Paratek Pharmaceuticals Announces NUZYRA® (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague

Rhea-AI Summary

Paratek Pharmaceuticals (Nasdaq: PRTK) announced that its antibiotic NUZYRA^® (omadacycline) has been included in the CDC's updated recommendations for treating plague infections. This addition highlights NUZYRA's potential as a bioterrorism countermeasure and its effectiveness in public health emergencies. The CDC's review reinforces the clinical utility of NUZYRA, which is already approved for community-acquired bacterial pneumonia and skin infections. The company is also pursuing additional applications for NUZYRA, indicating a significant market opportunity.

Positive

• Inclusion of NUZYRA in CDC's recommendations enhances its credibility as a treatment for plague.
• Potential validation of NUZYRA as a medical countermeasure against bioterrorism.
• NUZYRA's development aligns with increasing public health needs amid rising antimicrobial resistance.
• Paratek's ongoing Phase 2b study for NUZYRA in Nontuberculous Mycobacterial disease presents a potential $1 billion market.

Negative

• Concerns regarding mortality imbalance reported in clinical trials with NUZYRA.
• Warnings about adverse reactions and contraindications, particularly for vulnerable populations.

BOSTON, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), 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, today announced that the Company’s novel, once-daily oral and intravenous antibiotic NUZYRA^® (omadacycline) has recently been added to the Center for Disease Control and Prevention’s (CDC) updated report, “Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response”. NUZYRA was added as an alternative agent for the treatment, pre-exposure prophylaxis, and postexposure prophylaxis of primary bubonic and pharyngeal plague infections in adults 18 years of age and over.

According to the CDC, Yersinia pestis (Y. pestis), the bacterium that causes plague, leads to naturally occurring disease in the United States and other regions worldwide, and is recognized as a potential bioterrorism weapon. A bioweapon attack with Y. pestis could potentially infect thousands, requiring rapid and informed decision making by clinicians and public health agencies.

“We believe the inclusion of NUZYRA in the updated CDC recommendations provides additional validation of the potential clinical utility of this modernized tetracycline antibiotic to help address these types of public health emergencies including protecting our civilian and military personnel as a medical countermeasure,” said Randy Brenner, Chief Development and Regulatory Officer. “The development of new antibiotics that are effective against possible biosecurity threats is vital to ensuring our national security particularly at a time when antimicrobial resistance is growing.”

The CDC conducted a series of systematic literature reviews on human treatment of plague and other relevant topics to collect a broad evidence base to assist in the development of a comprehensive set of updated recommendations. In 2016 Paratek, through a cooperative effort with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), conducted a research study of NUZYRA against pathogenic agents, including Y. pestis, that have the potential to cause infectious diseases of public health and biodefense importance. The CDC’s full recommendations can be viewed at: Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response.

Novel Antibiotic for Pandemic Preparedness and a Bioterrorism MCM
NUZYRA is a novel once-daily oral and intravenous antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). A modernized tetracycline, NUZYRA’s attributes include a broad-spectrum of bacterial coverage that has the potential to address today’s efficacy and safety gaps in the Strategic National Stockpile (SNS) antibiotic portfolio for pandemic preparedness and offer potential utility as an important Medical Countermeasure (MCM) against bioterrorism pathogens (e.g., anthrax, plague).

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 up to $284.5 million, to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.

For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter.

About NUZYRA
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.

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. 

Usage
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

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 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.

Adverse Reactions
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.

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.

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 regarding validation of the potential clinical utility of NUZYRA to help address public health emergencies including protecting our civilian and military personnel as a medical countermeasure, including pandemics. 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.

For Investors:
Hans Vitzthum
LifeSci Advisors
ir@ParatekPharma.com 
Phone: 617-430-7578

For Media:
Beth Kramli
Scient PR
Beth@scientpr.com
Phone: 908-568-9721

FAQ

What is the significance of NUZYRA's inclusion in the CDC recommendations?

NUZYRA's inclusion validates its use as a treatment for plague and highlights its potential role in bioterrorism response.

How does NUZYRA compare to other treatments for plague?

NUZYRA is an alternative agent recommended by the CDC for treating primary bubonic and pharyngeal plague infections in adults.

What market opportunities does Paratek Pharmaceuticals have for NUZYRA?

Paratek estimates a potential $1 billion addressable market in the U.S. for NUZYRA in treating rare diseases.

What are the safety concerns associated with NUZYRA?

NUZYRA has been linked to a mortality imbalance in clinical trials, particularly in older patients with comorbid conditions.

What are the primary uses for NUZYRA?

NUZYRA is indicated for community-acquired bacterial pneumonia and acute bacterial skin infections.