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Details:
Under the terms of the collaboration, Novasep and Paratek will manufacture NUZYRA® (omadacycline), an FDA-approved tetracycline-class, once-daily oral and intravenous antibiotic for the treatment of adults with CABP and acute bacterial skin and skin structure infections.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Paratek Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 15, 2022
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Details:
Nuzyra (omadacycline) is a USFDA approved novel antibiotic for the treatment of community-acquired bacterial pneumonia. Now it is being evaluated for the treatment of post-exposure prophylaxis of inhalational anthrax.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 05, 2024
Details:
The proceeds from the acquisition will advance the commercialization of Nuzyra (omadacycline), a tetracycline antibiotic, indicated for the treatment of adult patients with community-acquired bacterial pneumonia, and support the development of additional therapies.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gurnet Point Capital
Deal Size: $462.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition September 21, 2023
Details:
The agreement aims to support the development of omadacycline for post-exposure prophylaxis and pulmonary anthrax and the US-based commercial manufacturing of Nuzyra, a novel once-daily antibiotic approved for the treatment of community-acquired bacterial pneumonia and ABSSSI.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $304.0 million Upfront Cash: Undisclosed
Deal Type: Agreement July 10, 2023
Details:
Nuzyra (omadacycline tosylate) is a novel antibiotic which binds to the 30S ribosomal subunit and blocks protein synthesis and is available for the treatment of of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
Details:
The proceeds from the acquisition will advance the commercialization of Nuzyra (omadacycline), a tetracycline antibiotic, indicated for the treatment of adult patients with community-acquired bacterial pneumonia, and support the development of additional therapies.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Gurnet Point Capital
Deal Size: $287.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition June 06, 2023
Details:
Nuzyra (omadacycline tosylate) is a novel antibiotic which binds to the 30S ribosomal subunit and blocks protein synthesis, available for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
NUZYRA® (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).
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $304.0 million Upfront Cash: Undisclosed
Deal Type: Funding January 05, 2023
Details:
NUZYRA® (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).
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
Under the terms of the agreement, BARDA will award initial funding for the development of NUZYRA (omadacycline tosylate) for the treatment of pulmonary anthrax and the purchase of an initial 2,500 treatment courses of NUZYRA to add to the current SNS.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $284.0 million Upfront Cash: Undisclosed
Deal Type: Partnership October 31, 2022
Details:
NUZYRA ® (omadacycline tosylate) 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).
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2022
Details:
NUZYRA® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Zai Lab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2022
Details:
NUZYRA® (omadacycline), a dynamic hollow fiber model of Mycobacterium avium complex pulmonary infection demonstrated efficacy and potency against MAC when tested in a hollow fiber system infection model at standard clinical doses approved for CABP and ABSSSI in adults.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 08, 2022
Details:
NUZYRA (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).
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2021
Details:
The Company's lead commercial product, NUZYRA® (omadacycline), is a 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.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $38.0 million Upfront Cash: Undisclosed
Deal Type: Funding June 29, 2021
Details:
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.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 10, 2021
Details:
Key highlights include data on NUZYRA as an alternative to standard of care to reduce Clostridioides Difficile infections and real-world experience with NUZYRA for nontuberculous mycobacterial and MDR/XDR gram negative infections.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Nuzyra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2020
Details:
Under the terms of the contract, Paratek will commit to ensure that all current suppliers meet BARDA security requirements and to onshore a secondary supply chain in the United States for NUZYRA.
Lead Product(s): Omadacycline
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: BARDA
Deal Size: $285.0 million Upfront Cash: $20.0 million
Deal Type: Funding April 01, 2020
Details:
Under the terms of the agreement, Flexion will be solely responsible for the manufacture and supply of ZILRETTA to HK Tainuo for all clinical and commercial activities.
Lead Product(s): Omadacycline
Therapeutic Area: Neurology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: HK Tainuo
Deal Size: $42.5 million Upfront Cash: $10.0 million
Deal Type: Licensing Agreement April 01, 2020
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