- Paratek Pharmaceuticals said Tuesday that two of its antibiotics have received Food and Drug Administration approval. One of the them, Seysara, is now cleared to treat moderate to severe acne while the other, Nuzyra, is indicated for both community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI).
- Nuzyra commanded much of the attention during a Wednesday morning conference call with Paratek leadership. Chief Commercial Officer Adam Woodrow said the company has already finished its managed markets hiring and plans to build out the Nuzyra sales team "judiciously" in 2019. Paratek is looking at a first quarter launch, at which point it should have around 70% of its sales team in place.
- Woodrow also noted that Paratek is in the middle of pricing research, but should have results from that in the next week or two. Investment bank Raymond James estimates Nuzyra's net price will settle around $250 per day given that Paratek has indicated it wants the drug's price to be in-line with Pfizer's Zyvox.
The world needs new antibiotics, but regulators are having a difficult time convincing drugmakers to develop them — largely because of unresolved commercial restraints.
Antibiotics, especially against the backdrop of antibiotic resistance, are administered sparingly to ensure they can stay useful long-term. That stipulation, coupled with reimbursement challenges, often leads to much lower return on investment than many manufacturers are willing to accept.
To its credit, the U.S. government has tried to incentivize antibiotics development through legislation like the GAIN Act, which offers quicker regulatory review and additional marketing exclusivity for certain antibiotics. Yet Nicole Mahoney, director of global regulatory policy at Merck & Co., one of the biggest players still in this space, told BioPharma Dive earlier this year that the company "would definitely like to see more incentives on the commercial side."
Paratek is one of the few pharmas basing its entire business on antibiotics. That's especially risky given that, until Tuesday, the company didn't have any commercially available products. Its balance sheet underscores this, as Paratek recorded just $40,000 in revenue and a net loss of $29.7 million during the second quarter.
The new approvals, particularly Nuzyra (omadacycline), could therefore help change the company's course.
"With a relatively clean label, and solid product profile, we think [Paratek] stands in a good launch position. Fully acknowledging sentiment towards antibiotics continues to be lackluster, we do think [Paratek]'s Nuzyra could prove to be an exception," Raymond James analyst Laura Chico wrote in an Oct. 2 investor note.
Paratek execs said they're working to build out Nuzyra's sales force ahead of its launch early next year. A field team of roughly 85 representatives will be "sufficient" for targeting the approximately 800 key hospital accounts the company has identified.
"I mentioned we're starting that recruitment now, and I don't want to rush it," Woodrow said. "We don't accept warm body syndrome in Paratek — we want to make sure we get the right people."
Woodrow added that two of the main tasks ahead of Nuzyra's launch were to: secure formulary access through contracting and test out the drug's supply chain.
"We are in that enviable situation where we have an IV and an oral [version of Nuzyra], and we have to ensure continuity of care from the hospital to home," he said.
Paratek's work won't be simply commercial, however.
Through an agreement with the FDA, Paratek will conduct post-marketing studies of Nuzyra in CABP and pediatric patients. Analysts largely anticipated such requirements after a Phase 3 study showed more patients died in the Nuzyra arm versus an active comparator arm.
Paratek shares were down 5% to $9.24 apiece at Tuesday's market close, but rallied back to $9.77 apiece by Wednesday morning. That's still a far cry from the company's 52-week high stock value of $26.10 per share seen last October, suggesting Paratek's path toward reinvigorating investor optimism has just begun.