AU2009237479B2 - Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation - Google Patents

Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation Download PDF

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Publication number
AU2009237479B2
AU2009237479B2 AU2009237479A AU2009237479A AU2009237479B2 AU 2009237479 B2 AU2009237479 B2 AU 2009237479B2 AU 2009237479 A AU2009237479 A AU 2009237479A AU 2009237479 A AU2009237479 A AU 2009237479A AU 2009237479 B2 AU2009237479 B2 AU 2009237479B2
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Prior art keywords
fsh
sialylation
rfsh
mol
sialic acid
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AU2009237479A
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AU2009237479A1 (en
Inventor
Ian Cottingham
Daniel Plaksin
Richard Boyd White
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Ferring International Center SA
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Ferring International Center SA
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Application filed by Ferring International Center SA filed Critical Ferring International Center SA
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Application granted granted Critical
Publication of AU2009237479B2 publication Critical patent/AU2009237479B2/en
Priority to AU2014203277A priority Critical patent/AU2014203277C1/en
Priority to AU2017204258A priority patent/AU2017204258B2/en
Priority to AU2017204259A priority patent/AU2017204259B2/en
Priority to AU2017225020A priority patent/AU2017225020B2/en
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • 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
    • A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • 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
    • A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/10—Transferases (2.)
    • C12N9/1048—Glycosyltransferases (2.4)
    • C12N9/1081—Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y204/00—Glycosyltransferases (2.4)
    • C12Y204/99—Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y204/00—Glycosyltransferases (2.4)
    • C12Y204/99—Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
    • C12Y204/99006—N-Acetyllactosaminide alpha-2,3-sialyltransferase (2.4.99.6)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Endocrinology (AREA)
  • General Health & Medical Sciences (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Wood Science & Technology (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Toxicology (AREA)
  • General Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Diabetes (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Microbiology (AREA)
  • Plant Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
AU2009237479A 2008-04-16 2009-04-16 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation Active AU2009237479B2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
AU2014203277A AU2014203277C1 (en) 2008-04-16 2014-06-17 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017204258A AU2017204258B2 (en) 2008-04-16 2017-06-23 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017204259A AU2017204259B2 (en) 2008-04-16 2017-06-23 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017225020A AU2017225020B2 (en) 2008-04-16 2017-09-05 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US4542408P 2008-04-16 2008-04-16
US61/045,424 2008-04-16
EP08251528.9 2008-04-25
EP08251528 2008-04-25
PCT/GB2009/000978 WO2009127826A1 (en) 2008-04-16 2009-04-16 Recombinant fsh including alpha 2,3- and alpha 2,6-sialylation

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2014203277A Division AU2014203277C1 (en) 2008-04-16 2014-06-17 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation

Publications (2)

Publication Number Publication Date
AU2009237479A1 AU2009237479A1 (en) 2009-10-22
AU2009237479B2 true AU2009237479B2 (en) 2014-05-15

Family

ID=39717519

Family Applications (5)

Application Number Title Priority Date Filing Date
AU2009237479A Active AU2009237479B2 (en) 2008-04-16 2009-04-16 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2014203277A Active AU2014203277C1 (en) 2008-04-16 2014-06-17 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017204259A Active 2032-03-31 AU2017204259B2 (en) 2008-04-16 2017-06-23 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017204258A Active 2032-03-31 AU2017204258B2 (en) 2008-04-16 2017-06-23 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017225020A Active 2032-03-31 AU2017225020B2 (en) 2008-04-16 2017-09-05 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation

Family Applications After (4)

Application Number Title Priority Date Filing Date
AU2014203277A Active AU2014203277C1 (en) 2008-04-16 2014-06-17 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017204259A Active 2032-03-31 AU2017204259B2 (en) 2008-04-16 2017-06-23 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017204258A Active 2032-03-31 AU2017204258B2 (en) 2008-04-16 2017-06-23 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation
AU2017225020A Active 2032-03-31 AU2017225020B2 (en) 2008-04-16 2017-09-05 Recombinant FSH including alpha 2,3- and alpha 2,6-sialylation

Country Status (29)

Country Link
US (6) US8951967B2 (https=)
EP (7) EP3045471B1 (https=)
JP (7) JP2011519359A (https=)
KR (5) KR20160056960A (https=)
CN (3) CN105906703A (https=)
AR (1) AR071479A1 (https=)
AU (5) AU2009237479B2 (https=)
BR (1) BRPI0910461B8 (https=)
CA (1) CA2725257A1 (https=)
CY (1) CY1115413T1 (https=)
DK (6) DK2808340T3 (https=)
ES (5) ES2468318T3 (https=)
FI (4) FI3098234T3 (https=)
FR (3) FR17C1020I2 (https=)
HR (5) HRP20140535T1 (https=)
HU (9) HUE068565T2 (https=)
IL (2) IL208538A (https=)
LT (8) LT2808340T (https=)
MX (3) MX355457B (https=)
NO (4) NO2017025I1 (https=)
NZ (1) NZ588381A (https=)
PL (6) PL3144318T3 (https=)
PT (6) PT3045471T (https=)
RU (3) RU2682270C2 (https=)
SA (1) SA109300228B1 (https=)
SI (6) SI2268666T1 (https=)
TW (1) TWI488640B (https=)
WO (1) WO2009127826A1 (https=)
ZA (1) ZA201007373B (https=)

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TWI532495B (zh) 2009-10-05 2016-05-11 菲瑞茵國際中心股份有限公司 藥學製劑
EP2417982A1 (en) 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
WO2012016576A1 (en) * 2010-08-04 2012-02-09 Glycotope Gmbh Improved recombinant human follicle-stimulating hormone
PT2621517E (pt) 2010-09-29 2015-10-16 Ferring Bv Composição para uso no tratamento da infertilidade
WO2012050175A1 (ja) 2010-10-15 2012-04-19 日本ケミカルリサーチ株式会社 糖鎖の非還元末端がマンノース残基である糖蛋白質の製造方法
PL2691119T3 (pl) 2011-03-31 2019-01-31 Ferring B.V. Preparat farmaceutyczny
EP2717904A1 (en) 2011-06-06 2014-04-16 Ferring BV Pharmaceutical preparation comprising recombinant fsh
JO3092B1 (ar) * 2011-08-08 2017-03-15 Ferring Bv مركب لتحفيز مسيطر عليه للمبيض
WO2013093760A2 (en) * 2011-12-19 2013-06-27 Grifols, S.A. Compositions, methods, and kits for preparing sialylated recombinant proteins
US9657310B2 (en) * 2012-04-27 2017-05-23 Jcr Pharmaceuticals Co., Ltd. Expression vector
EP2824176A1 (en) 2013-07-11 2015-01-14 Siamed'xpress Methods for producing sialylated therapeutic proteins
JP6652334B2 (ja) * 2014-05-31 2020-02-19 Ｊｃｒファーマ株式会社 ウリジンとｎ−アセチル−ｄ−マンノサミンとを含有する培地
WO2016102436A1 (en) * 2014-12-22 2016-06-30 F. Hoffmann-La Roche Ag Cmp-dependent sialidase activity
EP3283097B1 (en) 2015-04-17 2020-02-12 Ferring B.V. Fsh for treatment of infertility
MY179524A (en) 2015-06-26 2020-11-10 Ferring Bv Methods of purification and/or viral inactivation
EP3205719A1 (en) * 2016-02-15 2017-08-16 CEVEC Pharmaceuticals GmbH Cell lines for producing recombinant glycoproteins with di-antennary n-glycans, methods using the same, and recombinant glycoproteins
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
EP3382014A1 (en) * 2017-03-29 2018-10-03 CEVEC Pharmaceuticals GmbH Recombinant glycoproteins with reduced antennary fucosylation
EP3441471A1 (en) 2017-08-08 2019-02-13 CEVEC Pharmaceuticals GmbH Use of constitutively active variants of growth factor receptors as selection makers for the generation of stable producer cell lines
MX2020002235A (es) 2017-09-01 2020-07-20 Ferring Bv Composicion para la estimulacion ovarica controlada.
HUE071268T2 (hu) 2018-04-30 2025-08-28 Ferring Bv Készítmény szabályozott petefészek-stimuláláshoz
TWI846743B (zh) 2018-10-17 2024-07-01 荷蘭商菲林公司 用於控制性卵巢刺激之組成物及方法
US20220380785A1 (en) * 2019-11-01 2022-12-01 The University Of British Columbia Compositions and methods for sialylated mucin-type o-glycosylation of therapeutic proteins
TW202237173A (zh) 2020-12-09 2022-10-01 荷蘭商菲林公司 用於受控的卵巢刺激之組成物及方法
KR20240167660A (ko) 2022-04-01 2024-11-27 훼링 비.브이. 불임의 치료를 위한 혼합 프로토콜
AU2023275943A1 (en) 2022-05-26 2024-10-17 Ferring B.V. Compositions and methods for treatment of infertility in males
KR20250033230A (ko) 2022-07-08 2025-03-07 훼링 비.브이. 자궁내 인공수정(iui)을 위한 조성물 및 방법
AR133300A1 (es) 2023-07-20 2025-09-17 Ferring Bv Micropartículas cargadas con fármaco de liberación prolongada

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Also Published As

Publication number Publication date
KR20190092608A (ko) 2019-08-07
EP2268666B1 (en) 2014-03-12
US20240327487A1 (en) 2024-10-03
RU2682270C2 (ru) 2019-03-18
AU2017225020B2 (en) 2019-11-14
HRP20241187T1 (hr) 2024-12-06
AU2014203277C1 (en) 2017-07-27
HUS1700025I1 (hu) 2017-06-28
RU2014141994A3 (https=) 2018-05-28
US11952407B2 (en) 2024-04-09
JP2018021037A (ja) 2018-02-08
DK4015527T3 (da) 2025-04-14
CN105906703A (zh) 2016-08-31
ES2989729T3 (es) 2024-11-27
IL230571A (en) 2015-11-30
US9546204B2 (en) 2017-01-17
JP2020040956A (ja) 2020-03-19
AU2009237479A1 (en) 2009-10-22
HUS1700036I1 (hu) 2017-10-30
RU2014141994A (ru) 2016-05-10
PT3098234T (pt) 2024-10-21
ES2629392T3 (es) 2017-08-09
ES3023526T3 (en) 2025-06-02
RU2537268C2 (ru) 2014-12-27
SI3045471T1 (sl) 2017-07-31
BRPI0910461A2 (pt) 2018-03-27
AU2017225020A1 (en) 2017-09-28
PT2268666E (pt) 2014-06-25
US20150065695A1 (en) 2015-03-05
LT2808340T (lt) 2016-11-10
CY1115413T1 (el) 2017-01-04
IL208538A (en) 2014-03-31
US20110105398A1 (en) 2011-05-05
SI3144318T1 (sl) 2020-12-31
PT2808340T (pt) 2016-11-21
CN102066414A (zh) 2011-05-18
DK3045471T3 (en) 2017-06-26
US20180079794A1 (en) 2018-03-22
FR17C1020I2 (fr) 2020-04-10
HRP20250313T1 (hr) 2025-05-09
CA2725257A1 (en) 2009-10-22
US9771407B2 (en) 2017-09-26
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