BOSTON, Sept. 23, 2021 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) announced today that data from the NUZYRA® (omadacycline) clinical and microbiology programs are being presented at the IDWeek 2021 virtual meeting.
Poster presentations will be available beginning on Wednesday, Sept. 29 in the IDWeek ePoster Gallery.
Presentation Title: Incidence of C. difficile infection (CDI) Cases by CDI-Standardized Infection Ratio (SIR) Among Centers for Medicare & Medicaid Services (CMS)-Participating Short-Term Acute Care Hospitals (ACH) Post Implementation of the Hospital-Acquired Condition Reduction Program (HAC-RP)
Poster #: 767
Presenter: Thomas P. Lodise, PharmD, Ph.D.
Presentation Title: Omadacycline in Vitro Activity Against Bacillus Anthracis
Poster #: 1208
Presenter: Alisa W. Serio, Ph.D.
Presentation Title: Comparison of Healthcare Resource Utilization (HRU) Among Adult Patients Treated with Omadacycline (OMC) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) or Community-Acquired Bacterial Pneumonia (CABP) in the 30 Day Pre- and Post-OMC Prescription (Rx)
Poster #: 1372
Presenter: Thomas P. Lodise, PharmD, Ph.D.
In addition, two investigator-initiated studies involving NUZYRA will be presented:
Presentation Title: Efficacy of Germinants and Omadacycline for Preventing Clostridioides difficile Relapse in a Murine Model
Poster #: 1037
Presenter: Noah Budi, PharmD
Presentation Title: Real-World Experience with Omadacycline for Nontuberculous Mycobacterial Infections: A Multicenter Evaluation
Poster #: 1082
Presenter: Taylor Morrisette, PharmD
“With these presentations, Paratek continues to deepen the understanding of the utility of NUZYRA for serious community-acquired infections and nontuberculous mycobacterial infections, a rare disease for which there are no approved therapies,” said Randy Brenner, Chief Development & Regulatory Officer of Paratek. “Notably, we will share the results of two studies examining the potential of NUZYRA in treating anthrax infections, one of the agents most likely to be used in a bioterrorism attack, and a health economics study examining healthcare resource utilization among patients treated with NUZYRA for skin infections and pneumonia.”
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.
The Company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the U.S. for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.
Paratek is also conducting a Phase 2b Study in a rare disease, Nontuberculous Mycobacterial (NTM) Pulmonary Disease, caused by Mycobacterium abscessus Complex (MABc) with NUZYRA. Paratek estimates this opportunity represents a potential $1.0 billion addressable market in the U.S.
Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC (Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.
In 2019, Paratek was awarded a contract from BARDA, valued at approximately $285 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.
NUZYRA (omadacycline) is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). The 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 seven to 14 days. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and other drug-resistant strains including Y. pestis (plague), and bioterrorism pathogens such as B. anthracis (anthrax).
Indications and Usage
NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Important Safety Information
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 eight 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 eight 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 of 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.
The most common adverse reactions (incidence =2%) are nausea, vomiting, infusion site reactions, alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hypertension, headache, diarrhea, insomnia, and constipation.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Paratek Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for NUZYRA at www.NUZYRA.com.
Forward Looking Statements
This press release contains forward-looking statements related to our presentations of our clinical studies and real-world data, including understanding of the utility of NUZYRA against virulent pathogens and serious community-acquired infections, including anthrax and Nontuberculous Mycobacterial Infections. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “advancing,” “expect,” “look forward,” “anticipate,” “continue,” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.