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shionogi & co ltd (4507) Details

Shionogi & Co., Ltd. engages in the research, development, manufacture, and marketing of pharmaceuticals, diagnostic reagents, medical devices, etc. in Japan and internationally. It primarily focuses on prescription drugs, OTC drugs, and diagnostic reagents and devices. The company was formerly known as Shionogi Shoten Co., Ltd. and changed its name to Shionogi & Co., Ltd. in 1943. Shionogi & Co., Ltd. was founded in 1878 and is headquartered in Osaka, Japan.

5,896 Employees
Last Reported Date: 06/23/16
Founded in 1878

shionogi & co ltd (4507) Top Compensated Officers

Chief Executive Officer, President and Repres...
Total Annual Compensation: ¥129.0M
Compensation as of Fiscal Year 2016.
shionogi & co ltd
Shionogi & Co., Ltd. Presents Results of the First Clinical Efficacy Trial and in Vitro Data on Cefiderocol (S-649266), A Siderophore Cephalosporin

Shionogi & Co., Ltd. announced it will present for the first time clinical trial efficacy results, as well as supportive in vitro data, on cefiderocol (S-649266), an investigational siderophore cephalosporin in late stage development with activity against a broad range of Gram-negative pathogens, including those highly resistant to currently available agents such as colistin and carbapenem-resistant strains of Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacteriaceae (CRE) and Stenotrophomonas maltophilia, at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held in Vienna, Austria, April 22 - 25, 2017. The APEKS*-cUTI study was a multinational, multicenter, double-blind, randomized trial, that showed treatment with cefiderocol met non-inferiority versus imipenem/cilastatin (IPM/CS) on the U.S. Food and Drug Administration (FDA) pre-specified composite primary endpoint of clinical cure and microbiological eradication in patients with complicated urinary tract infection (cUTI) at test of cure (TOC). In the study, 72.6% (183/252) of patients in the cefiderocol arm met the primary endpoint vs 54.6% (65/119) in the IPM/CS arm. The weighted difference between groups was 18.58% (95% CI: 8.23%, 28.92%), consistent with superiority of cefiderocol. The study enrolled 452 patients with cUTI, randomized 2:1 to cefiderocol and IPM/CS, with a median duration of treatment of nine days in both treatment groups. This trial was designed to evaluate the efficacy and safety of cefiderocol versus IPM/CS in hospitalized adult patients with cUTI, with or without pyelonephritis, or acute uncomplicated pyelonephritis at TOC (approximately 7 days following the end of treatment). The study permitted enrollment of patients with complex co-morbid conditions, including renal transplant, limited the proportion of patients with acute uncomplicated pyelonephritis to less than 30%, and did not allow switch to oral therapy. Highlights of key results of the APEKS*-cUTI study include: Cefiderocol met non-inferiority versus IPM/CS on the FDA pre-specified primary composite endpoint of clinical cure and microbiological eradication in patients with cUTI caused by Gram-negative bacteria. The difference between groups at TOC was 18.58% (95% CI: 8.23%, 28.92%), consistent with superiority of cefiderocol. Cefiderocol's per patient microbiologic response at TOC was 73.0% versus 56.3% in the IPM/CS group. Although the study was a non-inferiority study, the difference between groups at TOC was 17.25% (95% CI: 6.92%, 27.58%), consistent with superiority of cefiderocol. Cefiderocol was well tolerated in the study, with adverse events reported for 40% of patients in the cefiderocol arm versus 50% of patients in the IPM/CS arm. Only 1% of cefiderocol treated patients were discontinued due to drug-related adverse events. Serious adverse events (SAEs) were reported for 4.7% of patients who received cefiderocol and 8.1% of patients who received IPM/CS. Additional in vitro cefiderocol data presented during poster session titled "cefiderocol" on April 24 highlight the following: A separate surveillance study SIDERO-WT-2014 evaluated the in vitro activity of cefiderocol and comparator agents against 4,966 strains of Gram-negative clinical isolates systematically collected from Europe. In this study, cefiderocol exhibited potent antibacterial activity with MIC90 of 1 mg/L. Cefiderocol demonstrated equally potent activity against the non-fermenters (Pseudomonas aeruginosa, Acinetobacter baumannii and Stenotrophomonas maltophilia as well as the broad group of Enterobacteriaceae) with more than 99.3% of all isolates having MIC values =4 mg/L. In subsets of carbapenem non-susceptible isolates of Enterobacteriaceae (N=125) and non-fermenters (N=1070), cefiderocol inhibited 96.0% and 98.0% at =4 mg/L, respectively, demonstrating the potential of cefiderocol for treating infections caused by these problematic organisms. The surveillance study SIDERO-CR-2014/2016 showed cefiderocol exhibited potent in vitro activity against a collection of 1,873 strains of highly-resistant Gram-negative bacteria, including carbapenem-resistant strains, from across the globe (53% from Europe, 21% Latin America, 12% from North America and 14% ROW). Against CRE, MIC90 of cefiderocol was 4 mg/L, while MIC90 of comparator agents ceftazidime-avibactam, ceftolozane-tazobactam and colistin were >64, >64 and >8 mg/L, respectively. Against MDR non-fermenters, MIC90 of cefiderocol was 1 mg/L, while MIC90 of the same comparators were >64, >64 and 4 mg/L, respectively. Antibacterial activity of cefiderocol was tested against Stenotrophomonas maltophilia, an increasingly important pathogen which is intrinsically resistant to carbapenems and other broad spectrum beta-lactam antibiotics. With a MIC50/MIC90 of 0.063/0.25 mg/L, cefiderocol demonstrated growth inhibition of all 645 strains, which were collected in the SIDERO-WT 2014 and SIDERO-CR 2014/2016 studies, at 4 mg/L or less, including isolates with decreased susceptibility to colistin. Comparator agents, including ceftazidime-avibactam, ceftolozane-tazobactam and meropenem were not effective (MIC50/MIC90: 8/64, 8/>64, >64/>64 mg/L, respectively). Additional in vitro data of cefiderocol activity against MDR pathogens is being presented in oral (abstract #1383 and #3177) and poster (poster #1312 and #1315) presentations. Cefiderocol is a siderophore cephalosporin with a novel mechanism for efficiently penetrating the outer cell membrane of Gram-negative pathogens. 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.2 This Trojan Horse strategy allows cefiderocol to achieve higher concentrations in the periplasmic space where it can then bind to receptors and inhibit cell wall synthesis in the bacterial cells.3 In addition, cefiderocol is stable against all known classes of beta-lactamases, including both the metallo- and serine-carbapenemases.4 Data from global surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacteriaceae and Stenotrophomonas maltophilia. Cefiderocol is currently in clinical development and recently completed a US registrational study in patients with cUTI (APEKS*-cUTI). An additional Phase 3 trial in patients with carbapenem-resistant pathogens at various infection sites (CREDIBLE-CR) is ongoing. In 2017 Shionogi will initiate a Phase 3 HAP/VAP/HCAP† (APEKS*-NP‡) clinical trial. The Company plans to submit a new drug application to the U.S.FDA in 2017 and to the EMA in 2018.

Shionogi to Present New Data on Cefiderocol (S-649266) and S-033188 at the 27th European Congress of Clinical Microbiology and Infectious Diseases

Shionogi & Co., Ltd. announced it will be presenting new data on cefiderocol (S-649266), an investigational siderophore cephalosporin in late stage development with activity against a broad range of Gram-negative pathogens, including those highly resistant to currently available agents such as colistin and carbapenem-resistant strains of Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacteriaceae (CRE) and Stenotrophomonas maltophilia, and S-033188, an investigational cap-dependent endonuclease inhibitor targeting influenza at this year's European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), held in Vienna, Austria, April 22 – 25, 2017. Highlights of cefiderocol presentations include first time clinical trial efficacy results, as well as supportive in vitro data, and S-033188 presentations will showcase both clinical and non-clinical data. Cefiderocol—an investigational antibiotic agent: Cefiderocol is a siderophore cephalosporin with a novel mechanism for efficiently penetrating the outer cell membrane of Gram-negative pathogens. 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. This Trojan Horse strategy allows cefiderocol to achieve higher concentrations in the periplasmic space where it can then bind to receptors and inhibit cell wall synthesis in the bacterial cells. In addition, cefiderocol is stable against all known classes of beta-lactamases, including both the metallo- and serine-carbapenemases. Data from global surveillance studies for cefiderocol demonstrated potent in vitro activity against a wide spectrum of Gram-negative pathogens including carbapenem-resistant Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacteriaceae and Stenotrophomonas maltophilia.

Shionogi & Co., Ltd. Receives Approval for INTUNIV® in Japan

Shire plc announced that its partner in Japan, Shionogi & Co., Ltd, has received the approval of the Japanese Ministry of Health, Labor and Welfare to manufacture and market INTUNIV. INTUNIV is a new, once-daily non-stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD), a common psychiatric disorder in children and adolescents. INTUNIV is a selective alpha-2A adrenergic receptor agonist. With a unique mechanism of action, INTUNIV represents an additional treatment option in the management of ADHD. As part of the partnership, a Phase 3 placebo-controlled clinical study and long-term extension study evaluating the efficacy and safety of INTUNIV in 254 patients was conducted in Japan. In the trial, INTUNIV administered once daily, showed significant improvements over placebo, as measured by ADHD-RS-IV total score, in all core symptoms of ADHD: hyperactivity/impulsivity, and inattention. The most common adverse events were somnolence in 146 patients (57.5%), decreased blood pressure in 39 patients (15.4%), and headache in 31 patients (12.2%).

 

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