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Details:
Oral Sulopenem (sulopenem etzadroxil/probenecid) is a cell wall inhibitor which is being evaluated in phase 3 clinical trials for the treatment of uncomplicated urinary tract infections & cystitis.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: PF-03709270
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2024
Details:
Sulopenem Etzadroxil is a novel penem anti-infective compound, in Phase 3 clinical development. Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2022
Details:
Food and Drug Administration under the special protocol assessment process on the design, endpoints and statistical analysis of a Phase 3 clinical trial for oral sulopenem etzadroxil-probenecid (“oral sulopenem”) for the treatment of uncomplicated urinary tract infections.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: U.S. Food and Drug Administration
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 11, 2022
Details:
Sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation, has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Sulopenem
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 25, 2022
Details:
Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 28, 2021
Details:
During the meeting, the FDA shared issues still under review regarding the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2021
Details:
The Company intends to use the net proceeds for the ongoing review of its NDA for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen, for pre-commercialization and potential launch activities for oral sulopenem.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co
Deal Size: $35.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 09, 2021
Details:
Sulopenem is a novel penem anti-infective compound. The NDA includes data from the SURE-1, SURE-2 and SURE-3 phase 3 clinical trials, in which oral sulopenem was well tolerated.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
Details:
The Company intends to use the net proceeds from this offering to support its planned NDA submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinical development of sulopenem.
Lead Product(s): Sulopenem Etzadroxil
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: H.C. Wainwright & Co.
Deal Size: $17.5 million Upfront Cash: Undisclosed
Deal Type: Public Offering October 23, 2020
Details:
The two data presentations will include a poster presentation of the results of SURE-2 in complicated urinary tract infections (cUTI) as well as a late breaker oral abstract presentation of the results from SURE-1 in uncomplicated urinary tract infections (uUTI).
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2020
Details:
In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI.
Lead Product(s): Sulopenem Etzadroxil,Probenecid
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020