GlobeNewswire Inc | Oct 21, 2020 08:00AM EDT

October 21, 2020

BOSTON, Oct. 21, 2020 (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 or other public health threats for civilian, government andmilitary use, announced today that data from its NUZYRA (omadacycline) clinical and microbiology programs are being presented at the IDWeek 2020 virtual meeting.

NUZYRA isa once-daily oral and intravenous antibiotic available in theU.S.for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

Poster presentations are available beginning on Wednesday, October 21 in the IDWeek ePoster Gallery.

Presentation Title: Subinhibitory Concentrations of Omadacycline InhibitStaphylococcus aureusHemolytic Activity In VitroPoster #: 1202Presenter: A. Serio

Presentation Title: In VitroActivity of Omadacycline Against 7000 Bacterial Pathogens from the United States Stratified by Infection Type (2019)Poster #: 1253Presenter: M. Huband

Presentation Title: Comparative Activity of Omadacycline Against Extended-spectrum Beta-lactamase Positive and NegativeEscherichia coliandKlebsiella pneumoniae Strains Recovered from Urine SpecimensPoster #: 1267Presenter: T. Stone

Presentation Title: Real-World Experience with Omadacycline for Nontuberculous Mycobacterial and Gram-Negative Infections: A Multicenter EvaluationPoster #: 1290Presenter: T. Morrisette

Presentation Title: Targeted Substitution of Omadacycline in Place of Standard of Care for CABP Treatment is Associated with a Risk Reduction ofClostridioides difficileInfection and Financial Cost Savings in the Acute Care SettingPoster #: 1492Presenter: M. Rodriguez

Presentation Title: Omadacycline in Female Adults with Acute Pyelonephritis: Results from a Randomized, Double-Blind, Adaptive Phase 2 StudyPoster #: 1687Presenter: K. Wright

Presentation Title: Omadacycline in Female Adults with Cystitis: Results from a Randomized, Double-Blinded, Adaptive Phase 2 StudyPoster #: 1688Presenter: K. Wright

"These poster presentations continue our commitment to share new data about the clinical safety and efficacy of NUZYRA and ensure clinicians have comprehensive information available to them as they make treatment decisions for their patients with community-acquired infections," said Randy Brenner, Chief Development & Regulatory Officer of Paratek. "To that end, Paratek supports analysis of real-world use of NUZYRA, including the potential utility of NUZYRA in nontuberculous mycobacterium abscessus lung infections, a rare, chronic and difficult-to-treat lung infection for which there are currently no FDA approved therapies."

AboutParatek 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 andmilitary use.

The Companys lead commercial product, NUZYRA(omadacycline), isa once-daily oral and intravenous antibiotic available in theU.S.for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement withZaiLab for the development and commercialization of omadacycline in the greaterChinaregion and retains all remaining global rights.

Paratek exclusively licensedU.S.rights and rights to the greaterChinaterritory for SEYSARA(sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, toAlmirall, 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 BARDAto support the development of NUZYRA for the treatment of pulmonary anthrax.

For more information, visitwww.ParatekPharma.comor follow @ParatekPharmaon Twitter.

About NUZYRANUZYRA(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 UsageNUZYRA 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 bythe 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.

UsageTo 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

ContraindicationsNUZYRA is contraindicated in patients with known hypersensitivity to omadacycline or tetracycline class antibacterial drugs, or to any of the excipients.

Warnings and PrecautionsMortality 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 ReactionsThe 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 InteractionsPatients 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 PopulationsLactation: Breastfeeding is not recommended during treatment with NUZYRA.

To report SUSPECTED ADVERSE REACTIONS, contactParatek Pharmaceuticals, Inc.at 1-833-727-2835 orFDAat 1-800-FDA-1088 orwww.fda.gov/medwatch.

Please see full Prescribing Information for NUZYRA atwww.NUZYRA.com.

Forward Looking StatementsThis press release contains forward-looking statements including statements related to our overall strategy, products, prospects and potential.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 forthe year endedDecember 31, 2019and our other filings with theSecurities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

CONTACTS:

Investor and Media Relations:Ben Strain617-807-6688ir@ParatekPharma.com