Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Spero Announces First Patient Visit in Phase 3 PIVOT-PO Trial of Tebipenem H Br
Details : SPR994 (tebipenem pivoxil hydrobromide) is an oral antibiotic in phase 3 trials for treating complicated urinary tract infections, including acute pyelonephritis.
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 01, 2024
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SPR994 is Spero’s novel late-stage development asset, an oral formulation tablet of tebipenem pivoxil hydrobromide, a carbapenem antibiotic of the β-lactam class.
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 31, 2023
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : GSK
Deal Size : $816.0 million
Deal Type : Licensing Agreement
Details : Under the licence agreement, Spero will be responsible for the execution and costs of the remaining phase III trial of tebipenem HBr. GSK will be responsible for the execution and costs of additional clinical development, including regulatory submission ...
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : $66.0 million
September 22, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : GSK
Deal Size : $816.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : GSK
Deal Size : $591.0 million
Deal Type : Licensing Agreement
Spero Therapeutics Announces Closing of Exclusive License Agreement with GSK for Tebipenem HBr
Details : Under the terms of the agreement, Spero is responsible for the execution and costs of Phase 3 trial of tebipenem HBr (tebipenem pivoxil hydrobromide), an investigational drug, is being developed as the potentially first oral carbapenem antibiotic for the...
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : $66.0 million
August 11, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : GSK
Deal Size : $591.0 million
Deal Type : Licensing Agreement
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tebipenem HBr is an investigational drug in the United States being developed for the treatment of cUTI, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited treatment options; tebipenem HBr is not FDA-approved.
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 27, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : FDA feedback indicates positive results from a single additional Phase 3 clinical trial in patients with complicated urinary tract infection (cUTI), with supportive confirmatory evidence of efficacy could support approval of SPR994 (tebipenem HBr).
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 09, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Oral tebipenem pivoxil hydrobromide, an investigational oral carbapenem antibiotic was noninferior to intravenous ertapenem in the treatment of complicated urinary tract infection and acute pyelonephritis and had a similar safety profile.
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 04, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Tebipenem HBr is an investigational drug in the United States being developed for the treatment of complicated urinary tract infection, including pyelonephritis, caused by certain microorganisms, in adult patients who have limited oral treatment options.
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 21, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : SPR994 (tebipenem pivoxil hydrobromide) is Spero’s novel investigational oral formulation of tebipenem, a carbapenem-class antibiotic in japan it is marketed as Orapenem® since 2009 for pediatric infections limited to pneumonia, otitis media and sinus...
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 05, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase III
Sponsor : BARDA
Deal Size : $59.7 million
Deal Type : Funding
Details : The additional funding option is expected to provide support for a clinical trial and related activities for orally administered tebipenem pivoxil’s use in treating pediatric patients with cUTI, including AP.
Product Name : SPR994
Product Type : Antibiotic
Upfront Cash : Undisclosed
January 19, 2022
Lead Product(s) : Tebipenem Pivoxil Hydrobromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase III
Sponsor : BARDA
Deal Size : $59.7 million
Deal Type : Funding