Shares of Paratek shot up 30% $PRTK in after-market trading on Monday as investors reacted to the Boston biotech’s proclamation of a clean sweep for its pivotal test of its new antibiotic omadacycline. Execs said that their broad spectrum antibiotic hit its primary and secondary endpoints for the FDA as well as the co-primaries needed for the EMA in their second positive late-stage trial.
Researchers went looking for evidence that omadacycline matched up with moxifloxacin in the treatment of patients with community-acquired bacterial pneumonia (CABP). And that’s what they got, with early clinical response rates scoring 81.1 % and 82.7% in new and old antibiotics.
The co-primary endpoints for the EMA were non-inferiority in the intent-to-treat group and the evaluable CABP populations in those patients with Pneumonia Severity Index (PORT) III and IV at the post treatment evaluation time point. And the safety profile looked comparable as well. Following a successful Phase III for skin infections, Paratek has the two positive studies it needs to satisfy the FDA.
This antibiotic is started as an IV and doctors can then switch to an oral version.
Antibiotic development, though, can be a slow process and Paratek says it has around a year left on the clock before it files for an approval. The applications may arrive at the FDA “as early as” Q1 2018, the company says, with the EMA on the receiving end sometime after that.
With applications that late, don’t look for any potential approvals before late 2018.
While the threat of drug resistant bacteria has increased the need for new antibiotics, Paratek is one of only a handful of biotechs which dived into this area. There are a number of cheap, generic antibiotics available for frontline use. And any new antibiotic is going to face an uphill battle gaining traction in this market.
Leerink noted recently:
For 2025 we currently model ~$230MM and ~$330MM opportunities in skin and pneumonia and also include a small amount of risk-adjusted (at 15%) credit for urinary tract infection.
Paratek and its US partner Allergan $AGN posted positive data from two Phase III studies of saracycline for acne. But Allergan controls the bulk of the revenue, and the company expects peak sales to tap out around $275 million. That FDA application will arrive sooner, though, with regulators getting the package in the second half of this year.
“We now have experience with omadacycline in more than 1,500 patients in our clinical program and we are very pleased with the safety, tolerability, and efficacy profile that we have seen to date,” said Evan Loh, president and CMO at Paratek.
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