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Combinations Of Liposomal Irinotecan, 5-Fu And Leucovorin For The Treatment Of Pancreatic Cancer - EP3266456

The patent EP3266456 was granted to Ipsen Biopharm on May 5, 2021. The application was originally filed on Jun 12, 2013 under application number EP17169098A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3266456

IPSEN BIOPHARM
Application Number
EP17169098A
Filing Date
Jun 12, 2013
Status
Granted And Under Opposition
Apr 3, 2021
Grant Date
May 5, 2021
External Links
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Patent Summary

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Patent Oppositions (3)

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GENERICS UKFeb 4, 2022ELKINGTON AND FIFEADMISSIBLE
TEVA PHARMACEUTICALSFeb 2, 2022D YOUNGADMISSIBLE
SANDOZFeb 1, 2022KRAUS & LEDERER PARTGMBBADMISSIBLE

Patent Citations (8) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS8147867
EXAMINATIONWO2012146610
EXAMINATIONWO2013138371
OPPOSITIONEP2861210
OPPOSITIONWO2012146610
OPPOSITIONWO2013138371
SEARCHWO2012146610
SEARCHWO2013138371

Non-Patent Literature (NPL) Citations (47) 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
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OPPOSITION- Chen Li-Tzong, "Phase I study of biweekly liposome irinotecan (PEP02, MM-398) in metastatic colorectal cancer failed on first-line oxaliplatin-based chemotherapy", Journal of Clinical Oncology, (20120101), vol. 30, no. 4S, pages 1 - 2, XP055893447-
OPPOSITION- Fda, "FDA approves new treatment for advanced pancreatic cancer", FDA - News Release, (20151022), FDA - News Release, URL: https://www.fda.gov, (20220217), XP055892881-
OPPOSITION- Ko A. H., M. A. Tempero, Y. Shan, W. Su, Y. Lin, E. Dito, A. Ong, G. Yeh, L. Chen, "abstr 237: A multinational phase II study of liposome irinotecan (PEP02) for patients with gemcitabinerefractory metastatic pancreatic cancer", J Clin Oncol. Gastrointestinal Cancers Symposium, (20110101), J Clin Oncol. Gastrointestinal Cancers Symposium, URL: https://ascopubs.org/doi/abs/10.1200/jco.2011.29.4_suppl.237, (20220217), XP055892871-
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OPPOSITION- "Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer", (20120809), pages 1 - 3, URL: http://clinicaltrials.gov/archive/NCT01494506/2012_08_09, (20130814), XP055075259-
OPPOSITION- Venditto Vincent, Et Al, "Cancer Therapies Utilizing the Camptothecins: A Review of the In Vivo Literature", Molecular Pharmaceutics, (20100101), vol. 7, no. 2, pages 307 - 349, XP055892704-
OPPOSITION- Wang-Gillam Andrea, Li Chung-Pin, Bodoky György, Dean Andrew, Shan Yan-Shen, Jameson Gayle, Macarulla Teresa, Lee Kyung-Hun, Cunningham David, Blanc Jean F, Hubner Richard A, Chiu Chang-Fang, Schwartsmann Gilberto, Siveke Jens T, Braiteh Fadi, Moyo Victor, Belanger Bruce, Dhindsa Navreet, Bayever Eliel, Hoff Daniel D, Chen Li-Tzong, "Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global,randomised, open-label, phase 3 trial", The Lancet, (20160206), vol. 387, no. 10018, pages 545 - 357, XP055892872-
OPPOSITION- Jeffrey R. Infante; Vicki L. Keedy; Suzanne F. Jones; William C. Zamboni; Emily Chan; Johanna C. Bendell; Wooin Lee; Huali Wu; Satoshi Ikeda; Hiroshi Kodaira; Mace L. Rothenberg; Howard A. Burris III, "Phase I and pharmacokinetic study of IHL-305 (PEGylated liposomal irinotecan) in patients with advanced solid tumors", Cancer Chemotherapy and Pharmacology, Springer, Berlin, DE, Berlin, DE , (20120902), vol. 70, no. 5, doi:10.1007/s00280-012-1960-5, ISSN 1432-0843, pages 699 - 705, XP035132528
OPPOSITION- Jeffrey R Infante; Vicki L Keedy; Suzanne F Jones; William C Zamboni; Emily Chan; Johanna C Bendell; Wooin Lee; Huali Wu; Satoshi Ikeda; Hiroshi Kodaira; Mace L Rothenberg; Howard A Burris III, "Phase I and pharmacokinetic study of IHL-305 (PEGylated liposomal irinotecan) in patients with advanced solid tumors", Cancer. Chemother. Pharmacol., (20120000), vol. 70, no. 5, pages 699 - 705, XP035132528
OPPOSITION- Tardi, P.G. et al, "Coencapsulation of irinotecan and floxuridine into low cholesterol-containing liposomes that coordinate drug release in vivo", Biochimica et Biophysica Acta, AMSTERDAM, NL , (20070222), vol. 1768, no. 3, doi:10.1016/j.bbamem.2006.11.014, ISSN 0005-2736, pages 678 - 687, XP005900726
OPPOSITION- Hedia Brixi-Benmansour; Jean-Louis Jouve; Emmanuel Mitry; Franck Bonnetain; Bruno Landi; Olivia Hentic; Laurent Bedenne; Guillaume Cadiot;, "Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma", Digestive and Liver Disease, W.B. Saunders, GB, GB , (20110701), vol. 43, no. 11, doi:10.1016/j.dld.2011.07.001, ISSN 1590-8658, pages 912 - 916, XP028296448
OPPOSITION- Hedia Brixi-Benmansour; Jean-Louis Jouve; Emmanuel Mitry; Franck Bonnetain; Bruno Landi; Olivia Hentic; Laurent Bedenne; Guillaume Cadiot, "Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma", Digest. Liver. Dis., (20110000), vol. 43, no. 11, pages 912 - 916, XP028296448
OPPOSITION- Eisenhauer, E.A. ; Therasse, P. ; Bogaerts, J. ; Schwartz, L.H. ; Sargent, D. ; Ford, R. ; Dancey, J. ; Arbuck, S. ; Gwyther, S. ; Mooney, M. ; Rubinstein, L. ; Shankar, L. ; Dodd, L. ; Kaplan, R. ; Lacombe, D. ; Verweij, J., "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)", European Journal of Cancer, Elsevier, Amsterdam NL, Amsterdam NL , (20090101), vol. 45, no. 2, doi:10.1016/j.ejca.2008.10.026, ISSN 0959-8049, pages 228 - 247, XP025841550
OPPOSITION- C Yoo, J Y Hwang, J-E Kim, T W Kim, J S Lee, D H Park, S S Lee, D W Seo, M-H Kim, D J Han, S C Kim, J-L Lee, "A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer", British Journal of Cancer, London, (20091117), vol. 101, no. 10, doi:10.1038/sj.bjc.6605374, ISSN 0007-0920, pages 1658 - 1663, XP055326781
OPPOSITION- C Yoo, J Y Hwang, J-E Kim, T W Kim, J S Lee, D H Park, S S Lee, D W Seo, M-H Kim, D J Han, S C Kim, J-L Lee, "A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer", British Journal of Cancer, Nature Publishing Group UK, London, London, (20091117), vol. 101, no. 10, doi:10.1038/sj.bjc.6605374, ISSN 0007-0920, pages 1658 - 1663, XP055326781
OPPOSITION- Yoo C; Hwang J Y; J-E Kim; Kim T W; Lee J S; Park D H; Lee S S; Seo D W; M-H Kim; Han D J; Kim S C; J-L Lee, "A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer", British Journal of Cancer, (20090000), vol. 101, no. 10, pages 1658 - 1663, XP055326781
OPPOSITION- Hoskins J M; Goldberg R M; Qu P; Ibrahim J G; Mcleod H L, "UGT1A1*28 Genotype and Irinotecan-Induced Neutropenia: Dose Matters", J. Nat Cancer. Inst, (20070905), vol. 99, no. 17, page 1290, XP055022025
OPPOSITION- J. M. Hoskins, R. M. Goldberg, P. Qu, J. G. Ibrahim, H. L. Mcleod, "UGT1A1*28 Genotype and Irinotecan-Induced Neutropenia: Dose Matters", JNCI Journal of the National Cancer Institute, (20070905), vol. 99, no. 17, doi:10.1093/jnci/djm115, ISSN 00278874, pages 1290 - 1295, XP055022025
OPPOSITION- Chen Pin-Yuan, Ozawa Tomoko, Drummond Daryl C., Kalra Ashish, Fitzgerald Jonathan B., Kirpotin Dmitri B., Wei Kuo-Chen, Butowski Nicholas, Prados Michael D., Berger Mitchel S., Forsayeth John R., Bankiewicz Krystof, James C. David, "Comparing routes of delivery for nanoliposomal irinotecan shows superior anti-tumor activity of local administration in treating intracranial glioblastoma xenografts", Neuro-Oncology, Oxford University Press, US, US , (20130201), vol. 15, no. 2, doi:10.1093/neuonc/nos305, ISSN 1522-8517, pages 189 - 197, XP055892860
OPPOSITION- Vittorio Gebbia, Maiello Evaristo, Giuliani Francesco, Borsellino Nicolò, Arcara Carlo, Colucci Giuseppe, "Irinotecan Plus Bolus/Infusional 5-Fluorouracil and Leucovorin in Patients With Pretreated Advanced Pancreatic Carcinoma : A Multicenter Experience of the Gruppo Oncologico Italia Meridionale", AMERICAN JOURNAL OF CLINICAL ONCOLOGY (CANCER CLINICAL TRIALS)., RAVEN PRESS LTD., NEW YORK NY., US, US , (20101001), vol. 33, no. 5, doi:10.1097/COC.0b013e3181b4e3b0, ISSN 0277-3732, pages 461 - 464, XP055461997
OPPOSITION- D. C. Drummond, C. O. Noble, Z. Guo, K. Hong, J. W. Park, D. B. Kirpotin, "Development of a Highly Active Nanoliposomal Irinotecan Using a Novel Intraliposomal Stabilization Strategy", Cancer research, American Association for Cancer Research, US, US , (20060315), vol. 66, no. 6, doi:10.1158/0008-5472.CAN-05-4007, ISSN 0008-5472, pages 3271 - 3277, XP055329486
OPPOSITION- D. C. Drummond, C. O. Noble, Z. Guo, K. Hong, J. W. Park, D. B. Kirpotin, "Development of a Highly Active Nanoliposomal Irinotecan Using a Novel Intraliposomal Stabilization Strategy", Cancer research, US , (20060315), vol. 66, no. 6, doi:10.1158/0008-5472.CAN-05-4007, ISSN 0008-5472, pages 3271 - 3277, XP055329486
OPPOSITION- DRUMMOND, D.C. et al., "Development of a highly active nanoliposomal irinotecan using a novel intraliposomal stabilisation strategy", Cancer Res, (20060000), vol. 66, no. 6, doi:10.1158/0008-5472.CAN-05-4007, XP055329486
OPPOSITION- L. Chen, Chang T., Cheng A., Yang C., Shiah H., Chang J., Yeh G., "Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients", Journal of Clinical Oncology, American Society of Clinical Oncology, US, US , (20080520), vol. 26, no. 15_suppl, doi:10.1200/jco.2008.26.15_suppl.2565, ISSN 0732-183X, page 2565, XP055462011
OPPOSITION- L. Chen, Chang T., Cheng A., Yang C., Shiah H., Chang J., Yeh G., "Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients", Journal of Clinical Oncology, US , (20080520), vol. 26, no. 15_suppl, doi:10.1200/jco.2008.26.15_suppl.2565, ISSN 0732-183X, pages 2565 - 2565, XP055462011
OPPOSITION- Chen L; Shiah H; Chao T; Hsieh R K; Chen G; Chang J; Yeh G, "Phase I study of liposome irinotecan (PEP02) in combination with weekly infusion of 5- FU/ LV in advanced solid tumors", Journal of Clinical Oncology, (20100000), vol. 28, no. 15, pages 1 - 2, XP002763720
OPPOSITION- L. Chen, H. Shiah, T. Chao, R. K. Hsieh, G. Chen, J. Chang, G. Yeh, "Phase I study of liposome irinotecan (PEP02) in combination with weekly infusion of 5-FU/LV in advanced solid tumors", Journal of Clinical Oncology, vol. 28, no. 15_Suppl., doi:10.1200/jco.2010.28.15_suppl.e13024, (20100101), Journal of Clinical Oncology, URL: http://ascopubs.org/doi/abs/10.1200/jco.2010.28.15_suppl.e13024, (20161102), XP002763720
OPPOSITION- L. Chen, H. Shiah, T. Chao, R. K. Hsieh, G. Chen, J. Chang, G. Yeh, "Phase I study of liposome irinotecan (PEP02) in combination with weekly infusion of 5-FU/LV in advanced solid tumors", Journal of Clinical Oncology, vol. 28, no. 15_Suppl., doi:10.1200/jco.2010.28.15_suppl.e13024, (20100101), page e13024, Journal of Clinical Oncology, URL: http://ascopubs.org/doi/abs/10.1200/jco.2010.28.15_suppl.e13024, (20161102), XP002763720
OPPOSITION- A. H. Ko, et al, "A multinational phase II study of PEP02 (liposome irinotecan) for patients with gemcitabine-refractory metastatic pancreatic cancer.", Journal of Clinical Oncology, US , (20110520), vol. 29, no. 15_suppl, doi:10.1200/jco.2011.29.15_suppl.4069, ISSN 0732-183X, pages 4069 - 4069, XP055462083
OPPOSITION- Ko A H; Tempero M A; Shan Y; Su W; Lin Y; Dito E; Ong A; Wang Y; Yeh G; Chen L, "A multinational phase II study of liposome irinotecan (PEP02) for patients with gemcitabine refractory metastatic pancreatic cancer", Journal of Clinical Oncology, (20110000), vol. 29, no. 15, pages 1 - 4, XP055462083
OPPOSITION- Chang-Sung Tsai; John W Park; Li-Tzong Chen, "Nanovector-based therapies in advanced pancreatic cancer", J. Gastrointest. Oncol., (20110000), vol. 2, no. 3, page 185, XP055075231
OPPOSITION- Chang-Sung Tsai, John W. Park, Li-Tzong Chen, "Nanovector-based therapies in advanced pancreatic cancer", Journal of Gastrointestinal Oncology, doi:10.3978/j.issn.2078-6891.2011.034, (20110901), pages 185 - 194, Journal of Gastrointestinal Oncology, (20130814), XP055075231
SEARCH- "Study of MM-398 Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer", (20111211), pages 1 - 3, URL: http://clinicaltrials.gov/archive/NCT01494506/2011_12_16, (20130814), XP055075223 [X] 1-7 * the whole document *-
SEARCH- "Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer", (20120809), pages 1 - 3, URL: http://clinicaltrials.gov/archive/NCT01494506/2012_08_09, (20130814), XP055075259 [XP] 1-7 * the whole document *-
SEARCH- JEFFREY R INFANTE ET AL, "Phase I and pharmacokinetic study of IHL-305 (PEGylated liposomal irinotecan) in patients with advanced solid tumors", CANCER CHEMOTHERAPY AND PHARMACOLOGY, SPRINGER, BERLIN, DE, (20120902), vol. 70, no. 5, doi:10.1007/S00280-012-1960-5, ISSN 1432-0843, pages 699 - 705, XP035132528 [XP] 1-7 * the whole document *
SEARCH- HEDIA BRIXI-BENMANSOUR ET AL, "Phase II study of first-line FOLFIRI for progressive metastatic well-differentiated pancreatic endocrine carcinoma", DIGESTIVE AND LIVER DISEASE, W.B. SAUNDERS, GB, vol. 43, no. 11, doi:10.1016/J.DLD.2011.07.001, ISSN 1590-8658, (20110701), pages 912 - 916, (20110707), XP028296448 [Y] 1-7 * page 915, column r, paragraph 5 *
SEARCH- C YOO ET AL, "A randomised phase II study of modified FOLFIRI.3 vs modified FOLFOX as second-line therapy in patients with gemcitabine-refractory advanced pancreatic cancer", BRITISH JOURNAL OF CANCER, GB, (20091013), vol. 101, no. 10, doi:10.1038/sj.bjc.6605374, ISSN 0007-0920, pages 1658 - 1663, XP055326781 [A] 1-7 * the whole document *
SEARCH- J. M. HOSKINS ET AL, "UGT1A1*28 Genotype and Irinotecan-Induced Neutropenia: Dose Matters", JNCI JOURNAL OF THE NATIONAL CANCER INSTITUTE, (20070905), vol. 99, no. 17, doi:10.1093/jnci/djm115, ISSN 0027-8874, pages 1290 - 1295, XP055022025 [Y] 1-7 * the whole document *
SEARCH- Chang-Sung Tsai ET AL, "Nanovector-based therapies in advanced pancreatic cancer", Journal of Gastrointestinal Oncology, doi:10.3978/j.issn.2078-6891.2011.034, (20110901), pages 185 - 194, URL: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397610/pdf/jgo-02-03-185.pdf, (20130814), XP055075231 [X] 1-7 * page 189, column r, paragraph 2 *

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