Date: 2016-06-02
Type of information: Services contract
Compound: plazomicin
Company: Achaogen (USA - CA) Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) (USA)
Therapeutic area: Infectious diseases
Type agreement: services contract
Action mechanism:
- antibiotic. Plazomicin is a novel aminoglycoside antibiotic designed to treat serious gram-negative infections. It has shown potent bactericidal activity in nonclinical studies against important gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae (CRE). It is currently evaluated for the treatment of bacteremia and nosocomial pneumonia caused by CRE.
Disease: complicated urinary tract infections (cUTI)
Details:
- • On June 2, 2016, Achaogen announced that it has been awarded $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin.
- The BARDA contract was originally awarded to Achaogen under BARDA's Broad Spectrum Antimicrobials program in August 2010. The original contract consisted of a base award as well as three options that, effective today, have all been exercised. With the granting of this last option, the unspent funding currently committed under the contract with BARDA now totals approximately $41 million.
- The funding from Option 3 is focused on the Phase 3 pivotal clinical trial of plazomicin, the EPIC study, in complicated urinary tract infections (cUTI). Achaogen expects to release top-line results from the EPIC study in the first quarter of 2017, and plans to submit a New Drug Application (NDA) to the FDA in the second half of 2017.
Financial terms:
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Is general: Yes
