WO2006083689A3 - Anti a beta antibody formulation - Google Patents

Anti a beta antibody formulation Download PDF

Info

Publication number
WO2006083689A3
WO2006083689A3 PCT/US2006/002837 US2006002837W WO2006083689A3 WO 2006083689 A3 WO2006083689 A3 WO 2006083689A3 US 2006002837 W US2006002837 W US 2006002837W WO 2006083689 A3 WO2006083689 A3 WO 2006083689A3
Authority
WO
WIPO (PCT)
Prior art keywords
formulations
histidine
mannitol
amino acid
molecular weight
Prior art date
Application number
PCT/US2006/002837
Other languages
French (fr)
Other versions
WO2006083689A2 (en
Inventor
Donna Luisi
Nicholas W Warne
Angela Kantor
Original Assignee
Neuralab Ltd
Wyeth Corp
Donna Luisi
Nicholas W Warne
Angela Kantor
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
Priority to AU2006211184A priority Critical patent/AU2006211184B8/en
Priority to CN2006800035305A priority patent/CN101262884B/en
Application filed by Neuralab Ltd, Wyeth Corp, Donna Luisi, Nicholas W Warne, Angela Kantor filed Critical Neuralab Ltd
Priority to KR1020077019596A priority patent/KR101188060B1/en
Priority to CA2593122A priority patent/CA2593122C/en
Priority to EA200701596A priority patent/EA015147B1/en
Priority to JP2007553242A priority patent/JP4977625B2/en
Priority to MX2007009050A priority patent/MX2007009050A/en
Priority to NZ556393A priority patent/NZ556393A/en
Priority to SI200631442T priority patent/SI1853310T1/en
Priority to PL06719621T priority patent/PL1853310T3/en
Priority to BRPI0607039-6A priority patent/BRPI0607039A2/en
Priority to DK06719621.2T priority patent/DK1853310T3/en
Priority to EP06719621A priority patent/EP1853310B1/en
Priority to ES06719621T priority patent/ES2391407T3/en
Publication of WO2006083689A2 publication Critical patent/WO2006083689A2/en
Publication of WO2006083689A3 publication Critical patent/WO2006083689A3/en
Priority to NO20073305A priority patent/NO20073305L/en
Priority to IL184599A priority patent/IL184599A/en
Priority to HK08102210.2A priority patent/HK1108132A1/en
Priority to HK08110924.2A priority patent/HK1118723A1/en

Links

Classifications

    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
    • A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • A61K9/14—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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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
    • 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
    • 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

Abstract

The present invention provides formulations for maintaining the stability of Aβ binding polypeptides, for example, Aβ antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.
PCT/US2006/002837 2005-01-28 2006-01-27 Anti a beta antibody formulation WO2006083689A2 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
BRPI0607039-6A BRPI0607039A2 (en) 2005-01-28 2006-01-27 formulation, unit dosage form, use of a formulation, pharmaceutical and method for the preparation of a pharmaceutical
PL06719621T PL1853310T3 (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation
DK06719621.2T DK1853310T3 (en) 2005-01-28 2006-01-27 The anti-Abeta antibody preparation
CN2006800035305A CN101262884B (en) 2005-01-28 2006-01-27 Anti A beta antibody formulation
EA200701596A EA015147B1 (en) 2005-01-28 2006-01-27 Stabilized antibody formulation to beta-amyloid peptide and use thereof
JP2007553242A JP4977625B2 (en) 2005-01-28 2006-01-27 Anti-Abeta antibody preparation
MX2007009050A MX2007009050A (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation.
NZ556393A NZ556393A (en) 2005-01-28 2006-01-27 Anti A beta antibody formulation
SI200631442T SI1853310T1 (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation
AU2006211184A AU2006211184B8 (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation
CA2593122A CA2593122C (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation
KR1020077019596A KR101188060B1 (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation
EP06719621A EP1853310B1 (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation
ES06719621T ES2391407T3 (en) 2005-01-28 2006-01-27 Anti-a-beta antibody formulation
NO20073305A NO20073305L (en) 2005-01-28 2007-06-28 Anti A beta antibody formulation
IL184599A IL184599A (en) 2005-01-28 2007-07-12 Formulations and pharmaceutical compositions containing an a?? binding polypeptide
HK08102210.2A HK1108132A1 (en) 2005-01-28 2008-02-28 Anti a beta antibody formulation
HK08110924.2A HK1118723A1 (en) 2005-01-28 2008-09-30 Anti a beta antibody formulation

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US64863105P 2005-01-28 2005-01-28
US60/648,631 2005-01-28

Publications (2)

Publication Number Publication Date
WO2006083689A2 WO2006083689A2 (en) 2006-08-10
WO2006083689A3 true WO2006083689A3 (en) 2006-10-19

Family

ID=36686080

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/002837 WO2006083689A2 (en) 2005-01-28 2006-01-27 Anti a beta antibody formulation

Country Status (30)

Country Link
US (2) US7635473B2 (en)
EP (2) EP2392353A1 (en)
JP (1) JP4977625B2 (en)
KR (1) KR101188060B1 (en)
CN (2) CN101262884B (en)
AR (1) AR052198A1 (en)
AU (1) AU2006211184B8 (en)
BR (1) BRPI0607039A2 (en)
CA (1) CA2593122C (en)
DK (1) DK1853310T3 (en)
DO (1) DOP2006000021A (en)
EA (2) EA015147B1 (en)
ES (1) ES2391407T3 (en)
GT (1) GT200600031A (en)
HK (3) HK1108132A1 (en)
IL (1) IL184599A (en)
JO (1) JO2740B1 (en)
MX (1) MX2007009050A (en)
MY (1) MY177052A (en)
NO (1) NO20073305L (en)
NZ (1) NZ556393A (en)
PE (1) PE20060879A1 (en)
PL (1) PL1853310T3 (en)
PT (1) PT1853310E (en)
SI (1) SI1853310T1 (en)
TW (1) TWI398263B (en)
UA (1) UA87549C2 (en)
UY (1) UY29351A1 (en)
WO (1) WO2006083689A2 (en)
ZA (1) ZA200705710B (en)

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US8895004B2 (en) 2007-02-27 2014-11-25 AbbVie Deutschland GmbH & Co. KG Method for the treatment of amyloidoses
US8987419B2 (en) 2010-04-15 2015-03-24 AbbVie Deutschland GmbH & Co. KG Amyloid-beta binding proteins
US9146244B2 (en) 2007-06-12 2015-09-29 Ac Immune S.A. Polynucleotides encoding an anti-beta-amyloid monoclonal antibody
US9176150B2 (en) 2003-01-31 2015-11-03 AbbVie Deutschland GmbH & Co. KG Amyloid beta(1-42) oligomers, derivatives thereof and antibodies thereto, methods of preparation thereof and use thereof
US9221900B2 (en) 2010-07-30 2015-12-29 Ac Immune S.A. Methods for identifying safe and functional humanized antibodies
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