WO2016122722A1 - Process for manufacturing glatiramer acetate product - Google Patents

Process for manufacturing glatiramer acetate product Download PDF

Info

Publication number
WO2016122722A1
WO2016122722A1 PCT/US2015/051203 US2015051203W WO2016122722A1 WO 2016122722 A1 WO2016122722 A1 WO 2016122722A1 US 2015051203 W US2015051203 W US 2015051203W WO 2016122722 A1 WO2016122722 A1 WO 2016122722A1
Authority
WO
WIPO (PCT)
Prior art keywords
aqueous pharmaceutical
pharmaceutical solution
temperature
filter
solution
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
PCT/US2015/051203
Other languages
English (en)
French (fr)
Inventor
Rakefet Cohen
Sasson Habbah
Muhammad Safadi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Teva Pharmaceuticals USA Inc
Original Assignee
Teva Pharmaceutical Industries Ltd
Teva Pharmaceuticals USA 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=54199060&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2016122722(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to US15/510,156 priority Critical patent/US20170312331A1/en
Priority to RU2017104222A priority patent/RU2669769C2/ru
Priority to JP2017534813A priority patent/JP2018503627A/ja
Priority to CA2945537A priority patent/CA2945537C/en
Priority to EA201691790A priority patent/EA028484B1/ru
Priority to KR1020167028604A priority patent/KR101737295B1/ko
Priority to EP15880609.1A priority patent/EP3113785A4/en
Priority to CN201580071551.XA priority patent/CN107530394B/zh
Priority to UAA201610444A priority patent/UA116060C2/uk
Priority to MX2016011219A priority patent/MX352734B/es
Priority to NZ724875A priority patent/NZ724875B2/en
Priority to KR1020177012458A priority patent/KR102268210B1/ko
Application filed by Teva Pharmaceutical Industries Ltd, Teva Pharmaceuticals USA Inc filed Critical Teva Pharmaceutical Industries Ltd
Priority to AU2015380381A priority patent/AU2015380381B2/en
Priority to BR112016023736A priority patent/BR112016023736A2/pt
Publication of WO2016122722A1 publication Critical patent/WO2016122722A1/en
Priority to IL247851A priority patent/IL247851A0/en
Priority to ZA2016/06903A priority patent/ZA201606903B/en
Anticipated expiration legal-status Critical
Priority to IL267152A priority patent/IL267152A/en
Priority to IL277601A priority patent/IL277601B/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/02—Peptides of undefined number of amino acids; Derivatives thereof
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/03—Peptides having up to 20 amino acids in an undefined or only partially defined sequence; Derivatives thereof
    • 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
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders

Definitions

  • Copaxone® is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection.
  • Each 1 mL of Copaxone® solution contains 20mg or 40mg of GA, the active ingredient, and 40mg of mannitol.
  • the pH of the solutions is approximately 5.5 to 7.0.
  • Copaxone® 20mg/mL in a prefilled syringe (PFS) is an approved product, the safety and efficacy of which are supported by over two decades of clinical research and over a decade of post-marketing experience.
  • Copaxone® 40mg/mL in a PFS was developed as a new formulation of the active ingredient GA.
  • This patent also provides a prefilled syringe containing 40mg of glatiramer acetate and 40mg mannitol, which syringe is prepared by a process of the invention.
  • the aqueous pharmaceutical solution is passed through the second filter at a rate of 3-25 liters/hour.
  • the pressure during the filtering step (ii) and the pressure during the filling step (iii) is maintained below 2.0 bar.
  • the temperature of the aqueous pharmaceutical solution is between 0°C and 14°C, or the temperature of the aqueous pharmaceutical solution is reduced to a temperature between 0°C and 14°C.
  • the process further comprises a step of lyophilizing the filtrate after it has been filled into the suitable container so as to form a lyophilized powder of glatiramer acetate and mannitol in the suitable container.
  • the aqueous pharmaceutical solution comprises glatiramer acetate having a viscosity in the range of 2.3-3.2 cPa.
  • the obtaining step (i) comprises compounding the aqueous pharmaceutical solution in a compounding vessel.
  • the process further comprises the step of reducing the temperature of the first filter to a temperature from above 0°C up to 17.5 °C.
  • compositions of Copaxone® 20mg/mL and Copaxone® 40mg/mL are detailed in Table 1.
  • Water for injection is the most widely used solvent and inert vehicle in parenteral formulations. Water is chemically stable in all physical states. It is the base for many biological life forms, and its safety in pharmaceutical formulations is unquestioned.
  • the first objective of Experiment No. 2 was to evaluate whether local cooling of GA 40mg/mL solution using a Heat Exchanger (HE) could improve the filterability through cooled Filter B compared to filterability of the same bulk solution at controlled room temperature.
  • HE Heat Exchanger
  • Reducing the temperature of the GA 40mg/mL bulk solution in the receiving vessel significantly reduces impairment of filterability caused by the total duration of the process (holding time) as well as by filtering larger volume, compared to the same bulk solution held under controlled room temperature.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Psychology (AREA)
  • Hospice & Palliative Care (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Psychiatry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2015/051203 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product Ceased WO2016122722A1 (en)

Priority Applications (18)

Application Number Priority Date Filing Date Title
BR112016023736A BR112016023736A2 (pt) 2015-01-28 2015-09-21 processo para a fabricação de produto de acetato de glatiramer
NZ724875A NZ724875B2 (en) 2015-09-21 Process for manufacturing glatiramer acetate product
JP2017534813A JP2018503627A (ja) 2015-01-28 2015-09-21 酢酸グラチラマーの製造方法
CA2945537A CA2945537C (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
EA201691790A EA028484B1 (ru) 2015-01-28 2015-09-21 Способ получения предварительно заполненного шприца, содержащего глатирамера ацетата
KR1020167028604A KR101737295B1 (ko) 2015-01-28 2015-09-21 글라티라머 아세테이트 제품의 제조 방법
EP15880609.1A EP3113785A4 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
CN201580071551.XA CN107530394B (zh) 2015-01-28 2015-09-21 制备醋酸格拉替雷产品的方法
UAA201610444A UA116060C2 (uk) 2015-01-28 2015-09-21 Спосіб одержання продукту на основі глатирамеру ацетату
US15/510,156 US20170312331A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
KR1020177012458A KR102268210B1 (ko) 2015-01-28 2015-09-21 글라티라머 아세테이트 제품의 제조 방법
RU2017104222A RU2669769C2 (ru) 2015-01-28 2015-09-21 Способ получения продукта глатирамера ацетата
MX2016011219A MX352734B (es) 2015-01-28 2015-09-21 Procedimiento para fabricar un producto de acetato de glatiramer.
AU2015380381A AU2015380381B2 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product
IL247851A IL247851A0 (en) 2015-01-28 2016-09-15 A process for producing a preparation containing glatiramer acetate
ZA2016/06903A ZA201606903B (en) 2015-01-28 2016-10-07 Process for manufacturing glatiramer acetate product
IL267152A IL267152A (en) 2015-01-28 2019-06-06 A process for producing a preparation containing glatiramer acetate
IL277601A IL277601B (en) 2015-01-28 2020-09-24 A process for producing a preparation containing glatiramer acetate

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14/608,126 US9155775B1 (en) 2015-01-28 2015-01-28 Process for manufacturing glatiramer acetate product
US14/608,126 2015-01-28

Publications (1)

Publication Number Publication Date
WO2016122722A1 true WO2016122722A1 (en) 2016-08-04

Family

ID=54199060

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/051203 Ceased WO2016122722A1 (en) 2015-01-28 2015-09-21 Process for manufacturing glatiramer acetate product

Country Status (30)

Country Link
US (6) US9155775B1 (enExample)
EP (3) EP3113785A4 (enExample)
JP (2) JP2018503627A (enExample)
KR (2) KR101737295B1 (enExample)
CN (1) CN107530394B (enExample)
AR (1) AR102096A1 (enExample)
AU (4) AU2015380381B2 (enExample)
BR (1) BR112016023736A2 (enExample)
CA (2) CA2945537C (enExample)
CL (1) CL2016002607A1 (enExample)
CY (1) CY1118826T1 (enExample)
DK (1) DK3050556T3 (enExample)
EA (3) EA028484B1 (enExample)
ES (1) ES2584190T3 (enExample)
HR (1) HRP20170625T1 (enExample)
HU (1) HUE034059T2 (enExample)
IL (3) IL247851A0 (enExample)
LT (1) LT3050556T (enExample)
ME (1) ME02721B (enExample)
MX (1) MX352734B (enExample)
PE (1) PE20170296A1 (enExample)
PL (1) PL3050556T3 (enExample)
PT (1) PT3050556T (enExample)
RS (1) RS55959B1 (enExample)
RU (1) RU2669769C2 (enExample)
SI (1) SI3050556T1 (enExample)
SM (1) SMT201700227T1 (enExample)
UA (1) UA116060C2 (enExample)
WO (1) WO2016122722A1 (enExample)
ZA (1) ZA201606903B (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE49251E1 (en) 2010-01-04 2022-10-18 Mapi Pharma Ltd. Depot systems comprising glatiramer or pharmacologically acceptable salt thereof
PL2627669T3 (pl) 2010-10-11 2017-02-28 Teva Pharmaceutical Industries Ltd. Biomarkery cytokinowe jako biomarkery prognostyczne odpowiedzi klinicznej na octan glatirameru
EP2765857A4 (en) 2011-10-10 2015-12-09 Teva Pharma SIMPLE NUCLEOTIDE POLYMORPHISMS USEFUL FOR PREDICTING CLINICAL RESPONSE TO GLATIRAMERATE ACETATE
HK1213830A1 (zh) 2012-10-10 2016-07-15 Teva Pharmaceutical Industries Ltd. 用於预测醋酸格拉替雷临床反应的生物标志物
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product
CN107550853B (zh) * 2016-06-30 2020-06-12 深圳翰宇药业股份有限公司 一种醋酸格拉替雷注射液的制备方法
US12097292B2 (en) 2016-08-28 2024-09-24 Mapi Pharma Ltd. Process for preparing microparticles containing glatiramer acetate
AU2017319728B2 (en) 2016-08-31 2024-09-05 Mapi Pharma Ltd Depot systems comprising glatiramer acetate
CA3046489A1 (en) 2016-12-07 2018-06-14 Progenity Inc. Gastrointestinal tract detection methods, devices and systems
MX2019010174A (es) 2017-03-26 2019-10-15 Mapi Pharma Ltd Sistemas de deposito de glatiramer para el tratamiento de formas progresivas de esclerosis multiple.
KR102675224B1 (ko) 2017-06-29 2024-06-14 리제너론 파아마슈티컬스, 인크. 약물 용기를 과충진하기 위한 디바이스 및 방법
US20200306516A1 (en) 2017-08-14 2020-10-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with glatiramer or a pharmaceutically acceptable salt thereof
CN112933210A (zh) * 2019-12-11 2021-06-11 深圳翰宇药业股份有限公司 一种西曲瑞克冻干药物组合物的制备方法

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070161566A1 (en) * 2006-01-11 2007-07-12 Teva Pharmaceutical Industries, Ltd. Method of treating multiple sclerosis
US7855176B1 (en) * 2009-07-15 2010-12-21 Teva Pharmaceutical Industries, Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
US8399413B2 (en) * 2009-08-20 2013-03-19 Yeda Research & Development Co., Ltd. Low frequency glatiramer acetate therapy
US8575198B1 (en) * 2011-09-07 2013-11-05 Momenta Pharmaceuticals, Inc. In-process control for the manufacture of glatiramer acetate
US20130323771A1 (en) * 2011-02-14 2013-12-05 Usv Limited Copolymer-1, process for preparation and analytical methods thereof

Family Cites Families (66)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL36670A (en) 1971-04-21 1974-09-10 Sela M Therapeutic basic copolymers of amino acids
FR2459619B1 (fr) 1979-06-26 1983-07-29 Agronomique Inst Nat Rech Procede pour l'obtention a partir de lactoserum, d'un produit enrichi en alpha-lactalbumine et applications dudit procede
US4350156A (en) 1980-05-29 1982-09-21 Japan Foundation For Artificial Organs Method and apparatus for on-line filtration removal of macromolecules from a physiological fluid
US4455256A (en) 1981-05-05 1984-06-19 The Regents Of The University Of California Bone morphogenetic protein
DE69427226T2 (de) 1993-03-24 2001-08-30 Owen Mumford Ltd., Woodstock Vorrichtung zur injektion
US5800808A (en) 1994-05-24 1998-09-01 Veda Research And Development Co., Ltd. Copolymer-1 improvements in compositions of copolymers
US5631347A (en) 1995-06-07 1997-05-20 Eli Lilly And Company Reducing gelation of a fatty acid-acylated protein
DE19543737A1 (de) 1995-11-24 1997-05-28 Hoechst Ag Verfahren zur Ultrafiltration von Peptide oder Proteine enthaltender biologischer Matrices
US6214791B1 (en) 1997-01-10 2001-04-10 Yeda Research And Development Co. Ltd. Treatment of multiple sclerosis through ingestion or inhalation of copolymer-1
IL119989A0 (en) 1997-01-10 1997-04-15 Yeda Res & Dev Pharmaceutical compositions for oral treatment of multiple sclerosis
ES2527760T3 (es) 1998-07-23 2015-01-29 Yeda Research And Development Co., Ltd. Tratamiento de enfermedad de Crohn con copolímero 1 y polipéptidos
CA2336238A1 (en) 1998-07-23 2000-02-03 The President And Fellows Of Harvard College Synthetic peptides and methods of use for autoimmune disease therapies
IL141021A0 (en) 1998-07-23 2002-02-10 Yeda Res & Dev Treatment of autoimmune conditions with copolymer 1 and related copolymers
US6800287B2 (en) 1998-09-25 2004-10-05 Yeda Research And Development Co., Ltd. Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use
HU229719B1 (en) 1998-09-25 2014-05-28 Yeda Res & Dev Copolymer-1-delated polipeptides for use as molecular weight markers and for therapeutic use
US6514938B1 (en) 1998-09-25 2003-02-04 Yeda Research And Development Co. Ltd. At The Weizmann Institute Of Science Copolymer 1 related polypeptides for use as molecular weight markers and for therapeutic use
WO2000020010A1 (en) 1998-10-02 2000-04-13 Yeda Research And Development Co., Ltd. Alternate day administration of copolymer 1 for treating autoimmune diseases
WO2000027417A1 (en) 1998-11-12 2000-05-18 Yeda Research And Development Co. Ltd. Pharmaceutical compositions comprising synthetic peptide copolymers and methods for preventing and treating gvhd and hvgd
EP1261361B1 (en) 2000-02-18 2006-06-14 Yeda Research And Development Company, Ltd. Oral, nasal and pulmonary dosage formulations of copolymer 1 (glatiramer acetate)
ZA200206457B (en) 2000-02-18 2003-08-13 Yeda Res & Dev Oral, nasal and pulmonary dosage formulations of copolymer 1.
IL153236A0 (en) 2000-06-05 2003-07-06 Teva Pharma The use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders
US20020077278A1 (en) 2000-06-05 2002-06-20 Yong V. Wee Use of glatiramer acetate (copolymer 1) in the treatment of central nervous system disorders
WO2002076503A1 (en) 2000-06-20 2002-10-03 Mayo Foundation For Medical Education And Research Treatment of central nervous system diseases by antibodies against glatiramer acetate
DE10158009A1 (de) * 2001-11-21 2003-05-28 Begerow E Gmbh & Co Verfahren zur Reduzierung der Gesamtkeimzahl in wäßrigen Dispersionen
NZ533327A (en) 2001-12-04 2006-11-30 Teva Pharma Processes for the measurement of the potency of glatiramer acetate
CA2411786C (en) 2002-11-13 2009-01-27 Brantford Chemicals Inc. A process for the preparation of polypeptides from n-carboxyanhydrides of amino acids
US7777006B2 (en) 2002-12-31 2010-08-17 Csl Behring L.L.C. Method for purification of alpha-1-antitrypsin
ZA200505733B (en) 2003-01-21 2006-10-25 Yeda Res & Dev COP 1 for treatment of inflammatory bowel diseases
WO2004091573A1 (en) 2003-03-04 2004-10-28 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and alphacalcidol for the treatment of multiple sclerosis
PL1638589T3 (pl) 2003-05-14 2014-10-31 Teva Pharmaceutical Industries Ltd Terapia kombinowana obejmująca octan glatirameru i mitoksantron do leczenia stwardnienia rozsianego
BRPI0412735A (pt) 2003-07-18 2006-09-26 Baxter Int métodos para a fabricação, uso e composição de partìculas esféricas pequenas preparadas mediante a separação de fase controlada
EA200600877A1 (ru) 2003-10-31 2006-12-29 Тева Фармасьютикал Индастриз, Лтд. Наночастицы для доставки лекарств
EP1701971A2 (en) 2003-12-31 2006-09-20 F.Hoffmann-La Roche Ag Peptide synthesis using decanting filter
AU2005218625A1 (en) 2004-03-03 2005-09-15 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and riluzole
US20060194725A1 (en) 2004-05-07 2006-08-31 James Rasmussen Methods of treating disease with random copolymers
US7655221B2 (en) 2004-05-07 2010-02-02 Peptimmune, Inc. Methods of treating disease with random copolymers
WO2006029036A2 (en) 2004-09-02 2006-03-16 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and n-acetylcysteine for the treatment of multiple sclerosis
ES2572811T3 (es) 2004-09-09 2016-06-02 Yeda Research And Development Co., Ltd. Mezclas de polipéptidos, composiciones que las contienen y procedimientos para obtener los mismos, y usos de los mismos
PT2361924E (pt) 2004-09-09 2014-03-13 Teva Pharma Processo para a preparação de misturas de acetato de glatirâmero trifluoroacetiílico utilizando ácido bromídrico purificado
AU2005302500B2 (en) 2004-10-29 2008-11-27 Sandoz Ag Processes for preparing glatiramer
EP1838326A4 (en) 2005-02-02 2009-09-30 Teva Pharma PROCESS FOR PREPARING POLYPEPTIDE MIXTURES BY HYDROGENOLYSIS
US20100167983A1 (en) 2007-10-22 2010-07-01 Teva Pharmaceutical Industries, Ltd. Combination therapy with glatiramer acetate and rasagiline for the treatment of multiple sclerosis
PT1848415E (pt) 2005-02-17 2013-06-27 Teva Pharma Terapia de combinação com acetato de glatirâmero e rasagilina para o tratamento da esclerose múltipla
WO2006116602A2 (en) 2005-04-25 2006-11-02 Yeda Research And Development Company Markers associated with the therapeutic efficacy of glatiramer acetate
US20070059798A1 (en) 2005-09-09 2007-03-15 Alexander Gad Polypeptides useful for molecular weight determinations
US20080118553A1 (en) 2006-06-12 2008-05-22 Anton Frenkel Tannate salt form of polypeptide mixtures, their preparation and use
DE602007003848D1 (de) 2006-07-05 2010-01-28 Momenta Pharmaceuticals Inc Verbessertes verfahren zur herstellung von copolymer-1
CN100569282C (zh) 2006-10-13 2009-12-16 俞嘉林 注射用骨肽冻干剂及其制备方法
AU2008265692A1 (en) 2007-06-21 2008-12-24 Momenta Pharmaceuticals, Inc. Copolymer assay
WO2009016643A1 (en) 2007-07-31 2009-02-05 Natco Pharma Limited Process for the preparation glatiramer acetate (copolymer-1)
EA201070656A1 (ru) 2007-11-28 2010-12-30 Тева Фармасьютикал Индастриз, Лтд. Способ задержки начала проявления клинически определенного рассеянного склероза
WO2009139924A2 (en) 2008-05-14 2009-11-19 Otonomy, Inc. Controlled release corticosteroid compositions and methods for the treatment of otic disorders
US8323685B2 (en) 2008-08-20 2012-12-04 Baxter International Inc. Methods of processing compositions containing microparticles
US8920373B2 (en) 2009-07-15 2014-12-30 Teva Pharmaceutical Industries, Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
ITMI20092069A1 (it) 2009-11-25 2011-05-26 Biofer Spa Metodo per ottenere una miscela di fattori biologici isolati da colostro e miscela di fattori biologici attivi derivata da colostro.
US8759302B2 (en) 2010-03-16 2014-06-24 Teva Pharmaceutical Industries, Ltd. Methods of treating a subject afflicted with an autoimmune disease using predictive biomarkers of clinical response to glatiramer acetate therapy in multiple sclerosis
PL2627669T3 (pl) 2010-10-11 2017-02-28 Teva Pharmaceutical Industries Ltd. Biomarkery cytokinowe jako biomarkery prognostyczne odpowiedzi klinicznej na octan glatirameru
EP2765857A4 (en) 2011-10-10 2015-12-09 Teva Pharma SIMPLE NUCLEOTIDE POLYMORPHISMS USEFUL FOR PREDICTING CLINICAL RESPONSE TO GLATIRAMERATE ACETATE
ES2706065T3 (es) * 2012-07-06 2019-03-27 3 D Matrix Ltd Proceso de llenado-acabado para soluciones de péptidos
HK1213830A1 (zh) 2012-10-10 2016-07-15 Teva Pharmaceutical Industries Ltd. 用於预测醋酸格拉替雷临床反应的生物标志物
MX2015008754A (es) 2013-01-04 2016-04-11 Teva Pharma Caracterizacion de un medicamento relacionado con acetato de glatiramer.
WO2014128079A1 (en) 2013-02-19 2014-08-28 Synthon B.V. Glatiramer acetate multidose formulation
KR20150138240A (ko) 2013-03-12 2015-12-09 테바 파마슈티컬 인더스트리즈 리미티드 리툭시맙 유도 요법과 글라티라머 아세테이트 요법
CN103169670B (zh) * 2013-03-22 2016-07-06 深圳翰宇药业股份有限公司 一种醋酸格拉替雷微球及其制备方法
UY35790A (es) 2013-10-21 2015-05-29 Teva Pharma Marcadores genéticos que predicen la respuesta al acetato de glatiramer
US9155775B1 (en) 2015-01-28 2015-10-13 Teva Pharmaceutical Industries, Ltd. Process for manufacturing glatiramer acetate product

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070161566A1 (en) * 2006-01-11 2007-07-12 Teva Pharmaceutical Industries, Ltd. Method of treating multiple sclerosis
US7855176B1 (en) * 2009-07-15 2010-12-21 Teva Pharmaceutical Industries, Ltd. Reduced volume formulation of glatiramer acetate and methods of administration
US8399413B2 (en) * 2009-08-20 2013-03-19 Yeda Research & Development Co., Ltd. Low frequency glatiramer acetate therapy
US20130323771A1 (en) * 2011-02-14 2013-12-05 Usv Limited Copolymer-1, process for preparation and analytical methods thereof
US8575198B1 (en) * 2011-09-07 2013-11-05 Momenta Pharmaceuticals, Inc. In-process control for the manufacture of glatiramer acetate

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP3113785A4 *

Also Published As

Publication number Publication date
ZA201606903B (en) 2019-02-27
DK3050556T3 (en) 2017-04-24
JP2018184433A (ja) 2018-11-22
JP6592150B2 (ja) 2019-10-16
ME02721B (me) 2017-10-20
SMT201700227T1 (it) 2017-07-18
JP2018503627A (ja) 2018-02-08
US20170196930A1 (en) 2017-07-13
CN107530394B (zh) 2021-05-25
US20170312331A1 (en) 2017-11-02
KR101737295B1 (ko) 2017-05-29
AU2018200518A1 (en) 2018-02-15
EA201791555A3 (ru) 2018-05-31
PL3050556T3 (pl) 2017-08-31
HRP20170625T1 (hr) 2017-06-30
AU2016273881A1 (en) 2017-01-05
BR112016023736A2 (pt) 2017-10-10
IL267152A (en) 2019-08-29
KR20160136348A (ko) 2016-11-29
HK1225309B (en) 2017-09-08
CA2945537C (en) 2017-08-22
KR20170101891A (ko) 2017-09-06
EP3238706A1 (en) 2017-11-01
AU2015380381A1 (en) 2016-09-01
US20180036363A1 (en) 2018-02-08
ES2584190T1 (es) 2016-09-26
EP3050556A1 (en) 2016-08-03
UA116060C2 (uk) 2018-01-25
EA201691790A1 (ru) 2017-01-30
CL2016002607A1 (es) 2017-05-26
CA2965890A1 (en) 2016-08-04
EP3050556B1 (en) 2017-03-22
EA028484B1 (ru) 2017-11-30
RU2669769C2 (ru) 2018-10-16
US20160213734A1 (en) 2016-07-28
HUE034059T2 (en) 2018-01-29
LT3050556T (lt) 2017-05-10
AU2015380381B2 (en) 2016-10-20
AU2016101453B4 (en) 2016-11-03
EA201500881A1 (ru) 2016-07-29
EA201791555A2 (ru) 2017-12-29
AR102096A1 (es) 2017-02-01
IL277601B (en) 2021-09-30
IL277601A (en) 2020-11-30
EA028811B1 (ru) 2018-01-31
US9763993B2 (en) 2017-09-19
ES2584190T3 (es) 2017-07-20
MX352734B (es) 2017-12-06
US9155775B1 (en) 2015-10-13
SI3050556T1 (sl) 2017-06-30
PT3050556T (pt) 2017-05-17
IL247851A0 (en) 2016-11-30
EP3113785A1 (en) 2017-01-11
NZ724875A (en) 2023-10-27
EP3113785A4 (en) 2017-05-10
CY1118826T1 (el) 2018-01-10
KR102268210B1 (ko) 2021-06-23
RS55959B1 (sr) 2017-09-29
US20180000884A1 (en) 2018-01-04
MX2016011219A (es) 2016-11-30
PE20170296A1 (es) 2017-04-14
CA2945537A1 (en) 2016-08-04
AU2016101453A4 (en) 2016-09-15
CN107530394A (zh) 2018-01-02

Similar Documents

Publication Publication Date Title
AU2016101453A4 (en) Process for manufacturing glatiramer acetate product
AU2015239736A1 (en) Solid pharmaceutical compositions comprising biopterin derivatives and uses of such compositions
EP4362912A1 (en) Aqueous, room-temperature stable rocuronium composition
HK1239526A1 (en) Prefilled syringe containing a glatiramer acetate product
HK1225309A1 (en) Process for manufacturing a pharmaceutical preparation containing glatiramer acetate
WO2019213268A1 (en) Ready-to-use liquid parenteral formulations of ribavirin
ES2585151T6 (es) Proceso para la fabricación de un producto de acetato de glatiramero
NZ724875B2 (en) Process for manufacturing glatiramer acetate product
US20230066798A1 (en) Compositions and methods for post-operative ocular care

Legal Events

Date Code Title Description
WWE Wipo information: entry into national phase

Ref document number: MX/A/2016/011219

Country of ref document: MX

ENP Entry into the national phase

Ref document number: 2015380381

Country of ref document: AU

Date of ref document: 20150921

Kind code of ref document: A

121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 15880609

Country of ref document: EP

Kind code of ref document: A1

WWE Wipo information: entry into national phase

Ref document number: 247851

Country of ref document: IL

REEP Request for entry into the european phase

Ref document number: 2015880609

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2015880609

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 201691790

Country of ref document: EA

ENP Entry into the national phase

Ref document number: 2945537

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 001955-2016

Country of ref document: PE

WWE Wipo information: entry into national phase

Ref document number: A201610444

Country of ref document: UA

ENP Entry into the national phase

Ref document number: 20167028604

Country of ref document: KR

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: NC2016/0002988

Country of ref document: CO

ENP Entry into the national phase

Ref document number: 2017104222

Country of ref document: RU

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 15510156

Country of ref document: US

REG Reference to national code

Ref country code: BR

Ref legal event code: B01A

Ref document number: 112016023736

Country of ref document: BR

ENP Entry into the national phase

Ref document number: 2017534813

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

ENP Entry into the national phase

Ref document number: 112016023736

Country of ref document: BR

Kind code of ref document: A2

Effective date: 20161011