Myoclonus

Now compatible with all major RFID kit and tray systems LAKE ZURICH, Ill.--(BUSINESS WIRE)-- Fresenius Kabi announced today it has introduced +RFID smart labels for Diprivan® (Propofol) Injectable Emulsion, USP, 200 mg per 20 mL in single-dose vials, sold in the United States. The +RFID labels are now fully compatible with all major RFID kit and tray systems in the U.S. This press release features multimedia. View the full release here: Fresenius Kabi Diprivan® (Propofol) Injectable Emulsion, USP, 200 mg per 20 mL in single-dose vials, now compatible with all major RFID kit and tray systems. (Photo: Business Wire) The launch expands Fresenius Kabi’s industry-leading +RFID portfolio of fully interoperable labeled medications. The use of radio-frequency identification (RFID) label technology eliminates the need to tag medicines manually which saves time and supports a safe, more efficient medication inventory process. Fresenius Kabi is the first pharmaceutical manufacturer to adopt GS1's EPC Tag Data Standard (TDS) to enhance interoperability. GS1 Standards for identifying, capturing and sharing supply chain data help ensure product and inventory information is accessible, accurate and easy to understand. Diprivan, the most prescribed propofol anesthetic in the U.S.1, was the first Fresenius Kabi product introduced with RFID labels in 2020 for use with some RFID kit and tray systems. The drug is now certified for use with all RFID systems and is available immediately to order through wholesalers and direct from Fresenius Kabi. To meet the highest standards of performance and quality, in addition to the company’s own testing, Diprivan +RFID has been tested by the Axia Institute of Michigan State University and certified by the ARC RFID lab of Auburn University. Fresenius Kabi is expanding its portfolio of fully compatible +RFID products based on demand from hospitals. In a recent study by the ASHP Foundation, nearly nine in 10 hospitals that participated reported they are already using RFID technology or are evaluating it. “We are dedicated to supporting our customers in the adoption of RFID technology that enhances patient care, improves efficiency and streamlines workflows for pharmacists,” said John Ducker, president and CEO of Fresenius Kabi USA. The company has also released newly labeled Vasopressin Injection, USP 20 units per 1 mL in single-dose vials with +RFID smart labels, adding to the company’s growing portfolio of products compatible with all major RFID kit and tray systems. About Diprivan® (Propofol), Injectable Emulsion, USP Indications and Usage – DIPRIVAN® (Propofol), Injectable Emulsion, USP is an intravenous general anesthetic and sedation drug for use in adults for initiation and maintenance of Monitored Anesthesia Care (MAC) sedation, combined sedation and regional anesthesia, and Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients. DIPRIVAN is also indicated for induction of general anesthesia for patients greater than or equal to 3 years of age and for maintenance of general anesthesia for patients greater than or equal to 2 months of age. Important Safety Information DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components, and also in patients with allergies to eggs, egg products, soybeans or soy products. DIPRIVAN is not indicated for use in pediatric patients for ICU sedation or for MAC sedation for surgical, nonsurgical or diagnostic procedures as safety and effectiveness have not been established. DIPRIVAN is not recommended for induction of anesthesia in patients below the age of 3 years or for maintenance of anesthesia in patients below the age of 2 months because its safety and effectiveness have not been established in those populations. Use of DIPRIVAN has been associated with both fatal and life-threatening anaphylactic and anaphylactoid reactions. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension occur rarely following DIPRIVAN administration. Strict aseptic technique must always be maintained during handling. DIPRIVAN is a single access parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards. Failure to use aseptic technique when handling DIPRIVAN was associated with microbial contamination of the product and with fever, infection, sepsis, other life-threatening illness, and death. Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and use of propofol vials intended for single use on multiple persons. A DIPRIVAN vial is never to be accessed more than once or used on more than one person. DIPRIVAN has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with DIPRIVAN. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. Diprivan should not be coadministered through the same IV catheter with blood or plasma because compatibility has not been established. For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and facilities for maintenance of a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available. Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. Administer DIPRIVAN with caution in patients with disorders of lipid metabolism such as primary hyperlipoproteinemia, diabetic hyperlipemia, and pancreatitis. Very rarely the use of DIPRIVAN may be associated with the development of a period of postoperative unconsciousness which may be accompanied by an increase in muscle tone. When DIPRIVAN is administered to an epileptic patient, there is a risk of seizure during the recovery phase. Attention should be paid to minimize pain on administration of Diprivan. Venous sequelae, i.e., phlebitis or thrombosis, have been reported rarely (less than 1%). Perioperative myoclonia, rarely including convulsions and opisthotonos, has occurred in association with DIPRIVAN administration. Rarely, cases of unexplained postoperative pancreatitis (requiring hospital admission) have been reported after anesthesia in which DIPRIVAN was one of the induction agents used. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit (ICU), DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management. Patients should be continuously monitored for early signs of significant hypotension and/or cardiovascular depression, which may be profound. Abrupt discontinuation of DIPRIVAN prior to weaning or for daily evaluation of sedation levels should be avoided. This may result in rapid awakening with associated anxiety, agitation, and resistance to mechanical ventilation. In pediatric patients, abrupt discontinuation of DIPRIVAN following prolonged infusion may result in flushing of the hands and feet, agitation, tremulousness and hyperirritability. Increased incidences of bradycardia, agitation, and jitteriness have also been observed. For both adult and pediatric ICU sedation, DIPRIVAN infusion has been associated with Propofol Infusion Syndrome, that have resulted in death. The syndrome is characterized by severe metabolic acidosis, hyperkalemia, lipemia, rhabdomyolysis, hepatomegaly, renal failure, ECG changes and/or cardiac failure. Since DIPRIVAN is formulated in an oil-in-water emulsion, elevations in serum triglycerides may occur when DIPRIVAN is administered for extended periods of time. Patients at risk of hyperlipidemia should be monitored for increases in serum triglycerides or serum turbidity. EDTA is a strong chelator of trace metals – including zinc. DIPRIVAN should not be infused for longer than 5 days without providing a drug holiday to safely replace estimated or measured urine zinc losses. At high doses (2 grams to 3 grams per day), EDTA has been reported, on rare occasions, to be toxic to the renal tubules. Monitor patients at risk for renal impairment. There have been rare reports of pulmonary edema in temporal relationship to the administration of DIPRIVAN, although a causal relationship is unknown. Neurosurgical Anesthesia: When DIPRIVAN is used in patients with increased intracranial pressure or impaired cerebral circulation, significant decreases in mean arterial pressure should be avoided because of the resultant decrease in cerebral perfusion pressure. Cardiac Anesthesia: Slower rates of administration should be utilized in premedicated patients, geriatric patients, patients with recent fluid shifts, and patients who are hemodynamically unstable. Pediatric Neurotoxicity: Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is unclear. Adverse reactions reported with an incidence greater than 1% were: bradycardia, arrhythmia, tachycardia, hypotension, decreased cardiac output, hypertension, movement, apnea, respiratory acidosis during weaning, rash, pruritus, burning/stinging or pain at injection site, and hyperlipemia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or . DIPRIVAN is not recommended for obstetrics, including Cesarean section deliveries. DIPRIVAN crosses the placenta, and as with other general anesthetic agents, the administration of DIPRIVAN may be associated with neonatal depression. DIPRIVAN is not recommended for use in nursing mothers because Propofol has been reported to be excreted in human milk, and the effects of oral absorption of small amounts of propofol are not known. This Important Safety Information does not include all the information needed to use DIPRIVAN® (Propofol), Injectable Emulsion, USP safely and effectively. Please see full prescribing information for DIPRIVAN® (Propofol), Injectable Emulsion, USP at . References 1. Data on file. About Fresenius Kabi Fresenius Kabi ( ) is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for patients with critical and chronic conditions. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. To learn about U.S. career opportunities at Fresenius Kabi, visit us at and follow us on LinkedIn.

STEVENAGE, England--( BUSINESS WIRE )--Autifony Therapeutics Limited (“Autifony”), which is pioneering the development of novel pharmaceutical treatments for rare CNS disorders and other serious brain diseases, today announced that a Phase Ib trial of AUT00201, a potent and selective modulator of Kv3 ion channels, is enrolling patients with Myoclonus Epilepsy and Ataxia due to Potassium (K+) Channel Mutation or MEAK (also known as EPM7) at the Hospital of the University of Pennsylvania. Epilepsy is a brain disorder that causes recurring, unprovoked seizures. It is the fourth most common neurological disorder worldwide. Patients with EPM7 have a very rare form of epilepsy, caused by reduced function of Kv3.1 ion channels, which gives rise to myoclonic seizures (brief shock-like jerks of a muscle or a group of muscles), action-induced myoclonus and a progressive ataxia (impairing co-ordination, balance and speech). EPM7 symptoms typically emerge between the ages of 3 and 15, with progressively severe myoclonus, ataxia, and occasional tonic-clonic seizures. Patients are typically wheel-chair bound by the time they are in their late teens. Current anti-seizure drugs can help to reduce the incidence of tonic-clonic seizures, but these drugs do not improve the myoclonus or ataxia. AUT00201 is a potent positive modulator of Kv3.1 ion channels. In a genetic mouse model of EPM7 conducted by Dr. Ethan Goldberg at the Children’s Hospital of Philadelphia, AUT00201 completely reversed the seizure and ataxia phenotype. The Phase Ib study in patients with EPM7 is a randomized, double-blind, placebo-controlled, crossover study in 8-10 patients aged 18 or over in which effects both on clinical symptoms and biomarkers related to dysfunction of Kv3.1 channels are evaluated. Separately, the US FDA has designated AUT00201 for treatment of EPM7 as a drug for a ‘rare pediatric disease’ as defined in section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act. The Office of Orphan Products Development has also granted orphan drug designation for AUT00201 for the treatment of EPM7. Dr. Charles Large, Chief Executive Officer of Autifony Therapeutics, commented: “This is a unique opportunity for precision medicine, in which we aim to reverse the impact of a genetic mutation that causes a highly debilitating disorder. We are hopeful that this will offer benefit to patients with EPM7 where there are currently no effective treatments, and might one day also bring benefits to patients suffering from other forms of myoclonic epilepsy, which we will be looking to investigate in future.” Notes to Editors About Autifony Therapeutics Ltd Autifony Therapeutics is an independent UK-based biotechnology company formed in 2011 as a spin-out from GSK, which retains equity in the company. The Company is focused on the development of high value, novel medicines to treat serious diseases of the central nervous system. It is funded by SV Health Investors, IP Group, Pfizer Ventures, International Biotechnology Trust PLC, and UCL Business plc. For more information, please visit www.autifony.com . About AUT00201 AUT00201 is a novel, orally active small molecule designed to selectively modulate Kv3 potassium channels. Safety and toxicology studies support the clinical development of AUT00201.

A retrospective chart review interim analysis demonstrated that cefiderocol achieved clinical cure in 65% and 60% of patients with Pseudomonas aeruginosa and Acinetobacter baumannii respectively, the majority of whom were severely ill with comorbidities. OSAKA, Japan--(BUSINESS WIRE)-- Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announces key data for Fetcroja® (cefiderocol), an innovative siderophore cephalosporin, to be presented at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), April 15-18, 2023, including new real-world evidence demonstrating its efficacy against some of the most difficult-to-treat Gram-negative bacterial infections. In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.1 In the US, cefiderocol is available under the brand name Fetroja® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms.2 Interim results are emerging from PROVE (Retrospective Cefiderocol Chart Review), an ongoing international, retrospective study of the real-world use of cefiderocol for Gram-negative infections across EU and US sites.3,4 The study includes 194 patients with Pseudomonas aeruginosa infections treated with cefiderocol (123 from the US and 71 from the EU). These were generally seriously ill patients, many requiring mechanical ventilation and/or vasopressor support. The interim results show that cefiderocol achieved clinical cure in 65% of these patients, and 81% of patients were alive within 30 days of starting cefiderocol treatment. The patients principally had respiratory tract and bloodstream infections. Cefiderocol was initiated for a documented pathogen in the majority of cases (77%), and as monotherapy in 57% of patients. Also in the study were 98 patients with Acinetobacter baumannii infections (71 from US and 27 from the EU). The patients had respiratory infection and bacteraemia as the most common infections. High levels of organ support were required in these patients, with 45% receiving mechanical ventilation and 30% requiring vasopressor support. Cefiderocol achieved clinical cure in 60% of patients, and 76% of patients were alive within 30-days of starting treatment. Cefiderocol was targeted as first treatment or as salvage therapy in 93% of patients, and as monotherapy in 41% of patients. “These interim results from PROVE build on a growing body of real-world evidence across Europe and the US demonstrating the efficacy of cefiderocol in treating patients with life-threatening infections, such as Acinetobacter baumannii and Pseudomonas aeruginosa, the majority of whom are very sick with multiple comorbidities,” commented Prof. Dr. Dominic Wichmann, Consultant in department of Intensive Care Medicine, University of Hamburg-Eppendorf. “These are pathogens that fall into the World Health Organization’s critical priority list, for which effective treatments are urgently needed.” Antimicrobial resistance (AMR) Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed. Globally, in 2019, there were 1.27 million deaths attributable to bacterial AMR.5 Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.6 If no action is taken, antimicrobial resistance is predicted to kill 10 million people every year by 2050, at a cumulative cost to global economic output of 100 trillion USD.7 About FETCROJA® (Cefiderocol) Cefiderocol is a siderophore cephalosporin antibiotic with an innovative mechanism for penetrating the outer cell membrane of Gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria.8 These mechanisms allow cefiderocol to achieve higher concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.9 Cefiderocol has also demonstrated in vitro activity against certain bacteria that contain very problematic resistant enzymes such as ESBLs, AmpC, serine- and metallo-carbapenemases.10,11 Data from multinational surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant A. baumannii, P. aeruginosa, Enterobacterales, and S. maltophilia.12 The clinical significance of the in vitro data is unknown. Cefiderocol has no clinically relevant activity against Gram-positive or anaerobic bacteria. FETCROJA® (Cefiderocol) INDICATION In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options. FETROJA® (Cefiderocol) US INDICATIONS Fetroja® (cefiderocol) is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Fetroja is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible Gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Fetroja and other antibacterial drugs, Fetroja should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Fetroja is contraindicated in patients with a known history of severe hypersensitivity to cefiderocol or other beta-lactam antibacterial drugs, or any other component of Fetroja. WARNINGS AND PRECAUTIONS Increase in All-Cause Mortality in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infections An increase in all-cause mortality was observed in patients treated with Fetroja as compared to best available therapy (BAT) in a multinational, randomized, open-label trial in critically ill patients with carbapenem-resistant Gram-negative bacterial infections (NCT02714595). Patients with nosocomial pneumonia, bloodstream infections, sepsis, or cUTI were included in the trial. BAT regimens varied according to local practices and consisted of 1 to 3 antibacterial drugs with activity against Gram-negative bacteria. Most of the BAT regimens contained colistin. The increase in all-cause mortality occurred in patients treated for nosocomial pneumonia, bloodstream infections, or sepsis. The 28-Day all-cause mortality was higher in patients treated with Fetroja than in patients treated with BAT [25/101 (24.8%) vs 9/49 (18.4%), treatment difference 6.4%, 95% CI (-8.6, 19.2)]. All-cause mortality remained higher in patients treated with Fetroja than in patients treated with BAT through Day 49 [34/101 (33.7%) vs 10/49 (20.4%), treatment difference 13.3%, 95% CI (-2.5, 26.9)]. Generally, deaths were in patients with infections caused by Gram-negative organisms, including non-fermenters such as Acinetobacter baumannii complex, Stenotrophomonas maltophilia, and Pseudomonas aeruginosa, and were the result of worsening or complications of infection, or underlying comorbidities. The cause of the increase in mortality has not been established. Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP. Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity was observed in Fetroja-treated patients in clinical trials. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before therapy with Fetroja is instituted, inquire about previous hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactam antibacterial drugs. Discontinue Fetroja if an allergic reaction occurs. Clostridioides difficile-associated Diarrhea (CDAD) Clostridioides difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Fetroja. CDAD may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile, and institute surgical evaluation as clinically indicated. Seizures and Other Central Nervous System (CNS) Adverse Reactions Cephalosporins, including Fetroja, have been implicated in triggering seizures. Nonconvulsive status epilepticus (NCSE), encephalopathy, coma, asterixis, neuromuscular excitability, and myoclonia have been reported with cephalosporins particularly in patients with a history of epilepsy and/or when recommended dosages of cephalosporins were exceeded due to renal impairment. Adjust Fetroja dosing based on creatinine clearance. Anticonvulsant therapy should be continued in patients with known seizure disorders. If CNS adverse reactions including seizures occur, patients should undergo a neurological evaluation to determine whether Fetroja should be discontinued. Development of Drug-Resistant Bacteria Prescribing Fetroja in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. ADVERSE REACTIONS The most common adverse reactions occurring in (≥2%) of patients receiving Fetroja compared to imipenem/cilastatin in the cUTI trial were: diarrhea (4% vs 6%), infusion site reactions (4% vs 5%), constipation (3% vs 4%), rash (3% vs <1%), candidiasis (2% vs 3%), cough (2% vs <1%), elevations in liver tests (2% vs <1%), headache (2% vs 5%), hypokalemia (2% vs 3%), nausea (2% vs 4%), and vomiting (2% vs 1%). The most common adverse reactions occurring in (≥4%) of patients receiving Fetroja compared to meropenem in the HABP/VABP trial were: elevations in liver tests (16% vs 16%), hypokalemia (11% vs 15%), diarrhea (9% vs 9%), hypomagnesemia (5% vs <1%), and atrial fibrillation (5% vs 3%). Click here for Full U.S. Prescribing Information for Fetroja® (cefiderocol). Shionogi’s commitment to fighting antimicrobial resistance Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives. The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies.13 For more information, please refer to: About Shionogi Shionogi & Co., Ltd. is a 145-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders, cardiovascular diseases and gastroenterology. Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders. For more information on Shionogi & Co., Ltd., please visit Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. References 1 FETCROJA SMPC. Available at: Last accessed March 2023 2 Fetroja FDA prescribing information. Available at: Last accessed March 2023 3 Larcher R, et al. Real-world use of cefiderocol in the EU and US for Pseudomonas aeruginosa: interim data from the PROVE study. ECCMID abstract P2274 4 Timsit JF, et al. Real-world use of cefiderocol in the EU and US for Acinetobacter baumannii: interim data from the PROVE study. ECCMID abstract P2272 5 Antimicrobial Resistance Collaborators. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. Lancet 2022; 399: 629–55 6 Perez F, et al. ‘Carbapenem-Resistant Enterobacteriaceae: A Menace to our Most Vulnerable Patients’. Cleve Clin J Med. Apr 2013; 80(4): 225–33 7 O’Neill. The Review on antimicrobial resistance. 2016. Available at: Last accessed March 2023 8 Ito A, Nishikawa T., Masumoto S, et al. Siderophore Cephalosporin Cefiderocol Utilizes Ferric Iron Transporter Systems for Antibacterial Activity against Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2016;60(12):7396-7401 9 Tillotson GS. Trojan Horse Antibiotics—A Novel Way to Circumvent Gram-Negative Bacterial Resistance? Infectious Diseases: Research and Treatment. 2016;9:45-52 doi:10.4137/IDRT.S3156 10 K Kazmierczak et al. In vitro activity of cefiderocol, a siderophore cephalosporin, against a recent collection of clinically relevant carbapenem-non-susceptible Gram-negative bacilli, including serine carbapenemase- and metallo-β-lactamase-producing isolates (SIDERO-WT-2014 Study). ). International Journal of Antimicrobial Agents, 2019; 53(2) 177-184 11 A Ito et al. In Vitro Antibacterial Properties of Cefiderocol, a Novel Siderophore Cephalosporin, against Gram-Negative Bacteria. Antimicrobial Agents and Chemotherapy, 2018, 62:e01454-17. 12 M Hackel, M Tsuji, Y Yamano, et al. In Vitro Activity of the Siderophore Cephalosporin, Cefiderocol, Against a Recent Collection of Clinically Relevant Gram-Negative Bacilli from North America and Europe, Including Carbapenem Non-Susceptible Isolates: The SIDERO-WT-2014 Study. Antimicrobial Agents Chemotherapy. 2017;61(9) 13 Antimicrobial Resistance Benchmark 2021. Last accessed March 2023