Achaogen performs less than average in Research & Development when compared to other small and medium-sized enterprises in scope.
Achaogen had four antibacterial projects for priority pathogens in its pipeline. Granted regulatory approval in 2018 for plazomicin, which targets a critical and/or urgent priority pathogen.
Sales & Operations
Sales & Operations
Filed for bankruptcy in April 2019
Therapeutic areas: Multidrug-resistant Gram-negative bacterial infections Products on the market: 1, plazomicin (Zemdri™) approved in June 2018 for cUTI R&D grants received since 2016: At least USD 30 million, awarded by four funders (BARDA; Bill & Melinda Gates Foundation; CARB-X; NIAID). Its latest award, from CARB-X, worth USD 4 million with the possibility of a USD 9.6 million extension, was granted in April 2018 to support its early-stage aminoglycoside programme developing antibiotics for difficult to treat infections that are associated with high mortality. Financing and investment structure: Achaogen was a publicly listed company. It completed its IPO in March 2014, raising USD 72 million, following four funding series raising a total of USD 116.6 million. The company’s lead investor was Domain Associates. Its post IPO equity amounted to USD 35.4 million. M&A since 2018: Achaogen filed for bankruptcy in April 2019 and all assets were sold for USD 16 million.
Pipeline & Portfolio
for diseases in scope
Pipeline size: 4 projects for priority pathogens* (4 antibacterial medicines) Development stages: 2 clinical projects, before filing for bankruptcy, including plazomicin for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia and complicated intra-abdominal infections, and ceftibuten/clavulanate for the treatment of complicated urinary tract infections, and 1 pre-clinical project Novelty: No novel clinical-stage medicine projects Regulatory approvals: 1, for plazomicin (Zemdri™) for the treatment of complicated urinary tract infections including acute pyelonephritis in patients 18 years of age and older. Access plans: Neither of its 2 late-stage R&D projects have project-specific access plans. Stewardship plans: Neither of its 2 late-stage R&D medicine projects have project-specific stewardship plans.
No opportunities are provided for Achaogen because it filed for bankruptcy in April 2019.
Changes since 2018
Changes since 2018
Filed for bankruptcy in April 2019.
Publicly shared data on the discontinued LpxC inhibitor antibiotic research programme on the SPARK open-access platform in October 2018.
Sold by auction the worldwide rights (excl. China) for plazomicin (Zemdri™) to Cipla USA and the rights for China to QiLu Antibiotics Pharmaceutical.
Performance by research area
Research & Development
Indicators scored on
Evaluated: medicine & vaccine pipelines for priority* bacteria & fungi
A.1 R&D investments Achaogen invested USD 198.6 million in the development of antibacterial medicines in 2017 and 2018. Achaogen filed for bankruptcy during the Benchmark’s period of analysis. As with all other small and medium-sized enterprises (SMEs) evaluated, Achaogen was not scored in this indicator.
A.2.1 Pipeline size of four projects Achaogen reports four projects targeting priority pathogens in its pipeline, all of which targeted bacterial pathogens. Two of its four projects were in clinical development, and one project, plazomicin (Zemdri™) received market approval within the period of analysis. The fourth project was in pre-clinical development.
A.2.2 No clinical-stage novel projects Achaogen’s clinical-stage medicine pipeline for priority pathogens consisted of both adapted and new R&D projects. It did not include candidates that were considered novel. Before filing for bankruptcy, Achaogen was developing one new, non-novel project: a fixed-dose combination of ceftibuten/clavulanate for the treatment of complicated urinary tract infections.
A.2.3 Vaccines in the pipeline Achaogen is not eligible for this indicator as it is not active in vaccine development.
A.2.4 One candidate targeting critical and/or urgent priorities Achaogen gained approval for its antibacterial medicine plazomicin (Zemdri™), which targets CRE, in June 2018. The company was also developing an adaptation of this product, in Phase III, which also targeted Carbapenem-resistant Enterobacteriaceae (CRE). CRE has been identified as a ‘critical’ R&D priority for limiting AMR by WHO and as an ‘urgent’ priority by the US Centers for Disease Control and Prevention (CDC).
A.3 Intellectual capital sharing Achaogen reported one intellectual capital sharing initiative. It shares data from its discontinued LpxC inhibitor antibiotic research programme on the Pew Charitable Trusts’ open-access Shared Platform for Antibiotic Research and Knowledge (SPARK). The data will provide other scientists with valuable information about potential drug targets. As an SME, Achaogen was not scored for this indicator, in line with the external stakeholder consensus defined by the Foundation.
A.4 No access or stewardship plans for late-stage R&D projects targeting priority pathogens Achaogen had two late-stage R&D projects targeting priority pathogens, for two different indications for plazomicin (Zemdri™). It obtained FDA approval for one, for the treatment of complicated urinary tract infections. The company did not report plans that addressed either the stewardship of or appropriate access to the product.
Pipeline targeting priority pathogens: 4
As a small- to medium-sized enterprise (SME), Achaogen is not evaluated in this Research Area. It has one antibacterial product on the market: plazomicin (Zemdri™).
Access & Stewardship
As an SME, Achaogen is not evaluated in this Research Area. It has one antibacterial and/or antifungal product on the market: the antibacterial plazomicin (Zemdri™). The Benchmark notes that Achaogen is active in two long-term AMR surveillance programmes, and that it openly publishes its results. Achaogen was not scored on these activities.
The two programmes are CANWARD and SENTRY. CANWARD is a national programme that is focused on pathogens isolated in Canadian hospitals. It is managed by the Canadian Antimicrobial Resistance Alliance with support from Achaogen, among other companies. Its results are shared in peer-reviewed open-access journal articles. The SENTRY programme is multinational and is managed by JMI laboratories with support from Achaogen, among other companies. Its results are shared in an open-access data platform.
Diagnostics, Animal & Agri
Activities in this area are not scored by the Benchmark. This information is provided given the importance of diagnostics, animal health and agriculture on the topic of AMR.
Prior to filing for bankruptcy, Achaogen, in partnership with Thermo Fisher Scientific, received FDA clearance for its QMS Plazomicin Immunoassay in late 2018. This diagnostic tool measures the levels of plazomicin in blood, in order to enable safe and effective individual treatment dosing.
* Bacteria and fungi that have been identified as priority R&D targets for limiting AMR, by either the WHO and/or the Centers for Disease Control and Prevention (CDC).