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Shionogi showcases real-world Fetroja data at ESCMID 2026. Shionogi highlights real-world effectiveness of fetroja/fetcroja against mbl-producing Enterobacterales at ESCMID global 2026. Shionogi & Co., Ltd. has unveiled new real-world and surveillance data highlighting the clinical utility of cefiderocol (marketed as Fetroja(R)/Fetcroja(R) in the treatment of highly resistant Gram-negative bacterial infections. The findings were presented at the European Society of Clinical Microbiology and Infectious Diseases Congress 2026, held in Munich from April 17 to 21, 2026, one of the world's leading forums for infectious disease research and antimicrobial resistance (AMR) discussions. The newly presented data provide important insights into the real-world effectiveness, safety, and microbiological performance of cefiderocol, particularly in infections caused by metallo-beta-lactamase (MBL)-producing Enterobacterales - pathogens that are among the most difficult to treat due to their extensive resistance to commonly used antibiotics. Cefiderocol is a novel siderophore cephalosporin antibiotic designed to overcome resistance mechanisms in Gram-negative bacteria. It utilizes a "Trojan horse" strategy, binding to iron and exploiting bacterial iron transport systems to gain entry into the cell, thereby bypassing resistance pathways that often render other antibiotics ineffective. The drug is currently approved for the treatment of serious infections in adults, including complicated urinary tract infections (cUTIs) and hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative organisms. Real-World evidence from the CIRCE study. A key highlight of the data presented at the congress was the CIRCE study, a retrospective, observational, multicenter chart review conducted across Spain between January 2023 and April 2025. The study evaluated 232 adult patients with confirmed infections caused by MBL-producing Enterobacterales, offering valuable real-world evidence on the use of cefiderocol in routine clinical practice. The patient population in the CIRCE study represented a highly complex and critically ill group. At baseline, 29% of patients were immunocompromised, 27% were admitted to intensive care units, and 13% presented with septic shock - conditions that are typically associated with high morbidity and mortality. These characteristics underscore the severity of infections being treated and the limited therapeutic options available in such cases. Despite these challenges, the outcomes observed in the study were encouraging. At day 14, 68% of patients treated with cefiderocol were considered clinically cured, while 82% achieved a clinical response, indicating either full resolution or significant improvement of infection-related symptoms. Survival rates were also notable, with 90% of patients alive at day 14 and 83% at day 28. In terms of safety, adverse events associated with cefiderocol were collected through routine chart reviews. The analysis did not identify any new safety signals beyond the drug's established safety profile, reinforcing its tolerability in a real-world setting. Addressing the challenge of mbl-producing pathogens. MBL-producing Enterobacterales represent a major global health threat due to their ability to inactivate nearly all beta-lactam antibiotics, including carbapenems, which are often reserved as last-line treatments for severe infections. This resistance significantly limits therapeutic options and is associated with poor clinical outcomes. Within the CIRCE study, the most commonly identified pathogens were carbapenem-resistant Klebsiella pneumoniae and Enterobacter species. Both are classified by the World Health Organization as critical priority pathogens due to their high levels of resistance and the urgent need for new treatment options. The study also reported microbiological eradication rates among patients with follow-up cultures. These rates were 85% for bloodstream infections and 82% for urinary tract infections, indicating that cefiderocol was effective not only in improving clinical symptoms but also in eliminating the causative pathogens. Approximately half of the patients in the study received cefiderocol based on susceptibility testing, highlighting the importance of diagnostic tools in guiding targeted antimicrobial therapy. This approach aligns with antimicrobial stewardship principles, which emphasize the use of appropriate, evidence-based treatments to minimize resistance development. Dr. Ricard Ferrer, Head of the Intensive Care Department at Vall d'Hebron Hospital in Barcelona, emphasized the significance of these findings. He noted that infections caused by MBL-producing Enterobacterales are a growing clinical challenge worldwide, particularly among critically ill patients. According to Dr. Ferrer, the CIRCE data provide meaningful evidence supporting the clinical effectiveness of cefiderocol and its role in addressing this unmet medical need. Long-Term surveillance data: stability against resistance. In addition to the CIRCE study, Shionogi presented data from in vitro surveillance programs evaluating cefiderocol's activity against Stenotrophomonas maltophilia, an opportunistic Gram-negative pathogen known for its intrinsic resistance to multiple antibiotic classes. The analysis included more than 4,000 clinical isolates collected over a 10-year period through the SIDERO-WT (2014-2019) and SENTRY (2020-2024) surveillance programs. Importantly, the data showed no significant change in cefiderocol susceptibility before and after its market introduction. This finding suggests that resistance to cefiderocol has not emerged at a meaningful level over time, an encouraging signal in the context of global AMR concerns. Stenotrophomonas maltophilia is particularly problematic in high-risk populations, such as immunocompromised patients and those in intensive care units, where treatment options are often limited. The stability of cefiderocol's activity against this pathogen underscores its potential as a reliable therapeutic option in difficult-to-treat infections. Clinical outcomes from the PROVE study. Further supporting evidence was presented from the PROVE study, which included a subgroup analysis of 119 patients with Stenotrophomonas maltophilia infections. The results demonstrated clinical cure in approximately two-thirds of patients, many of whom were critically ill and receiving care in intensive care settings. These findings reinforce cefiderocol's effectiveness across a range of resistant pathogens and clinical scenarios, highlighting its versatility as a treatment option in modern infectious disease management. The broader context: combating antimicrobial resistance. The data presented at ESCMID 2026 come at a time when antimicrobial resistance is widely recognized as one of the most pressing global health challenges. The increasing prevalence of multidrug-resistant Gram-negative bacteria threatens to undermine decades of progress in modern medicine, making it more difficult to treat common infections and perform routine medical procedures safely. Mark Hill, Global Head of Medical Affairs at Shionogi, emphasized the importance of continued innovation in this field. He noted that the growing body of evidence supporting cefiderocol highlights its potential role in addressing resistant infections, while also underscoring the need for sustained investment in antimicrobial research and development. Hill also pointed out that generating robust clinical and real-world evidence is essential for informing treatment decisions and optimizing patient outcomes. By contributing data from diverse sources, including observational studies and surveillance programs, Shionogi aims to support healthcare providers in making evidence-based choices in complex clinical situations. The comprehensive data presented by Shionogi at the European Society of Clinical Microbiology and Infectious Diseases Congress 2026 provide compelling evidence for the effectiveness and safety of cefiderocol in treating highly resistant Gram-negative infections. From real-world outcomes in the CIRCE study to long-term surveillance data and clinical results from the PROVE study, the findings collectively demonstrate the drug's potential to address critical gaps in current treatment options. As antimicrobial resistance continues to evolve, therapies like cefiderocol represent an important advancement in the fight against difficult-to-treat infections. By combining innovative mechanisms of action with strong clinical evidence, cefiderocol offers a promising solution for patients facing life-threatening bacterial diseases, particularly those caused by pathogens with limited or no effective treatment alternatives. Through ongoing research, collaboration, and investment, companies like Shionogi are playing a vital role in advancing the global response to antimicrobial resistance - helping to ensure that effective treatments remain available for future generations.

Shionogi enters $2.5 billion agreement to acquire all rights to Radicava. Shionogi completed its $2.5 billion acquisition of global rights to Radicava from Tanabe Pharma, adding one of the few approved treatments for ALS to its portfolio. Shionogi completed the acquisition of global rights to Radicava (edaravone), an approved treatment for amyotrophic lateral sclerosis. Emerging Pharma Leaders nominations are now open! Do you know someone who can make tough decisions that continue to face manufacturers? Are they destined to change the future of pharma? Nominate a colleague with impressive leadership and career intentions - even yourself! - for the Pharmaceutical Executive 2026 Emerging Pharma Leaders Awards. The acquisition builds on the originally announced terms of the agreement back from December 22, 2025, and will see Shionogi pay $2.5 billion to Tanabe Pharma Corporation, while establishing itself as a commercially active rare disease company in the process.[2] What was acquired? The deal transfers all intellectual property and sales rights for Radicava across major countries and regions from Tanabe Pharma to Shionogi, with additional markets to follow.[1] Along with the product rights, Shionogi is absorbing the Radicava commercial team, programs, and platforms from Tanabe, giving it immediate rare disease infrastructure and an established relationship with the ALS patient community.[2] The transaction is expected to add approximately $700 million in annual global sales and be immediately accretive in fiscal year 2026. Additional royalties on future sales may also apply under certain conditions.[1] What is Radicava? Radicava (edaravone) is one of the few approved treatments for ALS, a progressive and fatal neurodegenerative disease for which no cure exists. Originally discovered and developed by Tanabe Pharma, edaravone was first approved in Japan and South Korea in 2015 before receiving FDA approval for the U.S. market.[1] The oral suspension formulation, Radicava ORS, was approved by the FDA in 2022 and granted Orphan Drug Exclusivity in 2024 for its contribution to patient care by eliminating the burden of intravenous administration.[1] To date, Radicava has treated more than 22,000 people with ALS in the U.S., accumulating over 2.8 million days of therapy and prescribed by more than 2,800 healthcare providers.[1] Radicava ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period in the initial treatment cycle, with subsequent cycles consisting of 10 days of treatment within each 14-day window. Each dose must be taken in the morning after overnight fasting. "Radicava is an important option for people with ALS and we are committed to serving the community's needs today and working toward future innovations in care," said Nathan McCutcheon, president and CEO of Shionogi Inc. "Pharm Exec is excited to continue growing its rare disease capabilities with the addition of the talented cross-functional team from Tanabe. The Radicava team will complement its efforts to establish a best-in-class rare disease franchise in the U.S. and ensure readiness to deliver future innovations to patients Why is this deal significant for Shionogi? The acquisition marks a strategic inflection point for Shionogi, a Japanese pharmaceutical company better known for its infectious disease portfolio. The Radicava deal gives it a revenue-generating rare disease asset, a U.S. commercial organization, and the capabilities needed to pursue additional rare disease programs, all in a single transaction.[1] Isao Teshirogi, CEO of Shionogi, framed the deal as progress toward the company's 2030 Vision and a commitment to patients with serious unmet needs. "With Radicava we are not only acquiring a medication, we are also acquiring an established rare disease capability and assuming responsibility for a relationship with the ALS community," he said. The deal continues Shionogi's streak of acquisitions to begin 2026, as the company began the year $2.1 Billion ViiV Healthcare Shareholdings from Pfizer, and most recently completed a $100 million for 50% of Apnimed's Ownership of Shionogi-Apnimed Sleep Science. Sources. Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.