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BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline 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," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," 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, 2016, 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.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline 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," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," 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, 2016, 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.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline 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," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," 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, 2016, 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.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline 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," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," 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, 2016, 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.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline 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," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," 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, 2016, 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.


BOSTON, May 24, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that data from its omadacycline clinical and microbiology programs will be presented at ASM Microbe 2017, to be held June 1 – 5 in New Orleans. Paratek is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry. “As we advance our clinical program, we continue to be encouraged by the study outcomes that add to our breadth of knowledge about the safety and efficacy of once-daily oral and IV omadacycline in the treatment of bacterial infections,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “Results from the 10 studies being presented at ASM Microbe include new phase 1 data examining omadacycline in patients with uncomplicated urinary tract infection as well as additional analyses of microbiology date that help further our understanding of how omadacycline may be used in a clinical setting. We continue to be excited about the potential for this compound to treat severe bacterial infections, particularly when resistance is of concern.” Paratek Presentations on Friday, June 2, 2017 at 12:45 p.m. – 2:45 p.m. CDT (1:45 p.m. – 3:45 p.m. EDT) Poster Session 45: Infection Prevention and Control: Skin, Soft Tissue and Bone Infections Paratek Presentations on Saturday, June 3, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 185: Antibacterial Resistance: In vitro Activity and Resistance to Tigecyline, Fosfomycin and Derivatives Paratek Presentations Sunday, June 4, 2017 at 12:15 p.m. – 2:15 p.m. CDT (1:15 p.m. – 3:15 p.m. EDT) Poster Session 341: Antimicrobial Pharmacokinetics: PK/PD of New Antimicrobial Agents Poster Session 345: Clostridium difficile: Epidemiology and Strategies for Prevention and Treatment of CD Infections About Paratek Pharmaceuticals, Inc. Paratek Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon its expertise in novel tetracycline chemistry. Paratek's lead product candidate, omadacycline, when approved, will be the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria. Omadacycline is a new, once-daily oral and intravenous broad spectrum antibiotic being developed for use as empiric monotherapy for patients suffering from serious community-acquired bacterial infections, such as acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia, urinary tract infections, and other community-acquired bacterial infections, particularly when antibiotic resistance is of concern to prescribing physicians. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration for the target indications. In June 2016, Paratek announced positive efficacy data in a Phase 3 registration study in acute bacterial skin and skin structure infections (ABSSSI) demonstrating the efficacy and general safety and tolerability of intravenous (IV) to once-daily oral omadacycline compared to linezolid. In April 2017, Paratek announced positive efficacy data in a Phase 3 registration study in community-acquired bacterial pneumonia (CABP) demonstrating the efficacy and general safety and tolerability of IV to once-daily oral omadacycline compared to moxifloxacin. A Phase 3 registration study in ABSSSI comparing once-daily oral-only dosing of omadacycline to twice-daily oral-only dosing of linezolid was initiated in August 2016. This study completed enrollment in May 2017 and top-line data are expected in mid-July. The Company plans to submit its new drug application (NDA) in the U.S. as early as the first quarter of 2018 with an EMA submission later in 2018. In addition to its Phase 3 program for omadacycline, a Phase 1B study in uncomplicated urinary tract infections (UTI) was initiated in May 2016 and positive top-line PK proof-of-principle data was reported in November 2016. The Company plans to begin enrolling patients in a proof-of-concept Phase 2 study of omadacycline in acute pyelonephritis, the most common subset of complicated urinary tract infections, as early as December 2017. In October 2016, Paratek announced a research agreement with the U.S. Department of Defense to explore the utility of omadacycline against pathogenic agents causing infectious diseases of public health and biodefense importance including plague and anthrax. In April 2017, Paratek Bermuda Ltd., a wholly-owned subsidiary of the Company, and Zai Lab (Shanghai) Co., Ltd., entered into a License and Collaboration Agreement. Under the terms of the Agreement, the Company granted Zai an exclusive license to develop, manufacture, and commercialize omadacycline in the People’s Republic of China, Hong Kong, Macau and Taiwan, for all human therapeutic and preventative uses, other than biodefense. Paratek's second Phase 3 product candidate, sarecycline, is a well-tolerated, once-daily oral, narrow spectrum tetracycline-derived antibiotic with potent anti-inflammatory properties for the potential treatment of acne and rosacea in the community setting. Allergan owns the U.S. rights for the development and commercialization of sarecycline. Paratek retains all ex-U.S. rights. Allergan and Paratek reported positive results from two identical Phase 3 registration studies of sarecycline for the treatment of moderate to severe acne vulgaris in March 2017. Allergan has publicly announced plans to submit an NDA in the U.S. in the second half of 2017. Forward Looking Statements This press release contains forward-looking statements including statements related to our overall strategy, product candidates, clinical studies, prospects, potential and expected results, including statements about the timing of advancing omadacycline and otherwise preparing for clinical studies, the timing of enrollment in our clinical studies and our reporting of the results of such studies, the potential for omadacycline to serve as an empiric monotherapy treatment option for patients suffering from ABSSSI, CABP, UTI, and other bacterial infections when resistance is of concern, the prospect of omadacycline providing broad-spectrum activity, and our ability to obtain regulatory approval of omadacycline 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," "believe," "expect," "well positioned," "look forward," "anticipated," "continued," 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, 2016, 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.


News Article | May 1, 2017
Site: globenewswire.com

Dublin, May 01, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Global Hospital Infection Prevention And Control Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2013 to 2024" report to their offering. The global hospital infection prevention and control market was valued at US$ 142.6 Mn in 2015, and is expected to reach US$ 245.6 Mn by 2024, expanding at a CAGR of 6.3% from 2016 to 2024. The market experts suggest that healthcare associated infections are a costly issue faced by many hospitals across the globe. Hospital acquired infections are type of infections that are observed in patients during the course of receiving treatment for unrelated conditions. According to the World Health Organization (WHO), infectious waste contributes in this way to the risk of nosocomial infections, putting the health of hospital personnel, and patients, at risk. The Centers for Disease Control and Prevention (CDC) statistically suggested that, with approximately 300,000 occurrences each year, surgical site infections (SSIs) are the second most prevalent HAI in the United States, preceded only by urinary tract infections. At a cost of approximately US$ 10 Bn annually, this high incidence of SSIs significantly impacts the U.S. healthcare system, as well as the bottom line of individual hospitals. The occurrence of nosocomial infections has been observed worldwide in both developed and resource-poor countries. Key factors assisting the growth of hospital infections prevention and control market are rising prevalence of infections, implementation of stringent guidelines associated with hospital infection prevention and control, developing healthcare infrastructure in emerging countries, and rising number of hospitals across the world. The global hospital infection prevention and control market is segmented by infection type as pneumonia, urinary tract infection, blood stream infection, surgical site infection, MRSA and others. These are the major types of hospital acquired infections that find the highest prevalence. As sourced from the CDC, ventilator associated pneumonia and surgical site infection are the most common conditions followed by GI infection, UTI, and primary blood stream infection. Global Hospital Infection Prevention and Control Market are segmented by Product type as Infection Prevention Supplies, Infection Prevention Equipment and Infection Prevention Services. Infection prevention supplies held the largest share in the overall hospital infection prevention and control market. Based on the therapeutic application type, the global hospital infection prevention and control market is segmented as follows: Infection Prevention Supplies: For more information about this report visit http://www.researchandmarkets.com/research/zkgjh8/global_hospital


PubMed | Pathology and Laboratory Medicine, Northwestern University, Infection Prevention and Control., Preventive Medicine Biostatistics. and Ann & Robert H Lurie Childrens Hospital Of Chicago
Type: | Journal: Journal of the Pediatric Infectious Diseases Society | Year: 2016

Although Clostridium difficile infections (CDIs) are increasingly diagnosed in children, many children diagnosed with CDI lack classic risk factors. Frequent use of highly sensitive tcdB polymerase chain reaction (PCR) testing in low-risk patients leads to CDI misdiagnosis and unnecessary CDI antibiotic use in children with C difficile carriage.For this quasi-experimental study, we developed and implemented an educational intervention (EI) to inform healthcare providers (HCPs) about tcdB PCR test limitations. We provided HCP didactic education and built an electronic notification into the tcdB PCR test order that describes scenarios in which carriage is more likely than CDI. Segmented regression analysis assessed changes in level (ie, overall rates) and trend of C difficile testing rate ([TR] number of tests performed per 1000 patient encounters) and test positivity rate ([PR] number of positive tests per 1000 patient encounters) between the pre- (August 2009-August 2013) and postintervention (February 2014-July 2015) periods.Hospital-wide, absolute TR reduction was 0.71 (P[level] = .0067; P[trend] = .0042) and absolute PR reduction was 0.14 (P[level] = .22; P[trend] = .018). In the outpatient setting, absolute TR reduction was 0.30 (P[level] = .0015; P[trend] < .001) and absolute PR reduction was 0.09 (P[level] = .0069; P[trend] = .046). The incidence density of healthcare facility-associated CDI did not significantly change after the EI. The EI was associated with avoidance of 574 tests and 113 positive tests (and subsequent antibiotic courses) during the postintervention period, which saved approximately $250 000 in patient charges related to CDI testing and treatment.Healthcare provider education can cost-effectively reduce the frequency of C difficile testing and CDI misdiagnosis by improving test utilization among low-risk children.


Jeanes A.,Infection Prevention and Control | Bitmead J.,University College London
British Journal of Nursing | Year: 2015

The use of vascular access devices (VAD) is common in healthcare provision but there is a significant risk of acquiring an infection. Central venous catheters (CVC) are associated with the highest risk of intravenous catheter-related bloodstream infection (CRBSI). 3M Tegaderm CHG IV dressing is a semi-permeable transparent adhesive dressing with an integrated gel pad containing chlorhexidine gluconate 2%. This product was reviewed by the National Institute for Health and Care Excellence (NICE) in 2015, recommending that Tegaderm CHG could be used for CVC and arterial line dressings in high-dependency and intensive-care settings. This article discusses issues around CRBSI, interventions to reduce the risk of CRBSI, and the use of Tegaderm CHG dressing.


Taylor G.,University of Alberta | Bush K.,Infection Prevention and Control | Leal J.,Infection Prevention and Control | Henderson E.,Infection Prevention and Control | And 4 more authors.
Journal of Hospital Infection | Year: 2015

Most studies of meticillin-resistant Staphylococcus aureus (MRSA) bloodstream infection (BSI) reflect a convenience sample from a single hospital or a small group of hospitals. From April 2011 to March 2013, cases of MRSA BSI diagnosed in all hospitals in Alberta, Canada were captured prospectively. Isolates were spa typed. In total, there were 299 cases of MRSA BSI, equating to 3.95 cases per 100,000 population. Community-acquired BSI accounted for 66.9% of cases, and 33.1% of cases were hospital acquired. Cases were predominantly seen in tertiary care (36.4%) and large urban hospitals (34.3%), but were also common in regional and rural hospitals. Paediatric hospitals had very few cases (3.0%). Two clones, CMRSA 10 (USA 300; 40.2%) and CMRSA 2 (USA 100/800; 38.0%), predominated. © 2014 The Healthcare Infection Society.

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