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1. (WO2017173060) FORMULATIONS COMPRISING RECOMBINANT ACID ALPHA-GLUCOSIDASE
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Pub. No.: WO/2017/173060 International Application No.: PCT/US2017/024982
Publication Date: 05.10.2017 International Filing Date: 30.03.2017
IPC:
A61K 38/47 (2006.01) ,C12N 9/26 (2006.01) ,A61P 3/00 (2006.01)
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
38
Medicinal preparations containing peptides
16
Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
43
Enzymes; Proenzymes; Derivatives thereof
46
Hydrolases (3)
47
acting on glycosyl compounds (3.2), e.g. cellulases, lactases
C CHEMISTRY; METALLURGY
12
BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
N
MICRO-ORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICRO-ORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
9
Enzymes, e.g. ligases (6.); Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating, or purifying enzymes
14
Hydrolases (3.)
24
acting on glycosyl compounds (3.2)
26
acting on alpha-1, 4-glucosidic bonds, e.g. hyaluronidase, invertase, amylase
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
P
SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3
Drugs for disorders of the metabolism
Applicants: AMICUS THERAPEUTICS, INC.[US/US]; 1 Cedar Brook Drive Cranbury, New Jersey 08512, US
Inventors: CHAR, Hing; US
TESLER, Sergey; US
SUNDERLAND, Wendy; US
DILONÉ, Enrique; US
Agent: ALEGRIA, Rory P.; US
Priority Data:
15/473,99930.03.2017US
62/315,43630.03.2016US
62/457,58810.02.2017US
Title (EN) FORMULATIONS COMPRISING RECOMBINANT ACID ALPHA-GLUCOSIDASE
(FR) FORMULATIONS COMPRENANT UNE ALPHA-GLUCOSIDASE ACIDE RECOMBINANTE
Abstract:
(EN) Provided are pharmaceutical formulations comprising a recombinant acid α-glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa; at least one buffer selected from the group consisting of a citrate, a phosphate and combinations thereof; and at least one excipient selected from the group consisting of mannitol, polysorbate 80, and combinations thereof, wherein the formulation has a pH of from about 5.0 to about 7.0. Also provided are methods of treating Pompe disease using these pharmaceutical formulations.
(FR) La présente invention concerne des formulations pharmaceutiques comprenant une α-glucosidase acide recombinante, la α-glucosidase acide recombinante étant exprimée dans des cellules d'ovaire de hamster chinois (CHO) et comprenant un taux augmenté de motifs N-glycane comportant un ou deux résidus mannose-6-phosphate par rapport à une teneur en motifs N-glycane comportant un ou deux résidus mannose-6-phosphate d'alglucosidase alpha; au moins un tampon choisi dans le groupe constitué d'un citrate, d'un phosphate et des combinaisons de ceux-ci; et au moins un excipient choisi dans le groupe constitué du mannitol, du polysorbate 80, et des combinaisons de ceux-ci, la formulation ayant un pH d'environ 5,0 à environ 7,0. L'invention concerne en outre des procédés de traitement de la maladie de Pompe au moyen de ces formulations pharmaceutiques.
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Designated States: 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, 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
African Regional Intellectual Property Organization (ARIPO) (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW)
Eurasian Patent Office (AM, AZ, BY, KG, KZ, RU, TJ, TM)
European Patent Office (EPO) (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, TR)
African Intellectual Property Organization (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG)
Publication Language: English (EN)
Filing Language: English (EN)