Lead Product(s) : Fosfomycin Sodium
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Meitheal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Meitheal Pharmaceuticals Expands Portfolio with Acquisition of CONTEPO™ from Nabriva
Details : Meitheal has acquired the North American rights to CONTEPO (fosfomycin) from Nabriva. CONTEPO is a novel, intravenous, broad-spectrum antibiotic used for the treatment of urinary tract infections.
Product Name : Contepo
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 18, 2024
Lead Product(s) : Fosfomycin Sodium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Meitheal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Announces Positive Results From Phase 3 REASSURE Trial Of Oral Sulopenem In UTIs
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.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 30, 2024
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : US Food & Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA
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 ur...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Undisclosed
November 07, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : US Food & Drug Administration
Deal Size : Undisclosed
Deal Type : Agreement
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Announces Issuance of Allowance for a U.S. Patent Covering Oral Sulopenem
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 antibioti...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 19, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : AV7909
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : BARDA
Deal Size : Inapplicable
Deal Type : Inapplicable
ICON Selected By BARDA To Conduct Anthrax Vaccine Clinical Trial
Details : This clinical study will inform operational logistics and will not expose participants to anthrax. AV7909 is indicated for post-exposure prophylaxis of anthrax disease. Anthrax vaccine is also recommended for unvaccinated people of all ages who have been...
Product Name : AV7909
Product Type : Vaccine
Upfront Cash : Inapplicable
June 10, 2022
Lead Product(s) : AV7909
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : BARDA
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 antibio...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 25, 2022
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Provides Update from FDA Type A Meeting Regarding Oral Sulopenem
Details : Sulopenem has demonstrated potent in vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 28, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : H.C. Wainwright & Co
Deal Size : $35.0 million
Deal Type : Public Offering
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...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Undisclosed
September 02, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : H.C. Wainwright & Co
Deal Size : $35.0 million
Deal Type : Public Offering
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Provides Update on NDA Review
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-susce...
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
May 27, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem
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.
Product Name : Orlynvah
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 25, 2021
Lead Product(s) : Sulopenem Etzadroxil,Probenecid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable