SI2198007T1 - Pharmaceutical compositions containing Clostridium difficile A and B toxoids - Google Patents

Pharmaceutical compositions containing Clostridium difficile A and B toxoids Download PDF

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Publication number
SI2198007T1
SI2198007T1 SI200831906T SI200831906T SI2198007T1 SI 2198007 T1 SI2198007 T1 SI 2198007T1 SI 200831906 T SI200831906 T SI 200831906T SI 200831906 T SI200831906 T SI 200831906T SI 2198007 T1 SI2198007 T1 SI 2198007T1
Authority
SI
Slovenia
Prior art keywords
composition
sodium
clostridium difficile
toxoid
sucrose
Prior art date
Application number
SI200831906T
Other languages
English (en)
Slovenian (sl)
Inventor
C. Russell Middaugh
Richard Fahrner
Peter Ciarametaro
Original Assignee
Sanofi Pasteur Biologics, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Pasteur Biologics, Llc filed Critical Sanofi Pasteur Biologics, Llc
Publication of SI2198007T1 publication Critical patent/SI2198007T1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/08Clostridium, e.g. Clostridium tetani
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/12Antidiarrhoeals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Genetics & Genomics (AREA)
  • Biotechnology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Biomedical Technology (AREA)
  • Virology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • General Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
SI200831906T 2007-09-14 2008-09-15 Pharmaceutical compositions containing Clostridium difficile A and B toxoids SI2198007T1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US97249607P 2007-09-14 2007-09-14
EP08830210.4A EP2198007B1 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b
PCT/US2008/010767 WO2009035707A1 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing clostridium difficile toxoids a and b

Publications (1)

Publication Number Publication Date
SI2198007T1 true SI2198007T1 (en) 2018-04-30

Family

ID=40452372

Family Applications (1)

Application Number Title Priority Date Filing Date
SI200831906T SI2198007T1 (en) 2007-09-14 2008-09-15 Pharmaceutical compositions containing Clostridium difficile A and B toxoids

Country Status (21)

Country Link
US (3) US9320790B2 (enExample)
EP (3) EP3124044B8 (enExample)
JP (3) JP5503543B2 (enExample)
KR (2) KR20160005378A (enExample)
CN (2) CN101855336B (enExample)
AU (1) AU2008299885C1 (enExample)
BR (1) BRPI0816790A8 (enExample)
CA (1) CA2699435A1 (enExample)
CY (1) CY1119979T1 (enExample)
DK (1) DK2198007T3 (enExample)
ES (2) ES3001561T3 (enExample)
HR (1) HRP20180054T1 (enExample)
HU (1) HUE037932T2 (enExample)
IL (1) IL204366A (enExample)
MX (1) MX2010002815A (enExample)
NO (1) NO2198007T3 (enExample)
PL (1) PL2198007T3 (enExample)
PT (1) PT2198007T (enExample)
RU (1) RU2550271C2 (enExample)
SI (1) SI2198007T1 (enExample)
WO (1) WO2009035707A1 (enExample)

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NO2198007T3 (enExample) 2007-09-14 2018-03-24
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TWI701257B (zh) 2011-04-22 2020-08-11 美商惠氏有限責任公司 與難養芽胞梭菌(Clostridium difficile)之突變毒素有關之組成物及彼之方法
KR101135486B1 (ko) * 2011-05-25 2012-04-13 함종욱 보툴리눔 에이형 독소의 액상제품
BR122016023101B1 (pt) 2012-10-21 2022-03-22 Pfizer Inc Polipeptídeo, composição imunogênica que o compreende, bem como célula recombinante derivada de clostridium difficile
EP2917238A1 (en) 2012-11-08 2015-09-16 Eleven Biotherapeutics, Inc. Il-6 antagonists and uses thereof
TR201905272T4 (tr) 2012-12-05 2019-05-21 Glaxosmithkline Biologicals Sa İmmünojenik bileşim.
AU2014236804B2 (en) 2013-03-14 2018-12-13 Takeda Vaccines, Inc. Compositions and methods for live, attenuated alphavirus formulations
BR112015023332A2 (pt) * 2013-03-15 2017-08-22 Sanofi Pasteur Inc Toxóide, composições e método relacionados
SG11201507578PA (en) 2013-03-15 2015-10-29 Sanofi Pasteur Inc Toxoid, compositions and related methods
KR20160020543A (ko) 2013-06-14 2016-02-23 사노피 파스퇴르 인코포레이티드 씨. 디피실에 대해서 면역화시키는 조성물 및 방법
BR112015031541A2 (pt) 2013-06-17 2017-07-25 De Staat Der Nederlanden Vert Door De Mini Van Vws Miniie Van Volksgezondheid Welzijn En Sport métodos para o impedimento da agregação de componentes virais
US9930893B2 (en) * 2014-02-10 2018-04-03 The Johns Hopkins University Inhibitors of DXP synthase and methods of use thereof
PH12017500809B1 (en) 2014-11-07 2023-09-20 F Hoffmann La Roche Ltd Improved il-6 antibodies
CN107847576A (zh) 2015-05-15 2018-03-27 圣诺菲·帕斯图尔公司 针对艰难梭状芽孢杆菌的免疫方法
BE1023343B1 (nl) * 2015-05-20 2017-02-09 Mycartis Nv Opslagbuffer
JP2019510078A (ja) 2016-02-23 2019-04-11 セセン バイオ, インコーポレイテッド Il−6アンタゴニスト製剤およびその使用
TWI773686B (zh) 2016-09-13 2022-08-11 美商愛力根公司 非蛋白梭菌毒素組成物
WO2019225568A1 (ja) * 2018-05-21 2019-11-28 中外製薬株式会社 ガラス容器に封入された凍結乾燥製剤
WO2021255690A2 (en) * 2020-06-19 2021-12-23 Pfizer Inc. Immunogenic compositions against clostridioides (clostridium) difficile and methods thereof

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Also Published As

Publication number Publication date
IL204366A (en) 2013-02-28
US20180000920A1 (en) 2018-01-04
ES3001561T3 (en) 2025-03-05
US20160317640A1 (en) 2016-11-03
PT2198007T (pt) 2018-01-29
AU2008299885A1 (en) 2009-03-19
CA2699435A1 (en) 2009-03-19
KR101679812B1 (ko) 2016-11-28
US10639362B2 (en) 2020-05-05
PL2198007T3 (pl) 2018-03-30
ES2657485T3 (es) 2018-03-05
NO2198007T3 (enExample) 2018-03-24
EP2198007A4 (en) 2012-03-07
KR20160005378A (ko) 2016-01-14
JP2010539172A (ja) 2010-12-16
RU2010114730A (ru) 2011-10-20
BRPI0816790A2 (pt) 2014-10-14
EP3124044A1 (en) 2017-02-01
MX2010002815A (es) 2010-07-30
JP2014055174A (ja) 2014-03-27
RU2550271C2 (ru) 2015-05-10
EP2198007B1 (en) 2017-10-25
WO2009035707A1 (en) 2009-03-19
EP3124044C0 (en) 2024-12-18
JP2017052773A (ja) 2017-03-16
HUE037932T2 (hu) 2018-09-28
CN106039299A (zh) 2016-10-26
WO2009035707A9 (en) 2010-06-10
CN101855336B (zh) 2019-07-30
EP3124044B8 (en) 2025-01-22
DK2198007T3 (en) 2018-01-15
US20110045025A1 (en) 2011-02-24
EP4537849A2 (en) 2025-04-16
JP6258674B2 (ja) 2018-01-10
CN101855336A (zh) 2010-10-06
HRP20180054T1 (hr) 2018-02-09
US9687541B2 (en) 2017-06-27
BRPI0816790A8 (pt) 2017-05-16
CY1119979T1 (el) 2018-12-12
JP5503543B2 (ja) 2014-05-28
EP2198007A1 (en) 2010-06-23
KR20100075912A (ko) 2010-07-05
AU2008299885B2 (en) 2014-12-11
EP4537849A3 (en) 2025-07-09
US9320790B2 (en) 2016-04-26
EP3124044B1 (en) 2024-12-18
AU2008299885C1 (en) 2015-06-25

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