs, though, have taken their chances, looking to grow franchises as the need continues to swell around the world.

“With once-daily dosing and bioequivalent IV and oral formulations, omadacycline may help facilitate early discharge from the hospital or, in other cases, allow for safe and effective treatment in the outpatient setting,” said Michael F. Bigham, Paratek’s CEO, in a statement.


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