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WO 2018/005909 Al 04 January 2018 (04.01.2018) W !P O PCT
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2018/005909 Al 04 January 2018 (04.01.2018) W !P O PCT (51) International Patent Classification: A61P 31/12 (2006 .01) A61K 31/505 (2006 .0 1) A61K 31/4985 (2006.01) (21) International Application Number: PCT/US20 17/040 175 (22) International Filing Date: 30 June 2017 (30.06.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/357,458 0 1 July 2016 (01 .07.2016) US (71) Applicant: VIIV HEALTHCARE COMPANY [US/US]; 25 1 Little Falls Drive, Wilmington, DE 19808 (US). (72) Inventor: SPREEN, William, R.; 5 Moore Drive, Re search Triangle Park, NC 27709-3398 (US). (74) Agent: HAN, William, T. et al; Glaxosmithkline, Glob al Patents, UW2220, 709 Swedeland Road, P.O. Box 1539, King of Prussia, PA 19406-0939 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. -
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Kan Lu, PharmD New Antiretrovirals for Based on a presentation at prn by Roy M. Gulick, md, mph the Treatment of HIV: Kan Lu, PharmD | Drug Development Fellow University of North Carolina School of Pharmacy Chapel Hill, North Carolina The View in 2006 Roy M. Gulick, md, mph Reprinted from The prn Notebook® | october 2006 | Dr. James F. Braun, Editor-in-Chief Director, Cornell Clinical Trials Unit | Associate Professor of Medicine, Meri D. Pozo, PhD, Managing Editor. Published in New York City by the Physicians’ Research Network, Inc.® Weill Medical College of Cornell University | New York, New York John Graham Brown, Executive Director. For further information and other articles available online, visit http://www.prn.org | All rights reserved. ©october 2006 substantial progress continues to be made in the arena of cokinetics and a long extracellular half-life of approximately 10 hours antiretroviral drug development. prn is again proud to present its annual (Zhu, 2003). During apricitabine’s development, a serious drug interac- review of the experimental agents to watch for in the coming months and tion with lamivudine (Epivir) was noted. Although the plasma years. This year’s review is based on a lecture by Dr. Roy M. Gulick, a long- concentrations of apricitabine were unaffected by coadministration of time friend of prn, and no stranger to the antiretroviral development lamivudine, the intracellular concentrations of apricitabine were reduced pipeline. by approximately sixfold. Additionally, the 50% inhibitory concentration To date, twenty-two antiretrovirals have been approved by the Food (ic50) of apricitabine against hiv with the M184V mutation was increased and Drug Administration (fda) for the treatment of hiv infection. -
Interferon-Based and Interferon-Free New Treatment Options
Interferon-based and interferon-free new treatment options White Nights of Hepatology St. Petersburg, 7. June 2013 Christoph Sarrazin Klinikum der J. W. Goethe-Universität Medizinische Klinik I Frankfurt am Main Mode of action of Interferons natural immunomodulatory effects IFN-stimulated gene activation Antiviral Apoptotic Immunomodulatory activity activity activity B-cell proliferation Reduced transcription Elevates apoptosis by CTL proliferation Reduced translation multiple mechanisms MHC upregulation Reduced RNA stability Augments NK activity Host-mediated effects are important for DAA combination therapy • Potency and additive effects • Prevention of resistance and viral breakthrough Different types of Interferons Type I Interferons Type III Interferons Broad receptor Receptors distribution distributed throughout various primarily in body tissues epithelial cells and hepatocytes Antiviral effects Antiviral effects Adverse events of Type I IFNs treatment Peg‐Intron • Flu-like symptoms PegIFN‐2a Type III IFNs Potentially fewer • Haematologic IFN omega Peg‐IFN‐ adverse events disorders IFN‐alfa‐2b XL lambda than with type I • Psychiatric Belerofon (Peg‐rIL‐29) interferons symptoms Albuferon Locteron Adapted from 1. Marcello T et al. Gastroenterology 2006;131:1887–98; 2. Muir AJ et al. 2009 AASLD. Abstract 1591; 3. O'Brien TR. Nat Genet. 2009;41:1048–50. PEG-Interferon alfa / Ribavirin Approval studies: efficacy Approval study (n=1530) Approval study (n=1121) Therapy: IFN vs. PEG-IFN alfa 2b Therapy: IFN vs. PEG-IFN alfa 2a 1,0/1,5µg/kgKG -
Ep 2531027 B1
(19) TZZ ¥_Z _T (11) EP 2 531 027 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 31/4985 (2006.01) A61K 31/52 (2006.01) 06.05.2015 Bulletin 2015/19 A61K 31/536 (2006.01) A61K 31/513 (2006.01) A61K 38/55 (2006.01) A61P 31/18 (2006.01) (21) Application number: 11737484.3 (86) International application number: (22) Date of filing: 24.01.2011 PCT/US2011/022219 (87) International publication number: WO 2011/094150 (04.08.2011 Gazette 2011/31) (54) Therapeutic combination comprising dolutegravir, abacavir and lamivudine Therapeutische Zusammensetzung enthaltend Dolutegravir, Abacavir und Lamivudine Combinaison thérapeutique comprenant du dolutégravir, de l’abacavir et de la lamivudine (84) Designated Contracting States: (74) Representative: Gladwin, Amanda Rachel AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GlaxoSmithKline GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO Global Patents (CN925.1) PL PT RO RS SE SI SK SM TR 980 Great West Road Designated Extension States: Brentford, Middlesex TW8 9GS (GB) BA ME (56) References cited: (30) Priority: 27.01.2010 US 298589 P WO-A1-2010/011812 WO-A2-2009/148600 US-A1- 2006 084 627 US-A1- 2006 084 627 (43) Date of publication of application: US-A1- 2008 076 738 US-A1- 2009 318 421 12.12.2012 Bulletin 2012/50 US-A1- 2009 318 421 US-B1- 6 544 961 (73) Proprietor: VIIV Healthcare Company • SONG1 et al: "The Effect of Ritonavir-Boosted Research Triangle Park, NC 27709 (US) ProteaseInhibitors on the HIV Integrase Inhibitor, S/GSK1349572,in Healthy Subjects", INTERNET , (72) Inventor: UNDERWOOD, Mark, Richard 15 September 2009 (2009-09-15), XP002697436, Research Triangle Park Retrieved from the Internet: URL:http: North Carolina 27709 (US) //www.natap.org/2009/ICCAC/ICCAC_ 52.htm [retrieved on 2013-05-21] Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
PHARMACEUTICAL APPENDIX to the TARIFF SCHEDULE 2 Table 1
Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2020) Revision 19 Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names INN which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service CAS registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. -
2019 Icar Program & Abstracts Book
Hosted by the International Society for Antiviral Research (ISAR) ND International Conference 32on Antiviral Research (ICAR) Baltimore MARYLAND PROGRAM and USA Hyatt Regency BALTIMORE ABSTRACTS May 12-15 2019 ND TABLE OF International Conference CONTENTS 32on Antiviral Research (ICAR) Daily Schedule . .3 Organization . 4 Contributors . 5 Keynotes & Networking . 6 Schedule at a Glance . 7 ISAR Awardees . 10 The 2019 Chu Family Foundation Scholarship Awardees . 15 Speaker Biographies . 17 Program Schedule . .25 Posters . 37 Abstracts . 53 Author Index . 130 PROGRAM and ABSTRACTS of the 32nd International Conference on Antiviral Research (ICAR) 2 ND DAILY International Conference SCHEDULE 32on Antiviral Research (ICAR) SUNDAY, MAY 12, 2019 › Women in Science Roundtable › Welcome and Keynote Lectures › Antonín Holý Memorial Award Lecture › Influenza Symposium › Opening Reception MONDAY, MAY 13, 2019 › Women in Science Award Lecture › Emerging Virus Symposium › Short Presentations 1 › Poster Session 1 › Retrovirus Symposium › ISAR Award of Excellence Presentation › PechaKucha Event with Introduction of First Time Attendees TUESDAY, MAY 14, 2019 › What’s New in Antiviral Research 1 › Short Presentations 2 & 3 › ISAR Award for Outstanding Contributions to the Society Presentation › Career Development Panel › William Prusoff Young Investigator Award Lecture › Medicinal Chemistry Symposium › Poster Session 2 › Networking Reception WEDNESDAY, MAY 15, 2019 › Gertrude Elion Memorial Award Lecture › What’s New in Antiviral Research 2 › Shotgun Oral -
GSK and Vertex Pharmaceuticals Announce Presentation of Data Supporting Development of Investigational HIV Protease Inhibitor Brecanavir
December 16, 2005 GSK and Vertex Pharmaceuticals Announce Presentation of Data Supporting Development of Investigational HIV Protease Inhibitor Brecanavir - Positive Data Presented at 45th Annual ICAAC - Cambridge, MA, December 16, 2005 - GlaxoSmithKline (GSK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) presented positive results today from a study evaluating the safety, tolerability and antiviral activity of the investigational HIV-1 protease inhibitor (PI), brecanavir* (formerly known as GW640385 or VX-385)1. These data were presented at the 45th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) held in Washington DC. Interim findings following 24 weeks of dosing demonstrated potent antiviral activity for brecanavir in both PI-sensitive and PI-resistant HIV-infected adults. "These results support the ongoing development program for brecanavir, which is anticipated to enter Phase III development in 2006," said Lynn Marks, MD, Senior Vice President of the Infectious Disease Medicines Development Centre at GSK. "If approved, brecanavir may be useful in treating patients infected with strains of HIV that have become resistant to multiple protease inhibitors, and its clinical advancement underscores GSK's commitment to developing new anti-HIV drugs." Clinical Data on Brecanavir Brecanavir is an HIV protease inhibitor in Phase IIb clinical development. Brecanavir has received fast track designation from the U.S. Food and Drug Administration and is being developed by GSK as part of a collaboration with Vertex Pharmaceuticals. Data presented were from a planned, 24-week analysis of an open-label study (HPR10006) of 48 weeks' duration evaluating the safety, tolerability, antiviral activity and pharmacokinetics of ritonavir-boosted brecanavir. Thirty-one HIV-1 infected adults received 300mg of brecanavir twice-daily boosted with 100mg of ritonavir in combination with two nucleoside reverse transcriptase inhibitors based on patient medical history and viral genotype. -
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Review Article Chronic Hepatitis C Infection in Children: Current Treatment and New Therapies Andrew Lee1,2*, Jeremy Rajanayagam1,3 and Mona Abdel-Hady1 1Birmingham Children’s Hospital, Liver Unit, Birmingham, United Kingdom; 2The University of Queensland, School of Medicine, Brisbane, Australia; 3University of Birmingham, School of Infection and Immunity, Birmingham, United Kingdom Abstract remains the most common method of infection in the developing world.1,2 The overall rate of spontaneous viral Viral hepatitis C is responsible for a large burden of disease clearance following childhood infection is low, with the worldwide. Treatment of hepatitis C infection is currently majority of children developing chronic hepatitis C (CHC) undergoing a revolution with the development of new direct (54–86%).2 The clinical course of CHC in children is usually acting antivirals that offer higher cure rates and fewer side silent, with mildly abnormal liver function tests (LFTs) and effects than other medications currently available. Treatment minimal inflammation and fibrosis on histology.2–4 options for children, although well-defined and evidence- Nevertheless, fibrosis tends to progress with time, culminat- based, are limited relative to adults as there are few trials ing in cirrhosis in 5–10% or hepatocellular carcinoma (HCC) regarding the use of these newly developed agents in in 2–5% in adulthood.2,3 Thus, continued efforts to effectively children. With so much optimism in the development of novel treat children and reduce the long-term health and social therapeutic options for hepatitis C, it is timely to review and consequences in pediatric CHC are justified. summarize the current standard of care treatment and indications for treatment of chronic hepatitis C in children. -
Caracterización Molecular Del Perfil De Resistencias Del Virus De La
ADVERTIMENT. Lʼaccés als continguts dʼaquesta tesi queda condicionat a lʼacceptació de les condicions dʼús establertes per la següent llicència Creative Commons: http://cat.creativecommons.org/?page_id=184 ADVERTENCIA. El acceso a los contenidos de esta tesis queda condicionado a la aceptación de las condiciones de uso establecidas por la siguiente licencia Creative Commons: http://es.creativecommons.org/blog/licencias/ WARNING. The access to the contents of this doctoral thesis it is limited to the acceptance of the use conditions set by the following Creative Commons license: https://creativecommons.org/licenses/?lang=en Programa de doctorado en Medicina Departamento de Medicina Facultad de Medicina Universidad Autónoma de Barcelona TESIS DOCTORAL Caracterización molecular del perfil de resistencias del virus de la hepatitis C después del fallo terapéutico a antivirales de acción directa mediante secuenciación masiva Tesis para optar al grado de doctor de Qian Chen Directores de la Tesis Dr. Josep Quer Sivila Dra. Celia Perales Viejo Dr. Josep Gregori i Font Laboratorio de Enfermedades Hepáticas - Hepatitis Víricas Vall d’Hebron Institut de Recerca (VHIR) Barcelona, 2018 ABREVIACIONES Abreviaciones ADN: Ácido desoxirribonucleico AK: Adenosina quinasa ALT: Alanina aminotransferasa ARN: Ácido ribonucleico ASV: Asunaprevir BOC: Boceprevir CCD: Charge Coupled Device CLDN1: Claudina-1 CHC: Carcinoma hepatocelular DAA: Antiviral de acción directa DC-SIGN: Dendritic cell-specific ICAM-3 grabbing non-integrin DCV: Daclatasvir DSV: Dasabuvir -
Synthesis and Evaluation of New HCV NS3/4A Protease Inhibitors
Synthesis and Evaluation of New HCV NS3/4A Protease Inhibitors A Major Qualifying Project Report: Submitted to the Faculty Of WORCESTER POLYTECHNIC INSTITUTE In partial fulfillment of the requirements for the Degree of Bachelor of Science By: ______________________ Evangelos Koumbaros Advisor Destin Heilman In Cooperation with Akbar Ali, Ph.D. UMass Medical School Table of Contents Acknowledgments ..................................................................................................................................... 4 Abstract ..................................................................................................................................................... 5 Background ............................................................................................................................................... 6 Protease Inhibitors ................................................................................................................................ 8 Telaprevir .............................................................................................................................................. 8 Boceprevir ............................................................................................................................................. 9 MK-5172 ............................................................................................................................................... 9 Methods ................................................................................................................................................. -
Screening of Clinically Approved and Investigation Drugs As Potential
Screening of Clinically Approved and Investigation Drugs as Potential Inhibitors of COVID-19 Main Protease: A Virtual Drug Repurposing Study Serdar Durdagi1,*, Busecan Aksoydan1,2, Berna Dogan1, Kader Sahin1, Aida Shahraki1,3 1Computational Biology and Molecular Simulations Laboratory, Department of Biophysics, School of Medicine, Bahcesehir University, Istanbul, Turkey 2Neuroscience Program, Graduate School of Health Sciences, Bahçeşehir University, Istanbul, Turkey 3Department of Molecular Biology and Genetics, Bogazici University, Istanbul, Turkey Abstract There is an urgent need for a new drug against COVID-19. Since designing a new drug and testing its pharmacokinetics and pharmacodynamics properties may take years, here we used a physics-driven high throughput virtual screening drug re-purposing approach to identify new compounds against COVID-19. As the molecules considered in repurposing studies passed through several stages and have well-defined profiles, they would not require prolonged pre- clinical studies and hence, they would be excellent candidates in the cases of disease emergencies or outbreaks. While the spike protein is the key for the virus to enter the cell though the interaction with ACE2, enzymes such as main protease are crucial for the life cycle of the virus. This protein is one of the most attractive targets for the development of new drugs against COVID-19 due to its pivotal role in the replication and transcription of the virus. We used 7922 FDA approved small molecule drugs as well as compounds in clinical investigation from NIH Chemical Genomics Center (NCGC) Pharmaceutical Collection (NPC) database in our drug repurposing study. Both apo and holo forms of target protein COVID-19 main proteases were used in virtual screening. -
Section 2.6.4 Pharmacokinetics Written Summary EMTRICITABINE
SECTION 2.6 NONCLINICAL SUMMARY Section 2.6.4 Pharmacokinetics Written Summary EMTRICITABINE/ RILPIVIRINE/ TENOFOVIR DISOPROXIL FUMARATE FIXED-DOSE COMBINATION 17 August 2010 CONFIDENTIAL AND PROPRIETARY INFORMATION Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Section 2.6.4 Pharmacokinetics Written Summary Final TABLE OF CONTENTS SECTION 2.6 NONCLINICAL SUMMARY........................................................................................................1 TABLE OF CONTENTS .......................................................................................................................................2 GLOSSARY OF ABBREVIATIONS AND DEFINITION OF TERMS ..............................................................5 2.6. NONCLINICAL SUMMARY.......................................................................................................................8 2.6.4. PHARMACOKINETICS WRITTEN SUMMARY .........................................................................8 2.6.4.1. Brief Summary................................................................................................................8 2.6.4.2. Methods of Analysis .....................................................................................................14 2.6.4.2.1. Emtricitabine............................................................................................14 2.6.4.2.2. Rilpivirine ................................................................................................14 2.6.4.2.3. Tenofovir Disoproxil Fumarate