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Paratek Pharmaceuticals Presenting New Data from NUZYRA™ (Omadacycline) Development Program at ECCMID 2019

1144 Days ago

Data Highlight Paratek’s Commitment to Further Understanding Omadacycline’s Utility in Life-Threatening Infections such as CABP and ABSSSI

BOSTON, April 04, 2019 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics, announced today that data from its NUZYRA™ (omadacycline) clinical and microbiology programs will be presented at the 29th European Congress of Clinical Microbiology & Infectious Diseases, ECCMID 2019, to be held April 13-16 in Amsterdam, Netherlands.

Omadacycline is available in the United States under the brand name NUZYRA™. Omadacycline is a modernized tetracycline that is a once-daily intravenous (IV) and oral for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

"Our nine presentations at ECCMID continue to highlight the efficacy and safety profile of NUZYRA and add to the growing body of evidence of its utility against relevant pathogens and life-threatening infections such as CABP and ABSSSI," said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. "We remain committed to making our data accessible to clinicians to help inform decisions as they treat serious, often life-threatening, community-acquired infections."

Saturday, April 13

Mini-oral ePoster Session: OE049 Clinical Trials with Recently Approved or Late-stage Development Antibiotics

3:09-3:14 p.m. CEST (9:09 – 9:14 a.m. EDT)
Safety and efficacy of omadacycline for treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections in patients with mild to moderate renal insufficiency
Presentation #:
O0304; Presenter: O. Cornely

3:21-3:26 p.m. CEST (9:21 – 9:26 a.m. EDT)
Safety and efficacy of omadacycline by patient body mass index for the treatment of acute bacterial skin and skin structure infections
Presentation #:
O0306; Presenter: L. Garrity-Ryan

Poster Session: PS030 Clinical Aspects of Community-Acquired Pneumonia and Respiratory Tract Infection

3:30-4:30 p.m. CEST (9:30 – 10:30 a.m. EDT)
Early clinical response and clinical stability as predictors of overall clinical response in community-acquired bacterial pneumonia
Presentation #:
P0485; Presenter: P. McGovern

Monday, April 15, 1:30-2:30 p.m. CEST (7:30 – 8:30 a.m. EDT)

Poster Session: PS107 In-vitro Activity of Newer Antibacterial Agents

In vitro activity of omadacycline and comparators against Gram-positive and -negative clinical isolates collected in 2018 from patients in European medical centres: SENTRY surveillance program results
Presentation #:
P1876; Presenter: M. Huband

Poster Session: PS110 Clinical Efficacy Studies for Antimicrobial Agents

Safety and efficacy of omadacycline by body mass index in patients with community-acquired bacterial pneumonia
Presentation #:
P1918; Presenter: L. Garrity-Ryan

Poster Session: PS113 Recent Research on the Pharmacokinetics and Safety of Antibacterial Agents

Omadacycline pharmacokinetics: impact of comorbidities
Presentation #:
P1943; Presenter: C. Rubino

Assessment of pharmacokinetics-pharmacodynamics to support omadacycline dosing regimens for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI)
Presentation #:
P1944; Presenter: S. Bhavnani

Poster Session: PS116 Safety of Antibacterial Agents in the Clinic

Omadacycline hepatic safety: integrated analysis of randomized controlled phase III trials
Presentation #:
P2011; Presenter: P. McGovern

Tuesday, April 16, 12:30 – 1:30 p.m. CEST (6:30 – 7:30 a.m. EDT)

Poster Session: PS131 Skin and Soft Tissue Infections

Incidence of emergency department visits and hospitalisations after outpatient treatment with an oral antibiotic among patients with acute bacterial skin and skin structure infections
Presentation #:
P2288; Presenter: K. LaPensee

About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics. The company’s lead commercial product, NUZYRA™ (omadacycline), which has launched and is available in the U.S., is a once-daily oral and intravenous antibiotic for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek is also studying NUZYRA for the treatment of urinary tract infections (UTI).

Paratek has submitted a marketing authorization application of omadacycline in the European Union. Paratek has entered into a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

Under a research agreement with the U.S. Department of Defense, omadacycline also is being studied against pathogenic agents causing infectious diseases of public health and biodefense importance, including plague and anthrax.

SEYSARA™ (sarecycline) is an FDA-approved product with respect to which we have exclusively licensed certain rights in the United States to Almirall, LLC, or Almirall. SEYSARA is currently being marketed by Almirall in the U.S. as a new once-daily oral therapy for the treatment of moderate to severe acne vulgaris. Paratek retains development and commercialization rights with respect to sarecycline in the rest of the world.

Recognizing the serious threat of bacterial infections, Paratek is dedicated to providing solutions that enable positive outcomes and lead to better patient stories.

For more information, visit www.ParatekPharma.com or follow @ParatekPharma on Twitter.

NUZYRA (omadacycline) is a novel antibiotic with both once-daily intravenous (IV) and oral 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 antibiotic 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 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of NUZYRA during the second or third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause irreversible 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 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 for the year ended December 31, 2018 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.


Investor and Media Relations:
Ben Strain

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