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Paratek Announces Expansion of NUZYRA® Launch into the Community Setting
The revenue trajectory of the ongoing NUZYRA commercial launch has exceeded that of other antibiotics launched in the last five years. Based on NUZYRA’s product attributes, including its once-daily oral formulation, and broad reimbursement coverage secured to date, Paratek has initiated efforts to expand NUZYRA’s commercial promotion into the community setting. NUZYRA’s once-daily IV and oral treatment option, which is approved for both community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), fills a critical gap today at a time when it is essential to keep patients out of the hospital during the ongoing COVID-19 pandemic. The Company’s expansion of commercial promotion in the community setting will focus on ABSSSI, with a plan to broaden to include CABP after the anticipated approval of the oral-only loading-dose regimen for CABP, which is expected during the second quarter of 2021.
“In our conversations with clinicians over the past several years, it is clear there is a tremendous unmet need for a new, safe, well-tolerated and effective broad-spectrum once-daily oral antibiotic in the community setting. The existing older-generation agents are universally challenged by either significant resistance concerns that limit their utility or serious safety concerns,” said
To support the launch of NUZRYA into the community setting, Paratek has initiated the hiring of approximately 40 U.S. community-based sales representatives, which will complement its established and successful hospital-based sales organization. Upon completion of the current community-based expansion, Paratek anticipates having a sales force to address both the community and hospital settings of approximately 90-100 customer facing representatives. The Company expects to execute this expansion within its previously communicated cash runway guidance. The expansion of the sales organization builds upon a focused and targeted community sales pilot program conducted in the second half of 2020. The data provided by the pilot suggest NUZYRA has an opportunity to address significant unmet needs in the community setting through building awareness among primary care physicians, leading to meaningful trial and adoption with positive patient outcomes. Paratek expects to accomplish this initial phase of the community expansion within the first quarter of 2021.
“Every other sector of the pharmaceutical armamentarium has added new, more effective and better tolerated treatment options over the past 20 years while the community antibiotic segment has gone in the other direction, where our choice of treatments has become ever more limited because of a lack of innovation and overwhelming resistance. This shift significantly increases risks to patients,” said Dr.
The Company’s lead commercial product, NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the
Paratek exclusively licensed
In 2019, Paratek was awarded a contract from BARDA, valued at
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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). 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.
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 including statements related to our overall strategy, products, prospects, potential and expected results, including statements about the timing, size and scope of our Community based product launch and community and hospital-based field forces, cash runway expectations and the impact of the COVID-19 pandemic on our business. 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
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Source: Paratek Pharmaceuticals