{"id":523543,"date":"2021-08-04T16:33:25","date_gmt":"2021-08-04T20:33:25","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/"},"modified":"2021-08-04T16:33:25","modified_gmt":"2021-08-04T20:33:25","slug":"paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/","title":{"rendered":"Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague"},"content":{"rendered":"
\n

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\u00a0military use, today announced that the Company\u2019s novel, once-daily oral and intravenous antibiotic NUZYRA\u00ae\u00a0<\/strong><\/sup>(omadacycline) has recently been added to the Center for Disease Control and Prevention\u2019s (CDC) updated report, \u201cAntimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response\u201d. 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.<\/p>\n

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.<\/p>\n

\u201cWe 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,\u201d said Randy Brenner, Chief Development and Regulatory Officer. \u201cThe 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.\u201d<\/p>\n

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\u2019s full recommendations can be viewed at: Antimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response<\/a>.<\/p>\n

Novel Antibiotic for Pandemic Preparedness and a Bioterrorism MCM<\/strong>
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\u2019s attributes include a broad-spectrum of bacterial coverage that has the potential to address today\u2019s 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). <\/p>\n

About Paratek Pharmaceuticals, Inc.<\/strong>
Paratek Pharmaceuticals, Inc.\u00a0is 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\u00a0military use. <\/p>\n

The Company\u2019s lead commercial product, NUZYRA\u00ae\u00a0(omadacycline), is\u00a0a 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\u00a0Zai\u00a0Lab for the development and commercialization of omadacycline in the greater\u00a0China\u00a0region and retains all remaining global rights.<\/p>\n

Paratek is also conducting a Phase 2b Study in a rare disease, Nontuberculous Mycobacterial (NTM) Pulmonary Disease, caused by Mycobacterium abscessus<\/em> Complex (MABc) with NUZYRA. Paratek estimates this opportunity represents a potential $1.0 billion addressable market in the U.S. <\/p>\n

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA\u00ae (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to\u00a0Almirall, LLC\u00a0(Almirall). Paratek retains the development and commercialization rights for sarecycline in the rest of the world.<\/p>\n

In 2019, Paratek was awarded a contract from BARDA, valued up to $284.5 million,\u00a0to support the development and U.S.-based manufacturing of NUZYRA for the treatment of pulmonary anthrax.<\/p>\n

For more information, visit\u00a0www.ParatekPharma.com<\/a>\u00a0or follow us on LinkedIn<\/a> and Twitter<\/a>.<\/p>\n

About NUZYRA<\/strong>
NUZYRA\u00a0(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.<\/p>\n

Indications and Usage<\/strong>
NUZYRA is a tetracycline class antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:<\/p>\n

\n Community-Acquired Bacterial Pneumonia (CABP) caused by the following:<\/strong>\u00a0Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.<\/p>\n

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by\u00a0the following:<\/strong>\u00a0Staphylococcus 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.\u00a0<\/p>\n

Usage<\/strong>
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.<\/p>\n

Important Safety Information<\/strong><\/p>\n

Contraindications<\/strong>
NUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.<\/p>\n

Warnings and Precautions<\/strong>
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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

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.<\/p>\n

Adverse Reactions<\/strong>
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.<\/p>\n

Drug Interactions<\/strong>
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.<\/p>\n

Use in Specific Populations<\/strong>
Lactation: Breastfeeding is not recommended during treatment with NUZYRA.<\/p>\n

To report SUSPECTED ADVERSE REACTIONS, contact\u00a0Paratek Pharmaceuticals, Inc.\u00a0at 1-833-727-2835 or\u00a0FDA\u00a0at 1-800-FDA-1088 or<\/strong>\u00a0www.fda.gov\/medwatch<\/a>.<\/p>\n

Please see full Prescribing Information for NUZYRA at\u00a0www.NUZYRA.com<\/a>.<\/p>\n

Forward Looking Statements<\/strong>
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.<\/p>\n

\n For Investors:<\/strong>
\n
Hans Vitzthum
LifeSci Advisors
ir@ParatekPharma.com<\/a>\u00a0
Phone: 617-430-7578<\/p>\n

\n For Media:<\/strong>
\n
Beth Kramli
Scient PR
Beth@scientpr.com<\/u><\/a>
Phone: 908-568-9721<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

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\u00a0military use, today announced that the Company\u2019s novel, once-daily oral and intravenous antibiotic NUZYRA\u00ae\u00a0(omadacycline) has recently been added to the Center for Disease Control and Prevention\u2019s (CDC) updated report, \u201cAntimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response\u201d. 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 … <\/p>\n

Continue reading “Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-523543","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nParatek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"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\u00a0military use, today announced that the Company\u2019s novel, once-daily oral and intravenous antibiotic NUZYRA\u00ae\u00a0(omadacycline) has recently been added to the Center for Disease Control and Prevention\u2019s (CDC) updated report, \u201cAntimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response\u201d. 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. 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/","og_locale":"en_US","og_type":"article","og_title":"Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague - Market Newsdesk","og_description":"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\u00a0military use, today announced that the Company\u2019s novel, once-daily oral and intravenous antibiotic NUZYRA\u00ae\u00a0(omadacycline) has recently been added to the Center for Disease Control and Prevention\u2019s (CDC) updated report, \u201cAntimicrobial Treatment and Prophylaxis of Plague: Recommendations for Naturally Acquired Infections and Bioterrorism Response\u201d. 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 … Continue reading \"Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/","og_site_name":"Market Newsdesk","article_published_time":"2021-08-04T20:33:25+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMwMjc4NyM0MzQxMDUyIzIwMjg2ODQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague","datePublished":"2021-08-04T20:33:25+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/"},"wordCount":1590,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODMwMjc4NyM0MzQxMDUyIzIwMjg2ODQ=","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/paratek-pharmaceuticals-announces-nuzyra-omadacycline-has-been-added-to-the-cdc-plague-guidelines-for-the-treatment-pre-exposure-and-postexposure-prophylaxis-of-plague\/","name":"Paratek Pharmaceuticals Announces NUZYRA\u00ae (omadacycline) Has Been Added to the CDC Plague Guidelines for the Treatment, Pre-Exposure and Postexposure Prophylaxis of Plague - 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