Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-11-30T19:07:58.558Z Has data issue: false hasContentIssue false
  • English
  • Français

Origins and Ownership of Remdesivir

Implications for Pricing

Published online by Cambridge University Press:  01 January 2021

ChangWon C. Lee ,
Jonathan J. Darrow ,
Jerry Avorn  and
Aaron S. Kesselheim
Get access Rights & Permissions [Opens in a new window]

Abstract

An abstract is not available for this content so a preview has been provided. Please use the Get access link above for information on how to access this content.
Image of the first page of this content. For PDF version, please use the ‘Save PDF’ preceeding this image.'
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 48 , Issue 3: A Bold Agenda for the Next Steps in Health Reform , Fall 2020 , pp. 613 - 618
Copyright
Copyright © American Society of Law, Medicine and Ethics 2020

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Request for emergency use authorization for use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients, Food, U. and Drug Administration, available at <https://www.fda.gov/media/137564/download> (last visited May 1, 2020).+(last+visited+May+1,+2020).>Google Scholar
Wang, M., Cao, R., Zhang, L., Yang, X., et al., “Remdesivir and Chloroquine Effectively Inhibit the Recently Emerged Novel Coronavirus (2019- nCoV) in vitro,” Remdesivir and Chloroquine Effectively Inhibit the Recently Emerged Novel Coronavirus (2019- nCoV) in vitro, 30, no. 3 (2020): 269–271.Google Scholar
Beigel, J.H., Tomashek, K.M., L.Dodd, E., et al., “Remdesivir for the Treatment of Covid-19 - Preliminary Report,” New England Journal of Medicine (2020) (E-pub ahead of print).Google Scholar
HHS announces shipments of donated remdesivir for hospitalized patients with COVID-19, U.S. Department of Health & Human Services, available at <https://www.hhs.gov/about/news/2020/05/09/hhs-ships-firstdoses-of-donated-remdesivir-for-hospitalized-patients-with-covid-19.html> (last visited May 25, 2020).+(last+visited+May+25,+2020).>Google Scholar
Hill, A., Wang, J., Levi, J., Heath, K., and Fortunak, J., “Minimum Costs to Manufacture New Treatments for COVID- 19,” Minimum Costs to Manufacture New Treatments for COVID- 19, 6, no. 2 (2020): 61–69.Google Scholar
Alternative Pricing Models for Remdesivir and Other Potential Treatments for COVID-19, Institute for Clinical and Economic Review (ICER), available at <https://icer-review.org/wp-content/uploads/2020/05/ICER-COVID_Initial_Abstract_05012020-3.pdf> (last visited May 25, 2020).+(last+visited+May+25,+2020).>Google Scholar
Provides, I.E. First Update to Pricing Models for Remdesivir as a Treatment for COVID-19, Institute for Clinical and Economic Review (ICER), available at <https://icer-review.org/announcements/updated_icer-covid_models_june_24/> (last visited June 30, 2020).+(last+visited+June+30,+2020).>Google Scholar
“Remdesivir, the First Coronavirus Drug, Gets a Price Tag,” The New York Times, available at <https://www.nytimes.com/2020/06/29/health/coronavirus-remdesivir-gilead.html> (last visited June 30, 2020).+(last+visited+June+30,+2020).>Google Scholar
Antiviral Compound Provides Full Protection from Ebola Virus in Nonhuman Primates, United States Army Medical Research Institute of Infectious Diseases (USAMRIID), available at <https://www.usamriid.army.mil/press_releases/Travis%20ID%20Week%20FINAL.pdf> (last visited April 11, 2020); Siegel, D., H.Hui, C., Doerffler, E., M.Clarke, O., et al., “Discovery and Synthesis of a Phosphoramidate Prodrug of a Pyrrolo[2,1-f ][triazin- 4-amino] Adenine C-Nucleoside (GS-5734) for the Treatment of Ebola and Emerging Viruses,” Journal of Medicinal Chemistry 60, no. 5 (2017): 1648–1661.CrossRefGoogle Scholar
Siegel, supra note 9.Google Scholar
Siegel, supra note 9; T.Warren, K., Jordan, R., M.Lo, K., et al., “Therapeutic Efficacy of the Small Molecule GS-5734 Against Ebola Virus in Rhesus Monkeys,” Nature 531, no. 7594 (2016): 381–385. (published correction appears in ACS Chemical Biology 11, no. 5 (2016):1463).CrossRefGoogle ScholarPubMed
Siegel, supra note 9.Google Scholar
Koplon, S., “Investigational compound remdesivir, developed by UAB and researchers, NI., being used for treatment of novel coronavirus,” News, UA., available at <https://www.uab.edu/news/health/item/11082-investigational-compoundremdesivir-developed-by-uab-and-nihresearchers-being-used-for-treatmentof-novel-coronavirus> (last visited April 11, 2020).+(last+visited+April+11,+2020).>Google Scholar
Sheahan, T.P., Sims, A.C., R.Graham, L., et al., “Broad-spectrum Antiviral GS-5734 Inhibits Both Epidemic and Zoonotic Coronaviruses,” Science Translational Medicine 9, no. 396 (2017): eaal3653; M.Agostini, L., E.Andres, L., A.Sims, C., et al., “Coronavirus Susceptibility to the Antiviral Remdesivir (GS-5734) Is Mediated by the Viral Polymerase and the Proofreading Exoribonuclease,” mBio 9, no. 2 (2018): e00221-18.CrossRefGoogle ScholarPubMed
Sheahan, T.P., Sims, A.C., S.Leist, R., et al., “Comparative Therapeutic Efficacy of remdesivir and Combination lopinavir, ritonavir, and interferon beta against MERS-CoV,” Nature Communications 11, no. 1 (2020): 222.CrossRefGoogle ScholarPubMed
Role of the Federal Government in the Development of Remdesivir, Knowledge Ecology International, available at <https://www.keionline.org/wpcontent/uploads/KEI-Briefing-Note-2020_1GS-5734-Remdesivir.pdf> (last visited March 23, 2020).+(last+visited+March+23,+2020).>Google Scholar
GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen, ClinicalTrials.gov, available at <https://clinicaltrials.gov/ct2/show/NCT02818582> (last visited June 3, 2020).+(last+visited+June+3,+2020).>Google Scholar
Investigational Therapeutics for the Treatment of People With Ebola Virus Disease, ClinicalTrials.gov, available at <https://clinicaltrials.gov/ct2/show/NCT03719586> (last visited June 3, 2020); Mulangu, S., L.Dodd, E., R.Davey, T., O.Mbaya, T., et al., “A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics,” A Randomized, Controlled Trial of Ebola Virus Disease Therapeutics, 381, no. 24 (2019): 2293–2303.Google Scholar
Joseph, A., “As the Coronavirus Spreads, a Drug that Once Raised the World's Hopes is Given a Second Shot,” Stat News, available at <https://www.statnews.com/2020/03/16/remdesivirsurges-ahead-against-coronavirus/?utm_content=buffer8f626&utm_medium=social&utm_source=twitter&utm_campaign=twitter_organic.> (last visited April 11, 2020). (last visited April 11, 2020).' href=https://scholar.google.com/scholar?q=Joseph,+A.,+“As+the+Coronavirus+Spreads,+a+Drug+that+Once+Raised+the+World's+Hopes+is+Given+a+Second+Shot,”+Stat+News,+available+at++(last+visited+April+11,+2020).>Google Scholar
Cohen, J., “Chinese Researchers Reveal Draft Genome of Virus Implicated in Wuhan Pneumonia Outbreak,” American Association for the Advancement of Science, available at <https://www.sciencemag.org/news/2020/01/chinese-researchers-reveal-draft-genomevirus-implicated-wuhan-pneumoniaoutbreak> (last visited June 3, 2020).+(last+visited+June+3,+2020).>Google Scholar
Morse, J.S., Lalonde, T., Xu, S., and Liu, W.R., “Learning from the Past: Possible Urgent Prevention and Treatment Options for Severe Acute Respiratory Infections Caused by 2019- nCoV,” Learning from the Past: Possible Urgent Prevention and Treatment Options for Severe Acute Respiratory Infections Caused by 2019- nCoV, 21, no. 5 (2020): 730–738; W.Zhang, F., Stephen, P., J.Theriault, F., Wang, R., S.Lin, X., “Novel Coronavirus Polymerase and Nucleotidyl- Transferase Structures: Potential to Target New Outbreaks,” Journal of Physical Chemistry Letters 11 (2020):4430-4435.Google Scholar
Wang et al., supra note 2.Google Scholar
E. de Wit, Feldmann, F., Cronin, J., et al., “Prophylactic and Therapeutic Remdesivir (GS-5734) Treatment in the Rhesus Macaque Model of MERS-CoV Infection,” Prophylactic and Therapeutic Remdesivir (GS-5734) Treatment in the Rhesus Macaque Model of MERS-CoV Infection, 117, no. 2 (2020): 6771–6776; C.Gordon, J., E.Tchesnokov, P., J.Feng, Y., D.Porter, P., and Gotte, M., “The Antiviral Compound Remdesivir Potently Inhibits RNA-Dependent RNA Polymerase from Middle East Respiratory Syndrome Coronavirus,” Journal of Biological Chemistry 295, no. 15 (2020): 4773-4779.Google Scholar
de Wit, supra note 23.Google Scholar
Wang, Y., Zhang, D., Du, G., et al., “Remdesivir in Adults with Severe COVID- 19: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial,” Lancet 395, no. 10236 (2020):1569- 1578. (Published correction appears in Lancet, 395, no. 10238 (2020):1694).Google Scholar
Grein, J., Ohmagari, N., Shin, D., et al., “Compassionate Use of Remdesivir for Patients with Severe Covid-19,” New England Journal of Medicine (2020) (E-pub ahead of print).Google Scholar
Beigel, supra note 3.Google Scholar
Supra note 16.Google Scholar
Search Orphan Drug Designations and Approvals, U.Food, S. and Drug Administration (FDA), available at <https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=490515> (last visited April 11, 2020).+(last+visited+April+11,+2020).>Google Scholar
Fang, L. and Lerner, S., “Coronavirus Treatment Developed by Gilead Sciences Granted ‘Rare Disease’ Status, Potentially Limiting Affordability,” The Intercept, available at <https://theintercept.com/2020/03/23/gilead-sciences-coronavirus-treatment-orphandrugstatus/> (last visited April 11, 2020).+(last+visited+April+11,+2020).>Google Scholar
FDA gives Gilead a seven year regulatory monopoly for remdesivir to treat COVID-19, on grounds it is an “Orphan” treating a rare disease, Knowledge Ecology International, available at <https://www.keionline.org/32546> (last visited March 23, 2020).+(last+visited+March+23,+2020).>Google Scholar
Hemel, D. and Ouellette, L.L., “Pharmaceutical Profits and Public Health Are Not Incompatible,” New York Times, available at <https://www.nytimes.com/2020/04/08/opinion/coronavirus-drug-company-profits.html> (last visited April 11, 2020).+(last+visited+April+11,+2020).>Google Scholar
Sanders Calls on Trump to Rescind Pharma Giveaway of Potential Coronavirus Treatment, The Official U.S. Senate website of Senator Bernie Sanders of Vermont, available at <https://www.sanders.senate.gov/newsroom/press-releases/sanders-calls-on-trumpto-rescind-pharma-giveaway-of-potential-coronavirus-treatment> (last visited April 11, 2020); Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug Designation, Gilead Company Statements, available at <https://www.gilead.com/news-and-press/company-statements/gilead-sciences-statement-on-requestto-rescind-remdesivir-orphan-drugdesignation> (last visited April 11, 2020).+(last+visited+April+11,+2020);+Gilead+Sciences+Statement+on+Request+to+Rescind+Remdesivir+Orphan+Drug+Designation,+Gilead+Company+Statements,+available+at++(last+visited+April+11,+2020).>Google Scholar
Sheahan 2017, supra note 14; Supra note 14; Sheahan 2020, supra note 15.Google Scholar
Supra note 16.Google Scholar
Supra note 16.Google Scholar