DK3126373T3 - Fremgangsmåde til fremstilling af amg 416 - Google Patents
Fremgangsmåde til fremstilling af amg 416 Download PDFInfo
- Publication number
- DK3126373T3 DK3126373T3 DK15773570.5T DK15773570T DK3126373T3 DK 3126373 T3 DK3126373 T3 DK 3126373T3 DK 15773570 T DK15773570 T DK 15773570T DK 3126373 T3 DK3126373 T3 DK 3126373T3
- Authority
- DK
- Denmark
- Prior art keywords
- amg
- procedure
- manufacturing
- manufacturing amg
- Prior art date
Links
- ANIAZGVDEUQPRI-ZJQCGQFWSA-N etelcalcetide Chemical compound NC(N)=NCCC[C@H](C(N)=O)NC(=O)[C@@H](C)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](CCCN=C(N)N)NC(=O)[C@@H](C)NC(=O)[C@@H](CSSC[C@H](N)C(O)=O)NC(C)=O ANIAZGVDEUQPRI-ZJQCGQFWSA-N 0.000 title 1
- 229950006502 etelcalcetide Drugs 0.000 title 1
- 108091022127 etelcalcetide hydrochloride Proteins 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/02—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length in solution
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/107—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
- C07K1/1072—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups
- C07K1/1075—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides by covalent attachment of residues or functional groups by covalent attachment of amino acids or peptide residues
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones
- A61P5/20—Drugs for disorders of the endocrine system of the parathyroid hormones for decreasing, blocking or antagonising the activity of PTH
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201461974899P | 2014-04-03 | 2014-04-03 | |
| PCT/US2015/024347 WO2015154031A1 (en) | 2014-04-03 | 2015-04-03 | Method for preparing amg 416 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3126373T3 true DK3126373T3 (da) | 2020-05-04 |
Family
ID=54241346
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15773570.5T DK3126373T3 (da) | 2014-04-03 | 2015-04-03 | Fremgangsmåde til fremstilling af amg 416 |
Country Status (27)
| Country | Link |
|---|---|
| US (3) | US10407464B2 (da) |
| EP (3) | EP3708576B1 (da) |
| JP (1) | JP6710158B2 (da) |
| KR (1) | KR102397271B1 (da) |
| CN (1) | CN106795201A (da) |
| AU (1) | AU2015240527B2 (da) |
| BR (1) | BR112016022868A2 (da) |
| CA (1) | CA2944194C (da) |
| CL (1) | CL2016002513A1 (da) |
| CY (1) | CY1123100T1 (da) |
| DK (1) | DK3126373T3 (da) |
| EA (1) | EA032597B1 (da) |
| ES (2) | ES2786225T3 (da) |
| HR (1) | HRP20200527T1 (da) |
| HU (1) | HUE048489T2 (da) |
| IL (1) | IL248059B2 (da) |
| LT (1) | LT3126373T (da) |
| MA (2) | MA39628B1 (da) |
| ME (1) | ME03781B (da) |
| MX (1) | MX2016012965A (da) |
| PL (1) | PL3126373T3 (da) |
| PT (1) | PT3126373T (da) |
| RS (1) | RS60187B1 (da) |
| SG (1) | SG11201608176VA (da) |
| SI (1) | SI3126373T1 (da) |
| WO (1) | WO2015154031A1 (da) |
| ZA (1) | ZA201606844B (da) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3013318B1 (en) | 2013-06-28 | 2017-04-19 | Amgen Inc. | Stable liquid formulation of amg 416 (velcalcetide) |
| HUE048489T2 (hu) | 2014-04-03 | 2020-07-28 | Amgen Inc | Eljárás AMG 416 elõállítására |
| CN106928321B (zh) * | 2015-12-31 | 2019-07-26 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN106928320B (zh) * | 2015-12-31 | 2021-01-15 | 深圳翰宇药业股份有限公司 | 一种合成Etelcalcetide的方法 |
| CN109641946A (zh) * | 2016-03-23 | 2019-04-16 | 巴切姆股份公司 | 胰高血糖素样肽的制备方法 |
| US10858390B2 (en) * | 2016-09-02 | 2020-12-08 | Cem Corporation | Use of excess carbodiimide for peptide synthesis at elevated temperatures |
| CN108101959B (zh) * | 2016-11-24 | 2021-07-09 | 四川科伦药物研究院有限公司 | 一种制备高纯度多肽或其类似物的方法 |
| CN106928171B (zh) * | 2017-05-03 | 2019-08-13 | 成都郑源生化科技有限公司 | Fmoc-Arg（Pbf）-OH的合成方法 |
| TW201915009A (zh) * | 2017-10-03 | 2019-04-16 | 中化合成生技股份有限公司 | 合成依特卡肽（Ｅｔｅｌｃａｌｃｅｔｉｄｅ）或其鹽類之方法 |
| CN110498835B (zh) * | 2018-05-17 | 2021-06-08 | 深圳翰宇药业股份有限公司 | 一种合成etelcalcetide的方法 |
| CN109280078B (zh) * | 2018-10-30 | 2019-06-25 | 成都诺和晟泰生物科技有限公司 | 一种制备维拉卡肽的方法 |
| CN112062811B (zh) * | 2019-06-10 | 2022-03-25 | 深圳翰宇药业股份有限公司 | 一种维拉卡肽的合成方法 |
| US20220298206A1 (en) * | 2019-08-26 | 2022-09-22 | Auro Peptides Ltd | An improved process for the preparation of Etelcalcetide Hydrochloride |
| EP3875466A1 (en) * | 2020-03-05 | 2021-09-08 | Fresenius Kabi iPSUM S.r.l. | Process for the synthesis of etelcalcetide |
| US20230295221A1 (en) | 2020-06-03 | 2023-09-21 | Chugai Seiyaku Kabushiki Kaisha | Efficient peptide condensation method for difficult sequences |
| CN111925415A (zh) * | 2020-08-10 | 2020-11-13 | 海南中和药业股份有限公司 | 一种维拉卡肽杂质的制备方法 |
| TWI792442B (zh) * | 2021-07-23 | 2023-02-11 | 建誼生技股份有限公司 | 依特卡肽鹽酸鹽之製造方法 |
| CN114524860A (zh) * | 2021-12-29 | 2022-05-24 | 深圳翰宇药业股份有限公司 | 一种Etelcalcetide的合成方法及其应用 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3941763A (en) | 1975-03-28 | 1976-03-02 | American Home Products Corporation | PGlu-D-Met-Trp-Ser-Tyr-D-Ala-Leu-Arg-Pro-Gly-NH2 and intermediates |
| EP0339695A3 (en) | 1988-04-29 | 1990-05-30 | Stichting Voor De Technische Wetenschappen | A process for preparing an antigenic or immunogenic conjugate as well as the use of such conjugates |
| SE9603465D0 (sv) | 1996-09-23 | 1996-09-23 | Astra Ab | New compounds |
| NO311807B1 (no) * | 1999-03-04 | 2002-01-28 | Bionor Immuno As | HIV-peptider, antigener, vaksinepreparater, immunoassay- testsett og en metode for påvisning av antistoffer fremkalt av HIV |
| CA2703113A1 (en) | 2007-10-27 | 2009-04-30 | F. Hoffmann-La Roche Ag | Insulinotropic peptide synthesis using solid and solution phase combination techniques |
| CN101250172B (zh) | 2008-03-07 | 2012-05-02 | 上海瀚鸿化工科技有限公司 | 精氨酸双保护制备工艺 |
| CA2761265C (en) | 2009-05-06 | 2017-12-19 | Mallinckrodt Llc | Solid support for fmoc-solid phase synthesis of peptide acids |
| ES2607954T3 (es) | 2009-07-29 | 2017-04-04 | Kai Pharmaceuticals, Inc. | Agentes terapéuticos para reducir los niveles de hormona paratiroidea |
| WO2011133346A1 (en) * | 2010-04-21 | 2011-10-27 | Pharmacofore, Inc. | Peripheral opioid agonists and peripheral opioid antagonists |
| EP2614076A4 (en) * | 2010-09-08 | 2014-03-05 | Florey Howard Inst | MODIFIED RELAXIN POLYPEPTIDES |
| WO2013042129A1 (en) | 2011-09-23 | 2013-03-28 | Natco Pharma Limited | Improved process for preparation of bivalirudin |
| EP3013318B1 (en) | 2013-06-28 | 2017-04-19 | Amgen Inc. | Stable liquid formulation of amg 416 (velcalcetide) |
| HUE048489T2 (hu) | 2014-04-03 | 2020-07-28 | Amgen Inc | Eljárás AMG 416 elõállítására |
| CN105504012A (zh) * | 2014-09-30 | 2016-04-20 | 深圳翰宇药业股份有限公司 | 一种多肽的制备方法 |
| CN107434820A (zh) * | 2017-08-07 | 2017-12-05 | 南京工业大学 | 一种维拉卡肽的合成方法 |
-
2015
- 2015-04-03 HU HUE15773570A patent/HUE048489T2/hu unknown
- 2015-04-03 EP EP20160369.3A patent/EP3708576B1/en active Active
- 2015-04-03 MA MA39628A patent/MA39628B1/fr unknown
- 2015-04-03 WO PCT/US2015/024347 patent/WO2015154031A1/en active Application Filing
- 2015-04-03 BR BR112016022868-5A patent/BR112016022868A2/pt active Search and Examination
- 2015-04-03 US US15/300,209 patent/US10407464B2/en active Active
- 2015-04-03 IL IL248059A patent/IL248059B2/en unknown
- 2015-04-03 MX MX2016012965A patent/MX2016012965A/es active IP Right Grant
- 2015-04-03 ME MEP-2020-83A patent/ME03781B/me unknown
- 2015-04-03 CA CA2944194A patent/CA2944194C/en active Active
- 2015-04-03 SG SG11201608176VA patent/SG11201608176VA/en unknown
- 2015-04-03 EP EP23150870.6A patent/EP4219526A3/en active Pending
- 2015-04-03 JP JP2016560462A patent/JP6710158B2/ja active Active
- 2015-04-03 KR KR1020167030590A patent/KR102397271B1/ko active IP Right Grant
- 2015-04-03 ES ES15773570T patent/ES2786225T3/es active Active
- 2015-04-03 PL PL15773570T patent/PL3126373T3/pl unknown
- 2015-04-03 MA MA052906A patent/MA52906A/fr unknown
- 2015-04-03 RS RS20200448A patent/RS60187B1/sr unknown
- 2015-04-03 LT LTEP15773570.5T patent/LT3126373T/lt unknown
- 2015-04-03 CN CN201580029560.2A patent/CN106795201A/zh active Pending
- 2015-04-03 SI SI201531173T patent/SI3126373T1/sl unknown
- 2015-04-03 PT PT157735705T patent/PT3126373T/pt unknown
- 2015-04-03 EP EP15773570.5A patent/EP3126373B1/en active Active
- 2015-04-03 ES ES20160369T patent/ES2943671T3/es active Active
- 2015-04-03 EA EA201692001A patent/EA032597B1/ru not_active IP Right Cessation
- 2015-04-03 DK DK15773570.5T patent/DK3126373T3/da active
- 2015-04-03 AU AU2015240527A patent/AU2015240527B2/en active Active
-
2016
- 2016-10-03 CL CL2016002513A patent/CL2016002513A1/es unknown
- 2016-10-05 ZA ZA2016/06844A patent/ZA201606844B/en unknown
-
2019
- 2019-08-05 US US16/532,344 patent/US11377474B2/en active Active
-
2020
- 2020-04-01 HR HRP20200527TT patent/HRP20200527T1/hr unknown
- 2020-04-29 CY CY20201100391T patent/CY1123100T1/el unknown
-
2022
- 2022-06-28 US US17/852,263 patent/US20230099078A1/en not_active Abandoned
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