– Modernized Tetracycline for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Structure Infections (ABSSSI) specifically designed to overcome tetracycline resistance –
– First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in nearly 20 Years –
– US launch expected first quarter 2019 –
BOSTON, MA, USA I October 02, 2018 I Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). NUZYRA, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. The Company plans on making NUZYRA available in the first quarter 2019.
“In the face of ever-increasing antibiotic resistance, the FDA approved NUZYRA with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “NUZYRA offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”
The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.
“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” said Keith Kaye, M.D., MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as NUZYRA, to help physicians stay ahead of the evolving resistance landscape.”
The approval of NUZYRA is supported by multiple clinical trials within the company’s global development program. Nearly 2,000 adult patients received NUZYRA and it was found to be efficacious and generally safe and well tolerated. As part of the approval, Paratek has agreed to conduct post marketing studies in CABP and pediatrics.
“The approval of NUZYRA is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” said Michael F. Bigham, Chairman and CEO, Paratek. “There are countless champions of NUZYRA who have been tireless in their efforts to ensure its advancement to commercialization – from patients, clinicians and study investigators to our Paratek team. We are grateful to all who played a role in making NUZYRA available to patients in need. We are excited to launch NUZYRA early next year.”
Conference Call and Webcast
Paratek’s conference call for the NUZYRA approval will be broadcast tomorrow at 8:30 a.m. EDT on October 3, 2018. The webcast can be accessed under “Events and Presentations” in the Investor Relations section of Paratek’s website at www.ParatekPharma.com.
Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13683728. Investors can also access the call at http://public.viavid.com/index.php?id=131551.
About NUZYRA
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 antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
SOURCE: Paratek Pharmaceuticals
Post Views: 32
– Modernized Tetracycline for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Structure Infections (ABSSSI) specifically designed to overcome tetracycline resistance –
– First and only once-daily IV and oral antibiotic approved to treat both CABP and ABSSSI patients in nearly 20 Years –
– US launch expected first quarter 2019 –
BOSTON, MA, USA I October 02, 2018 I Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) today announced that the U.S. Food and Drug Administration (FDA) has approved NUZYRA™ (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). NUZYRA, a modernized tetracycline, is a once-daily IV and oral antibiotic that exhibits activity across a spectrum of bacteria, including Gram-positive, Gram-negative, atypicals, and drug resistant strains. The Company plans on making NUZYRA available in the first quarter 2019.
“In the face of ever-increasing antibiotic resistance, the FDA approved NUZYRA with a label having full approval for both CABP and ABSSSI. We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer, Paratek. “NUZYRA offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”
The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause 2 million illnesses and approximately 23,000 deaths each year in the United States. The main bacteria causing CABP, Streptococcus pneumoniae, is responsible for 1.2 million infections and 7,000 deaths, whereas ABSSSI is responsible for more than 750,000 hospitalizations. The increase of antibiotic resistance continues to drive the need for new, effective therapies.
“Treating pneumonia and skin infections has become increasingly complex as existing antibiotic therapies sometimes have reduced efficacy as resistance continues to grow. This reality makes it increasingly challenging to provide safe and effective treatments to patients,” said Keith Kaye, M.D., MPH, Director of Clinical Research, Division of Infectious Diseases, University of Michigan. “There continues to be a need for novel antibiotics with both IV and oral formulations, such as NUZYRA, to help physicians stay ahead of the evolving resistance landscape.”
The approval of NUZYRA is supported by multiple clinical trials within the company’s global development program. Nearly 2,000 adult patients received NUZYRA and it was found to be efficacious and generally safe and well tolerated. As part of the approval, Paratek has agreed to conduct post marketing studies in CABP and pediatrics.
“The approval of NUZYRA is an historic milestone for Paratek as it represents 20 years of research and development of this life-saving antibiotic for patients affected by community-acquired infections,” said Michael F. Bigham, Chairman and CEO, Paratek. “There are countless champions of NUZYRA who have been tireless in their efforts to ensure its advancement to commercialization – from patients, clinicians and study investigators to our Paratek team. We are grateful to all who played a role in making NUZYRA available to patients in need. We are excited to launch NUZYRA early next year.”
Conference Call and Webcast
Paratek’s conference call for the NUZYRA approval will be broadcast tomorrow at 8:30 a.m. EDT on October 3, 2018. The webcast can be accessed under “Events and Presentations” in the Investor Relations section of Paratek’s website at www.ParatekPharma.com.
Domestic investors wishing to participate in the call should dial: 877-407-0792 and international investors should dial: 201-689-8263. The conference ID is 13683728. Investors can also access the call at http://public.viavid.com/index.php?id=131551.
About NUZYRA
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 antibacterial indicated for the treatment of adult patients with the following infections caused by susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by the following: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by the following: Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Staphylococcus lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Enterococcus faecalis, Enterobacter cloacae, and Klebsiella pneumoniae.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
SOURCE: Paratek Pharmaceuticals
Post Views: 32
