SG11201901576QA - Dosage regimen for a controlled-release pth compound - Google Patents

Dosage regimen for a controlled-release pth compound

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Publication number
SG11201901576QA
SG11201901576QA SG11201901576QA SG11201901576QA SG11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA SG 11201901576Q A SG11201901576Q A SG 11201901576QA
Authority
SG
Singapore
Prior art keywords
controlled
international
pth
pth compound
pct
Prior art date
Application number
SG11201901576QA
Inventor
Lars Holten-Andersen
Kennett Sprogøe
David Brian Karpf
Original Assignee
Ascendis Pharma Bone Diseases As
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
Application filed by Ascendis Pharma Bone Diseases As filed Critical Ascendis Pharma Bone Diseases As
Publication of SG11201901576QA publication Critical patent/SG11201901576QA/en

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    • AHUMAN NECESSITIES
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    • 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
    • A61K38/22Hormones
    • A61K38/29Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
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    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
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    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
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    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/645Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K9/1605Excipients; Inactive ingredients
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    • A61P5/18Drugs for disorders of the endocrine system of the parathyroid hormones
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    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Pain & Pain Management (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

1 1-1 O O O GC O 1-1 C (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 05 April 2018 (05.04.2018) WIP0 I PCT °Ens °nolo omoiloonom m1111E11 oimIE (10) International Publication Number WO 2018/060310 Al (51) International Patent Classification: TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, A61K 38/29 (2006.01) A61K 47/34 (2017.01) KM, ML, MR, NE, SN, TD, TG). A61K 9/00 (2006.01) A61K 9/16 (2006.01) (21) International Application Number: PCT/EP2017/074592 Published: — with international search report (Art. 21(3)) — with sequence listing part of description (Rule 5.2(a)) (22) International Filing Date: 28 September 2017 (28.09.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 16191451.0 29 September 2016 (29.09.2016) EP 17155843.0 13 February 2017 (13.02.2017) EP (71) Applicant: ASCENDIS PHARMA BONE DISEASES A/ S [DK/DK]; Tuborg Boulevard 5, 2900 Hellerup (DK). (72) Inventors: HOLTEN-ANDERSEN, Lars; Rodtjornevej 8, st., 2720 Vanlose (DK). SPROGOE, Kennett; Vengestien 7, 2840 Holte (DK). KARPF, David Brian; 203 Sherland Ave., Mountain View, California 94043 (US). (74) Agent: BUCHEL, Edwin; Isenbruck Bosl Horschler LLP Patentanwalte, EASTSITE ONE, Seckenheimer LandstraBe 4, 68163 Mannheim (DE). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, (54) Title: DOSAGE REGIMEN FOR A CONTROLLED-RELEASE PTH COMPOUND (57) : The present invention relates to a pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, pharmaceutical composition comprising at least one controlled-release PTH compound or a pharmaceutically acceptable salt, hydrate or solvate thereof, for use in the treatment, control, delay or prevention of a condition that can be treated, controlled, delayed or prevented with PTH, wherein said pharmaceutical composition is administered no more frequent than once every 24 hours with a dosage of the controlled-release PTH compound that corresponds to no more than 70% of the molar equivalent dose of PTH 1-84 administered every 24 hours required to maintain serum calcium within normal levels over said 24 hour period in humans.
SG11201901576QA 2016-09-29 2017-09-28 Dosage regimen for a controlled-release pth compound SG11201901576QA (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16191451 2016-09-29
EP17155843 2017-02-13
PCT/EP2017/074592 WO2018060310A1 (en) 2016-09-29 2017-09-28 Dosage regimen for a controlled-release pth compound

Publications (1)

Publication Number Publication Date
SG11201901576QA true SG11201901576QA (en) 2019-03-28

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Country Status (23)

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US (5) US11590207B2 (en)
EP (2) EP4275677A3 (en)
JP (3) JP7197468B2 (en)
KR (2) KR20240013849A (en)
CN (2) CN109789189B (en)
AU (1) AU2017336249B2 (en)
BR (1) BR112019005533A2 (en)
CA (1) CA3037442A1 (en)
DK (1) DK3518960T5 (en)
ES (1) ES2959995T3 (en)
FI (1) FI3518960T3 (en)
HR (1) HRP20231079T1 (en)
HU (1) HUE063235T2 (en)
IL (2) IL304086A (en)
LT (1) LT3518960T (en)
MX (1) MX2019003181A (en)
NZ (1) NZ751969A (en)
PL (1) PL3518960T3 (en)
RS (1) RS64440B1 (en)
SG (1) SG11201901576QA (en)
SI (1) SI3518960T1 (en)
WO (1) WO2018060310A1 (en)
ZA (1) ZA201901811B (en)

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CA3113972C (en) * 2011-12-14 2023-08-01 The Board Of Trustees Of The University Of Arkansas Delivery of therapeutic agents using bacterial collagen-binding polypeptide segments
RU2747316C2 (en) * 2016-03-01 2021-05-04 Асцендис Фарма Боун Дизизис А/С Rtn prodrugs
JP7085535B2 (en) 2016-09-29 2022-06-16 アセンディス ファーマ ボーン ディジージズ エー/エス PTH compounds with a small peak-to-trough ratio
EP4275677A3 (en) * 2016-09-29 2024-01-10 Ascendis Pharma Bone Diseases A/S Dosage regimen for a controlled-release pth compound
US11624060B2 (en) 2017-02-10 2023-04-11 The Board Of Trustees Of The University Of Arkansas Collagen-binding agent compositions and methods of using the same
US20210196801A1 (en) * 2018-05-18 2021-07-01 Ascendis Pharma Bone Diseases A/S Starting Dose of PTH Conjugates
SG11202107722VA (en) 2019-02-11 2021-08-30 Ascendis Pharma Bone Diseases As Liquid pharmaceutical formulations of pth conjugates
CN117586372A (en) * 2022-08-10 2024-02-23 成都奥达生物科技有限公司 Long-acting teriparatide compound

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