SG11201809229VA - Pharmaceutical composition - Google Patents

Pharmaceutical composition

Info

Publication number
SG11201809229VA
SG11201809229VA SG11201809229VA SG11201809229VA SG11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA SG 11201809229V A SG11201809229V A SG 11201809229VA
Authority
SG
Singapore
Prior art keywords
international
ucb
rule
freeze
pct
Prior art date
Application number
SG11201809229VA
Inventor
Andrew Jeffrey Yates
Jan Ivo Massant
Original Assignee
Ucb Biopharma Sprl
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=56320265&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SG11201809229V(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Publication of SG11201809229VA publication Critical patent/SG11201809229VA/en

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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39566—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 16 November 2017 (16.11.2017) WIPO I PCT omit IIl mum o oimIE (10) International Publication Number WO 2017/194646 Al (51) International Patent Classification: A61K 39/395 (2006.01) A61K 9/08 (2006.01) A61K 9/19 (2006.01) A61K 47/26 (2006.01) (21) International Application Number: PCT/EP2017/061261 (22) International Filing Date: 11 May 2017 (11.05.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 1608323.0 12 May 2016 (12.05.2016) GB (71) Applicant: UCB BIOPHARMA SPRL [BE/BE]; 60, Al- lee de la Recherche, 1070 Brussels (BE). (72) Inventors: YATES, Andrew Jeffrey; c/o IPD, UCB Cell- tech, 208 Bath Road, Slough Berkshire SL1 2DT (GB). MASSANT, Jan Ivo; c/o IPD, UCB Celltech, 208 Bath Road, Slough Berkshire SL1 3WE (GB). (74) Agent: UCB INTELLECTUAL PROPERTY; c/o UCB Celltech, 208 Bath Road, Slough Berkshire SL1 3WE (GB). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (54) Title: PHARMACEUTICAL COMPOSITION Fig. 1 70 (57) : The present invention relates to pharmaceutical compositions comprising an antibody or a fragment thereof suitable for freeze-drying (i.e. lyophilizing) The pharmaceutical compositions, which comprise an antibody or an antigen-binding fragment thereof; from 1 % to 20% w/v sucrose; an amino acid or a mixture of amino acids; and surfactant, are provided as pharmaceutical compositions for freeze-drying; as freeze-dried (i.e. lyophilized) compositions which can be reconstituted into a solvent at the time of use or as reconstituted liquid formulations ready for administration. [Continued on next page] WO 2017/194646 Al MIDEDIMOMOIDEIROIDEMOMOIROMINIfillOINVOIMIE TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(1i)) of inventorship (Rule 4.17(iv)) Published: — with international search report (Art. 21(3)) — with sequence listing part of description (Rule 5.2(a))
SG11201809229VA 2016-05-12 2017-05-11 Pharmaceutical composition SG11201809229VA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1608323.0A GB201608323D0 (en) 2016-05-12 2016-05-12 Pharmaceutical compositions
PCT/EP2017/061261 WO2017194646A1 (en) 2016-05-12 2017-05-11 Pharmaceutical composition

Publications (1)

Publication Number Publication Date
SG11201809229VA true SG11201809229VA (en) 2018-11-29

Family

ID=56320265

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201809229VA SG11201809229VA (en) 2016-05-12 2017-05-11 Pharmaceutical composition

Country Status (17)

Country Link
US (1) US11407835B2 (en)
EP (1) EP3454899B1 (en)
JP (1) JP7126454B2 (en)
KR (1) KR102436694B1 (en)
CN (1) CN109069643A (en)
AR (1) AR108449A1 (en)
AU (1) AU2017264553A1 (en)
BR (1) BR112018072264A2 (en)
CA (1) CA3022124A1 (en)
CL (1) CL2018003178A1 (en)
CO (1) CO2018011733A2 (en)
EA (1) EA201892446A1 (en)
GB (1) GB201608323D0 (en)
IL (1) IL262654A (en)
MX (1) MX2018013215A (en)
SG (1) SG11201809229VA (en)
WO (1) WO2017194646A1 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201708655D0 (en) * 2017-05-31 2017-07-12 Ucb Biopharma Sprl Cell culture methods
AU2019237252A1 (en) * 2018-03-23 2020-10-22 AbbVie Deutschland GmbH & Co. KG Stable aqueous anti-tau antibody formulations
US11634485B2 (en) 2019-02-18 2023-04-25 Eli Lilly And Company Therapeutic antibody formulation
WO2021183781A1 (en) * 2020-03-11 2021-09-16 Selecta Biosciences, Inc. Methods and compositions related to synthetic nanocarriers
AU2022274319A1 (en) * 2021-05-12 2024-01-04 Anaptysbio, Inc. Antibody composition
AR127813A1 (en) 2021-12-01 2024-02-28 UCB Biopharma SRL PHARMACEUTICAL FORMULATIONS COMPRISING Fab-PEG
WO2023224112A1 (en) * 2022-05-20 2023-11-23 株式会社ダイセル Liquid pharmaceutical composition
US11926669B2 (en) 2022-05-30 2024-03-12 Hanall Biopharma Co., Ltd. Anti-FcRn antibody or antigen binding fragment thereof with improved stability

Family Cites Families (22)

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CA2454587C (en) * 2001-07-25 2012-11-13 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
AU2004290070A1 (en) * 2003-11-12 2005-05-26 Biogen Idec Ma Inc. Neonatal Fc receptor (FcRn)-binding polypeptide variants, dimeric Fc binding proteins and methods related thereto
CN101124245A (en) * 2003-11-12 2008-02-13 比奥根艾迪克Ma公司 Neonatal Fc receptor (FcRn)-binding polypeptide variants, dimeric Fc binding proteins and methods related thereto
US9283260B2 (en) 2006-04-21 2016-03-15 Amgen Inc. Lyophilized therapeutic peptibody formulations
US9642907B2 (en) * 2006-05-12 2017-05-09 Bharat Biotech International Limited Stabilized liquid rotavirus vaccine composition
AR070316A1 (en) 2008-02-07 2010-03-31 Merck & Co Inc PCSK9 ANTAGONISTS (SUBTILISINE-KEXINA TYPE 9 PROPROTEIN)
AR070315A1 (en) * 2008-02-07 2010-03-31 Merck & Co Inc ANTIBODIES 1B20 ANTAGONISTS OF PCSK9
KR20120027031A (en) 2009-06-18 2012-03-20 와이어쓰 엘엘씨 Lyophilized formulations for small modular immunopharmaceuticals
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
US8788028B2 (en) 2010-07-28 2014-07-22 Medtronic, Inc. Parasympathetic stimulation to enhance tachyarrhythmia detection
US9458240B2 (en) 2010-12-10 2016-10-04 Novartis Pharma Ag Anti-BAFFR antibody formulations
JP6014116B2 (en) * 2011-03-31 2016-10-25 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． Stable formulations of antibodies to human programmed death receptor PD-1 and related treatments
JOP20200043A1 (en) 2011-05-10 2017-06-16 Amgen Inc Methods of treating or preventing cholesterol related disorders
US9592289B2 (en) * 2012-03-26 2017-03-14 Sanofi Stable IgG4 based binding agent formulations
CA3204402A1 (en) * 2012-03-26 2013-10-03 Sanofi Stable anti-cxcr5 igg4 antibody formulations
GB201208370D0 (en) 2012-05-14 2012-06-27 Ucb Pharma Sa Antibodies
US8883979B2 (en) 2012-08-31 2014-11-11 Bayer Healthcare Llc Anti-prolactin receptor antibody formulations
US8613919B1 (en) 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
US20150307606A1 (en) 2012-12-13 2015-10-29 Ashwin Basarkar Lyophilized spherical pellets of anti-il-23 antibodies
US20150225479A1 (en) 2014-02-12 2015-08-13 Sanofi Anti-IL-4/Anti-IL-13 Bispecific Antibody/Polyglutamate Formulations
CN107073113A (en) 2014-10-18 2017-08-18 辉瑞大药厂 Anti- IL 7R antibody compositions
GB201508180D0 (en) 2015-05-13 2015-06-24 Ucb Biopharma Sprl Antibodies

Also Published As

Publication number Publication date
CA3022124A1 (en) 2017-11-16
US20200048346A1 (en) 2020-02-13
IL262654A (en) 2018-12-31
US11407835B2 (en) 2022-08-09
CN109069643A (en) 2018-12-21
KR102436694B1 (en) 2022-08-25
CL2018003178A1 (en) 2019-02-01
CO2018011733A2 (en) 2019-02-08
JP7126454B2 (en) 2022-08-26
AR108449A1 (en) 2018-08-22
JP2019514998A (en) 2019-06-06
WO2017194646A1 (en) 2017-11-16
KR20190008320A (en) 2019-01-23
BR112018072264A2 (en) 2019-02-12
EP3454899A1 (en) 2019-03-20
EP3454899B1 (en) 2024-03-20
MX2018013215A (en) 2019-02-21
RU2018141591A3 (en) 2021-01-13
AU2017264553A1 (en) 2018-12-13
RU2018141591A (en) 2020-06-15
EA201892446A1 (en) 2019-04-30
GB201608323D0 (en) 2016-06-29
EP3454899C0 (en) 2024-03-20

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