ME02477B - Genz 112638 za lečenje gošeove ili fabrijeve bolesti u kombinacionoj terapiji - Google Patents
Genz 112638 za lečenje gošeove ili fabrijeve bolesti u kombinacionoj terapijiInfo
- Publication number
- ME02477B ME02477B MEP-2016-163A MEP16316A ME02477B ME 02477 B ME02477 B ME 02477B ME P16316 A MEP16316 A ME P16316A ME 02477 B ME02477 B ME 02477B
- Authority
- ME
- Montenegro
- Prior art keywords
- therapeutic agent
- treatment
- use according
- compound
- effective amount
- Prior art date
Links
Classifications
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D405/00—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
- C07D405/02—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings
- C07D405/06—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/357—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having two or more oxygen atoms in the same ring, e.g. crown ethers, guanadrel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4025—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
-
- 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
- A61P3/06—Antihyperlipidemics
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C59/00—Compounds having carboxyl groups bound to acyclic carbon atoms and containing any of the groups OH, O—metal, —CHO, keto, ether, groups, groups, or groups
- C07C59/235—Saturated compounds containing more than one carboxyl group
- C07C59/245—Saturated compounds containing more than one carboxyl group containing hydroxy or O-metal groups
- C07C59/255—Tartaric acid
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D319/00—Heterocyclic compounds containing six-membered rings having two oxygen atoms as the only ring hetero atoms
- C07D319/10—1,4-Dioxanes; Hydrogenated 1,4-dioxanes
- C07D319/14—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems
- C07D319/16—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems condensed with one six-membered ring
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D319/00—Heterocyclic compounds containing six-membered rings having two oxygen atoms as the only ring hetero atoms
- C07D319/10—1,4-Dioxanes; Hydrogenated 1,4-dioxanes
- C07D319/14—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems
- C07D319/16—1,4-Dioxanes; Hydrogenated 1,4-dioxanes condensed with carbocyclic rings or ring systems condensed with one six-membered ring
- C07D319/18—Ethylenedioxybenzenes, not substituted on the hetero ring
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Heterocyclic Compounds That Contain Two Or More Ring Oxygen Atoms (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Steroid Compounds (AREA)
- Molecular Biology (AREA)
- Saccharide Compounds (AREA)
- Enzymes And Modification Thereof (AREA)
Claims (19)
1. Prvi terapijski agens predstavljen sledećom strukturalnom formulom: ili farmaceutski prihvatljiva so od toga, naznačeni time što su za korišćenje u lečenju Gošeove bolesti,u čemu pomenuto lečenje obuhvata primenu delotvorne količine prvog terapijskog agensa u kombinaciji sa delotvornom količinom drugog terapijskog agensa koji je delotvoran za lečenje Gošeove bolesti.
2. Korišćenje prvog terapijskog agensa predstavljenog sledećom strukturalnom formulom: ili farmaceutski prihvatljive soli od toga, naznačeno time što je za proizvodnju medikamenta za korišćenje u lečenju Gošeove bolesti, u čemu pomenuto lečenje obuhvata primenu delotvorne količine prvog terapijskog agensa u kombinaciji sa delotvornom količinom drugog terapijskog agensa koji je delotvoran za lečenje Gošeove bolesti.
3. Jedinjenje za korišćenje prema Patentnom zahtevu 1 ili korišćenje prema Patentnom zahtevu 2, naznačeno time što se drugi terapijski agens odabere između glukocerebrozidaze, analoga glukocerebrozidaze, inhibitora glukozilceramid sintaze i molekulskih šaperona koji se vežu na glukocerebrozidazu i obnavljaju njenu ispravnu konformaciju.
4. Jedinjenje za korišćenje prema Patentnom zahtevu 1 ili korišćenje prema Patentnom zahtevu 2, naznačeno time što drugi terapijski agens je imigluceraza, izofagomin, miglustat, taligluceraza alfa ili velagluceraza alfa.
5. Prvi terapijski agens predstavljen sa sledećom strukturalnom formulom: ili farmaceutski prihvatljiva so od toga, naznačeni time što su za korišćenje u lečenju Fabrijeve bolesti, u čemu pomenuto lečenje obuhvata primenu delotvorne količine prvog terapijskog agensa u kombinaciji sa delotvornom količinom drugog terapijskog agensa koji je delotvoran za lečenje Fabrijeve bolesti.
6. Korišćenje prvog terapijskog agensa predstavljenog sledećom strukturalnom formulom: ili farmaceutski prihvatljive soli od toga, naznačeno time što je za proizvodnju medikamenta za korišćenje u lečenju Fabrijeve bolesti, u čemu pomenuto lečenje obuhvata primenu delotvorne količine prvog terapijskog agensa u kombinaciji sa delotvornom količinom drugog terapijskog agensa koji je delotvoran za lečenje Fabrijeve bolesti.
7. Jedinjenje za korišćenje prema Patentnom zahtevu 5 ili korišćenje prema Patentnom zahtevu 6, naznačeni time što se drugi terapijski agens odabere između α galaktozidaze A, analoga α galaktozidaze A i molekulskih šaperona koji se vežu na α galaktozidazu A i obnavljaju njenu ispravnu konformaciju.
8. Jedinjenje za korišćenje prema Patentnom zahtevu 5 ili korišćenje prema Patentnom zahtevu 6, naznačeni time što drugi terapijski agens je migalastat, agalzidaza beta ili agalzidaza alfa.
9. Jedinjenje za korišćenje ili korišćenje prema bilo kojem od Patentnih zahteva 1 do 8, naznačeni time što se prvi terapijski agens primenjuje kao hemitartaratna so.
10. Jedinjenje za korišćenje ili korišćenje prema Patentnom zahtevu 9, naznačeni time što je pomenuta so amorfna ili je barem 70% težinski pomenute soli kristalno.
11. Jedinjenje za korišćenje ili korišćenje prema Patentnom zahtevu 9, naznačeni time što je barem 70% težinski pomenute soli u pojedinačnom kristalnom obliku.
12. Jedinjenje za korišćenje ili korišćenje prema Patentnom zahtevu 11, naznačeni time što je pojedinačni kristalni oblik karakterisan sa jednim, dva, tri, četiri ili pet glavnih vrhova difrakcije x-zraka na prahu pri 2θ uglovima od 5,1°, 6,6°, 10,7°, 11,0°, 15,9° i 21,7°.
13. Jedinjenje za korišćenje ili korišćenje prema Patentnom zahtevu 11, naznačeni time što je pojedinačni kristalni oblik karakterisan sa vrhovima difrakcije x-zraka na prahu pri 2θ uglovima od 5,1°, 6,6°, 10,7°, 11,0°, 13,3°, 15,1°, 15,9°, 16,5°, 17,6°, 18,6°, 18,7°, 19,0°, 20,2°, 21,7° i 23,5°.
14. Jedinjenje za korišćenje ili korišćenje prema Patentnom zahtevu 11, naznačeni time što je pojedinačni kristalni oblik is karakterisan sa uzorkom difrakcije x-zraka na prahu sa Slike 1.
15. Jedinjenje za korišćenje ili korišćenje prema bilo kojem od Patentnih zahteva 1 do 14, naznačeni time što se lečenje sa prvim terapijskim agensom otpočne nakon lečenja tokom perioda od barem deset sedmica sa drugim terapijskim agensom.
16. Jedinjenje za korišćenje ili korišćenje prema bilo kojem od Patentnih zahteva 1 do 14, naznačeni time što se lečenje sa prvim terapijskim agensom otpočne nakon lečenja sa drugim terapijskim agensom i u čemu se lečenje sa prvim terapijskim agensom otpočne nakon što je subjektov broj trombocita jednak ili veći od 100,000 mm3; koncentracija hemoglobina je jednaka ili veća od 11 g/dl (žensko) ili 12 g/dl (muško); i/ili je zapremina subjektove slezene manja od ili jednaka 10 količnika normale i zapremine jetre su manje od ili jednake 1,5 količnika normale.
17. Jedinjenje za korišćenje ili korišćenje prema Patentnom zahtevu 15 ili 16, naznačeni time što se lečenje sa drugim terapijskim agensom završi nakon početka lečenjenja sa prvim terapijskim agensom.
18. Jedinjenje za korišćenje ili korišćenje prema bilo kojem od Patentnih zahteva 1 do 17, naznačeni time što pomenuto lečenje obuhvata primenu prvog terapijskog agensa pri dvaput dnevno dozi od 25 miligrama do 200 miligrama.
19. Jedinjenje za korišćenje ili korišćenje prema bilo kojem od Patentnih zahteva 1 do 18, naznačeni time što pomenuto lečenje obuhvata primenu prvog terapijskog agensa pri dvaput dnevno dozi od 50 miligrama. Crteži
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US26474809P | 2009-11-27 | 2009-11-27 | |
| EP14164650.5A EP2796457B1 (en) | 2009-11-27 | 2010-11-24 | Genz 112638 for treating Gaucher or Fabry disease in combination therapy |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ME02477B true ME02477B (me) | 2017-02-20 |
Family
ID=43431870
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MEP-2016-163A ME02477B (me) | 2009-11-27 | 2010-11-24 | Genz 112638 za lečenje gošeove ili fabrijeve bolesti u kombinacionoj terapiji |
Country Status (40)
| Country | Link |
|---|---|
| US (6) | US11458119B2 (me) |
| EP (5) | EP2504332B2 (me) |
| JP (6) | JP2013512252A (me) |
| KR (6) | KR20200013105A (me) |
| CN (5) | CN112521366A (me) |
| AR (3) | AR079152A1 (me) |
| AU (3) | AU2010324810B2 (me) |
| BR (1) | BR112012012947B8 (me) |
| CA (3) | CA3140959A1 (me) |
| CL (2) | CL2012001348A1 (me) |
| CR (1) | CR20120277A (me) |
| CY (3) | CY1115880T1 (me) |
| DK (3) | DK2796457T3 (me) |
| DO (2) | DOP2012000141A (me) |
| EA (3) | EA029990B1 (me) |
| EC (2) | ECSP12011926A (me) |
| ES (4) | ES2586947T3 (me) |
| GT (1) | GT201200161A (me) |
| HR (3) | HRP20140780T4 (me) |
| HU (2) | HUE045784T2 (me) |
| IL (4) | IL310635A (me) |
| LT (2) | LT2796457T (me) |
| MA (1) | MA33838B1 (me) |
| ME (1) | ME02477B (me) |
| MX (2) | MX381242B (me) |
| MY (2) | MY192644A (me) |
| NI (1) | NI201200096A (me) |
| NZ (3) | NZ600155A (me) |
| PE (2) | PE20121337A1 (me) |
| PH (2) | PH12015502514B1 (me) |
| PL (4) | PL3599237T3 (me) |
| PT (4) | PT2796457T (me) |
| RS (3) | RS53503B2 (me) |
| SG (2) | SG10201407881WA (me) |
| SI (3) | SI2796457T1 (me) |
| SM (1) | SMT201600273B (me) |
| TN (1) | TN2012000237A1 (me) |
| TW (3) | TWI586663B (me) |
| UA (1) | UA113491C2 (me) |
| WO (1) | WO2011066352A1 (me) |
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| US8889127B2 (en) | 2004-07-01 | 2014-11-18 | Icahn School Of Medicine At Mount Sinai | Targeted protein replacement for the treatment of lysosomal storage disorders |
| SI2796457T1 (sl) | 2009-11-27 | 2016-10-28 | Genzyme Corporation | Genz 112638 za zdravljenje Gaucherjeve ali Fabryjeve bolezni v kombinirani terapiji |
| CN103764824B (zh) * | 2011-06-20 | 2018-04-24 | 西奈山医学院 | 粘多糖贮积症和其它溶酶体病症的抗TNF-α疗法 |
| SI2753346T1 (sl) | 2011-09-07 | 2020-09-30 | Mount Sinai School Of Medicine | Ceramidaza in diferenciacija celic |
| WO2013078413A1 (en) * | 2011-11-22 | 2013-05-30 | The United States Of America, As Represented By The Secretary, Department Of Health And Human Services | Modulators of lipid storage |
| LT2854910T (lt) | 2012-06-01 | 2020-05-25 | Icahn School Of Medicine At Mount Sinai | Ceramido lygiai infekcijos gydymo ir prevencijos metu |
| HUE046113T2 (hu) | 2013-03-14 | 2020-02-28 | Icahn School Med Mount Sinai | Terápiás sav ceramidáz készítmények és azok elõállítási és felhasználási eljárásai |
| US10227323B2 (en) * | 2013-09-20 | 2019-03-12 | Biomarin Pharmaceutical Inc. | Glucosylceramide synthase inhibitors for the treatment of diseases |
| EP3164128A4 (en) * | 2014-07-03 | 2018-02-28 | Dr. Reddy's Laboratories Ltd. | Amorphous form of eliglustat hemitartarate |
| ES2716420T3 (es) | 2015-04-14 | 2019-06-12 | Sandoz Ag | Clorhidrato de eliglustat cristalino |
| GB201508025D0 (en) | 2015-05-11 | 2015-06-24 | Ucl Business Plc | Fabry disease gene therapy |
| MX2018006250A (es) | 2015-11-18 | 2018-09-05 | Genzyme Corp | Biomarcador de enfermedad poliquistica renal y usos del mismo. |
| MX381953B (es) | 2016-02-25 | 2025-03-13 | Asceneuron S A | Sales de derivados de piperazina obtenidas por adicion de acidos. |
| CN107445938B (zh) * | 2016-05-31 | 2020-04-03 | 北京启慧生物医药有限公司 | 依利格鲁司他半酒石酸盐的结晶形式、制备方法和含有所述结晶形式的药用组合物 |
| CN106349210A (zh) * | 2016-08-24 | 2017-01-25 | 北京阳光诺和药物研究有限公司 | 一种制备酒石酸艾力骨司坦的方法 |
| EP3318277A1 (en) | 2016-11-04 | 2018-05-09 | Institut du Cerveau et de la Moelle Epiniere-ICM | Inhibitors of glucosylceramide synthase for the treatment of motor neuron diseases |
| WO2018193090A2 (en) | 2017-04-21 | 2018-10-25 | Amneal Pharmaceuticals Company Gmbh | Process for preparation of eliglustat hemitartrate and intermediates thereof |
| ZA201803719B (en) | 2017-06-05 | 2019-04-24 | Cipla Ltd | Stable solid dispersions of eliglustat hemitartrate |
| JP7045726B2 (ja) | 2017-06-16 | 2022-04-01 | ベータ ファーマ，インコーポレイテッド | Ｎ－（２－（２－（ジメチルアミノ）エトキシ）－４－メトキシ－５－（（４－（１－メチル－１ｈ－インドール－３－イル）ピリミジン－２－イル）アミノ）フェニル）アクリルアミドおよびその塩の医薬品製剤 |
| US12472144B2 (en) * | 2017-08-08 | 2025-11-18 | Amneal Pharmaceuticals Llc | Pharmaceutical composition comprising eliglustat |
| WO2019030645A1 (en) | 2017-08-08 | 2019-02-14 | Kashiv Pharma Llc | Pharmaceutical composition comprising eliglustat |
| AU2018386182B2 (en) | 2017-12-15 | 2024-03-28 | Genzyme Corporation | Methods for treating Gaucher disease |
| US12064414B2 (en) | 2017-12-20 | 2024-08-20 | Aizant Drug Research Solutions Private Limited. | Stable amorphous Eliglustat premix and process for the preparation thereof |
| US11760741B2 (en) | 2018-05-02 | 2023-09-19 | Kashiv Biosciences, Llc | Pro-drugs of eliglustat |
| US20210113703A1 (en) * | 2018-05-27 | 2021-04-22 | Bioasis Technologies Inc. | Treatment of gaucher disease |
| CN110878079A (zh) * | 2018-12-31 | 2020-03-13 | 北京启慧生物医药有限公司 | 一种高纯度依利格鲁司他的制备方法 |
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| CN116120274A (zh) | 2021-11-12 | 2023-05-16 | 曙方(上海)医药科技有限公司 | 依利格鲁司他可药用盐及其晶型 |
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