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

Dosage regimen for a controlled-release pth compound

Info

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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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone, i.e. parathormone; Parathyroid hormone-related peptides
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    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular 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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    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 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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    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/54—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 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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    • A61K47/60—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 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 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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    • A61K47/61—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 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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    • A61K47/645—Polycationic or polyanionic oligopeptides, polypeptides or polyamino acids, e.g. polylysine, polyarginine, polyglutamic acid or peptide TAT
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    • A61K9/1605—Excipients; Inactive ingredients
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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Immunology (AREA)
  • Diabetes (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (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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SG11201901576QA SG11201901576QA (en) 2016-09-29 2017-09-28 Dosage regimen for a controlled-release pth compound

Country Status (23)

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US (5) US11590207B2 (en)
EP (2) EP4275677A3 (en)
JP (3) JP7197468B2 (en)
KR (2) KR102627405B1 (en)
CN (2) CN117838873A (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) IL265591B2 (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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ES2816009T3 (en) * 2011-12-14 2021-03-31 Univ Arkansas Administration of therapeutic agents by means of a collagen-binding protein
DK3423103T3 (en) * 2016-03-01 2024-09-30 Ascendis Pharma Bone Diseases As PTH pro-drug
BR112019005793A2 (en) 2016-09-29 2019-06-18 Ascendis Pharma Bone Diseases As pth compounds with low peak-to-valley ratios
US20190224329A1 (en) * 2016-09-29 2019-07-25 Ascendis Pharma Bone Diseases A/S Incremental Dose Finding in Controlled-Release PTH Compounds
KR102627405B1 (en) 2016-09-29 2024-01-18 아센디스 파마 본 디지즈 에이/에스 Dosage Regimen for Controlled Release PTH Compounds
WO2018148573A1 (en) 2017-02-10 2018-08-16 The Board Of Trustees Of The University Of Arkansas Collagen-binding agent compositions and methods of using the same
JP7542442B2 (en) * 2018-05-18 2024-08-30 アセンディス ファーマ ボーン ディジージズ エー／エス Starting Dose of PTH Conjugate
CA3129357A1 (en) 2019-02-11 2020-08-20 Ascendis Pharma Bone Diseases A/S 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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