Paratek has bagged its first — and second — FDA OK for its antibiotics on the same day.
The big approval, 20 years in the making, goes to omadacycline — dubbed Nuzyra — for both community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
Earlier, regulators also gave a green light for sarecycline to treat a moderate to severe form of acne. Having out-licensed the drug years ago, Paratek still stands to receive $12 million in milestone payments and royalties upon commercialization.
Shares $PRTK saw a modest rise of 4% in pre-market trading, following a dip on Tuesday.
But let’s be clear: Omadacycline, the sole drug that Paratek has been built on, is the focus here.
“Antibiotics need a good story,” CMO Evan Loh told me in an interview earlier this year “There’s not been a good story in antibiotic development in the last five years. period. There’s not been. We want to be on the vanguard in being able to offer that.”
A modernized tetracycline available in both IV and oral form, omadacycline addresses a broad spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug-resistant strains.
“The beauty of broad spectrum is that in the right patient population for moderate to severe skin infection, moderate to severe community-acquired pneumonia — as well as potentially for urinary tract infection — this has exactly the right spectrum to be used in those patients who can’t tolerate first-line generics,” Loh told me.
This means little time would be wasted in the hospital even when it may be unclear to the physicians what exactly the patients have. Add that to their “go-home strategy” — where patients can take the oral version once a day after they finish a course of IV therapy in the hospital — and Paratek believes it has a strong case for breaking into the tough antibiotic market, from which Big Pharma players have largely bowed out.
The company already has boots on the ground working on market access for omadacycline, Loh said. With enough cash in the bank to reach 2021, the current priority is to ensure the launch “has the resources it needs to be successful.”
“The approval of Nyzyra is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” said Michael Bigham, chairman and CEO, in a statement. “We are excited to launch Nuzyra early next year.”
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 35,200+ biopharma pros who read Endpoints News by email every day.Free Subscription