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Combination Decitabine And Cedazuridine Solid Oral Dosage Forms - EP4069254

The patent EP4069254 was granted to Otsuka Pharmaceutical on Sep 11, 2024. The application was originally filed on Feb 24, 2021 under application number EP21761883A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4069254

OTSUKA PHARMACEUTICAL
Application Number
EP21761883A
Filing Date
Feb 24, 2021
Status
Granted And Under Opposition
Aug 8, 2024
Grant Date
Sep 11, 2024
External Links
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BOTTI & FERRARIJun 11, 2025BOTTI & FERRARIADMISSIBLE

Patent Citations (3) New

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

Citation PhasePublication NumberPublication Link
INTERNATIONAL-SEARCH-REPORTUS2006074046
INTERNATIONAL-SEARCH-REPORTUS2018120304
INTERNATIONAL-SEARCH-REPORTUS2020085848

Non-Patent Literature (NPL) Citations (14) 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
INTERNATIONAL-SEARCH-REPORT- Michael R Savona , Olatoyosi Odenike , Philip C Amrein , David P Steensma , Amy E DeZern , Laura C Michaelis , Stefan Faderl , Wael Harb , Hagop Kantarjian , James Lowder , Aram Oganesian , Mohammad Azab , Guillermo Garcia-Manero , "An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study", The Lancet Haematology, GB , (20190401), vol. 6, no. 4, doi:10.1016/S2352-3026(19)30030-4, ISSN 2352-3026, pages e194 - e203, XP009537445 [X] 1-4
OPPOSITION- Anonymous, "Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML", Clinical Trials - NCT03306264, (20180326), pages 1 - 24, XP093287422-
OPPOSITION- D4 - Response to the EPO communication under R. 70(2) and 70a(2) EPC Dated 20.02.2024-
OPPOSITION- D5 - Declaration of Nipun Davar Ph.D Dated 15.12.2023-
OPPOSITION- D7 - Response to the US Office Action dated November 20, 2023 Dated 18.11.2023-
OPPOSITION- Garcia-Manero Guillermo, Mccloskey James, Griffiths Elizabeth A., Yee Karen W.L., Zeidan Amer M., Al-Kali Aref, Dao Kim-Hien, Deeg H. Joachim, Patel Prapti A., Sabloff Mitchell, Keating Mary-Margaret, Zhu Nancy, Gabrail Nashat Y., Fazal Salman, Maly Joseph, Odenike Olatoyosi, Shastri Aditi, Dezern Amy E., O'connell Casey L., Roboz Gail J., Oganesian Aram, Hao Yong, Keer Harold N., Azab Mohammad, Savona Michael R., "Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine - PRESENTATION", 61st ASH Annual Meeting Abstract 846, (20191210), pages 1 - 15, XP093092766-
OPPOSITION- Gregory Thoorens, Krier Fabrice, Leclercq Bruno, Carlin Brian, Evrard Brigitte, "Microcrystalline cellulose, a direct compression binder in a quality by design environment—A review", International Journal of Pharmaceutics, AMSTERDAM, NL, (20141001), vol. 473, no. 1-2, doi:10.1016/j.ijpharm.2014.06.055, ISSN 0378-5173, pages 64 - 72, XP055461367
OPPOSITION- Michael R Savona , Olatoyosi Odenike , Philip C Amrein , David P Steensma , Amy E DeZern , Laura C Michaelis , Stefan Faderl , Wael Harb , Hagop Kantarjian , James Lowder , Aram Oganesian , Mohammad Azab , Guillermo Garcia-Manero , "An oral fixed-dose combination of decitabine and cedazuridine in myelodysplastic syndromes: a multicentre, open-label, dose-escalation, phase 1 study", Lancet Haematology, (20190401), vol. 6, no. 4, doi:10.1016/S2352-3026(19)30030-4, ISSN 2352-3026, pages e194 - e203, XP009537445
OPPOSITION- Rogstad Daniel K., Herring Jason L., Theruvathu Jacob A., Burdzy Artur, Perry Christopher C., Neidigh Jonathan W., Sowers Lawrence C., "Chemical Decomposition of 5-Aza-2′-deoxycytidine (Decitabine): Kinetic Analyses and Identification of Products by NMR, HPLC, and Mass Spectrometry", Chemical Research in Toxicology, US , (20090615), vol. 22, no. 6, doi:10.1021/tx900131u, ISSN 0893-228X, pages 1194 - 1204, XP093287421
OPPOSITION- Garcia-Manero Guillermo; McCloskey James; Griffiths Elizabeth A.; Yee Karen W.L.; Zeidan Amer M.; Al-Kali Aref; Dao Kim-Hien; Deeg H. Joachim; Patel Prapti A.; Sabloff Mitchell; Keating Mary-Margaret; Zhu Nancy; Gabrail Nashat Y.; Fazal Salman; Maly Joseph; Odenike Olatoyosi; Shastri Aditi; DeZern Amy E.; O'Connell Casey L.; Roboz Gail J.; Oganesian Aram; Hao Yong; Keer Harold N.; Azab Mohammad; Savona Michael R., "Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine", Blood, AMSTERDAM, NL, (20191113), vol. 134, doi:10.1182/blood-2019-122980, ISSN 0006-4971, page 846, XP086666363
OPPOSITION- Garcia-Manero Guillermo; Griffiths Elizabeth A.; Roboz Gail J.; Busque Lambert; Wells Richard A.; Odenike Olatoyosi; Steensma David P.; Yee Karen W.L.; Faderl Stefan; Amrein Philip C.; Michaelis Laura C.; Kantarjian Hagop M.; Oganesian Aram; Lowder James N.; Azab Mohammad; Savona Michael R., "A Phase 2 Dose-Confirmation Study of Oral ASTX727, a Combination of Oral Decitabine with a Cytidine Deaminase Inhibitor (CDAi) Cedazuridine (E7727), in Subjects with Myelodysplastic Syndromes (MDS)", Blood, AMSTERDAM, NL, (20171208), vol. 130, doi:10.1182/blood.V130.Suppl_1.4274.4274, ISSN 0006-4971, page 4274, XP086635361
OPPOSITION- Belali Nagina Gulab, Chaerunisaa Anis Yohana, Rusdiana Taofik, "Isolation and Characterization of Microcrystalline Cellulose Derived from Plants as Excipient in Tablet : A Review", Indonesian Journal of Pharmaceutics, (20190613), vol. 1, no. 22, doi:10.24198/idjp.v1i2.21515, ISSN 2597-8748, pages 23 - 29, XP093287420
SEARCH- GARCIA-MANERO GUILLERMO ET AL, "Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine - PRESENTATION", 61ST ASH ANNUAL MEETING ABSTRACT 846, (20191210), XP093092766 [X] 1-15 * Title; page 1 * * pages 3,14 *-
SEARCH- GARCIA-MANERO GUILLERMO ET AL, "Pharmacokinetic Exposure Equivalence and Preliminary Efficacy and Safety from a Randomized Cross over Phase 3 Study (ASCERTAIN study) of an Oral Hypomethylating Agent ASTX727 (cedazuridine/decitabine) Compared to IV Decitabine", BLOOD, AMERICAN SOCIETY OF HEMATOLOGY, US, (20191113), vol. 134, doi:10.1182/BLOOD-2019-122980, ISSN 0006-4971, page 846, XP086666363 [X] 1-15 * Introduction, Summary/Conclusions *

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