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Identifying Patient Response To S1P Receptor Modulator Administration - EP3647783

The patent EP3647783 was granted to Novartis on Dec 21, 2022. The application was originally filed on Apr 19, 2013 under application number EP19204477A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3647783

NOVARTIS
Application Number
EP19204477A
Filing Date
Apr 19, 2013
Status
Granted And Under Opposition
Nov 18, 2022
Grant Date
Dec 21, 2022
External Links
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Patent Oppositions (4)

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KRAUS & LEDERER PARTGMBBSep 21, 2023KRAUS & LEDERER PARTGMBBADMISSIBLE
SYNTHONSep 21, 2023HAMM & WITTKOPPADMISSIBLE
VENNER SHIPLEYSep 21, 2023RUSSELLADMISSIBLE
KILBURN & STRODESep 20, 2023LEONARDADMISSIBLE

Patent Citations (5) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONWO2010072703
OPPOSITIONWO2010072703
OPPOSITIONWO2011041146
OPPOSITIONWO2014161606
SEARCHWO2010072703

Non-Patent Literature (NPL) Citations (61) 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- GUENGERICH FP, "In vitro techniques for studying drug metabolism", Journal of Pharmacokinetics & Biopharmaceutics, (19960000), vol. 24, pages 521 - 533-
DESCRIPTION- "In vitro approaches for studying the inhibition of drug-metabolizing enzymes and identifying the drug-metabolizing enzymes responsible for the metabolism of drugs (Reaction phenotyping ) with emphasis on cytochrome P450", OGILVIE BWUSUKI EYERINO PPARKINSON A, Drug-drug Interactions, Informa Healthcare, (20080000), pages 231 - 358-
DESCRIPTION- NEWTON DJWANG R WLU AYH, "Cytochrome P450 inhibitors: Evaluation of specificities in the in vitro metabolism of therapeutic agents by human liver microsomes", Drug Metabolism and disposition, (19950000), vol. 25, pages 154 - 158, XP008090397-
DESCRIPTION- RETTIE AEJONES JP GT, "Clinical and toxicological relevance of CYP2C9: drug-drug interactions and pharmacogenetics", Annu. Rev. Pharmacol, (20050000), vol. 45, pages 477 - 494-
DESCRIPTION- ROWLAND YEO KROSTAMI-HODJEGAN ATRUCKER GT, "Abundance of cytochromes P450 in human liver: a meta-analysis", Br. J. Clinical Pharmacology, (20040000), vol. 57, pages 687 - 688-
DESCRIPTION- SHIMADA TYAMAZAKI HMIMURA M et al., "Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians", JPET, (19940000), vol. 270, pages 414 - 423-
DESCRIPTION- TUCKER GTHOUSTON JBHUANG SM, "Optimizing drug development: strategies to assess drug metabolism/transporter interaction potential-towards a consensus", Br J Clin Pharmacol, (20010000), vol. 52, pages 107 - 17-
DESCRIPTION- BJORNSSON TDCALLAGHAN JTEINOLF HJFISCHER VGAN LGRIMM SKAO JKING SPMIWA GNI L, "The conduct of in vitro and in vivo drug-drug interaction studies: A Pharmaceutical Research and Manufacturers of America (PhRMA) perspective", Drug Metab Dispos, (20030000), vol. 31, doi:10.1124/dmd.31.7.815, pages 815 - 832, XP055112811
OPPOSITION- Anonymous, "CELEBREX® (celecoxib) capsules", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20110101), XP093166111-
OPPOSITION- Anonymous, "COUMADIN (warfarin sodium) ", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20111001), XP093166118-
OPPOSITION- Anonymous, "Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling", PRELIMINARY CONCEPT PAPER, For Discussion Purposes Only, (20041001), pages 1 - 34, XP093134001-
OPPOSITION- Anonymous, "FLURBIPROFEN - flurbiprofen tablet, film coated STAT RX USA LLC ", Internet Citation, (20070101), pages 1 - 13, Internet Citation, URL: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=9ce60fd6-b58b-4b7c-835d-305107552f44&type=display, XP093208178-
OPPOSITION- Anonymous, "Guidance for Industry Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling", Clinical Pharmacology, U.S. Department of Health and Human Services, (20060101), pages 1 - 55, XP093134008-
OPPOSITION- Anonymous, "Guideline on the investigation of drug interactions", European Medicines Agency (EMA), Internet, Internet , (20120621), pages 2 - 59, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-drug-interactions-revision-1_en.pdf, (20200902), XP055727049-
OPPOSITION- Anonymous, "History of Changes for Study: NCT01665144 Exploring the Efficacy and Safety of Siponimod in Patients With Secondary Progressive Multiple Sclerosis (EXPAND)", Clinical Trials, (20130212), pages 1 - 33, XP093133654-
OPPOSITION- Anonymous, "MAYZENT® (siponimod)", HIGHLIGHTS OF PRESCRIBING INFORMATION, (20190101), pages 1 - 26, XP093134026-
OPPOSITION- Anonymous, "Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis", Clinical Trials, (20200113), no. NCT00879658, pages 1 - 17, XP093149191-
OPPOSITION- Beedham Christine, "The role of non-P450 enzymes in drug oxidation", Pharm World Sci, Kluwer Academic Publishers., (19970101), vol. 19, no. 6, pages 255 - 263, XP093208160-
OPPOSITION- Fda, "Guidance for Industry - Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling", (20130101), pages FP, 1 - 25, XP093166110-
OPPOSITION- Gergely P., "Phase I study with the selective S1P1/S1P5 receptor modulator BAF312 indicates that S1P1 rather than S1P3 mediates transient heart rate reduction in humans", Multiple Sclerosis, (20090101), vol. 15, pages S125 - S126, XP093149000-
OPPOSITION- Hartung Hans-Peter et al, "Phase 2 BOLD Extension Study Safety Results for Siponimod (BAF312) in Patients with Relapsing-Remitting Multiple Sclerosis", Neurology, Lippincott Williams & Wilkins , Philadelphia, US, US , (20130201), vol. 80, no. Suppl., ISSN 0028-3878, page P01176, XP055197399-
OPPOSITION- Horn John R, Philip D. Hansten, "Get to Know an Enzyme: CYP2C9", (20080301), pages 1 - 8, Pharmacy Times, URL: https://www.pharmacytimes.com/view/2008-03-8462, (20240221), XP093133665-
OPPOSITION- Horn John R, Philip D. Hansten, "Get to Know an Enzyme: CYP2C9", Pharmacy Times, (20080301), pages 1 - 8, Pharmacy Times, URL: https://www.pharmacytimes.com/view/2008-03-8462, (20240221), XP093133665-
OPPOSITION- Ionescu Corina, Caira Mino R., "Drug metabolism. IMPACT OF GENE VARIABILITY ON DRUG METABOLISM (Chapter 7)", Ionescu Corina, Caira Mino R., Ionescu Corina, Caira Mino R., Drug Metabolism, Current Consepts, Springer Verlag, (20050101), pages 29-31 - 269-273, XP093151844-
OPPOSITION- Jin Yi et al, "CYP4F Enzymes Are Responsible for the Elimination of Fingolimod (FTY720), a Novel Treatment of Relapsing Multiple Sclerosis", Drug Metabolism and Disposition, (20110101), vol. 39, no. 2, pages 191 - 198, XP093149114-
OPPOSITION- John R. Horn, "Get to Know an Enzyme: CYP2C9", Pharmacy Times, (20080301), pages 1 - 11, XP093166121-
OPPOSITION- Kappos Ludwig et al, "Siponimod (BAF312) for the Treatment of Secondary Progressive Multiple Sclerosis: Design of the Phase 3 EXPAND Trial", Neurology, Lippincott Williams & Wilkins , Philadelphia, US, US , (20130201), vol. 80, no. Suppl., ISSN 0028-3878, page P07126, XP055197407-
OPPOSITION- Lee Soo-Youn, June Soo Kim, Jong-Won Kim, "A Case of Intolerance to Warfarin Dosing in an Intermediate Metabolizer of CYP2C9", Yonsei Medical Journal, (20050101), vol. 46, no. 6, pages 843 - 846, XP093134014-
OPPOSITION- Levien Terri L, Baker Danial E, "Cytochrome P450 Drug Interactions", Pharmacist's Letter/Prescriber's Letter, (20030101), pages 1 - 4, XP093134034-
OPPOSITION- Mikko Niemi, Janne T. Backman, Martin F. Fromm, Pertti J. Neuvonen, Kari T. Kivisto, "Pharmacokinetic Interactions with Rifampicin - Clinical Relevance", Clin Pharmacokinet, (20030801), vol. 42, no. 9, pages 819 - 850, XP093133670-
OPPOSITION- Pfizer, "FELDENE® (piroxicam) CAPSULES 10 mg and 20 mg for oral use", FDA Label, (20100701), XP093166120-
OPPOSITION- Stuve Olaf et al, "Phase 2 BOLD Extension Study Efficacy Results for Siponimod (BAF312) in Patients with Relapsing-Remitting Multiple Sclerosis", Neurology, Lippincott Williams & Wilkins, (20130201), vol. 80, no. Suppl., ISSN 0028-3878, page P07110, XP055197403-
OPPOSITION- Uetrecht Jack, William Trager, "Oxidation Pathways and the Enzymes That Mediate Them", Uetrecht Jack, William Trager, Uetrecht Jack, William Trager, Drug Metalism, Chemical and Enzymatic Aspects, New York, London, Informa healthcare, (20070101), pages 33 - 52, XP093149050-
OPPOSITION- Wehling Martin, et al, "Pharmakokinetische Wechselwirkungen, Pharmakodynamische Wechselwirkungen", Wehling Martin, et al, Wehling Martin, et al, Klinische Pharmakologie, Stuttgart, New York, Georg Thieme Verlag, (20050101), pages 24-25, 29-31 - 34, XP093149092-
OPPOSITION- Jin Yi et al, "In vitro studies and in silico predictions of fluconazole and CYP2C9 genetic polymorphism impact on siponimod metabolism and pharmacokinetics", European Journal of Clinical Pharmacology, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20171222), vol. 74, no. 4, doi:10.1007/s00228-017-2404-2, ISSN 0031-6970, pages 455 - 464, XP036455971
OPPOSITION- Gardin Anne et al, "Effect of Fluconazole Coadministration and CYP2C9 Genetic Polymorphism on Siponimod Pharmacokinetics in Healthy Subjects", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20190301), vol. 58, no. 3, doi:10.1007/s40262-018-0700-3, ISSN 0312-5963, pages 349 - 361, XP093208043
OPPOSITION- Kirchheiner, J. Seeringer, A., "Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes", Biochimica et Biophysica Acta, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL , (20070125), vol. 1770, no. 3, doi:10.1016/j.bbagen.2006.09.019, ISSN 0304-4165, pages 489 - 494, XP005858798
OPPOSITION- Kirchheiner, J., Seeringer, A., "Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes", Biochimica et Biophysica Acta, Elsevier, AMSTERDAM, NL, AMSTERDAM, NL , (20070125), vol. 1770, no. 3, doi:10.1016/j.bbagen.2006.09.019, ISSN 0304-4165, pages 489 - 494, XP005858798
OPPOSITION- Juran, B.D. Egan, L.J. Lazaridis, K.N., "The AmpliChip CYP450 Test: Principles, Challenges, and Future Clinical Utility in Digestive Disease", Clinical Gastroenterology and Hepatology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20060701), vol. 4, no. 7, doi:10.1016/j.cgh.2006.05.002, ISSN 1542-3565, pages 822 - 830, XP005533465
OPPOSITION- Ingelman-Sundberg, M. Sim, S.C. Gomez, A. Rodriguez-Antona, C., "Influence of cytochrome P450 polymorphisms on drug therapies: Pharmacogenetic, pharmacoepigenetic and clinical aspects", Pharmacology & Therapeutics, GB , (20071120), vol. 116, no. 3, doi:10.1016/j.pharmthera.2007.09.004, ISSN 0163-7258, pages 496 - 526, XP022354106
OPPOSITION- Shifeng Pan et al., "Discovery of BAF312 (Siponimod), a Potent and Selective S1P Receptor Modulator", ACS Med. Chem. Lett., (2013), vol. 4, doi:10.1021/ml300396r, XP055263008
OPPOSITION- Shifeng Pan, Gray Nathanael S., Gao Wenqi, Mi Yuan, Fan Yi, Wang Xing, Tuntland Tove, Che Jianwei, Lefebvre Sophie, Chen Yu, Chu Alan, Hinterding Klaus, Gardin Anne, End Peter, Heining Peter, Bruns Christian, Cooke Nigel G., Nuesslein-Hildesheim Barbara, "Discovery of BAF312 (Siponimod), a Potent and Selective S1P Receptor Modulator", ACS Medicinal chemistry letters, US , (20130314), vol. 4, no. 3, doi:10.1021/ml300396r, ISSN 1948-5875, pages 333 - 337, XP055263008
OPPOSITION- John O. Miners; Donald J. Birkett, "Cytochrome P4502C9: an enzyme of major importance in human drug metabolism", British journal of clinical pharmacology, GB , (20020104), vol. 45, no. 6, doi:10.1046/j.1365-2125.1998.00721.x, ISSN 0306-5251, pages 525 - 538, XP071597015
OPPOSITION- Julia Kirchheiner et al, "Pharmacokinetics of diclofenac and inhibition of cyclooxygenases 1 and 2: no relationship to the CYP2C9 genetic polymorphism in humans", British journal of clinical pharmacology, BLACKWELL SCIENTIFIC PUBL., GB, GB , (20030114), vol. 55, no. 1, doi:10.1046/j.1365-2125.2003.01712.x, ISSN 0306-5251, pages 51 - 61, XP071598307
OPPOSITION- Van Booven Derek et al, "Cytochrome P450 2C9-CYP2C9", PHARMACOGENETICS AND GENOMICS, LIPPINCOTT WILLIAMS & WILKINS, PHILADELPHIA, PA, US, US , (20100401), vol. 20, no. 4, doi:10.1097/FPC.0b013e3283349e84, ISSN 1744-6872, pages 277 - 281, XP093134036
OPPOSITION- Gergely P et al, "The selective sphingosine 1-phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species-specific effects on heart rate.", British Journal of Pharmacology, John Wiley & Sons Ltd., GB, GB , (20121101), vol. 167, no. 5, doi:10.1111/j.1476-5381.2012.02061.x, ISSN 1476-5381, pages 1035 - 1047, XP002718009
OPPOSITION- P Gergely; B Nuesslein‐Hildesheim; D Guerini; V Brinkmann; M Traebert; C Bruns; S Pan; NS Gray; K Hinterding; NG Cooke; A Groenewegen; A Vitaliti; T Sing; O Luttringer; J Yang; A Gardin; N Wang; WJ Crumb Jr; M Saltzman; M Rosenberg; E Wallström, "The selective sphingosine 1‐phosphate receptor modulator BAF312 redirects lymphocyte distribution and has species‐specific effects on heart rate", British journal of pharmacology, UK , (20121008), vol. 167, no. 5, doi:10.1111/j.1476-5381.2012.02061.x, ISSN 0007-1188, pages 1035 - 1047, XP071171275
OPPOSITION- Glaenzel Ulrike et al, "Metabolism and Disposition of Siponimod, a Novel Selective S1P 1 /S1P 5 Agonist, in Healthy Volunteers and In Vitro Identification of Human Cytochrome P450 Enzymes Involved in Its Oxidative Metabolism", Drug Metabolism and Disposition, Pharmacology and Experimental Therapeutics, US, US , (20180701), vol. 46, no. 7, doi:10.1124/dmd.117.079574, ISSN 0090-9556, pages 1001 - 1013, XP055844317
OPPOSITION- T. D. Bjornsson et al, "THE CONDUCT OF IN VITRO AND IN VIVO DRUG-DRUG INTERACTION STUDIES: A PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) PERSPECTIVE", Drug Metabolism and Disposition, ¬American Society for Pharmacology and Experimental Therapeutics, etc.|, (20030701), vol. 31, no. 7, doi:10.1124/dmd.31.7.815, ISSN 00909556, pages 815 - 832, XP055112811
OPPOSITION- Rettie Allan E., Jones Jeffrey P., "CLINICAL AND TOXICOLOGICAL RELEVANCE OF CYP2C9: Drug-Drug Interactions and Pharmacogenetics", ANNUAL REVIEW OF PHARMACOLOGY AND TOXICOLOGY., ANNUAL REVIEW INC., PALO ALTO, CA., US, US , (20050922), vol. 45, no. 1, doi:10.1146/annurev.pharmtox.45.120403.095821, ISSN 0362-1642, pages 477 - 494, XP093149061
OPPOSITION- Li D. et al, "MRI Findings of BOLD: A Phase 2 Dose-Finding Study Using Adaptive Design and Modeling Methods for BAF312 in Relapsing-Remitting MS (S11.005)", Neurology, Lippincott Williams & Wilkins, (20120424), vol. 78, no. Meeting Abstracts 1, doi:10.1212/WNL.78.1_MeetingAbstracts.S11.005, ISSN 0028-3878, pages 1 - 3, XP093208048
OPPOSITION- Stuve Olaf et al, "BAF312, a Selective Sphingosine-1-Phosphate Receptor Modulator Improves MRI and Clinical Outcomes in Relapsing-Remitting Multiple Sclerosis (RRMS)", Neurology, Lippincott Williams & Wilkins, (20120401), vol. 78, no. Suppl. 1, doi:10.1212/WNL.78.1_MeetingAbstracts.S30.001, ISSN 0028-3878, page S30001, XP055197398
OPPOSITION- Martignoni Marcella et al, "Species differences between mouse, rat, dog, monkey and human CYP-mediated drug metabolism, inhibition and induction", Expert Opinion on Drug Metabolism & Toxicology, Ashley Productions London, GB, GB , (20061201), vol. 2, no. 6, doi:10.1517/17425255.2.6.875, ISSN 1742-5255, pages 875 - 894, XP093208054
OPPOSITION- Hemeryck Alex; Belpaire Frans M, "Selective serotonin reuptake inhibitors and cytochrome P-450 mediated drug-drug interactions: An update", CURRENT DRUG METABOLISM, BENTHAM SCIENCE PUBLISHERS,, US, US , (20020201), vol. 3, no. 1, doi:10.2174/1389200023338017, ISSN 1389-2002, pages 13 - 37, XP009157243
OPPOSITION- Kitzmiller Joseph P., Groen David K., Phelps Mitch A., Sadee Wolfgang, "Pharmacogenomic testing: Relevance in medical practice : Why drugs work in some patients but not in others", Cleveland clinic journal of medicine, US , (20110401), vol. 78, no. 4, doi:10.3949/ccjm.78a.10145, ISSN 0891-1150, pages 1 - 24, XP093133659
OPPOSITION- Ortiz De Montellano Paul R., "Cytochrome P450-Activated Prodrugs", Future Medicinal Chemistry, Future Science, (20130201), vol. 5, no. 2, doi:10.4155/fmc.12.197, ISSN 1756-8919, pages 213 - 228, XP093208167
SEARCH- GAMBOA F ET AL, "Pneumocystis carinii pneumoniae. Complicating cytotoxic therapy in systemic vasculitis", EMBASE,, (19950101), XP002699535 [A] 18-20 * the whole document *-
SEARCH- John R Horn ET AL, "Get to Know an Enzyme: CYP2C9", Pharmacy Times, (20080101), URL: http://www.pharmacytimes.com/publications/issue/2008/2008-03/2008-03-8462, (20170425), XP055367064 [A] 1-20 * the whole document *-
SEARCH- MIN D I ET AL, "COMPLICATIONS ASSOCIATED WITH IMMUNOSUPPRESSIVE THERAPY AND THEIR MANAGEMENT", BIOSIS,, (19910101), Database accession no. PREV199293011939, URL: BIOSIS, XP002699536 [A] 18-20 * abstract *-
SEARCH- KIRCHHEINER ET AL, "Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes", BIOCHIMICA ET BIOPHYSICA ACTA - GENERAL SUBJECTS, ELSEVIER SCIENCE PUBLISHERS, NL, (20070125), vol. 1770, no. 3, doi:10.1016/J.BBAGEN.2006.09.019, ISSN 0304-4165, pages 489 - 494, XP005858798 [Y] 1,3-4,7-16,19-20 * the whole document * [A] 2,5-6,17
SEARCH- ROHATAGI SHASHANK ET AL, "Use of an Exposure-Response Model to Aid Early Drug Development of an Oral Sphingosine 1-Phosphate Receptor Modulator", BIOSIS, BIOSCIENCES INFOR, (20090101), Database accession no. PREV200900115387, URL: BIOSIS, XP002699537 [A] 18-20 * abstract *

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