Achaogen was a biopharmaceutical company established in South San Francisco, California, in 2004. It focused on discovering, developing, and commercializing new medicines to address significant public health threats.
The Focus on Antibiotic Resistance
Achaogen’s core mission centered on combating the growing global health crisis of antibiotic resistance. The company specifically targeted multidrug-resistant (MDR) gram-negative bacteria, which posed a severe challenge to public health. These pathogens, including carbapenem-resistant Enterobacteriaceae (CRE), are particularly dangerous because they have developed ways to resist many existing antibiotic treatments, making infections difficult to manage. Achaogen’s work directly responded to this urgent medical need, aiming to develop new antibacterial agents.
The increasing prevalence of these resistant strains is associated with poorer clinical outcomes and higher mortality rates. Achaogen sought to engineer novel compounds that could overcome common bacterial resistance mechanisms. This focus positioned the company in the fight against antibiotic resistance. Developing effective treatments against these bacteria was the driving force behind Achaogen’s research.
Development of Plazomicin
Achaogen’s lead product was Plazomicin, marketed under the brand name Zemdri. This drug is a next-generation aminoglycoside antibiotic, designed to maintain activity against bacteria that have developed resistance to other antibiotics, particularly through aminoglycoside-modifying enzymes. Plazomicin was specifically developed to treat serious bacterial infections caused by multidrug-resistant Enterobacteriaceae.
Plazomicin was approved by the U.S. Food and Drug Administration (FDA) on June 28, 2018. This approval was for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in adult patients who had limited or no alternative treatment options. Plazomicin demonstrated activity against carbapenem-resistant and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, offering a new option for challenging infections. It was administered as a once-daily intravenous infusion.
The Path to Bankruptcy
Despite Plazomicin’s scientific success, Achaogen faced a major setback. The FDA issued a Complete Response Letter, declining approval for Plazomicin to treat bloodstream infections (BSI). This decision stemmed from insufficient evidence of efficacy for this specific indication. The clinical trial, known as CARE, encountered significant challenges in patient enrollment, leading to a small sample size that precluded robust statistical analysis of the drug’s effectiveness for bloodstream infections.
The commercial consequences of this limited approval were significant. Plazomicin’s market was significantly restricted to complicated urinary tract infections, which did not generate sufficient sales revenue to support the company’s operations. The drug recorded approximately $500,000 in net product sales during the fourth quarter of 2018, with total sales for the entire year falling below $1 million. Facing financial pressure from low sales and high development costs, Achaogen filed for Chapter 11 bankruptcy protection on April 15, 2019.
Post-Bankruptcy and Legacy
Following its bankruptcy filing, Achaogen’s assets were sold off through a Chapter 11 auction. In July 2019, the pharmaceutical company Cipla USA acquired the worldwide rights to Plazomicin (Zemdri), excluding Greater China, along with its associated assets and limited liabilities. This acquisition allowed the drug to remain available for patients.
Achaogen’s trajectory serves as a cautionary tale within the pharmaceutical industry. The company’s experience illustrates the significant market challenges and inherent financial risks involved in developing new antibiotics, even when scientific and regulatory milestones are achieved. The high costs associated with research and development in this area often do not align with sufficient market returns, highlighting a broader issue within the antibiotic development landscape.