After its buyout last summer by Novo Holdings and Gurnet Point, Paratek Pharmaceuticals reaffirmed the benefits of its Biomedical Advanced Research and Development Authority (BARDA)-backed Nuzyra with a positive post-marketing study.
With that, Paratek’s clinical trial database for the drug makes for the largest in pneumonia across all antibiotics green-lighted by the FDA in the last decade, the company’s chief development and regulatory officer Randy Brenner said in a press release.
“This study provides additional data confirming Nuzyra as an effective and well-tolerated treatment option for community-acquired bacterial pneumonia (CABP), a serious respiratory illness with significant impact to morbidity and mortality in the United States," Brenner noted, adding that the results support a “near-term” opportunity to update the current American Thoracic Society/Infectious Diseases Society of America CAP guidelines.
The company also aims to submit the data to the FDA and "engage in label update negotiations" later this year.
In the trial, once-daily IV-to-oral Nuzyra achieved statistical non-inferiority when compared to Bayer’s moxifloxacin (branded as Ayelox) in patients with moderate to severe CABP. Clinical success at the early clinical response timeframe of 72 hours to 120 hours post-therapy came in at a rate of 89.6% for Nuzyra and 87.7% for moxifloxacin.
The full results of the study, which was supported with BARDA funding, will be submitted for publication and presentation at an upcoming scientific meeting, according to the release.
BARDA contracted Paratek in 2019 to develop the antibiotic as a part of the government’s legislation to push medical countermeasures, Project BioShield. The agreement is now worth some $304 million and covers the development of Nuzyra for the treatment and post-exposure prophylaxis (PEP) of pulmonary anthrax, as well as FDA post-marketing requirements, U.S. onshoring and manufacturing security requirements and the procurement of up to 10,000 treatment courses for anthrax.
Nuzyra bagged its CABP nod in 2018 after proving its worth in a phase 3 study against Bayer’s rival med. The drug was specifically designed to overcome tetracycline resistance and marked the first in a new chemical class called aminomethycyclines. At the time, analysts put peak sales at over $500 million between its CABP and acute bacterial skin and skin structure infection indications.
Paratek has since been bought out by Novo Holdings and Gurnet Point in a deal worth approximately $462 million. In Paratek’s last financial quarter before the deal closed, 2023’s second quarter, the company reported revenue of $40 million, including $33.8 million in U.S. Nuzyra sales.