Business Wire

Shionogi presents New Data on Cefiderocol (S-649266), a Siderophore Cephalosporin, and S-033188 a Cap-Dependent Endonuclease Inhibitor for Treatment of Influenza at ECCMID 2017

Del

Shionogi & Co., Ltd. today 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 (e.g., non-clinical efficacy against avian influenza virus A/H5N1).

Below is an overview of the oral and poster presentations featuring cefiderocol and S-033188 at ECCMID 2017:

Cefiderocol
Session Title     Presentation    

Abstract Number &
Presentation Information

Late-breaker: Recent clinical trials     Cefiderocol Compared with Imipenem/Cilastatin in the Treatment of Adults with Complicated Urinary Tract Infections with or without Pyelonephritis or Acute Uncomplicated Pyelonephritis: Results from a Multicenter, Double-blind, Randomized Study (APEKS*-cUTI)    

Abstract #7582
Oral Presentation
Saturday, April 22, 2017
17:09-17:20 PM
Presenter: Simon Portsmouth

Advances in Japanese Chemotherapy     Mode of action of cefiderocol, a novel siderophore cephalosporin, active against highly resistant Gram-negative bacteria including carbapenem-resistant strains of Enterobacteriaceae and non-fermenting bacteria    

Abstract #3177
Oral Presentation
Monday, April 24, 2017
14:54-15:04 PM
Presenter: Yoshinori Yamano

Cefiderocol     In vitro activity of cefiderocol against globally collected carbapenem-resistant Gram-negative bacteria including isolates resistant to ceftazidime/avibactam, ceftolozane/tazobactam and colistin: SIDERO-CR-2014/2016 study    

Poster #1316
Poster Presentation
Monday, April 24, 2017
12:30-13:30 PM
Presenter: Yoshinori Yamano

Surveillance of cefiderocol in vitro activity against Gram-negative clinical isolates collected in Europe: SIDERO-WT-2014    

Poster #1314
Poster Presentation
Monday, April 24, 2017
12:30-13:30 PM
Presenter: Masakatsu Tsuji

    The in vitro activity of cefiderocol, a siderophore cephalosporin, against a global collection of Stenotrophomonas maltophilia    

Poster #1313
Poster Presentation
Monday, April 24, 2017
12:30-13:30 PM
Presenter: Masakatsu Tsuji

S-033188
Session Title     Presentation    

Abstract Number &
Presentation Information

Advances in Japanese chemotherapy     Pharmacokinetic/pharmacodynamic analysis of S-033188, an influenza Cap-dependent endonuclease inhibitor, from a phase 2, randomized, double-blind, placebo-controlled study in otherwise healthy adults with seasonal influenza    

Abstract #1033
Oral Presentation
Monday, April 24, 2017
15:18-15:28 PM
Presenter: Takeki Uehara

Novel and improved therapeutical approaches to viral infections One day oral dosing of S-033188, a novel inhibitor of influenza virus Cap-dependent endonuclease, exhibited significant reduction of viral titer and prolonged survival in mice infected with influenza B virus    

Poster #1971
Poster Presentation
Tuesday, April 25, 2017
12:30-13:30 PM
Presenter: Takao Shishido

Pharmacokinetic and pharmacodynamic analysis of S-033188/S-033447, a novel inhibitor of influenza virus Cap-dependent endonuclease, in mice infected with influenza A virus    

Poster #1973
Poster Presentation
Tuesday, April 25, 2017
12:30-13:30 PM
Presenter: Takeshi Noshi

    Inhibitory effect of S-033188/S-033447, a novel inhibitor of influenza virus Cap-dependent endonuclease, against highly pathogenic avian influenza virus A/H5N1    

Poster #1974
Poster Presentation
Tuesday, April 25, 2017
12:30-13:30 PM
Presenter: Keiichi Taniguchi

 

Cefiderocol—an investigational antibiotic agent 1

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. 5

About the regulatory pathway of cefiderocol

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. Information is available at www.clinicaltrials.gov under the identifiers NCT02321800, NCT02714595 and NCT03032380, respectively.

* Acinetobacter, Pseudomonas, Escherichia, Klebsiella and Stenotrophomonas
Hospital-Acquired Pneumonia/Ventilator-Acquired Pneumonia/Healthcare-Associated Pneumonia
Nosocomial Pneumonia

About Influenza

Epidemic and pandemic influenza remain a major public health concern, and novel influenza drugs that will offer significant improvement over current therapy are urgently needed. Worldwide, annual influenza epidemics are estimated to result in 3 to 5 million cases of severe illness, and about 250,000 to 500,000 deaths.6 In general, those at highest risk of influenza-associated complications include children under 2 years of age, adults over 65 years of age, pregnant women, and people of any age with certain medical conditions, including chronic heart, lung, metabolic diseases (such as diabetes) and weakened immune systems.

About S-033188

S-033188 is a cap-dependent endonuclease inhibitor with a novel mechanism of action being studied for the treatment of influenza. S-033188 is an investigational product being developed for one-time dosing, and has the potential to be more effective than existing marketed anti-influenza products. Development and commercialization are in collaboration with F. Hoffmann-La Roche Ltd.

About Shionogi

Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and well-being of the patients we serve.” Shionogi’s research and development currently target two therapeutic areas: infectious diseases, and pain/CNS disorders. For over 50 years, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic disease and oncology/immunology. Contributing to the health and quality of life of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp/en/. For more information on Shionogi Inc., the U.S.-based subsidiary of Shionogi & Co., Ltd., headquartered in Florham Park, NJ, USA, please visit www.shionogi.com. For more information on Shionogi Ltd., the UK-based subsidiary of Shionogi & Co. Ltd., headquartered in London, England, please visit www.shionogi.eu.

Forward Looking Statement

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, unavailability 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.

Kohira N, West J, Ito A, et al. In vitro antimicrobial activity of a siderophore cephalosporin, S-649266, against Enterobacteriaceae clinicalisolates, including carbapenem-resistant strains. Antimicrob Agents Chemother. 2015;60(2):729-734.

 

2.

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).

 

3.

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.S31567.

 

4.

Ito-Horiyama T, Ishii Y, Ito A, et al. Stability of Novel Siderophore Cephalosporin S-649266 against Clinically Relevant Carbapenemases. Antimicrob Agents Chemother. 2016;60(7):4384-4386.

 

5.

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 (In preparation)

 

6.

http://www.who.int/mediacentre/factsheets/fs211/en/ WHO website, Influenza (Seasonal), Fact sheet N°211, March 2014

 

Contact information

Shionogi & Co., Ltd.
Corporate Communications
+81-6-6209-7885
Fax: +81-6-6229-9596
or
Investor Relations
Shionogi & Co., Ltd.
Yoshimasa Kyokawa, +81-6-6209-7885
Associate Director of Corporate Communications
yoshimasa.kyokawa@shionogi.co.jp
or
Shionogi Inc. U.S. Media
Michele Mencer, +1-973-307-3353
Vice President
Michele.mencer@shionogi.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 14:51Pressemelding

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 11:00Pressemelding

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01Pressemelding

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz

NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 15:32Pressemelding

NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such

CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 15:29Pressemelding

Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen