Paratek Pharmaceuticals, Inc. (Paratek), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, recently announced that the FDA approved the company’s supplemental New Drug Application (sNDA) for the oral-only dosing regimen of NUZYRA® for the treatment of adults with Community-Acquired Bacterial Pneumonia (CABP).
Approved by the FDA on October 2, 2018, NUZYRA is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of CABP and acute bacterial skin and skin structure infections (ABSSSI).
The recently approved oral-only dose for CABP has an initial dose of 300 mg twice on day one and 300 mg once daily thereafter for a total of 7 to 14 days. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, and atypicals including other drug-resistant strains.
The company’s confidence in the long-term commercial success of Nuzyra remains strong upon growing demand of Nuzyra in the hospital care setting, combined with the recent initial positive signs of new prescriptions and adoption in the primary care commercial expansion. The company estimates the primary care market opportunity for CABP at approximately $1.5 billion.
The Nuzyra pharmacy network includes: CVS Specialty, Option Care, PantherRx Pharmacy, and the following Walgreens pharmacies:
- Walgreens Pharmacy at Piedmont Hospital in Atlanta, GA
- Community, a Walgreens Pharmacy in Mission Viejo, CA
- Walgreens Pharmacy at Baptist Beaumont in Beaumont, TX
- Community, a Walgreens Pharmacy in St. Louis, MO
- Community, a Walgreens Pharmacy in Chicago, IL
Takeaway: In 2019, Paratek was awarded a contract from BARDA, valued at ~$285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax