IP Verse

Fixed Dose Combinations Comprising Etc1002 And One Or More Statins For Treating Or Reducing Cardiovascular Risk - EP3270909

The patent EP3270909 was granted to Esperion Therapeutics on Nov 1, 2023. The application was originally filed on Mar 16, 2016 under application number EP16765682A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3270909

ESPERION THERAPEUTICS
Application Number
EP16765682A
Filing Date
Mar 16, 2016
Status
Granted And Under Opposition
Sep 29, 2023
Grant Date
Nov 1, 2023
External Links
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Patent Summary

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Patent Family

Patent Oppositions (6)

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INTAS PHARMACEUTICALSAug 1, 2024BRAND MURRAY FULLERADMISSIBLE
GALENICUM HEALTH SLUJul 31, 2024GALENICUM HEALTH SLUADMISSIBLE
HOEFER & PARTNER PATENTANWALTE MBBJul 31, 2024HOEFER & PARTNER PATENTANWALTE MBBADMISSIBLE
POLPHARMAJul 31, 2024HAMM & WITTKOPPADMISSIBLE
SYNTHONJul 30, 2024REDDIE & GROSEADMISSIBLE
STADA ARZNEIMITTELJul 26, 2024HAMM & WITTKOPPADMISSIBLE

Patent Citations (11) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2005043278
DESCRIPTIONUS7335799
DESCRIPTIONWO2005047276
EXAMINATIONUS7335799
INTERNATIONAL-SEARCH-REPORTUS2010297105
INTERNATIONAL-SEARCH-REPORTUS2015005386
INTERNATIONAL-SEARCH-REPORTWO2014099584
OPPOSITIONEP3270909
OPPOSITIONUS2015005386
OPPOSITIONWO2016149405
OTHEREP3270909

Non-Patent Literature (NPL) Citations (49) 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- A.L. LEHNINGER, Advanced Organic Chemistry, Worth Publishers, Inc., (19920000), vol. A, B-
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EXAMINATION- Anonymous, "SUMMARY OF PRODUCT CHARACTERISTICS - Nilemdo", European Medicines Agency, (20220209), URL: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf, (20220209), XP055905536-
OPPOSITION- Anonymous, "A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg", ClinicalTrials.gov; NCT02659397, (20160115), ClinicalTrials.gov; NCT02659397, URL: https://clinicaltrials.gov/study/NCT02659397?tab=history&a=1#version-content-panel, XP093201427-
OPPOSITION- Anonymous, "CRESTOR (rosuvastatin calcium) tablets - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20140701), XP093199811-
OPPOSITION- Anonymous, "CRESTOR (rosuvastatin calcium) tablets - HIGHLIGHTS OF PRESCRIBING INFORMATION", FDA, (20150601), XP093199805-
OPPOSITION- Anonymous, "Esperion Therapeutics Announces Initiation of Phase 2 Clinical Study of Bempedoic Acid in Patients Treated With High-Dose Statin Therapy", Esperion Therapeutics, Inc, Esperion Therapeutics, Inc, URL: https://www.globenewswire.com/en/news-release/2016/01/12/801422/0/en/Esperion-Therapeutics-Announces-Initiation-of-Phase-2-Clinical-Study-of-Bempedoic-Acid-in-Patients-Treated-With-High-Dose-Statin-Therapy.html, (20240405), XP093148436-
OPPOSITION- Anonymous, "Esperion Therapeutics Announces Positive Top-Line Phase 2b Results for ETC-1002 Added to Stable Statin Therapy in Patients With Hypercholesterolemia", Esperion Therapeutics, (20150317), XP093201421-
OPPOSITION- Anonymous, "Esperion Therapeutics Announces Positive Top-Line Phase 2 Results for ETC-1002 in Patients With Hypercholesterolemia and Hypertension", Esperion Therapeutics, (20150728), Esperion Therapeutics, URL: https://www.esperion.com/static-files/96386a79-53ca-4628-a0f9-1b374427c268, XP093201533-
OPPOSITION- Anonymous, "Esperion Therapeutics Provides Bempedoic Acid Development Program Update; Reports Fourth Quarter and Full Year 2015 Financial Results", Esperion Therapeutics, (20160225), Esperion Therapeutics, URL: https://www.esperion.com/static-files/065284eb-f23d-4f9a-90cb-7988aca2310f, XP093201426-
OPPOSITION- Anonymous, "Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Fourth Quarter and Full Year 2014 Financial Results", (20150305), URL: https://finance.yahoo.com/news/esperion-therapeutics-provides-etc-1002-210500577.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAKH2YREbtDE5wZhi0FE3qWEEzByArYfVPILXKZCxW0ORNSGxbJ4iIPwd3IzhTqtgfWux7wN-0N11oYTO9CAlo483aOcXsa_TAfNZE5M_qBUwFnrT6J9UW3Bt2mw-38c75ZAJoOCVMiPeJ-K7QIGC8O145vQpV_LNpZp78ZZYtZds, XP093201418-
OPPOSITION- Anonymous, "Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Third Quarter 2015 Financial Results", Esperion Therapeutics, (20151105), Esperion Therapeutics, URL: https://www.esperion.com/static-files/b9938be3-3e43-4e65-9873-a619a1c76a9c, XP093201428-
OPPOSITION- Anonymous, "Esperion Therapeutics Provides Further Updates on ETC-1002 Global Phase 3 Strategy Following Receipt of End-of-Phase 2 Meeting Minutes", Esperion Therapeutics, (20150928), Esperion Therapeutics, URL: https://www.esperion.com/static-files/0bd45800-4283-498b-b8f0-a43f47486294, XP093201425-
OPPOSITION- Anonymous, "Esperion Therapeutics Provides Update on the ETC-1002 Development Program Following End-of-Phase 2 Meeting With FDA", Esperion Therapeutics, (20150817), XP093201423-
OPPOSITION- Anonymous, "Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy; NCT02072161", ClinicalTrials.gov; NCT02072161, (20140224), ClinicalTrials.gov; NCT02072161, URL: https://clinicaltrials.gov/study/NCT02072161?tab=history&a=1#version-content-panel, XP093201417-
OPPOSITION- Anonymous, "Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy; NCT02072161", ClinicalTrials.gov; NCT02072161, (20140403), ClinicalTrials.gov; NCT02072161, URL: https://clinicaltrials.gov/study/NCT02072161?tab=history&a=2#version-content-panel, XP093201414-
OPPOSITION- Anonymous, "Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy; NCT02072161", ClinicalTrials.gov; NCT02072161, (20150827), ClinicalTrials.gov; NCT02072161, URL: https://clinicaltrials.gov/study/NCT02072161?tab=history&a=3#version-content-panel, XP093201416-
OPPOSITION- Anonymous, "Guideline on clinical development of fixed combination medicinal products", emeA European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) of the EMEA, (20090219), pages 1 - 9, XP093070202-
OPPOSITION- Anonymous, "Lipitor 80mg Film-coated Tablets 2 - Summary of Product Characteristics", Health Products Regulatory Authority, (20141223), XP093199823-
OPPOSITION- Anonymous, "LIPITOR ® (atorvastatin calcium) Tablets for oral administration - HIGHLIGHTS OF PRESCRIBING INFORMATION ", FDA, (20130101), XP093201532-
OPPOSITION- Anonymous, "Nilemdo - Summary of Product Characteristics", European Medicines Agency, European Medicines Agency, URL: https://www.ema.europa.eu/en/documents/product-information/nilemdo-epar-product-information_en.pdf, (20240405), XP093148382-
OPPOSITION- Fox Elliot, Lowe, Mindy, "Esperion Therapeutics Announces Initiation of Phase 2 Clinical Study of Bempedoic Acid in Patients Treated With High-Dose Statin Therapy", Press Release, Esperion Therapeutics, (20160112), pages 1 - 2, Press Release, URL: https://www.esperion.com/news-releases/news-release-details/esperion-therapeutics-announces-initiation-phase-2-clinical-0, XP093203555-
OPPOSITION- Fox Elliot, Lowe, Mindy, "Esperion Therapeutics Announces Positive Top-Line Phase 2b Results for ETC-1002 Added to Stable Statin Therapy in Patients With Hypercholesterolemia", Esperion Press Release, Esperion Therapeutics, (20150317), pages 1 - 2, Esperion Press Release, URL: https://www.esperion.com/news-releases/news-release-details/esperion-therapeutics-announces-positive-top-line-phase-2b-0, XP093203560-
OPPOSITION- Fox Elliot, Lowe, Mindy, "Esperion Therapeutics Provides ETC-1002 Development Program Update; Reports Third Quarter 2015 Financial Results", Esperion Press Release, Esperion Therapeutics, (20151105), pages 1 - 3, Esperion Press Release, URL: https://www.esperion.com/news-releases/news-release-details/esperion-therapeutics-provides-etc-1002-development-program-5, XP093203564-
OPPOSITION- Powell Denise, "Esperion Therapeutics Announces Positive Top-Line Results from Phase 2 Clinical Study of ETC-1002 as an Add-On to Statin Therapy in Patients with Hypercholesterolemia", Esperion Press Release, Esperion Therapeutics, (20130903), pages 1 - 2, Esperion Press Release, URL: https://www.esperion.com/static-files/b7b6b2ae-9726-49c3-b2c3-35e08921952c, XP093203568-
OPPOSITION- Zeljko Reiner, "ESC/EAS Guidelines for the Management of Dyslipidaemias", European Heart Journal, (2011), vol. 32, XP055662895-
OPPOSITION- Dragana Nikolic, "ETC-1002: A future option for lipid disorders?", Atherosclerosis, (2014), vol. 237, doi:10.1016/j.atherosclerosis.2014.10.099, XP002756256
OPPOSITION- Nikolic D, Mikhailidis D P, Davidson M H, Rizzo M, Banach M, "ETC-1002: a future option for lipid disorders?", Atherosclerosis, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20141201), vol. 237, no. 2, doi:10.1016/j.atherosclerosis.2014.10.099, ISSN 0021-9150, pages 705 - 710, XP002756256
OPPOSITION- Turner Traci; Stein Evan A., "Non-statin Treatments for Managing LDL Cholesterol and Their Outcomes", Clinical Therapeutics, AMSTERDAM, NL, (20151103), vol. 37, no. 12, doi:10.1016/j.clinthera.2015.09.004, ISSN 0149-2918, pages 2751 - 2769, XP029360534
OPPOSITION- Turner Traci; Stein Evan A., "Non-statin Treatments for Managing LDL Cholesterol and Their Outcomes", Clinical Therapeutics, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20151103), vol. 37, no. 12, doi:10.1016/j.clinthera.2015.09.004, ISSN 0149-2918, pages 2751 - 2769, XP029360534
OPPOSITION- Stone Neil J.; Robinson Jennifer G.; Lichtenstein Alice H.; Bairey Merz C. Noel; Blum Conrad B.; Eckel Robert H.; Goldberg Anne C.; Gordon David; Levy Daniel; Lloyd-Jones Donald M.; McBride Patrick; Schwartz J. Sanford; Shero Susan T.; Smith Sidney C.; Watson Karol; Wilson Peter W.F., "2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines", Journal of the American College of Cardiology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20131112), vol. 63, no. 25, doi:10.1016/j.jacc.2013.11.002, ISSN 0735-1097, pages 2889 - 2934, XP028871952
OPPOSITION- Hernán N. Lemus, Carlos O. Mendivil, "Adenosine triphosphate citrate lyase: Emerging target in the treatment of dyslipidemia", JOURNAL OF CLINICAL LIPIDOLOGY, ELSEVIER, NEW YORK, NY, US, US , (20150501), vol. 9, no. 3, doi:10.1016/j.jacl.2015.01.002, ISSN 1933-2874, pages 384 - 389, XP055263748
OPPOSITION- Christie M Ballantyne, Macdougall De, Margulies Jr, Robinson Pl, Hanselman Jc, Lalwani Nd, "Abstract 17499: ETC-1002 Incrementally Lowers Low Density Lipoprotein-cholesterol in Patients With Hypercholesterolemia Receiving Stable Statin Therapy", Circulation, American Heart Association, US, US , (20151110), vol. 132, no. Suppl 3, doi:10.1161/circ.132.suppl_3.17499, ISSN 0009-7322, page 1, XP055485809
OPPOSITION- Christie M Ballantyne, Macdougall De, Margulies Jr, Robinson Pl, Hanselman Jc, Lalwani Nd, "Abstract 17499: ETC-1002 Incrementally Lowers Low Density Lipoprotein-cholesterol in Patients With Hypercholesterolemia Receiving Stable Statin Therapy", Circulation, vol. 132, no. Suppl 3, page 1, XP055485809
OTHER- Anonymous, "Concept paper on the need to revise the Guideline on the clinical development of fixed dose combinations of medicinal products regarding dossier content requirements", EUROPEAN MEDICINES AGENCYSCIENCE MEDICINES HEALTH, Committee for Medicinal Products for Human Use (CHMP) of the EMA, (20130211), pages 1 - 3, XP093070230-
OTHER- Anonymous, "Guideline on clinical development of fixed combination medicinal products", EMEA European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) of the EMEA, (20090219), pages 1 - 9, XP093070202-
OTHER- Anonymous, "History of Changes for Study: NCT02659397 A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg", ClinicalTrials.gov archive, (20160115), pages 1 - 5, ClinicalTrials.gov archive , URL: https://clinicaltrials.gov/ct2/history/NCT02659397?A=1&B=1&C=merged#StudyPageTop, (20230120), XP093015925-
OTHER- Arbor Ann, "Esperion Therapeutics Announces Initiation of Phase 2 Clinical Study of Bempedoic Acid in Patients Treated With High-Dose Statin Therapy", Esperion Therapeutics, Inc., (20160112), pages 1 - 4, Esperion Therapeutics, Inc., URL: https://www.globenewswire.com/en/news-release/2016/01/12/801422/0/en/Esperion-Therapeutics-Announces-Initiation-of-Phase-2-Clinical-Study-of-Bempedoic-Acid-in-Patients-Treated-With-High-Dose-Statin-Therapy.html, (20230120), XP093015928-
OTHER- Mutschler Ernst, Gerd Geisslinger, Heyo K. Kroemer, Sabine Menzel, Peter Ruth, "Mutschler Arzneimittelwirkungen", Lehrbuch der Pharmakologie, der klinischen Pharmakologie und Toxikologie 10th edition, Wissenschaftliche Verlagsgesellschaft mbH Lehrbuch der Pharmakologie, der klinischen Pharmakologie und Toxikologie, (20130101), page 116, XP093070258-
OTHER- Chandler S. Gautam, Et Al., "Fixed dose drug combinations (FDCs): rational or irrational: a view point", British journal of clinical pharmacology, BLACKWELL SCIENTIFIC PUBL., GB, GB , (20080501), vol. 65, no. 5, doi:10.1111/j.1365-2125.2007.03089.x, ISSN 0306-5251, pages 795 - 796, XP055555549
SEARCH- Anonymous, "NCT02072161: Evaluation of ETC-1002 vs Placebo in Patients Receiving Ongoing Statin Therapy", Clinicaltrials.gov, (20140403), pages 1 - 9, URL: https://clinicaltrials.gov/ct2/history/NCT02072161?V_2=View#StudyPageTop, (20180620), XP055485769 [Y] 6-7,9-12,17 * page 2, "Study Description" page 3, "Outcome Measures" page 4, "Eligibility" *-
SEARCH[ ] - BALLANTYNE CHRISTIE M ET AL, "Effect of ETC-1002 on Serum Low-Density Lipoprotein Cholesterol in Hypercholesterolemic Patients Receiving Statin Therapy", AMERICAN JOURNAL OF CARDIOLOGY, CAHNERS PUBLISHING CO., NEWTON, MA, US, (20160406), vol. 117, no. 12, doi:10.1016/J.AMJCARD.2016.03.043, ISSN 0002-9149, pages 1928 - 1933, XP029554813 [ ] * the whole document *
SEARCH- NIKOLIC D ET AL, "ETC-1002: a future option for lipid disorders?", ATHEROSCLEROSIS, ELSEVIER, AMSTERDAM, NL, vol. 237, no. 2, doi:10.1016/J.ATHEROSCLEROSIS.2014.10.099, ISSN 0021-9150, (201412), pages 705 - 710, (20141031), XP002756256 [I] 1-5,8,13-16 * abstract * * table 1 * * page 708, column 2, paragraph l - page 709, column 1, paragraph 4 * [Y] 6-7,9-12,17
SEARCH- BALLANTYNE CHRISTIE M ET AL, "Efficacy and Safety of a Novel Dual Modulator of Adenosine Triphosphate-Citrate Lyase and Adenosine Monophosphate-Activated Protein Kinase in Patients With Hypercholesterolemia", JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, (20130924), vol. 62, no. 13, doi:10.1016/J.JACC.2013.05.050, ISSN 0735-1097, pages 1154 - 1162, XP028717576 [A] 1-17 * abstract *
SEARCH- GUTIERREZ MARIA J ET AL, "Efficacy and Safety of ETC-1002, a Novel Investigational Low-Density Lipoprotein-Cholesterol-Lowering Therapy for the Treatment of Patients With Hypercholesterolemia and Type 2 Diabetes Mellitus", ARTERIOSCLEROSIS THROMBOSIS AND VASCULAR BIOLOGY, (201403), vol. 34, no. 3, ISSN 1079-5642, pages 676 - 683, XP055485482 [A] 1-17 * abstract *
SEARCH- CHRISTIE M BALLANTYNE ET AL, "Abstract 17499: ETC-1002 Incrementally Lowers Low Density Lipoprotein-cholesterol in Patients With Hypercholesterolemia Receiving Stable Statin Therapy", CIRCULATION, (20151106), vol. 132, no. Suppl 3, page 1, XP055485809 [PI] 6-7,9-12,17 * abstract *

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