KR100596610B1 - Hsa-비함유 제제 내 nesp/epo에 대한안정화제로서의 l-메티오닌 - Google Patents

Hsa-비함유 제제 내 nesp/epo에 대한안정화제로서의 l-메티오닌 Download PDF

Info

Publication number
KR100596610B1
KR100596610B1 KR1020047002971A KR20047002971A KR100596610B1 KR 100596610 B1 KR100596610 B1 KR 100596610B1 KR 1020047002971 A KR1020047002971 A KR 1020047002971A KR 20047002971 A KR20047002971 A KR 20047002971A KR 100596610 B1 KR100596610 B1 KR 100596610B1
Authority
KR
South Korea
Prior art keywords
nesp
methionine
delete delete
formulation
epo
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
KR1020047002971A
Other languages
English (en)
Korean (ko)
Other versions
KR20040044194A (ko
Inventor
톈성 리
병 에스. 장
크리스토퍼 슬로이
Original Assignee
키린-암젠 인코포레이티드
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=25483206&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR100596610(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by 키린-암젠 인코포레이티드 filed Critical 키린-암젠 인코포레이티드
Publication of KR20040044194A publication Critical patent/KR20040044194A/ko
Application granted granted Critical
Publication of KR100596610B1 publication Critical patent/KR100596610B1/ko
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/18Growth factors; Growth regulators
    • A61K38/1816Erythropoietin [EPO]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
KR1020047002971A 2001-08-30 2002-08-29 Hsa-비함유 제제 내 nesp/epo에 대한안정화제로서의 l-메티오닌 Ceased KR100596610B1 (ko)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/945,517 2001-08-30
US09/945,517 US20030104996A1 (en) 2001-08-30 2001-08-30 L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
PCT/US2002/027855 WO2003020299A1 (en) 2001-08-30 2002-08-29 L-methionine as a stabilizer for nesp/epo in hsa-free formulations

Publications (2)

Publication Number Publication Date
KR20040044194A KR20040044194A (ko) 2004-05-27
KR100596610B1 true KR100596610B1 (ko) 2006-07-06

Family

ID=25483206

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020047002971A Ceased KR100596610B1 (ko) 2001-08-30 2002-08-29 Hsa-비함유 제제 내 nesp/epo에 대한안정화제로서의 l-메티오닌

Country Status (10)

Country Link
US (1) US20030104996A1 (https=)
EP (1) EP1439848B1 (https=)
JP (2) JP4493334B2 (https=)
KR (1) KR100596610B1 (https=)
CN (1) CN100384468C (https=)
CA (1) CA2458386C (https=)
MX (1) MXPA04001774A (https=)
PL (1) PL374122A1 (https=)
TW (1) TWI327068B (https=)
WO (1) WO2003020299A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011090305A2 (en) 2010-01-19 2011-07-28 Hanmi Holdings Co., Ltd Liquid formulations for long-acting g-csf conjugate

Families Citing this family (43)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ME00673B (me) * 2000-05-15 2011-12-20 Hoffmann La Roche Nova farmaceutska smjesa
US20030104996A1 (en) * 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
US7141544B2 (en) * 2003-10-10 2006-11-28 Baxter International, Inc. Stabilization of pharmaceutical protein formulations with small peptides
AU2006295340B2 (en) 2005-08-05 2010-11-11 Amgen Inc. Stable aqueous protein or antibody pharmaceutical formulations and their preparation
US8168206B1 (en) * 2005-10-06 2012-05-01 Allergan, Inc. Animal protein-free pharmaceutical compositions
US8137677B2 (en) * 2005-10-06 2012-03-20 Allergan, Inc. Non-protein stabilized clostridial toxin pharmaceutical compositions
TW200806317A (en) * 2006-03-20 2008-02-01 Wyeth Corp Methods for reducing protein aggregation
EP2170268A2 (en) * 2007-06-25 2010-04-07 Amgen, Inc. Compositions of specific binding agents to hepatocyte growth factor
EP2173163A4 (en) * 2007-07-06 2010-12-08 Glaxosmithkline Llc ANTIBODY FORMULATIONS
US8796206B2 (en) * 2007-11-15 2014-08-05 Amgen Inc. Aqueous formulation of erythropoiesis stimulating protein stabilised by antioxidants for parenteral administration
AU2009210741A1 (en) * 2008-02-07 2009-08-13 Amgen Inc. Stabilized protein compositions
PE20110543A1 (es) 2008-08-15 2011-08-04 Ironwood Pharmaceuticals Inc Formulacion solida oral que comprende linaclotida, cation de calcio y leucina
CN103599541A (zh) * 2008-09-10 2014-02-26 弗·哈夫曼-拉罗切有限公司 用于防止蛋白质氧化降解的组合物和方法
CA2765220A1 (en) * 2009-07-14 2011-01-20 Biogen Idec Ma Inc. Methods for inhibiting yellow color and peroxide formation in a composition
CA2770077A1 (en) * 2009-08-06 2011-02-10 Ironwood Pharmaceuticals, Inc. Formulations comprising linaclotide
FR2954325B1 (fr) 2009-12-23 2012-02-03 Flamel Tech Sa Polymere amphiphile fonctionnalise par la methionine
BR112012013148A2 (pt) * 2009-12-29 2017-03-21 F Hoffmann - La Roche Ag formulação farmacêutica e uso
EP2364690A1 (en) * 2010-02-12 2011-09-14 Centro De Ingenieria Genetica Y Biotecnologia Orally administrable pharmaceutical pellet of epidermal growth factor
UA108636C2 (xx) 2010-02-17 2015-05-25 Пептид
EP2603232B1 (en) 2010-08-11 2019-09-25 Ironwood Pharmaceuticals, Inc. Stable formulations of linaclotide
KR101303388B1 (ko) * 2010-10-26 2013-09-03 한미사이언스 주식회사 지속형 인터페론 알파 결합체의 액상 제제
MX347354B (es) 2011-08-17 2017-04-24 Ironwood Pharmaceuticals Inc Tratamientos para trastornos gastrointestinales.
CN108771655A (zh) 2011-10-28 2018-11-09 诚信生物公司 含有氨基酸的蛋白质制剂
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
EP2974734B1 (en) 2013-03-12 2018-10-10 Sumitomo Dainippon Pharma Co., Ltd. Liquid aqueous composition
EP2968468B1 (en) * 2013-03-13 2021-07-14 Buzzard Pharmaceuticals AB Chimeric cytokine formulations for ocular delivery
AU2014229282B2 (en) 2013-03-15 2017-02-02 Glaxosmithkline Intellectual Property (No.2) Limited Low concentration antibody formulations
BR122020004385B1 (pt) * 2014-01-13 2022-10-04 Amgen Inc Método para aumentar o teor de glicoforma de alta manose de uma glicoproteína recombinante e método de produção de uma glicoproteína recombinante
AR103173A1 (es) 2014-12-22 2017-04-19 Novarits Ag Productos farmacéuticos y composiciones líquidas estables de anticuerpos il-17
RU2599031C1 (ru) * 2015-08-11 2016-10-10 Общество с ограниченной ответственностью "АйВиФарма" Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты)
JP7046814B2 (ja) * 2015-12-30 2022-04-04 ジェネンテック, インコーポレイテッド タンパク質製剤のためのトリプトファン誘導体の使用
KR102480965B1 (ko) 2016-09-13 2022-12-26 알레간 인코포레이티드 안정화된 비단백질 클로스트리듐 독소 조성물
US11338018B2 (en) 2016-12-19 2022-05-24 Harrow Ip, Llc Adrenocorticotropic hormone-based pharmaceutical formulations and methods for fabricating and using thereof
JP6172880B1 (ja) * 2017-02-01 2017-08-02 協和発酵キリン株式会社 ダルベポエチンを含む液体医薬組成物
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
CN111278453A (zh) 2017-09-07 2020-06-12 Jcr制药股份有限公司 水性药物组合物
EP3833382A1 (en) * 2018-08-07 2021-06-16 GlaxoSmithKline Biologicals S.A. Processes and vaccines
CN119857138A (zh) * 2018-09-13 2025-04-22 豪夫迈·罗氏有限公司 Csf-1r抗体制剂
US20210251970A1 (en) 2018-10-10 2021-08-19 Presbyopia Therapies Inc Compositions and methods for storage stable ophthalmic drugs
WO2023091439A1 (en) 2021-11-17 2023-05-25 Lenz Therapeutics, Inc. Aceclidine derivatives, compositions thereof and methods of use thereof
CN118338910A (zh) * 2021-12-03 2024-07-12 杰科(天津)生物医药有限公司 一种制剂及其制备方法和应用
US11648247B1 (en) 2021-12-16 2023-05-16 Lenz Therapeutics, Inc. Compositions and methods for the treatment of presbyopia
US12414942B1 (en) 2024-03-15 2025-09-16 Lenz Therapeutics Operations, Inc. Compositions, methods, and systems for treating presbyopia

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6936694B1 (en) * 1982-05-06 2005-08-30 Intermune, Inc. Manufacture and expression of large structural genes
KR850004274A (ko) * 1983-12-13 1985-07-11 원본미기재 에리트로포이에틴의 제조방법
US4703008A (en) * 1983-12-13 1987-10-27 Kiren-Amgen, Inc. DNA sequences encoding erythropoietin
NZ210501A (en) * 1983-12-13 1991-08-27 Kirin Amgen Inc Erythropoietin produced by procaryotic or eucaryotic expression of an exogenous dna sequence
US4667016A (en) * 1985-06-20 1987-05-19 Kirin-Amgen, Inc. Erythropoietin purification
JPS63500636A (ja) * 1985-08-23 1988-03-10 麒麟麦酒株式会社 多分化能性顆粒球コロニー刺激因子をコードするdna
US4810643A (en) * 1985-08-23 1989-03-07 Kirin- Amgen Inc. Production of pluripotent granulocyte colony-stimulating factor
JPS6297229A (ja) * 1985-10-21 1987-05-06 Nec Kansai Ltd 螢光膜の形成方法
US4835260A (en) * 1987-03-20 1989-05-30 Genetics Institute, Inc. Erythropoietin composition
US5075222A (en) * 1988-05-27 1991-12-24 Synergen, Inc. Interleukin-1 inhibitors
US5372808A (en) * 1990-10-17 1994-12-13 Amgen Inc. Methods and compositions for the treatment of diseases with consensus interferon while reducing side effect
US5272135A (en) 1991-03-01 1993-12-21 Chiron Ophthalmics, Inc. Method for the stabilization of methionine-containing polypeptides
US5581476A (en) * 1993-01-28 1996-12-03 Amgen Inc. Computer-based methods and articles of manufacture for preparing G-CSF analogs
TW497972B (en) * 1995-06-08 2002-08-11 Kirin Brewery Stable thrombopoietin (TPO)-containing lyophilized compositions
IL122732A0 (en) * 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
JP2000247903A (ja) * 1999-03-01 2000-09-12 Chugai Pharmaceut Co Ltd 長期安定化製剤
AU1226901A (en) * 1999-10-22 2001-05-08 Amgen, Inc. Biodegradable microparticles with novel erythropoietin stimulating protein
ME00673B (me) * 2000-05-15 2011-12-20 Hoffmann La Roche Nova farmaceutska smjesa
JP5490972B2 (ja) * 2000-08-04 2014-05-14 中外製薬株式会社 タンパク質注射製剤
US20030104996A1 (en) * 2001-08-30 2003-06-05 Tiansheng Li L-methionine as a stabilizer for NESP/EPO in HSA-free formulations

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011090305A2 (en) 2010-01-19 2011-07-28 Hanmi Holdings Co., Ltd Liquid formulations for long-acting g-csf conjugate
US9867777B2 (en) 2010-01-19 2018-01-16 Hanmi Science Co., Ltd. Liquid formulations for long-acting G-CSF conjugate

Also Published As

Publication number Publication date
JP2010138195A (ja) 2010-06-24
MXPA04001774A (es) 2004-11-22
EP1439848A1 (en) 2004-07-28
JP4493334B2 (ja) 2010-06-30
CA2458386A1 (en) 2003-03-13
PL374122A1 (en) 2005-10-03
EP1439848A4 (en) 2009-06-24
HK1075198A1 (zh) 2005-12-09
CN100384468C (zh) 2008-04-30
EP1439848B1 (en) 2014-11-26
CA2458386C (en) 2012-05-08
KR20040044194A (ko) 2004-05-27
CN1592629A (zh) 2005-03-09
TWI327068B (en) 2010-07-11
WO2003020299A1 (en) 2003-03-13
US20030104996A1 (en) 2003-06-05
JP2005527470A (ja) 2005-09-15

Similar Documents

Publication Publication Date Title
KR100596610B1 (ko) Hsa-비함유 제제 내 nesp/epo에 대한안정화제로서의 l-메티오닌
KR100731559B1 (ko) 장기 안정화 제제
EP0909564B1 (en) Erythropoietin solution preparation stabilized with amino acids
US7163671B2 (en) Long-term stabilized formulations
EP0838221B1 (en) Lyophilized hgf preparations
EP1670495B1 (en) Stabilization of pharmaceutical epo formulations with small peptides
KR20060136364A (ko) 소형 펩티드에 의한 제약 단백질 제제의 안정화
KR100265222B1 (ko) 트롬보포이에틴조성물
AU2010201600B2 (en) L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
AU2003251284B2 (en) Stable pharmaceutical composition comprising erythropoietin
CN100425283C (zh) 包含红细胞生成素的稳定的药物组合物
EP3125922B1 (en) Liquid pharmaceutical composition of conjugated erythropoietin
AU2002329947A1 (en) L-methionine as a stabilizer for NESP/EPO in HSA-free formulations
HK1075198B (en) L-methionine as a stabilizer for nesp/epo in hsa-free formulations
CA2545880C (en) Erythropoietin solution formulation
KR20180049887A (ko) 페길레이션된 에리스로포이에틴을 포함하는 신규한 제제

Legal Events

Date Code Title Description
A201 Request for examination
PA0105 International application

Patent event date: 20040227

Patent event code: PA01051R01D

Comment text: International Patent Application

PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20040227

Comment text: Request for Examination of Application

PG1501 Laying open of application
E902 Notification of reason for refusal
PE0902 Notice of grounds for rejection

Comment text: Notification of reason for refusal

Patent event date: 20051026

Patent event code: PE09021S01D

E701 Decision to grant or registration of patent right
PE0701 Decision of registration

Patent event code: PE07011S01D

Comment text: Decision to Grant Registration

Patent event date: 20060405

GRNT Written decision to grant
PR0701 Registration of establishment

Comment text: Registration of Establishment

Patent event date: 20060627

Patent event code: PR07011E01D

PR1002 Payment of registration fee

Payment date: 20060628

End annual number: 3

Start annual number: 1

PG1601 Publication of registration
FPAY Annual fee payment

Payment date: 20090507

Year of fee payment: 4

PR1001 Payment of annual fee

Payment date: 20090507

Start annual number: 4

End annual number: 4

FPAY Annual fee payment

Payment date: 20100429

Year of fee payment: 5

PR1001 Payment of annual fee

Payment date: 20100429

Start annual number: 5

End annual number: 5

FPAY Annual fee payment

Payment date: 20110531

Year of fee payment: 6

PR1001 Payment of annual fee

Payment date: 20110531

Start annual number: 6

End annual number: 6

FPAY Annual fee payment

Payment date: 20120604

Year of fee payment: 7

PR1001 Payment of annual fee

Payment date: 20120604

Start annual number: 7

End annual number: 7

FPAY Annual fee payment

Payment date: 20130528

Year of fee payment: 8

PR1001 Payment of annual fee

Payment date: 20130528

Start annual number: 8

End annual number: 8

FPAY Annual fee payment

Payment date: 20140529

Year of fee payment: 9

PR1001 Payment of annual fee

Payment date: 20140529

Start annual number: 9

End annual number: 9

FPAY Annual fee payment

Payment date: 20150522

Year of fee payment: 10

PR1001 Payment of annual fee

Payment date: 20150522

Start annual number: 10

End annual number: 10

J204 Request for invalidation trial [patent]
PJ0204 Invalidation trial for patent

Patent event date: 20150728

Comment text: Request for Trial

Patent event code: PJ02042R01D

Patent event date: 20060627

Comment text: Registration of Establishment

Patent event code: PJ02041E01I

Appeal kind category: Invalidation

Request date: 20150728

Decision date: 20190516

Appeal identifier: 2015100004075

FPAY Annual fee payment

Payment date: 20160511

Year of fee payment: 11

PR1001 Payment of annual fee

Payment date: 20160511

Start annual number: 11

End annual number: 11

FPAY Annual fee payment

Payment date: 20170522

Year of fee payment: 12

PR1001 Payment of annual fee

Payment date: 20170522

Start annual number: 12

End annual number: 12

FPAY Annual fee payment

Payment date: 20180530

Year of fee payment: 13

PR1001 Payment of annual fee

Payment date: 20180530

Start annual number: 13

End annual number: 13

J301 Trial decision

Free format text: TRIAL NUMBER: 2015100004075; TRIAL DECISION FOR INVALIDATION REQUESTED 20150728

Effective date: 20190516

PJ1301 Trial decision

Patent event code: PJ13011S05D

Patent event date: 20190516

Comment text: Trial Decision on Invalidation (Patent, Utility Model, Industrial Design)

Appeal kind category: Invalidation

Request date: 20150728

Decision date: 20190516

Appeal identifier: 2015100004075

FPAY Annual fee payment

Payment date: 20190625

Year of fee payment: 14

PR1001 Payment of annual fee

Payment date: 20190625

Start annual number: 14

End annual number: 14

J2X1 Appeal (before the patent court)

Free format text: TRIAL NUMBER: 2019200005461; INVALIDATION

PJ2001 Appeal

Patent event date: 20190516

Comment text: Trial Decision on Invalidation (Patent, Utility Model, Industrial Design)

Patent event code: PJ20011S05I

Appeal kind category: Invalidation

Decision date: 20200813

Appeal identifier: 2019200005461

Request date: 20190719

FPAY Annual fee payment

Payment date: 20200423

Year of fee payment: 15

PR1001 Payment of annual fee

Payment date: 20200423

Start annual number: 15

End annual number: 15

EXTG Ip right invalidated
PC2102 Extinguishment

Termination category: Others

Termination date: 20200915

J302 Written judgement (patent court)

Free format text: TRIAL NUMBER: 2019200005461; JUDGMENT (PATENT COURT) FOR INVALIDATION REQUESTED 20190719

Effective date: 20200813

PJ1302 Judgment (patent court)

Patent event date: 20200914

Comment text: Written Judgment (Patent Court)

Patent event code: PJ13021S01D

Request date: 20190719

Decision date: 20200813

Appeal identifier: 2019200005461

Appeal kind category: Invalidation