BRPI0813699A2 - Formulações de proteína de fusão glp-1-fc - Google Patents

Formulações de proteína de fusão glp-1-fc

Info

Publication number: BRPI0813699A2
Authority: BR; Brazil
Prior art keywords: glp; fusion protein; protein formulations; formulation; polysorbate
Prior art date: 2007-07-10

Application number

BRPI0813699-8A2A

Other languages

English (en)

Inventor

Kingman Ng

Original Assignee

Lilly Co Eli

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.)

2007-07-10

Filing date

2008-07-09

Publication date

2014-12-30

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39870243&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BRPI0813699(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2008-07-09 Application filed by Lilly Co Eli filed Critical Lilly Co Eli

2014-12-30 Publication of BRPI0813699A2 publication Critical patent/BRPI0813699A2/pt

2021-06-22 Publication of BRPI0813699B1 publication Critical patent/BRPI0813699B1/pt

Links

239000000203 mixture Substances 0.000 title abstract 3
108020001507 fusion proteins Proteins 0.000 title abstract 2
238000009472 formulation Methods 0.000 abstract 2
FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
229930195725 Mannitol Natural products 0.000 abstract 1
208000008589 Obesity Diseases 0.000 abstract 1
239000007979 citrate buffer Substances 0.000 abstract 1
206010012601 diabetes mellitus Diseases 0.000 abstract 1
208000037265 diseases, disorders, signs and symptoms Diseases 0.000 abstract 1
102000037865 fusion proteins Human genes 0.000 abstract 1
239000000594 mannitol Substances 0.000 abstract 1
235000010355 mannitol Nutrition 0.000 abstract 1
235000020824 obesity Nutrition 0.000 abstract 1
239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 abstract 1
235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 abstract 1
229940068968 polysorbate 80 Drugs 0.000 abstract 1
229920000053 polysorbate 80 Polymers 0.000 abstract 1
239000000243 solution Substances 0.000 abstract 1

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
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/26—Glucagons
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
- 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
- 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
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/04—Anorexiants; Antiobesity agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Medicinal Chemistry (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Bioinformatics & Cheminformatics (AREA)
Diabetes (AREA)
Endocrinology (AREA)
Organic Chemistry (AREA)
Hematology (AREA)
Obesity (AREA)
Immunology (AREA)
Dermatology (AREA)
Gastroenterology & Hepatology (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Zoology (AREA)
Emergency Medicine (AREA)
Child & Adolescent Psychology (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Peptides Or Proteins (AREA)
Medicinal Preparation (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

BRPI0813699-8A 2007-07-10 2008-07-09 Formulação de proteína de fusão glp-1-fc BRPI0813699B1 (pt)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
US94885507P	2007-07-10	2007-07-10
US60/948,855		2007-07-10
PCT/US2008/069473 WO2009009562A2 (en)	2007-07-10	2008-07-09	Glp-1-fc fusion protein formulation

Publications (2)

Publication Number	Publication Date
BRPI0813699A2 true BRPI0813699A2 (pt)	2014-12-30
BRPI0813699B1 BRPI0813699B1 (pt)	2021-06-22

Family

ID=39870243

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
BRPI0813699-8A BRPI0813699B1 (pt)	2007-07-10	2008-07-09	Formulação de proteína de fusão glp-1-fc

Country Status (18)

Country	Link
US (1)	US20100196405A1 (pt)
EP (1)	EP2175834B8 (pt)
JP (1)	JP2010533197A (pt)
KR (1)	KR20100020516A (pt)
CN (1)	CN101730523A (pt)
AT (1)	ATE499088T1 (pt)
AU (1)	AU2008275180A1 (pt)
BR (1)	BRPI0813699B1 (pt)
CA (1)	CA2691695C (pt)
DE (1)	DE602008005155D1 (pt)
EA (1)	EA201070121A1 (pt)
HR (1)	HRP20110242T1 (pt)
MX (1)	MX2010000380A (pt)
NZ (1)	NZ582480A (pt)
RS (1)	RS52378B (pt)
UA (1)	UA97673C2 (pt)
WO (1)	WO2009009562A2 (pt)
ZA (1)	ZA201000149B (pt)

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PT2525787T (pt)	2010-01-19	2017-12-18	Hanmi Science Co Ltd	Formulações líquidas para conjugado de g-csf de longa ação
JP5800527B2 (ja) *	2010-03-30	2015-10-28	日東電工株式会社	安定化医薬組成物、安定化医薬組成物溶液製剤、フィルム状製剤及びフィルム状製剤の製造方法
CN102533655A (zh) *	2010-12-21	2012-07-04	青岛黄海制药有限责任公司	高效表达人源重组蛋白GLP1/Fc的CHO-S细胞株及其建立方法
UA126465C2 (uk)	2011-06-10	2022-10-12	Ханмі Сайенс Ко., Лтд.	Пептид, що має активність оксинтомодуліну, та фармацевтична композиція для лікування ожиріння, яка його містить
RU2607365C2 (ru)	2011-06-17	2017-01-10	Ханми Сайенс Ко., Лтд.	Конъюгат, содержащий оксинтомодулин и фрагмент иммуноглобулина, и его применение
WO2014014206A1 (en) *	2012-07-20	2014-01-23	University-Industry Cooperation Group Of Kyung Hee University	Novel peptide tag and uses thereof
AR092862A1 (es) *	2012-07-25	2015-05-06	Hanmi Pharm Ind Co Ltd	Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
KR101968344B1 (ko)	2012-07-25	2019-04-12	한미약품 주식회사	옥신토모듈린 유도체를 포함하는 고지혈증 치료용 조성물
AR091902A1 (es) *	2012-07-25	2015-03-11	Hanmi Pharm Ind Co Ltd	Formulacion liquida de un conjugado de insulina de accion prolongada
US10441665B2 (en)	2012-07-25	2019-10-15	Hanmi Pharm. Co., Ltd.	Liquid formulation of long acting insulinotropic peptide conjugate
AR094821A1 (es)	2012-07-25	2015-09-02	Hanmi Pharm Ind Co Ltd	Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
UA116217C2 (uk)	2012-10-09	2018-02-26	Санофі	Пептидна сполука як подвійний агоніст рецепторів glp1-1 та глюкагону
KR101993393B1 (ko)	2012-11-06	2019-10-01	한미약품 주식회사	옥신토모듈린 유도체를 포함하는 당뇨병 또는 비만성 당뇨병 치료용 조성물
WO2014073842A1 (en)	2012-11-06	2014-05-15	Hanmi Pharm. Co., Ltd.	Liquid formulation of protein conjugate comprising the oxyntomodulin and an immunoglobulin fragment
AU2013366692B2 (en)	2012-12-21	2017-11-23	Sanofi	Dual GLP1/GIP or trigonal GLP1/GIP/Glucagon agonists
CN104173275A (zh) *	2013-05-21	2014-12-03	深圳翰宇药业股份有限公司	度拉鲁肽注射剂及其制备方法
WO2015086733A1 (en)	2013-12-13	2015-06-18	Sanofi	Dual glp-1/glucagon receptor agonists
WO2015086728A1 (en)	2013-12-13	2015-06-18	Sanofi	Exendin-4 peptide analogues as dual glp-1/gip receptor agonists
EP3080152A1 (en)	2013-12-13	2016-10-19	Sanofi	Non-acylated exendin-4 peptide analogues
EP3080154B1 (en)	2013-12-13	2018-02-07	Sanofi	Dual glp-1/gip receptor agonists
TW201625670A (zh)	2014-04-07	2016-07-16	賽諾菲公司	衍生自ｅｘｅｎｄｉｎ－４之雙重ｇｌｐ－１／升糖素受體促效劑
TW201625669A (zh)	2014-04-07	2016-07-16	賽諾菲公司	衍生自艾塞那肽－４（Ｅｘｅｎｄｉｎ－４）之肽類雙重ＧＬＰ－１／升糖素受體促效劑
TW201625668A (zh)	2014-04-07	2016-07-16	賽諾菲公司	作為胜肽性雙重ｇｌｐ－１／昇糖素受體激動劑之艾塞那肽－４衍生物
US9932381B2 (en)	2014-06-18	2018-04-03	Sanofi	Exendin-4 derivatives as selective glucagon receptor agonists
TWI802396B (zh)	2014-09-16	2023-05-11	南韓商韓美藥品股份有限公司	長效glp-1/高血糖素受體雙促效劑治療非酒精性脂肝疾病之用途
CN104293834B (zh) *	2014-10-11	2018-03-23	上海兴迪金生物技术有限公司	GLP‑1或其类似物与抗体Fc片段融合蛋白的制备方法
KR102418477B1 (ko)	2014-12-30	2022-07-08	한미약품 주식회사	글루카곤 유도체
PT3257524T (pt) *	2015-02-11	2020-11-27	Gmax Biopharm Llc	Preparação de solução estabilizada de proteína de fusão de anticorpo glp-1r farmacêutica
AR105616A1 (es)	2015-05-07	2017-10-25	Lilly Co Eli	Proteínas de fusión
AR105319A1 (es)	2015-06-05	2017-09-27	Sanofi Sa	Profármacos que comprenden un conjugado agonista dual de glp-1 / glucagón conector ácido hialurónico
TW201706291A (zh)	2015-07-10	2017-02-16	賽諾菲公司	作為選擇性肽雙重ｇｌｐ－１／升糖素受體促效劑之新毒蜥外泌肽（ｅｘｅｎｄｉｎ－４）衍生物
CN107661288A (zh) *	2016-07-29	2018-02-06	江苏泰康生物医药有限公司	含有glp‑1 类似物融合蛋白的稳定液体制剂及其制备
WO2018024162A1 (en) *	2016-08-03	2018-02-08	Sunshine Lake Pharma Co., Ltd.	Glp-1 fusion protein comprising mutated immunoglobulin fc portion
CN108210890A (zh) *	2016-12-09	2018-06-29	江苏泰康生物医药有限公司	重组人胰高血糖素样肽-1类似物融合蛋白的新型稳定制剂
GB201621987D0 (en) *	2016-12-22	2017-02-08	Archer Virgil L See Archer Sheri A Arecor Ltd	Novel composition
CA3065295C (en)	2017-06-01	2023-08-29	Eli Lilly And Company	Dulaglutide for the treatment of chronic kidney disease
US12297272B2 (en)	2017-08-15	2025-05-13	Eianco US inc.	IgG Fc variants for veterinary use
KR102589234B1 (ko)	2017-11-21	2023-10-16	일라이 릴리 앤드 캄파니	둘라글루티드를 함유하는 조성물 및 사용 방법
CN109836503B (zh) *	2017-11-24	2022-09-16	浙江道尔生物科技有限公司	一种治疗代谢疾病的多重活性蛋白
TWI705820B (zh)	2018-06-22	2020-10-01	美商美國禮來大藥廠	Gip/glp1促效劑組合物
WO2020190591A1 (en)	2019-03-15	2020-09-24	Eli Lilly And Company	Preserved formulations
CA3177693A1 (en)	2019-04-05	2020-10-05	Eli Lilly And Company	Therapeutic uses of dulaglutide
GB201917723D0 (en) *	2019-12-04	2020-01-15	Nv Rose Llc	Stable liquid formulations of glucagon-like peptide 1 or analogues thereof
KR102349717B1 (ko) *	2020-03-12	2022-01-11	주식회사 에스엘메타젠	신규 대사증후군 및 그와 관련된 질환 치료용 약학 조성물
CN114053217B (zh) *	2020-08-03	2023-04-18	华兰生物工程股份有限公司	一种Exendin-4-Fc融合蛋白注射制剂及其制备方法
CN112494658B (zh) *	2020-12-04	2024-07-12	苏州药明生物技术有限公司	一种稳定的Fc融合蛋白制剂
CN114685644A (zh)	2020-12-29	2022-07-01	苏州康宁杰瑞生物科技有限公司	一种人glp-1多肽变体及其应用
TW202317607A (zh)	2021-07-06	2023-05-01	大陸商蘇州康寧杰瑞生物科技有限公司	融合蛋白及其應用
CN120917038A (zh)	2023-03-23	2025-11-07	伊莱利利公司	生产含有Fc的蛋白质的方法
CN117143242B (zh) *	2023-10-30	2024-03-29	南京佰抗生物科技有限公司	抗Galectin-3蛋白的单克隆抗体组合物及应用
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DK1831252T3 (da) *	2004-12-22	2009-10-05	Lilly Co Eli	GLP-1 analog fusionsproteinformuleringer

2008
- 2008-07-09 AT AT08772467T patent/ATE499088T1/de not_active IP Right Cessation
- 2008-07-09 EP EP08772467A patent/EP2175834B8/en active Active
- 2008-07-09 BR BRPI0813699-8A patent/BRPI0813699B1/pt active IP Right Grant
- 2008-07-09 KR KR1020107000435A patent/KR20100020516A/ko not_active Ceased
- 2008-07-09 AU AU2008275180A patent/AU2008275180A1/en not_active Abandoned
- 2008-07-09 EA EA201070121A patent/EA201070121A1/ru unknown
- 2008-07-09 JP JP2010516211A patent/JP2010533197A/ja not_active Withdrawn
- 2008-07-09 CN CN200880023539A patent/CN101730523A/zh active Pending
- 2008-07-09 CA CA2691695A patent/CA2691695C/en active Active
- 2008-07-09 WO PCT/US2008/069473 patent/WO2009009562A2/en not_active Ceased
- 2008-07-09 NZ NZ582480A patent/NZ582480A/en unknown
- 2008-07-09 DE DE602008005155T patent/DE602008005155D1/de active Active
- 2008-07-09 US US12/665,053 patent/US20100196405A1/en not_active Abandoned
- 2008-07-09 MX MX2010000380A patent/MX2010000380A/es active IP Right Grant
- 2008-07-09 UA UAA201000210A patent/UA97673C2/ru unknown
- 2008-07-09 HR HR20110242T patent/HRP20110242T1/hr unknown
- 2008-07-09 RS RS20110188A patent/RS52378B/sr unknown
2010
- 2010-01-08 ZA ZA2010/00149A patent/ZA201000149B/en unknown

Also Published As

Publication number	Publication date
US20100196405A1 (en)	2010-08-05
MX2010000380A (es)	2010-03-29
ZA201000149B (en)	2011-04-28
DE602008005155D1 (de)	2011-04-07
EP2175834B1 (en)	2011-02-23
CN101730523A (zh)	2010-06-09
RS52378B (sr)	2012-12-31
UA97673C2 (ru)	2012-03-12
NZ582480A (en)	2011-03-31
WO2009009562A3 (en)	2009-07-09
HRP20110242T1 (hr)	2011-05-31
ATE499088T1 (de)	2011-03-15
BRPI0813699B1 (pt)	2021-06-22
WO2009009562A2 (en)	2009-01-15
CA2691695C (en)	2014-03-18
HK1141237A1 (en)	2010-11-05
JP2010533197A (ja)	2010-10-21
KR20100020516A (ko)	2010-02-22
AU2008275180A1 (en)	2009-01-15
EP2175834A2 (en)	2010-04-21
CA2691695A1 (en)	2009-01-15
EP2175834B8 (en)	2012-08-22
EA201070121A1 (ru)	2010-06-30

Legal Events

Date	Code	Title	Description
2018-03-06	B07D	Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
2018-04-17	B06F	Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
2019-07-02	B07E	Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]	Free format text: NOTIFICACAO DE ANUENCIA RELACIONADA COM O ART 229 DA LPI
2019-07-16	B06T	Formal requirements before examination [chapter 6.20 patent gazette]
2021-01-12	B06A	Patent application procedure suspended [chapter 6.1 patent gazette]
2021-05-04	B09A	Decision: intention to grant [chapter 9.1 patent gazette]
2021-06-22	B16A	Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]	Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/07/2008, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, , QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO.

Publication	Publication Date	Title
BRPI0813699A2 (pt)	2014-12-30	Formulações de proteína de fusão glp-1-fc
EA200870019A1 (ru)	2008-12-30	Лактамовые соединения и способы их применения
EA200602062A1 (ru)	2007-04-27	Амидосоединения и их применение в качестве фармацевтических средств
MY147643A (en)	2012-12-31	Use of benzo-fused heterocycle sulfamide derivatives for the treatment of mania and bipolar disorder
GEP20125628B (en)	2012-09-10	Pharmaceutical compositions containing antagonist anti-cd40 antibody
TW200833357A (en)	2008-08-16	Stable polypeptide formulations
CL2007000789A1 (es)	2008-01-18	Compuestos derivados de malonamida, inhibidores de la gamma-secretasa; proceso de preparacion; composicion farmaceutica; y su uso en el tratamiento de la enfermedad de alzheimer.
BR0313629B1 (pt)	2013-04-02	composiÇço detergente bifÁsica lÍquida aquosa de limpeza pessoal.
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