IP Verse

Methods For Increasing Growth In Pediatric Subjects Having Cholestatic Liver Disease - EP3923970

The patent EP3923970 was granted to Mirum Pharmaceuticals on May 15, 2024. The application was originally filed on Feb 12, 2020 under application number EP20756251A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3923970

MIRUM PHARMACEUTICALS
Application Number
EP20756251A
Filing Date
Feb 12, 2020
Status
Granted And Under Opposition
Apr 12, 2024
Publication Date
May 15, 2024
External Links
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SANDOZFeb 14, 2025MAIWALDADMISSIBLE

Patent Citations (5) New

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

Citation PhasePublication Number
INTERNATIONAL-SEARCH-REPORTUS2013108573
INTERNATIONAL-SEARCH-REPORTUS2016193277
INTERNATIONAL-SEARCH-REPORTUS2017210717
INTERNATIONAL-SEARCH-REPORTUS2017368085
INTERNATIONAL-SEARCH-REPORTWO2011137135

Non-Patent Literature (NPL) Citations (45) 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- "ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Livmarli", European Medicines Agency, pages 1 - 38, European Medicines Agency, URL: https://www.ema.europa.eu/en/documents/product-information/livmarli-epar-product-information_en.pdf, XP093310109
OPPOSITION- Anonymous, "Study Record Versions History of Changes for Study: NCT04168385 MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study (MERGE)", clinicaltrials.gov, (20200122), pages 1 - 9, clinicaltrials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT04168385?V_2=View#StudyPageTop, (20221103), XP055977617
OPPOSITION- Anonymous, "Study Record Versions History of Changes for Study: NCT04185363 An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)", Clinical trials.gov, clinical trials, clinical trials, (20191206), pages 1 - 9, Clinical trials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT04185363?V_2=View#StudyPageTop, (20221103), XP055977607
OPPOSITION- Baker A., Et Al, "A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED STUDY (IMAGO) OF LUM001, A NOVEL INHIBITOR OF THE APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER (ASBT), IN PAEDIATRIC PATIENTS WITH ALAGILLE SYNDROME (ALGS)", Journal of Hepatology, (20150101), vol. 62, page S259, XP093264309
OPPOSITION- D10B: Presentation slides of D10a (presented on 10 November 2019), which were published on the Mirum pharmaceuticals website in November 2019
OPPOSITION- D11B: Presentation slides of D11a (presented on 11 November 2019), which were published on the Mirum pharmaceuticals website in November 2019
OPPOSITION- D15a Thompson et al. Abstract
OPPOSITION- D15B: Full presentation slides of D15a (which was presented in December 2017), which were published on the Mirum pharmaceuticals website in July 2019
OPPOSITION- D16B: Presentation slides for “Phase 2 open-label efficacy and safety study of the apical sodium-dependent bile acid transporter inhibitor maralixibat in children with progressive familial intrahepatic cholestasis: 48-week interim efficacy analysis” (which was presented in December 2017). These slides were published on the Mirum pharmaceuticals website in July 2019
OPPOSITION- D20A: Efficacy and Safety of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC): A Randomized Placebo-Controlled Phase 3 Study”, presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting (NASPGHAN); October 4-7, 2023, San Diego, California. Downloaded from Mirum Pharmaceuticals website
OPPOSITION- D20B: Maralixibat Leads to Significant Reduction in Pruritus and Improvements in Sleep for Children With Progressive Familial Intrahepatic Cholestasis: Data From MARCH-PFIC”, presented at the European Association for the Study of the Liver (EASL) Congress 2023; Vienna, Austria; 21-24 June 2023. Downloaded from Mirum Pharmaceuticals website
OPPOSITION- D20C: Maralixibat Leads to Significant Reduction in Pruritus and Improvements in Sleep for Children With Progressive Familial Intrahepatic Cholestasis: Data From the MARCH Trial”, presented at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting (NASPGHAN); October 4-7, 2023, San Diego, California. Downloaded from Mirum Pharmaceuticals website
OPPOSITION- D22: Improvements in Pruritus Are Associated with Improvements in Growth in Patients with Progressive Familial Intrahepatic Cholestasis: Data from the MARCH-ON Trial”, presented at American Association for the Study of Liver Diseases. AASLD: The Liver Meetings - Nov. 15­ 19, 2024. Downloaded from Mirum Pharmaceuticals website
OPPOSITION- D24 - Information Disclosure Statement (IDS) submission filed on 2nd November 2023
OPPOSITION- D25 - Study details for NCT04168385 (MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study (MERGE)) from 3rd March 2025
OPPOSITION- D26 - D31 Waybackmachine links to calendar
OPPOSITION- D9B: Presentation slides of D9a (presented on 13 April 2019), which were published on the Mirum pharmaceuticals website in July 2019
OPPOSITION- "Durability of Treatment Effect of Mirum Pharmaceuticals' Maralixibat for Children With Alagille Syndrome Featured in Late Breaking Session at the Liver Meeting 2019", Press release, Mirum, (20191021), pages 1 - 2, XP093264237
OPPOSITION- Gonzales Emmanuel, Et Al, "Phase 2 open-label study with a placebo-controlled drug withdrawal period of the apical sodium-dependent bile acid transporter inhibitor maralixibat in children with Alagille Syndrome: 48-week interim efficacy analysis", Journal of Hepatology, PS-193, (20190101), pages e119 - e120, XP093264281
OPPOSITION- Gonzales Emmanuel, Hardikar Winita, Stormon Michael, Baker Alastair, Hierro Loreto, Gliwicz Dorota, Lacaille Florence, Lachaux Alain, Sturm Ekkehard, Setchell Kenneth D R, Kennedy Ciara, Dorenbaum Alejandro, Steinmetz Jana, Desai Nirav K, Wardle Andrew J, Garner Will, Vig Pamela, Jaecklin Thomas, Sokal Etienne M, Jacquemin Emmanuel, "Efficacy and safety of maralixibat treatment in patients with CrossMark Alagille syndrome and cholestatic pruritus (ICONIC): a randomised phase 2 study", The Lancet, (20211030), vol. 398, pages 1581 - 1592, XP093310750
OPPOSITION- Gonzales Emmanuel M., Et Al, "DURABILITY OF TREATMENT EFFECT WITH LONG-TERM MARALIXIBAT IN CHILDREN WITH ALAGILLE SYNDROME: 4-YEAR SAFETY AND EFFICACY RESULTS FROM THE ICONIC STUDY", HEPATOLOGY L03, (20190101), vol. 70, no. 6, page 1479A, XP093264296
OPPOSITION- Gonzales Emmanuel, Vig Pamela, Tucker Ed, Garner Will, Jaecklin Thomas, Jacquemin Emmanuel, Kamath Binita M, "Pruritus intensity is associated with cholestasis biomarkers and quality of life measures after maralixibat treatment in children with Alagille syndrome", North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting (Virtual), US, (20211218), XP093310102
OPPOSITION- "Mirum Pharmaceuticals Initiates Phase 3 Clinical Trial for Pediatric Patients with Progressive Familial Intrahepatic Cholestasis", Press release, Mirum, (20190709), page 1, XP093264234
OPPOSITION- "Mirum Pharmaceuticals Presents Data Demonstrating Long-term Durability of Treatment Effect of Maralixibat in Children With Cholestatic Liver Diseases", Press release, Mirum, (20191108), pages 1 - 3, XP093264241
OPPOSITION- "Mirum Pharmaceuticals Presents New Data Demonstrating Durable Improvements in Clinical Outcome Measures in Patients with PFIC2 and Alagille Syndrome Treated with Maralixibat", Press release, Mirum, (20190415), pages 1 - 3, XP093264231
OPPOSITION- "Mirum Pharmaceuticals to Present Phase 2 Clinical Results of Maralixibat in Alagille Syndrome and Progressive Familial Intrahepatic Cholestasis at the International Liver Congress", Press release, Mirum, (20190327), page 1, XP093264229
OPPOSITION- "Mirum to Present New Data at The Liver Meeting 2019", press release, Mirum, (20191001), pages 1 - 2, XP093264235
OPPOSITION- "Programs", Mirum, (20191210), pages 1 - 14, Mirum, URL: https://mirumpharma.com/programs, XP093264249
OPPOSITION- Thompson8 Richard J., Et Al , "A long-term phase 2 safety and efficacy study of the apical sodium-dependent bile acid transporter inhibitor maralixibat in children with Alagille syndrome: preliminary results from the IMAGINE study", HEPATOLOGY, (20171201), vol. 66, no. 6, pages 1255A - 1256A, XP093264321
OPPOSITION- Thompson Richard J., Et Al, "GENOTYPE AND DOSE-DEPENDENT RESPONSE TO MARALIXIBAT IN PATIENTS WITH BILE SALT EXPORT PUMP DEFICIENCY", HEPATOLOGY, 82, (20191001), page 56A, XP093264292
OPPOSITION- Thompson Richard J, Kelly Deirdre A, Mcclean Patricia, Miethke Alexander G, Soufi Nisreen, Rivet8 Christine, Jankowska Irena, Mack Cara L, Karthikeyan Palaniswamy, Gu Joan, Jaecklin Thomas, Squires Robert H, Leen Kath, Loomes M, Rivet Christine, Loomes Kathleen M, "Phase 2 open-label efficacy and safety study of the apical sodium-dependent bile acid transporter inhibitor maralixibat in chil dren with progressive familial intrahepatic cholestasis: 48-week interim efficacy analysis", Hepatology, (20190701), pages 57A - 57A, XP093276291
OPPOSITION- Thompson Richard, Kelly Deirdre, Rajwal Sanjay, Miethke Alexander, Soufi Nisreen, Rivet Christine, Jankowska Irena, Mack Cara, Jaecklin Thomas, Squires Robert H, Loomes Kathleen M, "Presentation slides, Growth analysis in children with PFIC treated with the ASBT inhibitor maralixibat, INDIGO Study", Mirum pharmaceuticals, (20190413), pages 1 - 16, XP093264260
OPPOSITION- Malatack Jeffrey, Daniel Doyle, "Case RepoRt A Drug Regimen for Progressive Familial Cholestasis Type 2", PEDIATRICS, American Academy of Pediatrics, doi:10.1542/peds.2016-3877, (20180101), pages 1 - 5, PEDIATRICS, URL: https://publications.aap.org/pediatrics/article/141/1/e20163877/37702/A-Drug-Regimen-for-Progressive-Familial, (20221027), XP055975631
OPPOSITION- Benjamin L Shneider et al., "Placebo-Controlled Randomized Trial of an Intestinal Bile Salt Transport Inhibitor for Pruritus in Alagille Syndrome", Hepatology CommuniCations, (20180101), vol. 2, no. 10, doi:10.1002/hep4.1244/suppinfo, pages 1184 - 1198, XP055732834
OPPOSITION- Thompson Ridchard, Kelly Deirdre, Rajwal Sanjay, MMiethke Alexander, Soufi Nisreen, Rivet Christine, Jankowska Irena, Mack Cara, Jaecklin Thomas, Squires Robert, Loomes Kathleen, "LBO-08-Growth analysis in children with progressive familial intrahepatic cholestasis treated with the apical sodium-dependent bile acid transporter inhibitor maralixibat", Journal of Hepatology, (20190413), vol. 70, no. 1, doi:10.1016/S0618-8278(19)30232-4, pages e131 - e132, XP093264272
OPPOSITION- Klischies S., "The Liver Meeting 2017 - American Association for the Study of Liver Diseases (AASLD) - 2017 Annual Meeting. Washington, D.C., USA - October 20-24, 2017", Drugs of the Future, J.R. Prous, vol. 42, no. 12, doi:10.1358/dof.2017.042.12.2739615, ISSN 2013-0368, page 0779, XP093264314
OPPOSITION- Kamath Binita M, Gonzalès Emmanuel, Kelly Deirdre, Mogul Douglas B, Garner Will, Vig Pamela, Jacquemin Emmanuel, "Clinical Benefits With Maralixibat for Patients With Alagille Syndrome Are Durable Through 7 Years of Treatment: Data From the MERGE Study", doi:10.3252/pso.eu.EASL2024.2024, (20240608), URL: https://www.postersessiononline.eu/173580348_eu/congresos/EASL2024/aula/-THU_94_EASL2024.pdf, XP093310679
OPPOSITION- Shirley Matt, "Maralixibat: First Approval", Drugs, (20220101), vol. 82, doi:10.6084/m9.figshare.l7019878, pages 71 - 76, XP093264331
SEARCH- Anonymous, "Study Record Versions History of Changes for Study: NCT04168385 MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study (MERGE)", clinicaltrials.gov, (20200122), pages 1 - 9, URL: https://clinicaltrials.gov/ct2/history/NCT04168385?V_2=View#StudyPageTop, (20221103), XP055977617 [YP] 1-13 * page 5 - page 7 *
SEARCH- Anonymous, "Study Record Versions History of Changes for Study: NCT04185363 An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)", Clinical trials.gov, clinical trials, (20191206), pages 1 - 9, URL: https://clinicaltrials.gov/ct2/history/NCT04185363?V_2=View#StudyPageTop, (20221103), XP055977607 [YP] 1-13 * page 5 - page 6 * * page 8 *
SEARCH- Clinical Trials.Gov, "Study Record Versions Contacts/Locations and Study Status History of Changes for Study: NCT03566238 This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC 1 or 2 (PEDFIC 1)", clinical trials .gov, (20190208), pages 1 - 16, URL: https://clinicaltrials.gov/ct2/history/NCT03566238?V_18=View#StudyPageTop, (20221028), XP055975866 [Y] 1-13 * pages 5-8 *
SEARCH- Clinical Trials.Gov, "Study Record Versions History of Changes for Study: NCT03659916 Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC Types 1 & 2", clinical trials.gov, (20190211), pages 1 - 11, URL: https://clinicaltrials.gov/ct2/history/NCT03659916?V_5=View#StudyPageTop, (20221028), XP055975930 [Y] 1-13 * page 5 - page 8 *
SEARCH- Mirum Pharmaceuticals, "Mirum Pharmaceuticals Presents New Data Demonstrating Durable Improvements in Clinical Outcome Measures in Patients with PFIC2 and Alagille Syndrome Treated with Maralixibat", (20190415), URL: https://www.prnewswire.com/news-releases/mirum-pharmaceuticals-presents-new-data-demonstrating-durable-improvements-in-clinical-outcome-measures-in-patients-with-pfic2-and-alagille-syndrome-treated-with-maralixibat-300831721.html, (20220215), XP055892012 [XP] 1,2,4,6,11,12 * page 1, paragraph 2 * * page 2, paragraph 5 * * page 3, paragraph 2 * * page 3; table 1 *
SEARCH- Malatack Jeffrey ET AL, "Case RepoRt A Drug Regimen for Progressive Familial Cholestasis Type 2", PEDIATRICS, doi:10.1542/peds.2016-3877, (20180101), pages 1 - 5, URL: https://publications.aap.org/pediatrics/article/141/1/e20163877/37702/A-Drug-Regimen-for-Progressive-Familial, (20221027), XP055975631 [X] 1,2,4,6,7 * page 2, column 1st, paragraph 2 * * page 3, column 1st, paragraph 1 * * page 4, column 3rd, paragraph 2 * * figure 2 *
SEARCH- MELISSA PALMER ET AL, "A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis", BMC PHARMACOLOGY AND TOXICOLOGY, BIOMED CENTRAL LTD, LONDON, UK, (20180316), vol. 19, no. 1, doi:10.1186/S40360-018-0200-Y, pages 1 - 13, XP021254505 [Y] 1-13 * the whole document *

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