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ME01334B - Polivalentni pripravak konjugata pneumokoknog polisaharida s proteinom - Google Patents

Polivalentni pripravak konjugata pneumokoknog polisaharida s proteinom

Info

Publication number
ME01334B
ME01334B MEP-2012-39A MEP3912A ME01334B ME 01334 B ME01334 B ME 01334B ME P3912 A MEP3912 A ME P3912A ME 01334 B ME01334 B ME 01334B
Authority
ME
Montenegro
Prior art keywords
aluminum
immunogenic preparation
adjuvant
preparation according
crm197
Prior art date
Application number
MEP-2012-39A
Other languages
English (en)
Inventor
William P Hausdorff
George Rainer Siber
Peter R Paradiso
Original Assignee
Wyeth 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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=36709976&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ME01334(B) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Wyeth Llc filed Critical Wyeth Llc
Publication of ME01334B publication Critical patent/ME01334B/me

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/385—Haptens or antigens, bound to carriers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/02—Bacterial antigens
    • A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092—Streptococcus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/16—Otologicals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031—Proteins
    • A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/70—Multivalent vaccine

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Virology (AREA)
  • Pulmonology (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Polysaccharides And Polysaccharide Derivatives (AREA)

Claims (8)

1.Polivalentni imunogeni pripravak, naznačen tome što sadrži: 13 različitih polisaharidno-proteinskih konjugata, kao i fiziološki prihvatljiv vehikulum, gdje svaki od konjugata sadrži kapsularni polisaharid iz različitih serotipova bakterije Streptococcus pneumoniae, konjugiran s proteinom-nosačem, gdje su kapsularni polisaharidi dobiveni iz serotipova 1, 3, 4, 5, 6A, 68, 7F, 9V, 14, 18C, 19A, 19F i 23F, a protein-nosač je CRM197.
2.Imunogeni pripravak u skladu s patentnim zahtjevom 1, naznačen time što dodatno sadrži adjuvans.
3.je adjuvans na bazi aluminija.
4.Imunogeni pripravak u skladu s patentnim zahtjevom 3, naznačen time što se adjuvans bira iz skupine koju čine aluminijev fosfat, aluminijev sulfat i aluminijev hidroksid.
5.Imunogeni pripravak u skladu s patentnim zahtjevom 4, naznačen time što je adjuvans aluminijev fosfat.
6.Polivalentni imunogeni pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što je namijenjen upotrebi kao cjepivo.
7.Sterilna tekuća formulacija pneumokoknih kapsularnih polisaharida iz serotipova 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, te 23F, od kojih je svaki konjugiran s CRM197, naznačena time što je namijenjena upotrebi kao cjepivo.
8. Sterilna tekuća formulacija u skladu s patentnim zahtjevom 7, naznačena time što je svaka doza od 0,5 ml tako formulirana da sadrži: 2 µg svakog saharida, izuzev 6B (4 µg); otprilike 29 µg proteina CRM197 kao nosača; adjuvans s 0,125 mg elementarnog aluminija (0,5 mg aluminijevog fosfata); te pufer od natrijevog klorida i natrijevog sukcinata, kao pomoćne tvari.
MEP-2012-39A 2005-04-08 2006-03-31 Polivalentni pripravak konjugata pneumokoknog polisaharida s proteinom ME01334B (me)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US66960505P 2005-04-08 2005-04-08
PCT/US2006/012354 WO2006110381A1 (en) 2005-04-08 2006-03-31 Multivalent pneumococcal polysaccharide-protein conjugate composition
EP06740419A EP1868645B1 (en) 2005-04-08 2006-03-31 Multivalent pneumococcal polysaccharide-protein conjugate composition

Publications (1)

Publication Number Publication Date
ME01334B true ME01334B (me) 2013-12-20

Family

ID=36709976

Family Applications (1)

Application Number Title Priority Date Filing Date
MEP-2012-39A ME01334B (me) 2005-04-08 2006-03-31 Polivalentni pripravak konjugata pneumokoknog polisaharida s proteinom

Country Status (29)

Country Link
US (9) US20060228380A1 (me)
EP (9) EP4005595A1 (me)
JP (3) JP4472770B2 (me)
KR (11) KR102611449B1 (me)
CN (6) CN113198013B (me)
AR (2) AR053354A1 (me)
AT (1) ATE548051T1 (me)
AU (1) AU2006235013B2 (me)
BR (1) BRPI0607025B8 (me)
CA (4) CA2604363C (me)
CL (2) CL2016000566A1 (me)
CY (1) CY1112777T1 (me)
DK (1) DK1868645T3 (me)
ES (1) ES2382048T3 (me)
HK (3) HK1120416A1 (me)
HR (1) HRP20120278T1 (me)
IL (5) IL308456A (me)
ME (1) ME01334B (me)
MX (3) MX358148B (me)
MY (1) MY145150A (me)
NZ (1) NZ562406A (me)
PL (1) PL1868645T3 (me)
PT (1) PT1868645E (me)
RS (1) RS52249B (me)
SA (1) SA06270323B1 (me)
SI (1) SI1868645T1 (me)
TW (3) TWI511739B (me)
WO (1) WO2006110381A1 (me)
ZA (1) ZA200709483B (me)

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