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PE20141159A1 - Metodos para tratar o prevenir trastornos relacionados con el colesterol - Google Patents

Metodos para tratar o prevenir trastornos relacionados con el colesterol

Info

Publication number
PE20141159A1
PE20141159A1 PE2013002471A PE2013002471A PE20141159A1 PE 20141159 A1 PE20141159 A1 PE 20141159A1 PE 2013002471 A PE2013002471 A PE 2013002471A PE 2013002471 A PE2013002471 A PE 2013002471A PE 20141159 A1 PE20141159 A1 PE 20141159A1
Authority
PE
Peru
Prior art keywords
sec
monoclonal antibody
amount
methods
related disorders
Prior art date
Application number
PE2013002471A
Other languages
English (en)
Inventor
Timothy David Osslund
Christi L Clogston
Original Assignee
Amgen Inc
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=46124771&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20141159(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Amgen Inc filed Critical Amgen Inc
Publication of PE20141159A1 publication Critical patent/PE20141159A1/es

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity determining region [CDR]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Endocrinology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Steroid Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

SE REFIERE A UNA FORMULACION ESTABLE QUE COMPRENDE: a) UN ANTICUERPO MONOCLONAL QUE SE UNE ESPECIFICAMENTE A PCSK9, EN DONDE PCSK9 COMPRENDE LOS AMINOACIDOS DE SEC. ID. N�:1, EL ANTICUERPO MONOCLONAL EN UNA CANTIDAD DE ENTRE 40 MG/ML Y 300MG/ML; b) UN TAMPON FARMACEUTICAMENTE ACEPTABLE EN UNA CANTIDAD DE 0,05 mM - 40 mM, QUE SE SELECCIONA DE GLUTAMATO, FOSFATO, CITRATO DE SODIO, ENTRE OTROS; c) UN SURFACTANTE EN UNA CANTIDAD DE 0,01%P/V-20%P/V, QUE SE SELECCIONA DE POLISORBATO 80, POLISOBATO 20; d) UN ESTABILIZADOR FARMACEUTICAMENTE ACEPTABLE QUE SE SELECCIONA DE UN DISACARIDO, POLIOL, PROLINA, ENTRE OTROS; EN CANTIDADES DE 0,5%P/V Y 10% P/V. EN DONDE LA FORMULACION ESTABLE TIENE UN PH DE 4,0- 6,0. DICHO ANTICUERPO MONOCLONAL SE SELECCIONA DEL GRUPO QUE CONSISTE EN 21B12, 11F1, 31H4, 8 A3 Y 8 A1, ADEMAS PRESENTA UNA REGION VARIABLE DE CADENA LIGERA QUE COMPRENDE SEC. ID N�: 23, SEC. ID N�: 465, ENTRE OTROS Y UNA REGION VARIABLE DE CADENA PESADA QUE COMPRENDE SEC. ID. N�: 49, SEC. ID N�: 463, ENTRE OTROS. SE REFIERE TAMBIEN A METODOS PARA PRODUCIR DICHA FORMULACION QUE SON UTILES PARA EL TRATAMIENTO DE TRASTORNOS RELACIONADOS CON EL COLESTEROL.
PE2013002471A 2011-05-10 2012-05-10 Metodos para tratar o prevenir trastornos relacionados con el colesterol PE20141159A1 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161484610P 2011-05-10 2011-05-10
US201161562303P 2011-11-21 2011-11-21
US201261595526P 2012-02-06 2012-02-06
US201261614417P 2012-03-22 2012-03-22
US201261642363P 2012-05-03 2012-05-03

Publications (1)

Publication Number Publication Date
PE20141159A1 true PE20141159A1 (es) 2014-09-19

Family

ID=46124771

Family Applications (3)

Application Number Title Priority Date Filing Date
PE2023003011A PE20240547A1 (es) 2011-05-10 2012-05-10 Metodos para tratar o prevenir trastornos relacionados con el colesterol
PE2013002471A PE20141159A1 (es) 2011-05-10 2012-05-10 Metodos para tratar o prevenir trastornos relacionados con el colesterol
PE2018001494A PE20181790A1 (es) 2011-05-10 2012-05-10 Metodos para tratar o prevenir trastornos relacionados con el colesterol

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PE2023003011A PE20240547A1 (es) 2011-05-10 2012-05-10 Metodos para tratar o prevenir trastornos relacionados con el colesterol

Family Applications After (1)

Application Number Title Priority Date Filing Date
PE2018001494A PE20181790A1 (es) 2011-05-10 2012-05-10 Metodos para tratar o prevenir trastornos relacionados con el colesterol

Country Status (36)

Country Link
US (1) US20210047434A1 (es)
EP (2) EP2707029B1 (es)
JP (3) JP6166717B2 (es)
KR (5) KR20250127346A (es)
CN (3) CN107261139A (es)
AP (1) AP2013007303A0 (es)
AR (1) AR086344A1 (es)
AU (5) AU2012253434B2 (es)
CA (1) CA2835294C (es)
CL (2) CL2013003214A1 (es)
CR (1) CR20130640A (es)
CY (1) CY1122967T1 (es)
DK (1) DK2707029T3 (es)
EA (1) EA031228B1 (es)
ES (1) ES2781749T3 (es)
HR (1) HRP20200545T1 (es)
HU (1) HUE049018T2 (es)
IL (4) IL311262B2 (es)
JO (2) JOP20200043A1 (es)
LT (1) LT2707029T (es)
ME (1) ME03765B (es)
MX (2) MX378241B (es)
MY (2) MY173860A (es)
PE (3) PE20240547A1 (es)
PH (2) PH12013502287A1 (es)
PL (1) PL2707029T3 (es)
PT (1) PT2707029T (es)
RS (1) RS60292B1 (es)
SG (1) SG194855A1 (es)
SI (1) SI2707029T1 (es)
SM (1) SMT202000183T1 (es)
TW (5) TWI610683B (es)
UA (2) UA114602C2 (es)
UY (1) UY34063A (es)
WO (1) WO2012154999A1 (es)
ZA (1) ZA201309173B (es)

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