Paratek aims to strengthen pneumonia antibiotic Nuzyra with post-marketing study success

After being acquired by Novo Holdings and Gurnet Point last summer, Paratek Pharmaceuticals has reaffirmed the benefits of its FDA-backed antibiotic, Nuzyra, through a positive post-marketing study. This antibiotic, initially approved in 2018 and later receiving an oral-only approval in 2021, has been supported by the Biomedical Advanced Research and Development Authority (BARDA).

Paratek's clinical trial database for Nuzyra is the largest among all FDA-approved antibiotics for pneumonia in the last decade, according to Randy Brenner, the company's chief development and regulatory officer. Brenner emphasized that the recent study confirms Nuzyra as an effective and well-tolerated treatment for community-acquired bacterial pneumonia (CABP), a severe respiratory illness with significant impact in the United States. The results of this study, he added, could lead to a near-term update of the American Thoracic Society/Infectious Diseases Society of America CAP guidelines.

The company plans to submit the study data to the FDA and engage in label update negotiations later this year. In the clinical trial, Nuzyra demonstrated statistical non-inferiority compared to Bayer’s moxifloxacin (Ayelox) in patients with moderate to severe CABP. Clinical success within 72 to 120 hours post-therapy was achieved at a rate of 89.6% for Nuzyra compared to 87.7% for moxifloxacin.

The study, funded by BARDA, will be submitted for publication and presented at an upcoming scientific meeting. BARDA contracted Paratek in 2019 as part of Project BioShield, a government initiative aimed at developing medical countermeasures. The agreement, valued at approximately $304 million, includes the development of Nuzyra for treating and preventing pulmonary anthrax, meeting FDA post-marketing requirements, ensuring U.S. manufacturing security, and procuring up to 10,000 treatment courses for anthrax.

Nuzyra received its initial approval for CABP in 2018 after demonstrating its efficacy in a phase 3 trial against Bayer’s competing medication. Designed to overcome tetracycline resistance, Nuzyra belongs to a new chemical class called aminomethycyclines. At the time of its approval, analysts projected peak sales of over $500 million for its CABP and acute bacterial skin and skin structure infection indications.

Since the acquisition by Novo Holdings and Gurnet Point, valued at approximately $462 million, Paratek has continued to perform well financially. In the second quarter of 2023, the company's last financial quarter before the acquisition was finalized, Paratek reported revenue of $40 million, with $33.8 million coming from U.S. sales of Nuzyra.