Cylodextrin Complexation Methods For Formulating Peptide Proteasome Inhibitors - EP2662094

The patent EP2662094 was granted to Onyx Therapeutics on Apr 17, 2024. The application was originally filed on May 8, 2013 under application number EP13167148A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP2662094

ONYX THERAPEUTICS
Application Number
EP13167148A
Filing Date
May 8, 2013
Status
Granted And Under Opposition
Mar 15, 2024
Grant Date
Apr 17, 2024
External Links
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Patent Summary

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Patent Family

Patent Oppositions (6)

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BRAND MURRAY FULLERJan 17, 2025BRAND MURRAY FULLERADMISSIBLE
HGFJan 17, 2025HGFADMISSIBLE
RUMIJan 17, 2025TER MEER STEINMEISTER & PARTNERADMISSIBLE
STADA ARZNEIMITTELJan 17, 2025KERNEBECKADMISSIBLE
TER MEER STEINMEISTER & PARTNER PATENTANWALTE MBBJan 17, 2025TER MEER STEINMEISTER & PARTNERADMISSIBLE
FRESENIUS KABI DEUTSCHLANDJan 9, 2025FRESENIUS KABI DEUTSCHLANDADMISSIBLE

Patent Citations (14) New

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

Citation PhasePublication Number
OPPOSITIONCO6571868
OPPOSITIONEP2662094
OPPOSITIONUS2004209843
OPPOSITIONUS2006128611
OPPOSITIONUS4870060
OPPOSITIONUS5831081
OPPOSITIONUS7232818
OPPOSITIONUS7635773
OPPOSITIONUS7737112
OPPOSITIONWO2006063154
OPPOSITIONWO2011133479
OPPOSITIONWO2013130666
OPPOSITIONWO2014066274
SEARCHUS7737112

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 Text
OPPOSITION- Anonymous, "CAPTISOL β-Cyclodextrin Sulfobutylethers", Cloud Front, (20231109), pages 1 - 6, Cloud Front, URL: https://d1io3yog0oux5.cloudfront.net/captisol/files/pages/resources/LIG_Brochure10-13-22.pdf, (20250313), XP093258947
OPPOSITION- Anonymous, "CyDex, Inc. Announces Captisol Technology Used In Recently Launched Injection Formulation Of Antipsychotic Medication ABILIFY(R) (aripiprazole)", Bio Space, (20061214), pages 1 - 2, Bio Space, URL: https://www.biospace.com/cydex-inc-announces-captisol-technology-used-in-recently-launched-injection-formulation-of-antipsychotic-medication-abilify-r-aripiprazole-125546, (20250312), XP093258722
OPPOSITION- Anonymous, "FDA Accepts NDA for Carfilzomib Onyx Pharmaceuticals Announces FDA Acceptance of New Drug Application for Carfilzomib for the Treatment of Relapsed and Refractory Multiple Myeloma", Drugs.com, (20111129), pages 1 - 4, Drugs.com, URL: https://www.drugs.com/nda/carfilzomib_111129.html, (20250312), XP093258668
OPPOSITION- Anonymous, "FDA Advisory Committee to Review Carfilzomib - Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma", Drugs, Drugs.com, (20120426), pages 1 - 3, Drugs , URL: https://www.drugs.com/nda/carfilzomib_120427.html, (20250312), XP093258671
OPPOSITION- Anonymous, "Hydrochloric acid", Wikipedia, (20241218), pages 1 - 11, Wikipedia , URL: https://en.wikipedia.org/w/index.php?title=Hydrochloric_acid&oldid=1263826885, (20250110), XP093258684
OPPOSITION- Anonymous, "Hydrogen chloride", Wikipedia, (20241025), pages 1 - 10, Wikipedia , URL: https://en.wikipedia.org/w/index.php?title=Hydrogen_chloride&oldid=1253373565, (20250110), XP093258688
OPPOSITION- Anonymous, "ICH Harmonised Tripartite Guideline", INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN US, (20020912), pages 1 - 24, XP093258851
OPPOSITION- Anonymous, "Kyprolis - EMEA/H/C/003790/0000", European Medicines Agency science medicines health - EMA Assessment Report, (20150924), pages 1 - 142, XP093258655
OPPOSITION- Anonymous, "Official Monographs for NF 30", Drug Future, (20120801), pages 1 - 4, Drug Future, URL: https://www.drugfuture.com/Pharmacopoeia/usp35/PDF/5423-5426%20Betadex%20Sulfobutyl%20Ether%20Sodium.pdf, (20250312), XP093258841
OPPOSITION- Anonymous, "Passage ; Pharmaceutical Dosage Forms and Drug Delivery - second edition ", Anonymous, Ram I, Mahato Ajit S. Narang, Pharmaceutical Dosage Forms and Drug Delivery - second edition , CRC Press , (20120101), pages 358 - 358, ISBN N 978-1-4398-4918-7, XP093258860
OPPOSITION- Anonymous, "Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma-NCT01080391", Clinical Trials, Clinicaltrials.gov, (20220921), pages 1 - 25, Clinical Trials , URL: https://clinicaltrials.gov/study/NCT01080391?term=NCT01080391&rank=1, XP093258614
OPPOSITION- Anonymous, "Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma-NCT0108039", Clinical Trials, ClinicalTrials.gov, (20220921), pages 1 - 28, Clinical Trials, URL: https://clinicaltrials.gov/study/NCT01080391?term=NCT01080391&rank=1, (20250312), XP093258619
OPPOSITION- Anonymous, "UNITED STATES SECURITIES AND EXCHANGE COMMISSION", 10-K 1 a2212722z10-k.htm 10-K, (20120101), pages 1 - 123, 10-K 1 a2212722z10-k.htm 10-K, URL: https://www.sec.gov/Archives/edgar/data/1012140/000104746913001966/a2212722z10-k.htm, (20250312), XP093258633
OPPOSITION- Anonymous, "What is CAPTISOL", CyDex Pharmaceuticals, Inc., URL: https://d1io3yog0oux5.cloudfront.net/captisol/files/pages/resources/Captisol_Brochure_2015.pdf, (20221117), XP055982762
OPPOSITION- Bengston Karen E, Janet K Jamison, "Other Review(s) - 202714Orig1s000", FDA - CENTER FOR DRUG EVALUATION AND RESEARCH, (20111122), pages 1 - 144, XP093258825
OPPOSITION- Bhosale S V, "β-Cyclodextrin as a Catalyst in Organic Synthesis", Mini-Reviews in Organic Chemistry, (20070101), vol. 4, pages 143 - 157, XP093258711
OPPOSITION- Bray Jeffrey, "202714Orig1s000 Pharmacology review(s)", Center for drug evaluation and research application number, (20120628), pages 1 - 208, XP093255873
OPPOSITION- Cottrell Christy L, Ann T Farrell, "Administrative and Correspondence Documents - 202714Orig1s000", FDA - CENTER FOR DRUG EVALUATION AND RESEARCH, (20081110), pages 1 - 233, XP093258794
OPPOSITION- CPET delivery http://staging-area.internal.epo.org/staging-area-web/#/cpet/1458602
OPPOSITION- D12 - Datenblatt Captisol
OPPOSITION- D16- Schreiben FDA zur Zulassung von Kyprolis® (Carfilzomib), unterzeichnet am 20.Juli 2012
OPPOSITION- D23 - EMA : Zusammenfassung der Merkmale des Arzneimittels
OPPOSITION- D27 - Geschaftsbericht 2012 Ligand Pharmaceuticals Inc.
OPPOSITION- D29:- "Auskunft über die Bewertung des Journals "Tetrahedron"
OPPOSITION- D30: "Search Orphan Drug Designations and Approvals"
OPPOSITION- D31 - "Bescheid des EPA vom 8. Juni 2018"
OPPOSITION- D48 - Officer/Employee List
OPPOSITION- De Fronzo Kimberly A, Todd D Bridges , Carol A Holquist, "Proprietary Name Review(s) - 202714Orig1s000", FDA - CENTER FOR DRUG EVALUATION AND RESEARCH, (20111208), pages 1 - 36, XP093258815
OPPOSITION- Deisseroth Albert B , "Cross discipline team leader review - 202714Orig1s000", FDA- CENTER FOR DRUG EVALUATION AND RESEARCH, (20120618), pages 1 - 23, XP093258805
OPPOSITION- Farrell Ann T, "CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202714Orig1s000 SUMMARY REVIEW", (20120727), pages 1 - 11, XP093258596
OPPOSITION- Herndon Thomas M., "CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202714Orig1s000 MEDICAL REVIEW(S)", (20120101), pages 1 - 64, XP093256395
OPPOSITION- "International Nonproprietary Names for Pharmaceutical Substances (INN)", WHO Drug Information - List 59, (20080101), vol. 22, no. 1, pages 41 - 76, XP093253293
OPPOSITION- Kim Tamy E, Richard Pazdur, "Office Director Memo - 202714Orig1s000", FDA - CENTER FOR DRUG EVALUATION AND RESEARCH, (20120720), pages 1 - 7, XP093258819
OPPOSITION- Koti Kallappa M, Mark D Rothmann, "Statistical Review(s) - 202714Orig1s000", FDA - CENTER FOR DRUG EVALUATION AND RESEARCH, (20111102), pages 1 - 35, XP093258836
OPPOSITION- Lacivita Cynthia L, Claudia B Manzo, "Risk Assessment and Risk Mitigation Review(s) - 202714Orig1s000", FDA- CENTER FOR DRUG EVALUATION AND RESEARCH, (20120713), pages 1 - 7, XP093258831
OPPOSITION- "Ligand Licensee Onyx Pharmaceuticals Receives FDA Accelerated Approval of Kyprolisâ„¢ (carfilzomib) for Injection", Ligand, (20120720), pages 1 - 4, Ligand , URL: https://investor.ligand.com/news-and-events/press-releases/news-details/2012/Ligand-Licensee-Onyx-Pharmaceuticals-Receives-FDA-Accelerated-Approval-of-Kyprolis-carfilzomib-for-Injection-07-20-2012/default.aspx, (20250225), XP093253678
OPPOSITION- Mahayni Houda , Angelica Dorantes, "Clinical Pharmacology and Biopharmaceutics Review(s) - 202714Orig1s000", FDA - CENTER FOR DRUG EVALUATION AND RESEARCH, (20111109), pages 1 - 44, XP093258802
OPPOSITION- Metcalfe John W, Bryan S Riley, "Dates of Submission(s) Covered by this Review- 202714ORIG1S000", FDA CENTER FOR DRUG EVALUATION AND RESEARCH, (20111104), pages 1 - 9, XP093258810
OPPOSITION- Sigma Aldrich, "Hydrogen chloride solution - 455180", Product Description, (20250514), Product Description, URL: https://www.sigmaaldrich.com/GB/en/product/sigald/455180, XP009561152
OPPOSITION- U.S. Department Of Health And Human Services Food And Drug Administration, Center For Drug Evaluation And Research (cder) ; Center For Biologics Evaluation And Research (cber), "Guidance for Industry Q8(R2) Pharmaceutical Development - revision 2", (20091101), pages 1 - 25, URL: https://www.fda.gov/media/71535/download, XP093236372
OPPOSITION- "Venter for drug evaluation and research ", FDA - US Food & Drug Administration, (20120820), no. 202714Orig1s000, pages 1 - 75, XP093253282
OPPOSITION- Whalen Dale L., Ross Angela M., "Specific Effects of Chloride Ion on Epoxide Hydrolysis. The pH-Dependence of the Rates and Mechanisms for the Hydrolysis of Indene Oxide", Journal of the American Chemical Society, (19761124), vol. 98, no. 24, pages 7859 - 7861, XP093255610
OPPOSITION- Smith, Michael B, "Chapter 10: Halogen Nucleophiles (1036)", Smith, Michael B, SMITH MICHAEL B, MARSH J, March's advanced organic chemistry : reactions, mechanisms, and structure, vol. 6th Edition, pages 574 - 587, doi:10.1002/9780470084960.ch10, ISBN 978-0-471-72091-1, XP009559889
OPPOSITION- Buddrus J., "Basic Behavior of Epoxides in the Presence of Halide Ions", Angewante Chemie International edition, DE , (19721201), vol. 11, no. 12, doi:10.1002/anie.197210411, ISSN 0570-0833, pages 1041 - 1050, XP093253286
OPPOSITION- Larry K. Golightly, Susan S. Smolinske, Michael L. Bennett, Earl W. Sutherland, Barry H. Rumack, "Pharmaceutical Excipients : Adverse Effects Associated with Inactive Ingredients in Drug Products (Part I)", MEDICAL TOXICOLOGY, NZ , (19880401), vol. 3, no. 2, doi:10.1007/BF03259937, ISSN 0112-5966, pages 128 - 165, XP055427003
OPPOSITION- GORECKA BARBARA A ET AL, "Effect of SBE4-beta-CD, a sulfobutyl ether beta-cyclodextrin, on the stability and solubility of O-6-benzylguanine (NSC-637037) in aqueous solutions", International Journal of Pharmaceutics, NL, (19950101), vol. 125, no. 1, doi:10.1016/0378-5173(95)00112-V, ISSN 0378-5173, pages 55 - 61, XP002423709
OPPOSITION- Stella Valentino J., Rajewski Roger A., "Sulfobutylether-β-cyclodextrin", International Journal of Pharmaceutics, Elsevier, NL, (20200601), vol. 583, doi:10.1016/j.ijpharm.2020.119396, ISSN 0378-5173, page 119396, XP093219477
OPPOSITION- Reddy, M.A. Surendra, K. Bhanumathi, N. Rao, K.R., "Highly facile biomimetic regioselective ring opening of epoxides to halohydrins in the presence of @b-cyclodextrin", Tetrahedron, AMSTERDAM, NL , (20020722), vol. 58, no. 30, doi:10.1016/S0040-4020(02)00614-2, ISSN 0040-4020, pages 6003 - 6008, XP004379328
OPPOSITION- Ribeiro Laura S.S, Ferreira Domingos C, Veiga Francisco J.B, "Physicochemical investigation of the effects of water-soluble polymers on vinpocetine complexation with β-cyclodextrin and its sulfobutyl ether derivative in solution and solid state", European Journal of Pharmaceutical Sciences, NL, (20031101), vol. 20, no. 3, doi:10.1016/S0928-0987(03)00199-4, ISSN 0928-0987, pages 253 - 266, XP093255584
OPPOSITION- AGATSUMA T ET AL, "Halohydrin and oxime derivatives of radicicol: synthesis and antitumor activities", Bioorganic & Medicinal Chemistry, NL, (20021101), vol. 10, no. 11, doi:10.1016/S0968-0896(02)00260-2, ISSN 0968-0896, pages 3445 - 3454, XP002425976
OPPOSITION- Michael Groll, Kyung Bo Kim, Norman Kairies, Robert Huber, and Craig M. Crews, "Crystal Structure of Epoxomicin: 20S Proteasome Reveals a Molecular Basis of Selectivity of alpha',beta'-Epoxyketone Proteasome Inhibitors", Journal of the American Chemical Society, (20000128), vol. 122, doi:10.1021/ja993588m, ISSN 0002-7863, pages 1237 - 1238, XP008128036
OPPOSITION- MACHERLA V R,ET AL, "Structure-activity relationship studies of salinosporamide a (NPI-0052), a novel marine derived proteasome inhibitor", Journal of Medicinal Chemistry, American Chemical Society, US , (20050505), vol. 48, no. 11, doi:10.1021/jm048995+, ISSN 0022-2623, pages 3684 - 3687, XP002376432
OPPOSITION- Hafner Verena, Czock David, Burhenne Jürgen, Riedel Klaus-Dieter, Bommer Jürgen, Mikus Gerd, Machleidt Christoph, Weinreich Thomas, Haefeli Walter E., "Pharmacokinetics of Sulfobutylether-Beta-Cyclodextrin and Voriconazole in Patients with End-Stage Renal Failure during Treatment with Two Hemodialysis Systems and Hemodiafiltration", ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, US , (20100601), vol. 54, no. 6, doi:10.1128/AAC.01540-09, ISSN 0066-4804, pages 2596 - 2602, XP093255618

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