GILEAD: Massive Markup on Taxpayer-Funded COVID-19 Drug Remdesivir Should Be “Wake-up Call” to Policymakers

Gilead charging 400X what analysts say is necessary for them to profit from drugFLASHBACK: WaPo: Taxpayers paid to develop remdesivir but will have no say when Gilead sets the price

REMINDER: Gilead sued by government last year for price gouging on HIV drug developed with taxpayer funds…charging up to $20,000/year

Washington, DC – Today, Patients Over Pharma reacted to the news that Gilead Sciences has set the price of a full treatment course of its COVID-19 drug remdesivir at up to $4,290 for governments and $5,720 for private insurers starting in July.

“Gilead just can’t seem to help itself from profiteering off of drugs that taxpayers helped develop and patients desperately need,” said Eli Zupnick, spokesman for Patients Over Pharma. “This is exactly why policymakers shouldn’t leave it up to the drug companies to unilaterally set prices on drugs that wouldn’t exist without taxpayer support. This should be a wake-up call for Congress to push aside the drug company lobbyists and move quickly to ensure that the vaccines that the Administration is currently pouring billions of taxpayer dollars into are affordable for every American.”

Last month, Public Citizen released an analysis showing that Gilead could price remdesivir at less than $1 per dose, or $10 for a full treatment, and still earn a profit.

Background: Remdesivir developed with taxpayer support

Headline: Washington Post: “Taxpayers paid to develop remdesivir but will have no say when Gilead sets the price.” [Washington Post, 5/26/20]

Washington Post: “Gilead Needed Help From U.S. Taxpayers. Lots Of Help. Three Federal Health Agencies Were Deeply Involved In Remdesivir’s Development.” “To make progress, Gilead needed help from U.S. taxpayers. Lots of help. Three federal health agencies were deeply involved in remdesivir’s development every step of the way, providing tens of millions of dollars of government research support. Now that big government role has set up a political showdown over pricing and access.” [Washington Post, 5/26/20]

Analysis Found U.S. Government Likely Has Legal Right To Patent Claim On Remdesivir. “The HIV-prevention advocacy group PrEP4All Collaboration, working with the Technology Law & Policy Clinic at New York University, released an analysis Tuesday that said the government, because it helped cull the drug from hundreds of compounds, probably has a legal right to claim it co-invented remdesivir. It contends government scientists should have been listed as co-inventors on remdesivir patents because of their contributions. It says the Trump administration should be leveraging the government’s involvement to ensure the United States and other countries can get access at a low cost.” [Washington Post, 5/26/20]

Remdesivir, Originally Labeled GS-5734, Was Discovered Through A Collaboration Between Gilead, CDC And The U.S. Army Medical Research Institute Of Infectious Diseases (USAMRIID) On Ebola Treatments.“GS-5734 is a monophosphoramidate prodrug of an adenosine analog that was discovered through a collaboration among Gilead, the Centers for Disease Control & Prevention, and the U.S. Army Medical Research Institute of Infectious Diseases. Discovered in 2014, the compound already has been shown to wipe out signs of the virus in monkeys.” [American Chemical Society – Chemical & Engineering News, 7/6/16]

October 2015: Gilead Press Release Confirmed GS-5734 Was Identified In Collaboration With CDC And USAMRIID. “GS-5734 was discovered as part of Gilead’s program to screen compounds in its libraries for activity against a range of potential emerging viruses, including Ebola. In collaboration with the Centers for Disease Control and Prevention (CDC) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the company identified GS-5734 in vitro activity against the Ebola virus. In animal studies conducted at USAMRIID, treatment initiated on day 3 post-infection with Ebola virus resulted in 100 percent survival of monkeys.” [Gilead press release, 10/21/15]

March 2016 Study Of Effect Of GS-5734 In Monkeys Was Led By Researchers At USAMRIID. “Travis Warren, Ph.D., a principal investigator at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and first author of the paper, said the work published today is the result of continuing collaborations between USAMRIID and Gilead Sciences of Foster City, Calif. Scientists at the Centers for Disease Control and Prevention (CDC) also contributed by performing initial screening of the Gilead Sciences compound library to find molecules with promising antiviral activity. That initial work identified the precursor to GS-5734, a small-molecule antiviral agent, which led to the effort by Gilead and USAMRIID to further refine, develop and profile the compound. Led by USAMRIID Science Director Sina Bavari, Ph.D., the paper’s senior author, the research team used cell culture and animal models to demonstrate the compound’s antiviral activity against several pathogens, including Ebola virus.” [USAMRIID press release, 3/3/16]

Initial GS-5734 Studies Were Conducted With Funding From The Department Of Defense And CDC. “These studies were in part supported by The Joint Science and Technology Office for Chemical and Biological Defense (JSTO-CBD) of the Defense Threat Reduction Agency (DTRA) under Plan No. CB10218. CDC core funding supported the work done by M.K.L. at CDC.” [Journal of Medicinal Chemistry, 1/26/17]

2016: Department Of Defense Awarded $1.2M To Gilead To Fund A Study On Ebola Treatment. In 2016, the Department of Defense awarded Gilead $1,196,950 for a “blinded randomized controlled study for Ebola.” [USASpending.gov, start date 5/12/16]

Background on Gilead Sciences, taxpayer funding, and price-gouging

Headline: Washington Post: “An HIV treatment cost taxpayers millions. The government patented it. But a pharma giant is making billions.” [Washington Post, 3/26/19]

U.S. Government Funded Research That Led To Gilead HIV Drug Truvada – Gilead Has Fought Government Attempts To Collect Royalties Or Distribute The Drug More Widely. “Thomas Folks spent years in his U.S. Centers for Disease Control and Prevention lab developing a treatment to block deadly HIV in monkeys. Then San Francisco AIDS researcher Robert Grant, using $50 million in federal grants, proved the treatment worked in people who engaged in risky sex. Their work — almost fully funded by U.S. taxpayers — created a new use for an older prescription drug called Truvada: preventing HIV infection. But the U.S. government, which patented the treatment in 2015, is not receiving a penny for that use of the drug from Gilead Sciences, Truvada’s maker, which earned $3 billion in Truvada sales last year. Gilead argues that the government’s patents for Truvada for PrEP, as the prevention treatment is called, are invalid. And the government has failed to reach a deal for royalties or other concessions from the company — benefits that could be used to distribute the drug more widely.” [Washington Post, 3/26/19]

November 2019: Trump Administration Sued Gilead For Abusing Patents On HIV Drug It Developed With Taxpayer-Funded Research.“The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back. The government said the company infringed upon patents owned by the Department of Health and Human Services, and had refused attempts by the department to license its patents and collect royalties. The company sells two drugs, Truvada and Descovy, that can be taken once daily to prevent H.I.V. infection, a strategy called pre-exposure prophylaxis, or PrEP.” [New York Times, 11/7/19]

Gilead Priced Its HIV Drug At As Much As $20,000/Year In The U.S. “The Trump administration on Wednesday sued Gilead Sciences, a pharmaceutical company that sells H.I.V.-prevention drugs that can cost patients up to $20,000 a year, accusing the company of earning billions from research funded by taxpayers without paying taxpayers back.” [New York Times, 11/7/19]

Generic Versions Of Gilead’s HIV Drug, Truvada, Cost Roughly $60/Year In Africa – Gilead Has Sued To Prevent Efforts To Introduce A Generic In U.S. “In Africa, generic Truvada costs about $60 per patient per year. Gilead has sued companies that have tried to bring generic versions to the United States, keeping them out of the market after secret settlements.” [New York Times, 11/7/19]

Gilead CEO Defended Company’s Pricing Practices As Necessary For Research Investment, Noting It Spent $6B On HIV/AID Research Since 2000. “The chief executive of Gilead Sciences, the nation’s leading manufacturer of HIV drugs, defended the high cost of a key drug that prevents the lethal infection, telling a House committee Thursday that its hefty profits pay for continued research. “We have taken the disease from a death sentence to a manageable clinical condition, but we’re not done yet,” Gilead CEO Daniel O’Day told committee members. “We have to be sure that Americans get our medicines at a price that allows us to invest in research.’’ He said Gilead has spent $6 billion on HIV/AIDS research since 2000.” [Washington Post, 5/16/19]

Gilead’s HIV Drug, Truvada, Has Earned Them Six Times That – $36 Billion – Since 2004. “Truvada has earned Gilead about $3 billion a year and $36 billion since the drug was approved in 2004, but it is about to lose its exclusive patent protection.” [Washington Post, 5/16/19]

Headline: FiercePharma: “Pfizer, BMS, Gilead, AbbVie and others hike prices on hundreds of meds to ring in 2020.” [FiercePharma, 1/2/20]

Gilead Raised HIV Drug Prices By 4.9% For 2020; Claimed It Wouldn’t Affect Patient Access. “For its part, Gilead raised HIV drug list prices by 4.9% to “reflect the rising costs of goods and services necessary to produce groundbreaking medicine,” a spokesman said. The company doesn’t anticipate that the changes will affect patient access, and Gilead further supports access programs for HIV prevention and treatment options, he added.” [FiercePharma, 1/2/20]

Headline: CBS News: “VA can’t afford drug for veterans suffering from hepatitis C.” [CBS News, 12/1/15]

2015: Gilead Priced Hepatitis C Medication At $1,000 Per Pill – So Cost Prohibitive That Department Of Veterans Affairs Told Some Patients It Couldn’t Afford To Offer The Treatment. “On Tuesday, a Senate report found Gilead Sciences, which makes a cure for a fatal form of hepatitis, is more interested in profits than patients. The cure was invented under the leadership of a celebrated doctor in the Department of Veterans Affairs, but at $1,000 a pill, even the VA can’t afford to save the lives of veterans who need it. . . . The drug — sofosbuvir — is sold as Sovaldi and Harvoni — and claims to cure up to 99 percent of hepatitis C patients. But there’s a catch, the retail price for a 12 week treatment is $84,000. The Department of Veterans Affairs gets a 50 percent discount, but even with that the VA told Yisrael they can’t afford to give it to everyone who needs it — including him.” [CBS News, 12/1/15]

Headline: FiercePharma: “Gilead prices hepatitis C giant Sovaldi in China at one-fifth the U.S. price: report.” [FiercePharma, 11/28/17]

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Moderna

Slaoui Joined Board Of Directors Of Moderna In July 2017. “Moderna Therapeutics, a clinical stage biotechnology company that is pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced today that Moncef M. Slaoui, Ph.D., has joined its Board of Directors. Dr. Slaoui served in several senior research & development (R&D) roles with GlaxoSmithKline PLC (GSK) during his time with the company, most recently as its Chairman of Global Vaccines. While at GSK, Dr. Slaoui also served on its Board of Directors for 11 years and led its global pharmaceutical R&D activities from 2006 through to 2015. In conjunction with Dr. Slaoui’s appointment to Moderna’s board, Lee Babiss, Ph.D., will be stepping down from his role as a director.” [Moderna press release, 7/27/17]

Headline: Fierce Pharma: “’Warp Speed’ head Slaoui, challenged for ‘huge conflict of interest,’ sells off $12.4M in Moderna stock.” [FiercePharma, 5/19/20]

Moderna Received Fast Track Approval From The FDA To Move To Phase II Testing Of Potential Coronavirus Vaccine. “On May 12, Moderna Therapeutics, based in Cambridge, Mass., received fast-track approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine candidate, mRNA-1273. Days earlier, the FDA gave the company the green light to proceed to Phase 2 testing of the vaccine, which is expected to begin shortly. The company plans to launch the final stage of human testing, Phase 3, this summer, assuming the Phase 2 studies are complete, says Dr. Stephen Hoge, president of Moderna.” [TIME, 5/12/20]

Moderna Received $453 Million Contract From BARDA To Accelerate Development Of Vaccine Candidate. “Moderna announced last month it had received a $483 million contract from the Biomedical Advanced Research and Development Authority to accelerate the development of its vaccine candidate.” [SeacoastOnline, 5/1/20]

GlaxoSmithKline

Slaoui Worked At GlaxoSmithKline For 30 Years And Has Been A Venture Capitalist Since Leaving The Company In 2017. “Mr. Slaoui, who has been a venture capitalist since leaving GlaxoSmithKline in 2017, worked for 30 years at the company, helping lead the development of dozens of vaccines.” [New York Times, 5/13/20]

Lonza

Slaoui Elected To Board Of Directors For Lonza In April 2020. “Lonza Group Ltd. has hosted its Annual General Meeting, according to a press release. . . . The shareholders elected Dorothée Deuring and Moncef Slaoui as new members of the board, and elected Angelica Kohlmann, Christoph Mäder, and Jürgen Steinemann as the three acting members of the Nomination and Compensation Committee.” [Lonza press release, 4/28/20]

Moderna And Lonza Launched Agreement To Partner On Coronavirus Vaccine Development. “Moderna, a Cambridge, Massachusetts-based biotechnology company, on Friday announced it is manufacturing a potential COVID-19 vaccine – called mRNA-1273 – in cooperation with Lonza. . . . According to a joint statement from the companies, the technology transfer is expected to begin in June, and the companies intend to make the first batches of mRNA-1273 at the Lonza facility at Pease in July. Over time, the parties say they intend to establish additional production sites across Lonza’s worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide.” [SeacoastOnline, 5/1/20]

Medicxi

Slaoui Joined Life Sciences Investment Firm Medicxi As Partner In September 2017. “Medicxi, the leading European life sciences investment firm, today announces that Dr Moncef Slaoui, alongside his other commitments, has joined its team as Partner. Dr Slaoui was formerly GSK’s Chairman of Pharmaceutical R&D and of its vaccines division.” [Medicxi press release, 9/19/17]

Medicxi Scientific Advisory Boards Included Representatives From Novartis, Verily Life Sciences, GlaxoSmithKline And Johnson & Johnson. [Medicxi press release, 9/19/17]

Vaxcyte (SutroVax)

Slaoui Served On Board Of Directors For Biopharmaceutical Company Vaxcyte (Previously SutroVax) Since July 2017. “SutroVax, a biopharmaceutical company dedicated to the delivery of best-in-class conjugate vaccines and novel complex antigen-based vaccines to prevent serious infectious diseases, today announced the appointment of Moncef Slaoui, PhD, to the company’s Board of Directors. Dr. Slaoui recently retired following a nearly 30-year career at GlaxoSmithKline, during which time he oversaw research and development as Chairman of GSK R&D, served on the board, and most recently built the GSK vaccine division into the lead position in the industry as the Chairman of GSK Vaccines.” [SutroVax press release, 7/19/17]

Slaoui Was Named Chairman Of SutroVax In June 2018. “A little more than a year after it raised $64 million to develop a next-gen pneumococcal conjugate vaccine, SutroVax is back with another raise. And this time, it’s tapping an industry veteran to help steer the ship. Foster City, Calif.-based SutroVax on Thursday unveiled an $85 million series C funding round to advance its lead program, a pneumococcal shot aimed at taking on a multibillion-dollar market now owned by Pfizer’s Prevnar 13. The biotech also stepped former GSK vaccines president Moncef Slaoui up to its chairman role after he joined the board nearly one year ago.” [Fierce Pharma, 6/7/18]

Slaoui Was Listed As Chairman Of Board Of Directors Of Vaxcyte As Of June 25, 2020. [Vaxcyte – Board of Directors, accessed 6/25/20]

Brii Biosciences

Slaoui Served As Scientific And Strategic Adviser To Brii Biosciences. [Brii Biosciences, accessed 5/14/20]

Brii Biosciences Partnered With Chinese Hospital And University On Coronavirus Antibody Research As Potential Treatment. “Brii Biosciences has teamed up with a Chinese hospital and university to develop antibodies against COVID-19. The partners leveraged their proximity to the initial outbreak and experience with SARS and MERS to build up a library of potentially neutralizing antibodies, putting them on track to start testing candidates in humans in the third quarter. . . . Sino-U.S. biotech Brii has established itself as a one of the rising stars of the infectious disease space in recent years, reeling in hundreds of thousands of dollars in VC funding to buy in a slew of assets. Late last year, Brii wound down its deal-making to focus on advancing its existing assets, but COVID-19 has led it to rethink.” [Fierce Biotech, 4/1/20]

Intellia Therapeutics

Slaoui Named To Board Of Directors Of Intellia Therapeutics In July 2017. “Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on the development of potentially curative therapeutics using CRISPR technology, announced today the appointment of Moncef Slaoui, Ph.D. and Frank Verwiel, M.D. to its Board of Directors. Drs. Slaoui and Verwiel will begin Board responsibilities effective immediately. Intellia’s Board of Directors also is establishing a Science and Technology Committee, which will be chaired by Dr. Slaoui. Additionally, Carl L. Gordon, Ph.D., CFA, General Partner, OrbiMed Advisors, LLC, has informed the Company of his resignation from the Intellia Board of Directors effective at that close of business on July 25, 2017.” [Intellia Therapeutics press release, 7/24/17]

Slaoui Resigned From Intellia Board After Two Weeks Due To Unspecified Conflict Of Interest. “The former head of GlaxoSmithKline’s vaccines division has resigned suddenly from the board of Cambridge gene editing biotech Intellia Therapeutics after just two weeks in that role due to an unexplained conflict of interest, according to a federal filing on Tuesday…. The filing said only that the resignation was “due to a conflict of interest” and did not relate to “any disagreement with the company on any matter relating to the company’s operations, policies or practices.” A spokesperson for Intellia declined to comment further.” [Boston Business Journal, 8/9/17]

Galvani Bioelectronics

Slaoui Named Chair Of GSK/Google Galvani Bioelectronics In August 2016. “Galvani Bioelectronics – named for the 18th century Italian bioelectricity pioneer – will combine GSK’s drug discovery and development expertise in disease biology with Verily’s expertise in highly miniaturised technologies, including data analytics and software development for clinical application. Moncef Slaoui, chairman of global vaccines at GSK and chair of the newly-created biotech, said: “Together, we can rapidly accelerate the pace of progress in this exciting field, to develop medicines that truly speak the electrical language of the body.’” [PMLive, 8/1/16]

Galvani Is A Bioelectronic Medicine Company Established As A Partnership Between GlaxoSmithKline And Verily Life Sciences. “Galvani Bioelectronics is a new company, established in November 2016, dedicated to the development of bioelectronic medicines – a new class of medicines consisting of miniaturised, implantable devices. Formed through a partnership between global healthcare company, GSK, and leading technology company, Verily Life Sciences, Galvani Bioelectronics combines the complementary expertise of its parent companies to enable the research, development and commercialisation of bioelectronic therapies.” [Galvani – About Us, accessed 5/14/20]

Artizan Biosciences

Slaoui Serves On Board Of Directors For Artizan Biosciences. [Artizan Biosciences – Board, accessed 6/25/20]

PhRMA and BIO

Slaoui Previously Served On Board Of Directors For PhRMA And BIO. “Dr. Slaoui has authored more than 100 scientific papers and presentations and served on the board of directors for the Pharmaceutical Research and Manufacturers of America’s Foundation, the Biotechnology Innovation Organization’s board of directors, and was a member of the National Institutes of Health’s Advisory Committee until 2016. Currently, he is a member of the Advisory Board for the Qatar Foundation.” [Intellia Therapeutics press release, 7/24/17]

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