BR112018017031A2 - formulações de antagonista de il-6 e usos das mesmas - Google Patents

formulações de antagonista de il-6 e usos das mesmas

Info

Publication number
BR112018017031A2
BR112018017031A2 BR112018017031A BR112018017031A BR112018017031A2 BR 112018017031 A2 BR112018017031 A2 BR 112018017031A2 BR 112018017031 A BR112018017031 A BR 112018017031A BR 112018017031 A BR112018017031 A BR 112018017031A BR 112018017031 A2 BR112018017031 A2 BR 112018017031A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical compositions
antagonist
formulations
antagonist formulations
interleukin
Prior art date
Application number
BR112018017031A
Other languages
English (en)
Inventor
Zarbis-Papastoitsis Grigorios
Lowden Patricia
Original Assignee
Sesen Bio 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
Application filed by Sesen Bio Inc filed Critical Sesen Bio Inc
Publication of BR112018017031A2 publication Critical patent/BR112018017031A2/pt

Links

Classifications

    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • 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
    • A61P27/02—Ophthalmic agents
    • A61P27/14—Decongestants or antiallergics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C07K16/248—IL-6
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Abstract

a presente invenção refere-se a composições e formulações farmacêuticas contendo um antagonista de interleucina-6 (il-6), por exemplo, uma molécula de anticorpo il-6, projetado para a administração a um indivíduo. as composições e formulações farmacêuticas providas aqui são adequadas para uso na fabricação de medicamentos ou métodos de tratamento de indivíduos com doenças associadas à il-6, por exemplo, doenças oculares associadas com elevados níveis de il-6.
BR112018017031A 2016-02-23 2017-02-23 formulações de antagonista de il-6 e usos das mesmas BR112018017031A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662298774P 2016-02-23 2016-02-23
PCT/US2017/019131 WO2017147293A1 (en) 2016-02-23 2017-02-23 Il-6 antagonist formulations and uses thereof

Publications (1)

Publication Number Publication Date
BR112018017031A2 true BR112018017031A2 (pt) 2019-01-22

Family

ID=59685584

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018017031A BR112018017031A2 (pt) 2016-02-23 2017-02-23 formulações de antagonista de il-6 e usos das mesmas

Country Status (11)

Country Link
US (2) US20190046642A1 (pt)
EP (1) EP3419599A4 (pt)
JP (2) JP2019510078A (pt)
KR (1) KR20180116359A (pt)
CN (1) CN108718522A (pt)
AR (1) AR107708A1 (pt)
AU (1) AU2017223687A1 (pt)
BR (1) BR112018017031A2 (pt)
CA (1) CA3012350A1 (pt)
MX (1) MX2018010032A (pt)
WO (1) WO2017147293A1 (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111110842B (zh) * 2017-11-30 2020-12-11 百奥泰生物制药股份有限公司 一种治疗il-6相关疾病的人源化抗体的液体制剂
WO2020054871A1 (ja) * 2018-09-14 2020-03-19 田辺三菱製薬株式会社 ヒト抗ｉｌ－３３モノクローナル抗体含有医薬用組成物
MX2021005015A (es) * 2018-10-31 2021-07-21 Richter Gedeon Nyrt Formulaciones farmaceuticas acuosas.
CN116234576A (zh) * 2020-07-31 2023-06-06 阿拉玛布治疗学股份有限公司 抗-连接蛋白抗体制剂
WO2022037606A1 (en) * 2020-08-19 2022-02-24 Bio-Thera Solutions, Ltd. Liquid formulations comprising high concentrations humanized antibodies for treating il-6 related diseases
KR20220028972A (ko) * 2020-08-31 2022-03-08 (주)셀트리온 안정한 약제학적 제제
US20230073821A1 (en) * 2021-08-27 2023-03-09 International Business Machines Corporation Antigen-binding proteins targeting coronavirus (cov) variants
CN114525235B (zh) * 2022-02-25 2023-07-14 郑州大学 一种提高人表皮生长因子分泌生产效率的方法
WO2024073718A1 (en) * 2022-09-30 2024-04-04 Sonnet BioTherapeutics, Inc. Low dose il-6 formulations and methods of use thereof

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PT1441589E (pt) * 2001-11-08 2012-08-13 Abbott Biotherapeutics Corp Formulação farmacêutica líquida estável de anticorpos igg
AU2003293543A1 (en) * 2002-12-13 2004-07-09 Abgenix, Inc. System and method for stabilizing antibodies with histidine
JP5503543B2 (ja) * 2007-09-14 2014-05-28 サノフィ パスツール バイオロジクス リミテッド ライアビリティ カンパニー クロストリジウム・ディフィシレトキソイドａおよびｂを含有する薬学的組成物
US20120005773A1 (en) * 2008-10-01 2012-01-05 Aasen Eric D Transgenic plants with enhanced agronomic traits
US8992920B2 (en) * 2008-11-25 2015-03-31 Alderbio Holdings Llc Anti-IL-6 antibodies for the treatment of arthritis
KR20110108398A (ko) * 2009-01-29 2011-10-05 메디뮨 엘엘씨 연장된 생체내 반감기를 갖는 인간 안티-ｉｌ-6 항체 및 종양학, 자가면역 질환 및 염증성 질환의 치료에 있어서의 이들의 용도
JO3417B1 (ar) * 2010-01-08 2019-10-20 Regeneron Pharma الصيغ المستقرة التي تحتوي على الأجسام المضادة لمضاد مستقبل( interleukin-6 (il-6r
PE20130643A1 (es) * 2010-07-12 2013-06-07 Covx Technologies Ireland Ltd Conjugados de anticuerpos multifuncionales
EP2788097A4 (en) * 2011-12-07 2015-09-09 Amgen Inc IGG2 DISULFIDE ISOFORMATION SEPARATION
TW201400122A (zh) * 2012-06-01 2014-01-01 Ophthotech Corp 包含抗－ｐｄｇｆ適體及ｖｅｇｆ拮抗劑之組合物
KR102238677B1 (ko) * 2012-09-07 2021-04-12 코히러스 바이오사이언시즈, 인코포레이티드 아달리무맙의 안정한 수성 제형
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Also Published As

Publication number Publication date
CA3012350A1 (en) 2017-08-31
WO2017147293A1 (en) 2017-08-31
AR107708A1 (es) 2018-05-23
JP2022084922A (ja) 2022-06-07
US20190046642A1 (en) 2019-02-14
AU2017223687A1 (en) 2018-08-09
KR20180116359A (ko) 2018-10-24
US20220241414A1 (en) 2022-08-04
JP2019510078A (ja) 2019-04-11
EP3419599A1 (en) 2019-01-02
EP3419599A4 (en) 2019-09-11
MX2018010032A (es) 2019-03-11
CN108718522A (zh) 2018-10-30

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B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B350 Update of information on the portal [chapter 15.35 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

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B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2711 DE 20-12-2022 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.