Methods And Compositions For Cns Delivery Of Iduronate-2-Sulfatase - EP3626258

The patent EP3626258 was granted to Shire Human Genetic Therapies on Aug 4, 2021. The application was originally filed on Jun 25, 2011 under application number EP19192679A. The patent is currently recorded with a legal status of "Revoked".

EP3626258

SHIRE HUMAN GENETIC THERAPIES
Application Number
EP19192679A
Filing Date
Jun 25, 2011
Status
Revoked
Sep 25, 2025
Grant Date
Aug 4, 2021
External Links
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Patent Citations (7) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS6217552
DESCRIPTIONUS6534300
DESCRIPTIONUS6537785
OPPOSITIONEP3103469
OPPOSITIONUS2009130079
SEARCHUS2009017005
SEARCHWO2012023623

Non-Patent Literature (NPL) Citations (53) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
DESCRIPTION- ALTSCHUL et al., Methods in Enzymology-
DESCRIPTION- ALTSCHUL et al., Nucleic Acids Res., (19970000), vol. 25, pages 3389 - 3402-
DESCRIPTION- BENIAMINOVITZ et al., N. Engl J. Med., (20000000), vol. 342, pages 613 - 619-
DESCRIPTION- BERARD et al., Pharmacotherapy, (19990000), vol. 19, pages 1127 - 1137-
DESCRIPTION- "Bioinformatics Methods and Protocols", Methods in Molecular Biology, Humana Press, (19990000), vol. 132-
DESCRIPTION- BOBO et al., Proc. Natl. Acad. Sci. U.S.A, (19940000), vol. 91, pages 2076 - 2080-
DESCRIPTION- BRANCO et al., Transplantation, (19990000), vol. 68, pages 1588 - 1596-
DESCRIPTION- CHIRMULE et al., J. Virol., (20000000), vol. 74, pages 3345 - 3352-
DESCRIPTION- DEKABAN AS, "Changes in brain weights during the span of human life: relation of brain weights to body heights and body weights", Ann Neurol, (19780000), vol. 4, pages 345 - 56-
DESCRIPTION- ECKHOFF et al., Transplantation, (20000000), vol. 69, pages 1867 - 1872-
DESCRIPTION- EKBERG et al., Transpl. Int., (20000000), vol. 13, pages 151 - 159-
DESCRIPTION- FISHWILD et al., Clin. Immunol., (19990000), vol. 92, pages 138 - 152-
DESCRIPTION- "Fundamentals of freeze-drying", NAIL S.L. et al., Development and manufacture of protein pharmaceuticals, Kluwer Academic/Plenum Publishers, (20020000), pages 281 - 353-
DESCRIPTION- GAZIEV et al., Bone Marrow Transplant., (19990000), vol. 25, pages 689 - 696-
DESCRIPTION- GRAHAM et al., J. Gen Virol., (19770000), vol. 36, page 59-
DESCRIPTION- GUMMERT et al., J. Am. Soc. Nephrol., (19990000), vol. 10, pages 1366 - 1380-
DESCRIPTION- HENRY, Clin. Transplant., (19990000), vol. 13, pages 209 - 220-
DESCRIPTION- HONG et al., Semin. Nephrol., (20000000), vol. 20, pages 108 - 125-
DESCRIPTION- IDEGUCHI et al., Neuroscience, (20000000), vol. 95, pages 217 - 226-
DESCRIPTION- ITO et al., J. Immunol., (20000000), vol. 164, pages 1230 - 1235-
DESCRIPTION- JOHANSON CE et al., "Multiplicity of cerebrospinal fluid functions: New challenges in health and disease", Cerebrospinal Fluid Res., (20080514), vol. 5, no. 10-
DESCRIPTION- KURLBERG et al., Scand. J. Immunol., (20000000), vol. 51, pages 224 - 230-
DESCRIPTION- Lancet, (19630000), vol. 2, pages 983 - 84-
DESCRIPTION- LAZORTHES et al., Advances in Drug Delivery Systems and Applications in Neurosurgery, pages 143 - 192-
DESCRIPTION- MARINOVA-MUTAFCHIEVA et al., Arthritis Rheum., (20000000), vol. 43, pages 638 - 644-
DESCRIPTION- Mather, Biol. Reprod., (19800000), vol. 23, pages 243 - 251-
DESCRIPTION- MATHER et al., Annals N.Y. Acad. Sci., (19820000), vol. 383, pages 44 - 68-
DESCRIPTION- MODER, Ann. Allergy Asthma Immunol., (20000000), vol. 84, pages 280 - 284-
DESCRIPTION- NEVINS, Curr. Opin. Pediatr., (20000000), vol. 12, pages 146 - 150-
DESCRIPTION- NGUYEN et al., J. Neurosurg., (20030000), vol. 98, pages 584 - 590-
DESCRIPTION- OMAYA et al., Cancer Drug Delivery, vol. 1, pages 169 - 179-
DESCRIPTION- PONTICELLI et al., Drugs R. D., (19990000), vol. 1, pages 55 - 60-
DESCRIPTION- POTTERET, Ann. N.Y. Acad. Sci., (19990000), vol. 875, pages 159 - 174-
DESCRIPTION- Proc. Natl. Acad. Sci. USA, (19800000), vol. 77, page 4216-
DESCRIPTION- PRZEPIORKA et al., Blood, (19980000), vol. 92, pages 4066 - 4071-
DESCRIPTION- SLAVIK et al., Immunol. Res., (19990000), vol. 19, pages 1 - 24-
DESCRIPTION- The Metabolic and Molecular Basis of Inherited Disease, McGraw Hill, (19950000), vol. II-
DESCRIPTION- WILLIAMS N.A. et al., "The lyophilization of pharmaceuticals; A literature review", J. Parenteral Sci. Techno!., (19840000), vol. 38, pages 48 - 59, XP000670830-
DESCRIPTION- WISEMAN et al., Drugs, (19990000), vol. 58, pages 1029 - 1042-
DESCRIPTION- ALTSCHUL et al., "Basic local alignment search tool", J. Mol. Biol., (19900000), vol. 215, no. 3, doi:doi:10.1006/jmbi.1990.9999, pages 403 - 410, XP002949123
DESCRIPTION- WANG et al., "Lyophilization and development of solid protein pharmaceuticals", Int. J. Pharm., (20000000), vol. 203, doi:doi:10.1016/S0378-5173(00)00423-3, pages 1 - 60, XP002428586
DESCRIPTION- TANG X. et al., "Design of freeze-drying processes for pharmaceuticals: Practical advice", Pharm. Res., (20040000), vol. 21, doi:doi:10.1023/B:PHAM.0000016234.73023.75, pages 191 - 200, XP002370775
DESCRIPTION- ALTSCHUL et al., "Gapped BLAST and PSI-BLAST: a new generation of protein database search programs", Nucleic Acids Res., (19970000), vol. 25, doi:doi:10.1093/nar/25.17.3389, pages 3389 - 3402, XP002905950
OPPOSITION- Alam M. Intakhab, Beg Sarwar, Samad Abdus, Baboota Sanjula, Kohli Kanchan, Ali Javed, Ahuja Alka, Akbar M., "Strategy for effective brain drug delivery", European Journal of Pharmaceutical Sciences, (20100516), vol. 40, no. 5, pages 385 - 403, XP027093081-
OPPOSITION- Anonymous, "A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®", History of Changes for Study: NCT00920647, (20190430), pages 1 - 11, URL: https://clinicaltrials.gov/ct2/history/NCT009206477V_1 =View%20-., XP055844650-
OPPOSITION- Anonymous, "Elliotts B® Solution (buffered intrathecal electrolyte/dextrose injection) Prescribing Information", Elliotts B®, ( ), pages 1 - 2, XP055924597-
OPPOSITION- Auclair D; Finnie J; White J; Nielsen T; Fuller M; Kakkis E; Cheng A; ONeill C A; Hopwood J J, "Repeated intrathecal injections of recombinant human 4-sulphatase remove dural storage in mature mucopolysaccharidosis VI cats primed with a short-course tolerisation regimen", Molecular Genetics and Metabolism, (20091013), vol. 99, no. 2, pages 132 - . 141, XP026835387-
OPPOSITION- Zahra Shahrokh; Perry Callas; Lawrence Charnas, "Intrathecal Delivery of Protein Therapeutics to Treat Genetic Diseases Involving the CNS", ONdrugDelivery, pages 16 - 20, XP055074790-
OPPOSITION- Tsai Shih-Yen, Markus Tiffanie M., Andrews Ellen M., Cheatwood Joseph L., Emerick April J., Mir Anis K., Schwab Martin E., Kartje Gwendolyn L., "Intrathecal treatment with anti-Nogo-A antibody improves functional recovery in adult rats after stroke", Exp Brain Res, (20070000), vol. 182, no. 2, pages 261 - 266, XP019537874
OPPOSITION- Daniele A, Tomanin R, Villani G.R.D, Zacchello F, Scarpa M, Di Natale P, "Uptake of recombinant iduronate-2-sulfatase into neuronal and glial cells in vitro", Biochimica et Biophysica Acta, (20020000), vol. 1588, pages 203 - 209, XP004389111
OPPOSITION- LEE et al., "Single-dose intracerebroventricular administration of galactocerebrosidase improves survival in a mouse model of globoid cell leukodystrophy", FASEB J, (20070000), vol. 21, pages 2520 - 2527, XP055074782
SEARCH- ANONYMOUS, "Scientific Discussion - Elaprase", INTERNET CITATION, (20070118), pages 1 - 43, URL: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Scientific_Discussion/human/000222/WC500032033.pdf, (20131120), XP002717916 [A] 1-15 * the whole document *-
SEARCH- Zahra Shahrokh ET AL, "INTRATHECAL DELIVERY OF PROTEIN THERAPEUTICS TO TREAT GENETIC DISEASES INVOLVING THE CNS", Ondrugdelivery, (20100101), pages 16 - 20, URL: http://www.ondrugdelivery.com/publications/Injectable Formulations 2010/Shire.pdf, (20130809), XP055074790 [A] 1-15 * page 19, cf. especially the text in the middle column, figures 7-10 *-

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