BOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc., a biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings, announces that its U.S. supply and manufacturing capabilities for its novel antibiotic NUZYRA(R) (omadacycline) are now complete.
NUZYRA is the company's broad-spectrum, novel antibiotic available in both intravenous and oral formulations approved by the U.S. Food and Drug Administration (FDA) for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
“Establishing a U.S. manufacturing and supply chain is the culmination of one of the most important elements of our public-private partnership with BARDA, an agreement intended to strengthen our national security,” said Evan Loh, M.D., Paratek chief executive officer. “This onshoring milestone is significant because it ensures that NUZYRA has a secure domestic supply chain that reduces dependency on foreign production and decreases the national security risk for the manufacturing and supply of antibiotics.”
Major onshoring milestones that established the U.S. capabilities included the successful technology transfer by Paratek and its manufacturing partners and related FDA approval/implementation for 1) U.S. manufacturing of NUZYRA tablets in 2022; 2) U.S. manufacturing of the active pharmaceutical ingredient (API) as of August 2024; and 3) U.S. manufacturing of NUZYRA's IV formulation (vials) in October 2024.
“Paratek continues to deliver on the milestones of this important agreement with BARDA, in many cases exceeding agreed-upon timelines, thanks to ongoing, highly productive collaboration and communication between BARDA and Paratek,” said Randy Brenner, Paratek's chief development and regulatory officer. “We are grateful to BARDA for their partnership and look forward to completing our studies to support our sNDA filing for NUZYRA for treatment and prophylaxis of pulmonary anthrax in the near term.”
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00001.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on providing innovative medical therapies that create positive patient stories in the hospital, community and public health settings.
The company's lead commercial product, NUZYRA(R) (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab Limited for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Zai Lab received approval for both IV and oral NUZYRA as a Category 1 innovative drug by the National Medical Products Administration of China for the treatment of CABP and ABSSSI in December 2021 and in Macao for the treatment of CABP and ABSSSI in May 2023.
In December 2019, BARDA awarded Paratek a contract (75A50120C00001) that is now valued at up to approximately $304 million. In addition to supporting the development of NUZYRA for both the treatment and prophylaxis of pulmonary anthrax, this contract supports the U.S. onshoring of NUZYRA and manufacturing security requirements; FDA post-marketing requirements associated with the initial NUZYRA approval; and the procurement of up to 10,000 treatment courses of NUZYRA for the treatment of anthrax.
Paratek is conducting a Phase 2b study with NUZYRA in a rare disease, non-tuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex.
For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter.
About NUZYRA(R)
NUZYRA(R) (omadacycline) is an antibiotic with both once-daily oral and intravenous (IV) formulations indicated for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible microorganisms. A next generation tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypical and other drug-resistant strains.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline-class antibacterial drugs, or to any of the excipients.
WARNINGS AND PRECAUTIONS
Mortality imbalance was observed in the CABP clinical trial with eight deaths (2%) occurring in patients treated with NUZYRA compared to four deaths (1%) in patients treated with moxifloxacin. The cause of the mortality imbalance has not been established. All deaths, in both treatment arms, occurred in patients > 65 years of age; most patients had multiple comorbidities. The causes of death varied and included worsening and/or complications of infection and underlying conditions. Closely monitor clinical response to therapy in CABP patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.
The use of NUZYRA during the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.
Hypersensitivity reactions have been reported with NUZYRA. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with other tetracycline-class antibacterial drugs. NUZYRA is structurally similar to other tetracycline-class antibacterial drugs and is contraindicated in patients with known hypersensitivity to tetracycline-class antibacterial drugs. Discontinue NUZYRA if an allergic reaction occurs.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests), have been reported for other tetracycline-class antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
ADVERSE REACTIONS
The most common adverse reactions (incidence greater-than or equal to2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
DRUG INTERACTIONS
Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage while taking NUZYRA. Absorption of tetracyclines, including NUZYRA is impaired by antacids containing aluminum, calcium, or magnesium, bismuth subsalicylate and iron containing preparations.
USE IN SPECIFIC POPULATIONS
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.
See full prescribing information here.
MEDIA CONTACT:
Christine Fanelle
Scient PR
Christine@ScientPR.com
215-595-5211
