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  1. forum rang 4 FatCool 13 april 2020 19:52
    Eli Lilly Arthritis Drug Will Be Tested in Seriously Ill Covid-19 Patients

    April 13, 2020 1:04 pm ET

    An Eli Lilly drug designed to treat arthritis is the latest anti-inflammatory being tested as a potential treatment for seriously ill Covid-19 patients.

    On Friday, Eli Lilly (ticker: LLY) said its drug baricitinib, which the Food and Drug Administration has approved as a treatment for rheumatoid arthritis, would be included in a large study run by the National Institute of Allergy and Infectious Diseases to test various potential therapies to treat Covid-19.

    Called the Adaptive Covid-19 Treatment Trial, the randomized, controlled study will give patients potential treatments that include Lilly’s baricitinib and Gilead’s (GILD) remdesivir, while others will receive a placebo.

    In an interview on Monday, the president of Lilly Bio-Medicines, Patrik Jonsson, said the decision to test baricitinib in Covid-19 patients came after the artificial-intelligence firm BenevolentAI published an article in the medical journal The Lancet arguing that the drug might be able to keep the virus from infecting lung cells.

    “The first priority is to see if baricitinib is effective in treating those patients,” Jonsson said. “The data needs to be compelling, but if that’s the case, we’re also in the position to rapidly work with regulatory bodies across the globe.”

    The NIAID trial will test baricitinib in hospitalized patients with Covid-19. Jonsson said the first patient would be receive treatment at the end April, with data expected two months later. He said that hundreds of patients would receive baricitinib during the trial.

    Other arthritis drugs are also being tested in Covid-19 patients, including at least two so-called IL-6 inhibitors, Sanofi (SNY) and Regeneron’s (REGN) Kevzara, and Roche’s (RHBBY) Actemra. Baricitinib is a JAK inhibitor, rather than an IL-6 inhibitor, but part of the theory for why it might help Covid-19 patients is the same as for the IL-6 inhibitors. The idea is that the drug could beat back the inflammation in the lungs that can cause serious complications in some Covid-19 patients.

    Jonsson also said that there is a secondary hypothesis that baricitinib could have an antiviral effect. He said there is a hypothesis, laid out in BenevolentAI’s Lancet article, that the drug could disrupt a particular receptor used by the virus that causes Covid-19 to infect lung cells.

    Independent investigators have already run some small trials involving baricitinib. Jonsson said the company has been in touch with those scientists, though it hasn’t been involved in the trials. “What we have heard so far is the experience is a positive experience,” he said, but the trials have involved small numbers of patients.

    The NIAID trial will be key to finding answers about baricitinib in Covid-19, along with other drugs.

    “I am very proud of the partnership with NIAID, and I am very proud of the speed at which we’ve been able to act,” Jonsson said.

    Lilly also announced Friday it will begin a smaller Covid-19 trial late this month of a monoclonal antibody initially developed to treat cancer patients. The drug, called LY3127804, will be tested in patients hospitalized with Covid-19 who are at higher risk of developing acute respiratory distress syndrome. The trial will test whether the drug can diminish the need for ventilators, or keep those patients progressing to ARDS.

    www.barrons.com/articles/dont-fear-in...
  2. forum rang 4 FatCool 14 april 2020 19:14
    Gilead’s experimental COVID-19 drug shows promise but analysts remain cautious

    April 14, 2020 at 6:08 a.m. ET

    There’s a lot of hope riding on remdesivir, which is being studied in multiple trials in the U.S. and abroad, including two conducted by Chinese health authorities


    Analysts say early data showing Gilead Sciences Inc.’s remdesivir improved clinical outcomes for two-thirds of a small group of severely ill COVID-19 patients is promising, but they caution against viewing the experimental drug as a silver bullet in the fight against the novel coronavirus.

    The data showed that 68% of 53 hospitalized patients showed clinical improvement after taking the drug. It’s a “promising first look,” J.P. Morgan’s Cory Kasimov wrote in a note on Monday. “The results need to be kept in context. It’s difficult, if not impossible, to make any firm conclusions from an uncontrolled data set with a small sample size.”

    The findings, which were published Friday in the New England Journal of Medicine, examined the use of remdesivir, a drug that Gilead has also been testing as an Ebola Virus Disease treatment, in COVID-19 patients who have been hospitalized. These patients received the drug through Gilead’s compassionate use program, not through a formal clinical trial. (As of April 4, more than 1,700 people have been treated with remdesivir through Gilead’s compassionate and expanded use programs, CEO Daniel O’Day has said.)

    Patients in nine countries each received their first dose of remdesivir around March 7; about 68% showed clinical improvement, 47% were discharged, and 13% died, and no new safety issues were raised in this group of patients. The analysis didn’t have a preset number of patients, site locations, or duration.

    The mortality data, in particular, was flagged by some analysts as not really noteworthy.

    “Our conclusion is, unfortunately, remdesivir may not be doing much,” Raymond James analyst Steven Seedhouse told investors on Monday. “We hope we’re wrong.”

    “We believe remdesivir could show benefit and clinical improvement; however, we cannot draw definitive conclusions from a compassionate use data given the limitations (such as small sample size, lack of controls and randomization and short follow-up periods),” SunTrust Humphrey Robinson analysts wrote April 10.

    That’s an issue that Gilead’s chief executive acknowledges. O’Day, who has taken to sharing updates about remedesivir every weekend for the past three weeks, said in a letter published on Friday: “In studying remdesivir, the question is not just whether it is safe and effective against COVID-19 but in which patients it shows activity, how long should they receive treatment and at what stage of their disease would treatment be most beneficial.”

    There are no proven treatments or vaccines for COVID-19, the infection caused by the virus that was first identified in Wuhan, China, late last year and has since sickened nearly two million people and killed more than 100,000 people. In the U.S., some hospital systems are stretched to the limit, health care workers themselves have been sickened or even died from the virus, and in some cases two patients are being hooked up to the same ventilator. The Food and Drug Administration has used its emergency powers to grant a number of emergency use authorizations to therapies like hydroxychoroquine and blood purification devices given the lack of available treatment options.

    There’s a lot of hope riding on remdesivir, which is being studied in multiple trials, in the U.S., and abroad, including two conducted by Chinese health authorities. It has also been touted by President Donald Trump. However, the investigational therapy has never been approved by regulators in any country for any reason.

    There are at least 11 clinical trials under way, in the U.S. and abroad, evaluating remdesivir in COVID-19 patients, according to ClinicalTrials.gov, including an adaptive, randomized, double-blind, placebo-controlled trial with 440 participants that is being run by the National Institute of Allergy and Infectious Diseases. Trial data is expected to be published this month, including from two trials in China. (O’Day said in his note that a Chinese study of patients with severe COVID-19 had been halted due to “stalled enrollment” and publication of that data will come from Chinese authorities.)

    Gilead is expected to share findings from two Phase 3 trials evaluating remdesivir in moderate and severe COVID-19 patients in May. Last week the drugmaker increased the number of participants in those trials, from 600 to 1,600 patients in the moderate trial, and from 400 to 2,400 in the severe trial. It also updated the trials’ endpoints to include a measure of improvement in hospital outcomes, according to SunTrust analysts.

    www.marketwatch.com/story/gileads-exp...
  3. forum rang 4 FatCool 15 april 2020 20:01
    Is hydroxychloroquine hype hampering enrollment in Gilead’s Covid-19 drug trials?

    Two investigators in Gilead's Phase III remdesivir trials were unsurprised at recent protocol changes. However, they said enrollment in the moderate-disease study was slow due to difficulty capturing those patients, with one also citing publicity-driven interest in two unproven malaria drugs.

    Last week, Gilead Sciences made significant adjustments to the Phase III trials of its drug remdesivir in hospitalized patients with Covid-19, leading to some speculation that the company may have lowered its expectations for the drug. Two investigators in the trials weighed in on what the changes could mean, as well as some of the challenges they have encountered in enrolling patients in the trial.

    Foster City, California-based Gilead launched the two randomized, but non-blinded trials – comparing standard treatment plus remdesivir given for five or 10 days – last month. One was a 400-patient study in severe disease that measured the proportion of patients with normalization of fever and oxygen saturation over two weeks. The other was a 600-patient trial in moderate disease measuring the proportion of patients discharged from the hospital in the same time frame.

    But on April 6, the company increased the enrollment targets to 2,400 patients for the severe-disease study and 1,600 for the moderate-disease study. In addition, it changed the primary endpoints to measure patients’ odds for clinical improvement after 14 and 11 days on a seven-point scale that ranges from the patient dying to being well enough not to require hospitalization.

    A Gilead spokesperson wrote in an email that the enrollment targets were adjusted to increase access to remdesivir and provide additional data, but did not address the question of why the endpoints were changed except to say that the change was unrelated to the enrollment target increase.

    “The way I interpreted that is that they wanted to provide access to remdesivir while they were analyzing the data from the first part of the study,” said Dr. Debra Poutsiaka, an infectious disease physician and lead investigator of the study for Tufts Medical Center in Boston, in a phone interview, referring to the enrollment increase. “That’s how it was conveyed to us.”

    In a note to investors, RBC Capital Markets analyst Brian Abrahams gave some potential reasons for why the endpoints were changed.

    “We believe the changes improve alignment to the latest understanding of COVID-19’s course and should maximize sensitivity to detect any potential treatment effect, though they also imply that – perhaps based on data the company may be observing from ongoing experience with the drug – the magnitude of benefit, if any, is likely to be modest,” Abrahams wrote. He added that it would align with the view that like other drugs in development for COVID-19, remdesivir is more likely to have incremental benefit rather than being a panacea.

    But Dr. Prashant Malhotra, lead investigator of the studies for New York City-area health system Northwell Health, said in a phone interview that the new endpoints still reflect the information sought for the ones that were previously used, with measures encompassing the spectrum of the patient dying to being well enough for discharge, along with some based on “statistical finesse.”

    “I wouldn’t read too much into the change,” Malhotra said.

    Poutsiaka added that the new endpoint is in line with the six-point scale recommended by the World Health Organization, with the addition of a seventh point specific to use of remdesivir. Other Covid-19 studies have used similar endpoints, such as the failed trial of AbbVie’s HIV drug Kaletra (lopinavir, ritonavir).

    Despite the changes, Abrahams wrote that data from the Gilead trials is still anticipated in May.

    But while it’s unclear whether it would affect the timing of trial data, both interviewed investigators said enrollment in the moderate-disease trial has been slower at their centers than that in the severe-disease trial, for several reasons.

    The Gilead spokesperson did not respond to a request for comment about study enrollment. Neither investigator had the current enrollment number; Poutsiaka said the last figure she saw showed the moderate-disease study was less than one-third enrolled, but that was “weeks ago.”

    Poutsiaka said that it appears many patients with moderate disease are simply staying home rather than going to the hospital – hospitalization is a requirement for taking part, and the drug is administered intravenously – even if they fit the study’s criteria for enrollment. The drug is intravenous, and hospitalization is required for trial participation.

    “I think that the people who come into the hospital are by definition sicker, and that’s why we’re seeing more that would qualify as severe disease in the Gilead trials,” she said.

    In New York, Malhotra said, the issue is that because of the extraordinary pressure the disease is exerting on hospitals – including being asked to increase capacity by 50% – some patients who would ordinarily be admitted for observation are instead being discharged or transitioned to home observation, thereby disqualifying them for enrollment into the trials.

    As of Tuesday morning, New York City, a major epicenter of the pandemic, had 106,763 cases and 7,349 deaths, with the U.S. total far surpassing half a million.

    But another factor slowing enrollment in the moderate-disease trial and even the severe-disease trial, Malhotra said, is that thanks to the publicity around the antimalarial drugs hydroxychloroquine and chloroquine, patients who are admitted to the hospital are frequently put on those drugs and thus rendered ineligible for the remdesivir trials. Both studies’ exclusion criteria include participation in other clinical trials for Covid-19 treatments and “concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2” less than 24 hours before remdesivir dosing. Malhotra explained that patients in the remdesivir studies must have received a positive diagnosis no more than four days prior to randomization, and together with the need to be off the other drugs thus shortens the window for possible enrollment.

    “It’s anecdotal, but I do think it plays a role,” Malhotra said, adding that he had heard similar accounts from investigators at other centers.

    Consenting patients has also been a challenge due to the need to avoid direct contact with them and concerns that the traditional paper forms could act as fomites that could spread the virus. Poutsiaka said TMC has adopted a completely remote process involving the investigator, an impartial witness, the patient and any family members and friends getting on the phone to coordinate consent, though the logistics of a phone call with four or five people are the “most difficult part” of the study. Northwell has adopted workarounds like calling patients’ legal representatives.

    medcitynews.com/2020/04/is-hydroxychl...
  4. forum rang 4 FatCool 15 april 2020 23:51
    Het valt niet mee om trials te doen op Covid-19. Patiënten die niet naar het ziekenhuis komen (de moderate cases), patiënten die te snel ontslagen worden om plaats te maken voor anderen, patiënten die al wat anders hebben gebruikt, verplegend personeel/dokters die geen tijd hebben voor de administratieve rompslomp,...

    Hier wordt je toch wel heel somber van. Dit gaat veel langer duren dan gepland :(.

    fc
  5. forum rang 4 FatCool 16 april 2020 23:00
    Investigational therapy gaining reputation as promising antiviral drug to fight COVID-19

    Houston Methodist sole Remdesivir clinical trial site in Houston for treating novel coronavirus

    HOUSTON-(April 16, 2020) - COVID-19 patients in a clinical trial at Houston Methodist Hospital are responding quickly to the antiviral drug Remdesivir. The trial's criteria allows for the treatment of patients early in their clinical course and, in some cases, at times where they might have otherwise been intubated.

    "Early results are promising, and that is important right now. Much of what we are learning about COVID-19 management is centered around preventing quick deterioration. Timing is everything. I can't say for certain they would have been intubated otherwise, but it's encouraging," said infectious diseases pharmacist Katherine K. Perez, Pharm.D.

    One of the most challenging things with COVID-19 is the way this virus makes copies of itself once it finds its way into the body. This is how COVID-19 can ultimately take over and send someone into respiratory distress and in need of intubation if not stopped early enough. Remdesivir has demonstrated a potent ability to inhibit this viral replication in human cells and is now being tried in clinical trials of patients with the SARS-CoV-2 virus, which causes COVID-19. Houston Methodist is the only clinical trial site in Houston for this investigational new drug.

    Working with pharmaceutical company Gilead Sciences, Remdesivir's manufacturer and sponsor of the studies, Houston Methodist Hospital was the fifth site in the U.S. to join the clinical trials and has been enrolling and treating patients since mid-March. Initially, five patients received early access to Remdesivir on a compassionate use basis, and since being activated as a clinical trial site, more than 35 patients have been enrolled.

    The two Phase 3 clinical trials at Houston Methodist are randomized, open-label, multicenter studies and are treating patients with moderate to severe symptoms to evaluate the safety and efficacy of Remdesivir in adults diagnosed with COVID-19. One study is for patients with moderate COVID-19 and tests either a 5-day or 10-day Remdesivir treatment. The second study is evaluating a 10-day course of Remdesivir for patients with severe COVID-19, including those on mechanical ventilation.

    Infectious diseases physician Kevin A. Grimes, M.D., M.P.H., and Perez are leading efforts for both the clinical trials at Houston Methodist and say they've been encouraged by the results.

    Perez says early results at Houston Methodist have been promising, courses have been well tolerated, and a number of COVID-19 patients who have undergone treatment with Remdesivir are showing signs of recovery and have been released from the hospital to go home. While it's too early to tell, she says there also are indications that treatment with Remdesivir can possibly stave off being intubated.

    Grimes agrees that acting quickly is critical.

    "If given early enough, we're hoping that Remdesivir interferes with the virus and blocks its ability to replicate in patients' cells," Grimes said. "The goal is that it staves off the deadly inflammatory cascade that leads to respiratory failure and the need to be intubated and put on a ventilator."

    That crucial turning point is what makes COVID-19 become deadly. The main cause of death from this disease results from an extreme inflammatory response in the lungs brought on by the coronavirus. The immune system becomes hyperactive with its inflammatory disease-fighting processes going into overdrive, attempting to defeat the virus, but doing more harm than good by destroying cells in the lungs.

    A broad-spectrum antiviral drug, Remdesivir was originally developed to treat Ebola more than a decade ago. It's known to be generally safe in humans and is backed by a large body of preclinical research, as well as a number of studies that have shown it be quite successful in stopping SARS and MERS, the viral cousins of the new coronavirus strain. The testing stopped short of clinical trials, so its efficacy against SARS and MERS in patients is unknown.

    www.eurekalert.org/pub_releases/2020-...
  6. forum rang 4 FatCool 18 april 2020 11:44
    Uitbreiding van de "severe" Covid-19 studie van 2400 naar 6000 patiënten.

    www.youtube.com/watch?v=pVhpq4kLDsE&a...

    Stop er maar mee, zou ik zeggen. Dit geeft alleen maar extra overbelasting van het verzorgend personeel. De mensen die aan het zuurstof liggen zijn het stadium van de virale aanval al lang voorbij.

    Mensen die nog niet/nauwelijks ziek zijn hebben Remdesivir nodig, dan kan de virale aanval nog worden gestopt. Dus daarop concentreren is mijn mening.

    fc
  7. forum rang 4 FatCool 18 april 2020 12:05
    Mogelijk minder coronapatiënten naar ic door medicijn tegen hoge bloeddruk

    Door coronapatiënten te behandelen met het hogebloeddrukmedicijn Valsartan kunnen mogelijk veel ic-opnames en daarmee sterfgevallen bespaard worden. Nederlandse specialisten starten een groot onderzoek waaraan zeshonderdvijftig patiënten in zo’n vijftien ziekenhuizen meedoen.

    Bij veel ernstig zieke coronapatiënten belandt vocht vanuit de bloedvaten in de longen, wat de kans om het virus te overleven ernstig verkleint. Valsartan - een vaak voorgeschreven geneesmiddel tegen hoge bloeddruk dat al sinds 1996 op de markt is - gaat deze vochtophopingen tegen. ,,Nagenoeg alle mensen die nu met corona op de intensive care liggen, kampen met dat probleem. Dit is de belangrijkste complicatie van corona’’, verklaart cardioloog Roland van Kimmenade van het Nijmeegse Radboud UMC.

    Mocht Valsartan werken, dan zou dat een enorme opsteker zijn in de strijd tegen corona. Om hier achter te komen worden komende maanden driehonderdvijfentwintig coronapatiënten behandeld met het medicijn, nog eens driehonderdvijfentwintig patiënten ontvangen een placebo. "Er zijn al experimentele onderzoeken waaruit blijkt dat het zou kunnen werken. Zo’n robuuste studie is de enige manier om ook echt aan te tonen of het werkt", betoogt de cardioloog.

    Schadelijk stofje

    Het geneesmiddel weet de bloeddruk te verlagen door een eiwit te blokkeren dat de bloeddruk in de vaten verhoogt. Van Kimmenade: "Wij hebben al dertig à veertig jaar ervaring met medicijnen die ervoor zorgen dat de werking van dit schadelijk stofje vermindert. In de cardiologie zorgt dat voor een hoge bloeddruk." "Bij een corona-infectie zie je dat ditzelfde stofje ervoor zorgt dat de bloedvaten in de longen lekken, waardoor er vocht de longblaasjes instroomt", vult intensivist Peter de Jager van het Brabantse Jeroen Bosch Ziekenhuis aan.

    Aan het grootschalige onderzoek, dat door de Hartstichting en het Netherlands Heart Institute wordt ondersteund, moeten tien tot vijftien ziekenhuizen meedoen. Vanwege het acute belang is gisteren al gestart maar er is nog dringend behoefte aan onderzoeksgeld en centra die meedoen. De eerste deelnemers liggen in het Brabantse Jeroen Bosch Ziekenhuis, één van de eerste ziekenhuizen waar coronapatiënten lagen en die vanaf het begin bij dit project betrokken zijn. De onderzoekers hopen binnen een paar maanden te concluderen of Valsartan werkt en ertoe leidt dat minder coronapatiënten naar de ic hoeven of overlijden.

    Ontwikkelingslanden

    Nederland beschikt over grote voorraden van dit medicijn, waardoor patiënten meteen geholpen kunnen worden. Ook voor ontwikkelingslanden zou Valsartan enorm kunnen helpen bij de bestrijding van corona. Doordat het middel al bestaat, kan het bij resultaat meteen worden geslikt. Van Kimmenade: "Er hoeven niet eerst nog medicijnfabrieken worden opgestart."

    De cardioloog waarschuwt wel dat eerst bewezen moet worden dat het werkt, en dat patiënten het medicijn alleen op doktersvoorschrift moeten nemen en er niet zelf mee moeten experimenteren ‘door bij corona ineens het medicijnkastje van opa en oma te plunderen’.

    www.dvhn.nl/groningen/Mogelijk-minder...
  8. forum rang 4 FatCool 18 april 2020 15:52
    Why an analyst bullish on Gilead says antiviral drug ‘won’t solve’ COVID-19

    April 17, 2020 at 8:55 a.m. ET

    Stat News, an award-winning publication for medical news, reported that a Chicago hospital treating severe COVID-19 patients with the antiviral medicine remdesivir is seeing rapid recoveries in fever and respiratory symptoms.

    Shares of the maker of the drug, Gilead Sciences, surged in after-hours trading. The broader market took off as well.

    So, is this it? Is the end of the coronavirus crisis simply a matter of Gilead wrapping up the trial, submitting the proper paperwork and scaling up manufacturing?

    “Did remdesivir just ‘solve’ COVID? No,” says Umer Raffat, an analyst at Evercore ISI who has a reason to be bullish on the Gilead news, given that he had an outperform rating on the stock.

    Raffat notes that the study specifically excluded patients on mechanical ventilation. Moreover, an earlier study on Chinese patients wasn’t stopped for efficacy reasons. Unlike the Chicago study, the China trial tested patients given a placebo.

    “I did a deep dive into the statistics for this interim [China] analysis: remdesivir needed to show [much more than a] 60% effect size vs. placebo to stop at interim…and it clearly didn’t,” he says.

    Raffat said there should be cautious optimism around remdesivir, which is administered intravenously.

    “Remdesivir is not a silver bullet,” he writes. “Remdesivir is also not a zero (which many investors thought after China studies got paused because of lack of enrollment).”

    Gilead itself says Phase 3 trial data to be available at the end of April and data from other studies to be available in May. “Anecdotal reports, while encouraging, do not provide the statistical power necessary to determine the safety and efficacy profile of remdesivir as a treatment for COVID-19,” the company said.

    www.marketwatch.com/story/why-an-anal...
  9. r66 18 april 2020 21:20
    quote:

    FatCool schreef op 18 april 2020 11:44:


    Uitbreiding van de "severe" Covid-19 studie van 2400 naar 6000 patiënten.

    www.youtube.com/watch?v=pVhpq4kLDsE&a...

    Stop er maar mee, zou ik zeggen. Dit geeft alleen maar extra overbelasting van het verzorgend personeel. De mensen die aan het zuurstof liggen zijn het stadium van de virale aanval al lang voorbij.

    Mensen die nog niet/nauwelijks ziek zijn hebben Remdesivir nodig, dan kan de virale aanval nog worden gestopt. Dus daarop concentreren is mijn mening.

    fc


    Ik zou gewoon even op de feiten wachten. Voorlopig succes juist bij corona patiënten die opgenomen zijn, dus wat anders dan mensen die 'nog niet/nauwelijks' ziek zijn.
    Voorlopig lijk je vooral je best te doen om negatief Gilead nieuws te proberen te brengen. Heb je daar belang bij?
    Of wil je mensen beschermen, omdat je denkt dat ze alleen positief nieuws over Gilead lezen?
  10. forum rang 4 FatCool 19 april 2020 09:01
    quote:

    r66 schreef op 18 april 2020 21:20:


    [...]

    Ik zou gewoon even op de feiten wachten. Voorlopig succes juist bij corona patiënten die opgenomen zijn, dus wat anders dan mensen die 'nog niet/nauwelijks' ziek zijn.
    Voorlopig lijk je vooral je best te doen om negatief Gilead nieuws te proberen te brengen. Heb je daar belang bij?
    Of wil je mensen beschermen, omdat je denkt dat ze alleen positief nieuws over Gilead lezen?

    Ik geef alleen aan wat ik denk, gebaseerd op wat ik lees. Totdat er meer data is zie ik alleen anekdotische verhalen.

    Maar het staat je vrij om te lezen wat ik schrijf...

    IEX weekend, heeft ook nog een stukje op Gilead.

    www.iex.nl/Premium/Adviezen/497713/IE...

    Punt 4. Gilead en Remdesivir.

    fc
  11. forum rang 4 FatCool 19 april 2020 11:01
    Congressman calls for SEC investigation into leak about possible coronavirus drug

    Updated 1841 GMT (0241 HKT) April 18, 2020

    A congressman on Friday called for the Securities and Exchange Commission to investigate the leak of a video showing physicians at the University of Chicago speaking enthusiastically about an experimental drug to treat Covid-19.

    Texas Democrat Rep. Lloyd Doggett, chair of the House Ways and Means Health Subcommittee, said the leak was "so significant" at a time when the world is "so desperate to find a cure."

    University of Chicago physicians are helping test remdesivir, an antiviral drug made by Gilead Sciences in patients with Covid-19.

    Dr. Kathleen Mullane, an infectious disease specialist at the University of Chicago, is leading the clinical trial funded by Gilead.

    "The best news is that most of our patients have already been discharged, which is great. We've only had two patients perish,"?Mullane is quoted as saying in the video.

    The video was leaked to STAT News, a health news website, which published it Thursday afternoon. The story was picked up widely by other news outlets, including CNN, and Gilead stock soared 12%.

    Doggett, an attorney, noted that "providing information that's designed to impact the stock market is not something that is permitted under federal securities law."

    He said it's not clear where the leak came from. "That's why we need a thorough SEC investigation," he said.

    A Gilead spokesman Chris Ridley said his company was not involved in the leak. "Gilead had nothing to do with the information sourced by STAT from an internal recording out of the University of Chicago hospital," Ridley wrote to CNN in an email.

    Effect of remdesivir unclear

    A spokesman for the SEC declined to comment. A spokeswoman from the University of Chicago did not respond to a request from CNN for comment.

    The University of Chicago is conducting two remdesivir trials being paid for by Gilead: one in patients with severe symptoms and the other in patients with moderate symptoms.

    "Most of our patients are severe and most of them are leaving at six days, so that tells us duration of therapy doesn't have to be 10 days," Mullane was quoted in the STAT article as saying in the video.

    The Gilead trial for patients who are severely ill does not include what's known as a control group, so it could be difficult to say whether the drug is truly helping patients recover better. With a control arm, some patients do not receive the drug being tested so that doctors can determine whether it's the drug that is really affecting their condition.

    The company's trial for moderately ill Covid-19 patients does have a control group.

    There's a separate large trial of remdesivir sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, which does include a control group.

    Dr. Kathryn Hibbert, director of the medical intensive care unit at Massachusetts General Hospital, is participating in the NIAID trial. She said it's not at all clear to her if the drug is having an impact. "We have seen patients who've received remdesivir who've had remarkable recoveries and we've seen patients who've not received remdesivir and had remarkable recoveries," said Hibbert, also an instructor at Harvard Medical School. "Overall, patients are doing well and have made recoveries, even the sickest of the sick."?

    Voor de rest van het lange artikel: edition.cnn.com/2020/04/18/us/sec-inv...
  12. r66 19 april 2020 18:20
    Lijkt me logisch dat men het lek probeert boven te krijgen.

    Studie is nu uitgebreid naar 6000 personen:
    clinicaltrials.gov/ct2/show/NCT042928...

    The primary objective of this study is to evaluate the efficacy of 2 remdesivir (RDV) regimens with respect to clinical status assessed by a 7-point ordinal scale on Day 14.

    Experimental: Part A: Remdesivir (RDV), 5 Days (Not Mechanically Ventilated)
    Participants who are not mechanically ventilated will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.

    Experimental: Part A: Remdesivir, 10 Days (Not Mechanically Ventilated)
    Participants who are not mechanically ventilated will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, 5, 6, 7, 8, 9, and 10.

    Experimental: Part B: Remdesivir, 5 or 10 Days (Extension)
    Part B (Extension) will enroll participants after enrollment to Part A is complete. Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10.

    Experimental: Part B: Remdesivir 10 days (Mechanically Ventilated)
    Participants on mechanical ventilation will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2-10
  13. forum rang 6 Endless 19 april 2020 21:02
    Summary
    Gilead Sciences is a quality company that is currently leading the front of the line treatments for Remdesivir.

    While there is some risk in terms of the various treatment options and competition, assuming COVID-19 is similar to HIV, the returns are significant.

    Worst case scenario, we still expect the company's treatment revenue to help subsidize infrastructure it can use for other things.

    I do much more than just articles at The Energy Forum: Members get access to model portfolios, regular updates, a chat room, and more. Get started today »

    Gilead Sciences (NASDAQ:GILD) watched its stock price perform incredibly well after hours as a result of new information about the company's Remdesivir drug and its potential in treating COVID-19. I recommend investors start by reading my most recent article discussing the company as a whole, but the point of this article is to discuss the company's direct financial potential from Remdesivir in detail.



    Gilead Sciences - Barron's

    Gilead Sciences' Remdesivir Drug Trials

    I want to preface this section by stating that I'm not a doctor and that as a result of the COVID-19 difficulties, it's incredibly hard to run a proper drug trial. However, with that said, Remdesivir's initial results in treating COVID-19 are very promising.



    Several days ago, Gilead Sciences published its initial results for 53 patients. The results showed, through compassionate use studies, that 84% of patients saw a need to have ventilation removed or a 2 point improvement in their oxygen scale. Over the timeline of the study, 47% of patients were discharged from the hospital.

    Those are impressive results versus an early study from the University of Washington that saw 50% of people die.

    However, additional data on April 16 highlights that Remdesivir has the potential to generate even better results for COVID-19 patients. A University of Chicago study showed that 125 people with COVID-19, of which 113 had a severe form of the diseases, who were treated with Remdesivir, saw only 2 deaths.

    Given the high death rate for patients with the severe form of the disease, this is promising. New data will be coming over the next several weeks. I recommend investors pay close attention to this data.
  14. forum rang 6 Endless 19 april 2020 21:02
    A Look At Flu

    To analyze the potential benefits of treating COVID-19, we look at one of the widest spread severe diseases known, the flu. It killed 80 thousand people this past year in the United States alone.



    Top-Selling Flu Treatments - Evaluate

    The above image shows some of the top selling flu treatments. There are several important things worth noting here. The first is that Xofluza is doing well but selling only in Japan. If it expanded internationally, the overall worldwide flu market could do incredibly well. The second thing to note is several popular drugs (like Tamiflu) coming off patent could hurt the market with generics.

    The last important thing to note is that none of these treatments are a true solution for the flu, and that the flu is much less deadly than COVID-19. However, if we assume a new world model that treats COVID-19 as the flu 2.0, then it will effectively be a new $1 billion pharmaceutical market that Gilead Sciences can dominate. Not super-exciting, but not bad either.

    A Look At HIV

    As a result, we believe that a much better disease to compare Gilead Sciences' COVID-19 potential to is HIV. HIV is a deadly disease that emerged on the scene in the 1970s-1980s. It rapidly spread to infect 10s of millions of people, causing a significant number of deaths, before treatment standards made it a disease that one can live with.

    While people eventually survive COVID-19 and can recover from it without needing continuous treatment, the HIV model is much more similar to COVID-19 that comes back each year, as a deadly disease, like the flu.



    Gilead Sciences HIV - Gilead Sciences Investor Presentation

    Gilead Sciences HIV drug sales are visible above. The company has managed to continue to retain and grow its market share, while continuously improving the treatment options for patients. As a result, the company's HIV revenue is approaching an astounding $20 billion per year, with the company having a long-term pipeline for revenue here.

    Gilead Sciences charges roughly $1800 for a 30 pill treatment of Descovy or $60/pill. Let's assume that COVID-19 patients are treated immediately at a one-time dose of the same amount ($1800). That's a significant market potential, given that already more than 2 million people have COVID-19.
  15. forum rang 6 Endless 19 april 2020 21:03
    Remdesivir Financial Potential Forecast

    * We assume that Remdesivir will become a front line treatment, given to all symptomatic people regardless of their severity of symptoms.

    Putting this together, let's take a look at Gilead Sciences' Remdesivir financial potential forecast. We will assume that the company becomes a front-line treatment for COVID-19 and that the price paid for treatment is proportional to healthcare expenditures per capita. We will also assume that this is a one-time deal for shareholders i.e. that a vaccine is created in a year.


    Healthcare Spending per Capita - Forbes

    The above image shows healthcare spending per capita by country. We'll take the $1800 treatment number above for the U.S. and adjust proportionally. That means, for OECD, which has half the average healthcare expenditures of ~45% of the United States. That means that the OECD average expenditure for COVID-19 will be $810/person.

    Additionally, let's look at India ($209/capita, so $36/COVID-19 treatment). China spends more than double that per capita, so we'll put it at ~$80/COVID-19 treatment. We'll also stick to estimates that COVID-19 will affect approximately half of the world's population, and we'll assume that 25% of asymptomatic people don't need treatment.

    The total OECD population is 1.3 billion people. India's population is 1.35 billion people and China's population is 1.4 billion people. Putting all of this together means that these 4 billion people have the potential to generate a massive amount of COVID-19 revenue. In fact, using our 50% statistic, (37.5% with asymptomatic), that's the potential for more than $450 billion in revenue.

    That's significant potential for shareholder returns and profits.

    Additionally, even if the company sells Remdesivir at breakeven prices, or slightly lower prices, the company has significant potential. If it makes only $5 profit/pill with 50% of the population and 25% asymptomatic and our same numbers, that means the potential for $15 billion in profit. For a company with a $100 billion market capitalization, that's the potential for significant returns.

    Even if the company doesn't make profits, there's significant potential. That's because the company becoming the face of COVID-19 treatment could mean significant potential from customers learning about the country's other drugs. Even if they don't, the company will get significant benefits from the manufacturing infrastructure selling drugs at cost will subsidize.

    Either way, it's likely that Gilead Sciences makes billions from this.

    Risks

    The main risk that investors in Gilead Sciences should pay attention to in terms of its COVID-19 potential is investors pricing in too much growth and then an alternative treatment being found. Work is being done around the world to find potential treatments, and success in any of these fields would mean that investors unfairly bid up Gilead Sciences' share price, and it would drop back down.

    However, currently, Gilead Sciences seems to have one of the best treatments.

    Conclusion

    Gilead Sciences' recent Remdesivir treatment news is exciting, and we take the time to analyze it in this article. We expect that this treatment has the potential to generate significant results for shareholders, even if the company is incredibly responsible about how much it charges, in one of the world's worst pandemics ever.

    Compared to HIV and the flu, this treatment, which has the potential to be a new front of the line treatment, can save many lives. In the best scenario, the treatment has the potential to return several times the company's market cap, but even in the worst case, infrastructure will likely be subsidized for the company. Overall, the company is a quality investment.

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  16. forum rang 4 FatCool 20 april 2020 19:20
    Novartis to run COVID-19 trial of antimalaria drug touted by Trump

    April 20, 2020 at 9:01 a.m. ET

    The antimalaria drug that President Donald Trump has repeatedly touted will be put to the test.

    Novartis, the Swiss pharmaceutical, said it would conduct a Phase III clinical trial of hydroxychloroquine in hospitalized patients with COVID-19 disease, after reaching an agreement with the U.S. Food and Drug Administration.

    The deadly coronavirus that has killed more than 165,000 people doesn’t have any proven treatment, though doctors globally have tried hydroxychloroquine as one measure. One person died after consuming fish cleaner that contains the chemical.

    Another drug from Gilead Sciences was reported to have success in treating patients at a Chicago hospital, though the company said it has not completed its trial.

    The Novartis trial of hydroxychloroquine will be of approximately 440 patients at more than a dozen sites in the U.S.

    The first group or arm will receive hydroxychloroquine. The second group will receive hydroxychloroquine in combination with azithromycin, which is an antibiotic therapy. The third group will receive a placebo.

    Novartis said it plans to begin enrollment for this study within the next few weeks and is committed to reporting results as soon as possible.

    It won’t be a big money winner for the company, regardless of results.

    Novartis said it would make its hydroxychloroquine intellectual property available to support broad access if the medicine is approved for COVID-19. Novartis also said it would donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of COVID-19, and said its generics arm Sandoz has already donated 30 million tablets to the U.S. Department of Health and Human Services.

    U.S.-listed Novartis shares have dropped 6% this year, while the S&P 500 SPX, has dropped 11%.

    www.marketwatch.com/story/novartis-to...
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