The $95 billion biotech Gilead just announced plans to test a promising potential coronavirus treatment in 1,000 people
Gilead Sciences just announced plans for two late-stage clinical studies to test a treatment for COVID-19, the disease caused by the growing coronavirus outbreak. The California biotech will enroll approximately 1,000 patients with confirmed cases of COVID-19 across Asian countries and other areas with high rates of cases, the company said on Wednesday. The two trials will test an antiviral medication called remdesivir, a therapy that was previously tested against the Ebola virus. A Gilead executive said other studies of remdesivir in China would "give us a more expansive breadth of data globally on the drug's profile in a short amount of time." Visit Business Insider's homepage for more stories.
The $95 billion biotech Gilead Sciences is accelerating its effort to test a promising potential drug to treat COVID-19, the disease caused by the spreading coronavirus outbreak. Gilead announced Wednesday plans for two late-stage clinical trials. The studies will assess different doses and treatment courses of the experimental antiviral medication, remdesivir, in about 1,000 patients with COVID-19. A sense of urgency has been placed on the drug industry to identify and develop vaccines and treatments to halt the coronavirus outbreak that has killed more than 2,700 people and sickened more than 81,000. Since originating in China, the virus has spread to at least 40 other countries, encompassing six continents. The efforts build on other ongoing tests of the drug in China and the US. Gilead said these new studies will start enrolling patients in March "across Asian countries, as well as other countries globally with high numbers of diagnosed cases." Gilead said we're likely to get the first results from some of those earlier studies in April. The National Institutes of Health's infectious disease unit recently started a trial of remdesivir in the US with COVID-19 patients. Read more: The US is gearing up to test the first coronavirus treatments and vaccines. Here's how 6 top drugmakers are racing to tackle an outbreak that's spreading around the world. "Gilead's primary focus is on rapidly determining the safety and efficacy of remdesivir as a potential treatment for COVID-19, and this complementary array of studies helps to give us a more expansive breadth of data globally on the drug's profile in a short amount of time," said Merdad Parsey, Gilead's chief medical officer, in a statement. Health officials and experts have emphasized the potential for remdesivir. A single case reported in The New England Journal of Medicine has stirred initial excitement about the drug's potential. "There is only one drug right now that we think may have real efficacy and that's remdesivir," Bruce Aylward, an assistant director-general of the World Health Organization, said at a recent press conference, CNN reported.
Read more: The US is gearing up to test the first coronavirus treatments and vaccines. Here's how 6 top drugmakers are racing to tackle an outbreak that's spreading around the world. Buzzy biotech Moderna is 'looking at all options' to ramp up production just days after shipping the first potential coronavirus vaccine A vaccine for Wuhan coronavirus could take years to develop, based on our experience trying to fight Zika and Ebola Pharma giant Sanofi is developing a vaccine to fight the deadly coronavirus outbreak using its previous research on SARS Join the conversation about this story » NOW WATCH: Most maps of Louisiana aren't entirely right. Here's what the state really looks like.
More like this (3)
Gilead has yet to set a price for the coronavirus treatment remdesivir, but an influential drug pricing watchdog says it could be worth up to $4,500 per patient (GILD)
Gilead Sciences could be justified in charging up to $4,500 per coronavirus patient for its drug,...Gilead Sciences could be justified in charging up to $4,500 per coronavirus patient for its drug, a nonprofit pricing watchdog said in a recent report. The California biotech is the maker of remdesivir, an experimental antiviral treatment that helped hospitalized COVID-19 patients recover 31% faster, shaving four days off hospital stays. The company has yet to give a pricing strategy for remdesivir, beyond pledging to donate its current supply of the drug. One Wall Street analyst calculated that Gilead could make $1 billion in 2020 by selling remdesivir at a $1,000 price tag, which he called "pretty reasonable." Visit Business Insider's homepage for more stories. While the big biotech Gilead Sciences has yet to outline its sales plan for the first effective coronavirus treatment, an influential drug pricing group has calculated the drug is worth up to $4,500 per patient. The experimental antiviral called remdesivir was authorized for emergency use in the US on Friday, after a trial showed patients on the drug recovered 31% faster than those on a placebo. That translates to shaving four days off the typical hospital stay among these patients. It is the first drug to show a clinical benefit for COVID-19 patients in a high-quality randomized study. The Institute for Clinical and Economic Review (ICER) is a Boston-based nonprofit that analyzes drug pricing. The pharma industry regularly clashes with ICER, criticizing its models for being too rigid. The group often finds drugs to be overpriced compared to their value in the healthcare system. But in the case of remdesivir, ICER said Friday a price of up to $4,500 per treatment course is justified for remdesivir. The organization cautioned its findings are based on preliminary data that may change over time. ICER's analysis is focused on list prices for drug, which do not take into account rebates or discounts offered by drug companies. "We are releasing these estimates now, despite the fact that the evidence is highly uncertain and evolving, because now is the time when the public and policymakers should be actively debating how to link pricing to an overall platform to develop treatments for COVID-19," said Steven Pearson, ICER's president, in a statement. "The consequential discussion about the tradeoffs and priorities involved with different pricing approaches cannot wait." But the California biotech has called it too early to set a long-term pricing strategy. So far, the company pledged to donate its current supply of remdesivir, which amounts to 140,000 treatment courses. The pricing question has become a top uncertainty among many investors and Wall Street analysts. "The fact that ICER is typically conservative in all their analyses, and yet they can justify up to $4,500, seems pretty interesting," Jefferies biotech analyst Michael Yee wrote in a Sunday note to investors. Read more: Gilead plans to spend up to $1 billion to ramp up manufacturing of its coronavirus treatment, but execs dodged Wall Street's questions about turning a profit Using a placeholder of a $1,000 price, Yee estimated Gilead could make $1 billion on remdesivir by the end of 2020 if it sells 1 million treatment courses in the US and internationally. A $1,000 pricetag is "pretty reasonable" in the context of modern drug pricing, the analyst said. Gilead has pledged it will donate its current supply of remdesivir, which amounts to about 140,000 treatment courses. CEO Daniel O'Day said Sunday the drug should start reaching patients within the next few days. Remdesivir is given as a 10-day IV infusion and has only been tested in hospitalized COVID-19 patients. The company is also researching ways to administer the drug subcutaneously or through inhalation but has not provided any timetables on those efforts. Read more: Coronavirus researchers are crafting drug cocktails with Gilead's antiviral remdesivir, tapping the HIV playbook to fight the coronavirusJoin the conversation about this story » NOW WATCH: 4 potential coronavirus treatments that researchers are working on right now
Coronavirus researchers are crafting drug cocktails with Gilead's antiviral remdesivir, tapping the HIV playbook to fight the coronavirus
With the antiviral drug remdesivir showing modest benefits for COVID-19 patients, scientists are already plotting how...With the antiviral drug remdesivir showing modest benefits for COVID-19 patients, scientists are already plotting how to rapidly build on this progress. On its own, remdesivir is unlikely to be a game-changer in treating the coronavirus, researchers said. But finding the right drugs to combine it with could produce a much more potent therapy. It is likely to spur a flurry of combination trials that test remdesivir plus additional experimental drugs, leading COVID-19 researchers and physicians said. This mirrors the approach used for HIV, where the first drugs showed modest benefits. It took years of testing combinations to find cocktails of two or three drugs that knocked out the virus. There's optimism this testing will happen more quickly than HIV, with many therapeutic candidates already identified. Biomedical breakthroughs have built an understanding of the virus in record time, as shown by research published Thursday by a group of more than 100 scientists. Visit Business Insider's homepage for more stories. Researchers are already plotting how to build on top of the first effective coronavirus treatment. The key will be crafting the right cocktail of medications, testing additional drugs in combination with the antiviral remdesivir, COVID-19 researchers told Business Insider. This will likely lead to an explosion in combination trials testing Gilead's treatment in addition to experimental drugs to see if any boosts the benefits. HIV and cancer research have both followed a similar path, providing lessons to guide speedy COVID-19 work. Hospitalized COVID-19 patients recovered 31% faster when taking remdesivir instead of a placebo, according to preliminary study results released Wednesday by the US National Institutes of Health. Unlike the majority of early coronavirus studies, this trial's design was high quality, with data from more than 1,000 patients randomized to receive either Gilead's drug or a placebo. That 31% benefit is significant, said Dr. Jeffrey Gold, the chancellor of the University of Nebrasksa's Medical Center, one of the first hospitals to start testing remdesivir. Remdesivir's use should help free up hospital beds, intensive care units, and ventilators as patients recover faster on the drug. But the real advantage will be its potential to serve as a backbone in combination studies, Gold said. "It's a very healthy starting point," Gold said. "It opens the door to multiple combination therapies working in different ways to attack the pandemic, which will hopefully be accelerated." Read more: A failed Ebola drug is now the frontrunner to be the first effective coronavirus treatment. Here's everything you need to know about Gilead's remdesivir. Combination therapies were the true game-changers in fighting HIV The first medications for HIV were single drugs with modest benefits. The real breakthroughs came after years of testing combinations of these drugs, when three-drug cocktails led to dramatic improvements in patients. "We know clearly, as instructed by the global experience in HIV, that combination therapies often have advantages compared to single-drug therapy," Dr. Andrew Badley, director of the Mayo Clinic's HIV Immunology Laboratory, said in an interview. It won't be long before researchers start launching trials testing additional therapies on top of remdesivir, he said. "Those are critical trials, and I think will be coming in the relatively near term," said Badley, who chairs Mayo's COVID-19 research task force. At least one such trial is about to start. Remdesivir will be tested in combination with an arthritis drug The NIH's trial will soon start testing a combination therapy, said Dr. Taison Bell, an assistant professor of medicine and infectious disease at the University of Virginia, where he is a principal investigator for this study. Potentially as soon as next week, patients in the NIH study will all receive remdesivir. They will also be randomized to receive either a placebo or an arthritis drug called Olumiant, Bell said. Olumiant, made by Eli Lilly, works by interfering with the inflammatory response of the immune system. This could help patients suffering from severe cases of COVID-19, which are often marked by their immune systems overreacting. The NIH confirmed they are testing Olumiant, but declined to provide specifics on the design. The agency said details would be shared in a future announcement. Gilead outlined this trial design Thursday on an earnings call, saying the positive trial results for remdesivir will change how COVID-19 drug research is done. "This now changes the landscape of drug development within COVID-19, being one now has to think about comparing to remdesivir and/or adding to remdesivir," said CEO Daniel O'Day. The two drugs work in different ways. Remdesivir is focused on stopping the virus, while Olumiant may help alleviate some of the worst symptoms that patients suffer. Bell said he is most excited about combination trials where each of the drugs can treat distinct phases of the disease. "Looking at an agent that tries to attack the virus replication, and then an agent that targets the immune system response when it goes out of whack, looks like that would be the ideal combination for people with severe disease," Bell said. There's already a deep bench of drugs to test Finding the best HIV combinations took years and hundreds, if not thousands of trials, Badley said. But he is optimistic coronavirus research will progress much faster, given recent breakthroughs in biomedical capabilities. One research project published Thursday in the journal Nature maps a blueprint of how the coronavirus works. An international team of more than 100 researchers identified the dozens of proteins critical to the coronavirus and the hundreds of proteins in humans it needs to grow and replicate. Then, they found existing drugs that could inhibit these human proteins, hoping that could prevent the virus from growing in cells. They identified 10 drugs that showed strong ability to inhibit the virus when tested in monkey cells. It's an eclectic group of compounds, including antihistamines, antipsychotics, and even cancer treatments. Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic Nevan Krogan, a leader of the project and a biologist at the University of California, San Francisco, said he sees the future of COVID-19 research in "adding multiple drugs like a cocktail." "We are excited to be testing our drugs and compounds in combination with each other as well as other antivirals such as remdesivir," Krogan said. These drugs hold particular potential to work with remdesivir, since they have different targets that aren't covered by Gilead's drug, said UCSF chemist Kevan Shokat, another author of the research. "In that way, we hit multiple aspects of the viral life cycle all at once," Shokat said. Mayo's Badley said research like this project has identified dozens of drugs that can be repurposed against the coronavirus. It gives him hope the timeline for breakthroughs will be much quicker than HIV. "The fact that those publications exist is a testament to where we are with biomedical science today," he said. "We were not in a similar place when HIV came along." "I am personally very optimistic that within weeks to months, we will begin to get significant signals of activity of some of these agents as therapies of COVID," he added.Join the conversation about this story » NOW WATCH: 4 potential coronavirus treatments that researchers are working on right now
Gilead plans to spend up to $1 billion to ramp up manufacturing of its coronavirus treatment, but execs dodged Wall Street's questions about turning a profit (GILD)
The California biotech giant Gilead Sciences is planning to spend up to $1 billion to ramp...The California biotech giant Gilead Sciences is planning to spend up to $1 billion to ramp up production of its promising coronavirus treatment remdesivir. The manufacturing ambitions come before the antiviral drug is approved by any health regulators for use in COVID-19, the disease caused by the coronavirus. Hospitalized patients with COVID-19 who got remdesivir recovered 31% faster than a similar group taking placebos, the US National Institutes of Health announced Wednesday. On a Thursday earnings call, Gilead executives said they will donate roughly 1.5 million doses of the drug. But beyond that, they dodged Wall Street's questions about a pricing strategy for the treatment. They pledged to make the drug affordable. Visit Business Insider's homepage for more stories. Gilead Sciences is planning to spend some serious cash to boost production of a promising coronavirus drug. The company is expecting to commit as much as $1 billion to manufacturing the antiviral treatment remdesivir, executives at the biotech company said on a Thursday earnings call. Remdesivir has not been approved to treat coronavirus patients by health regulators. But study results released Wednesday showed the treatment helps patients recover more quickly from COVID-19, the disease caused by the novel coronavirus. The ultimate size of the investment will depend on how the drug's data and the pandemic evolve, said Andrew Dickinson, Gilead's chief financial officer. Through the end of March, Gilead had spent about $50 million on remdesivir, without knowing whether or not it worked. CEO Daniel O'Day said there will be an "exponential increase" in remdesivir supply during the second half of 2020. The biotech anticipates making more than 1 million treatment courses by year's end. Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic The company also pledged to donate its current supply of remdesivir, which amounts to about 140,000 courses of treatment. Looking beyond the immediate term, Gilead executives declined to say how they'll set a price for the pill, which is now the frontrunner to be the first effective coronavirus treatment. Hospitalized patients who got remdesivir recovered 31% faster than a group taking placebo, the US National Institutes of Health found in a clinical trial. The Gilead executives called it "too premature" to discuss pricing for the drug, which is given as an IV infusion in hospitals. Several Wall Street analysts inquired, but company leaders offered little beyond a general aim to make the drug "accessible and affordable." SVB Leerink biotech analyst Geoff Porges, for instance, referenced the profit margins Gilead has made selling medicines for other infectious diseases like HIV and Hepatitis C. "What's special about COVID?" Porges asked. "I don't think there is a precedent for this," O'Day replied, saying a market for a COVID-19 treatment will be unique and different from these other diseases. "There is no rule book out there. other than that we need to be very thoughtful about how we can make sure we provide access of our medicine to patients around the globe and do that in a sustainable way for the company, for you as shareholders, and we acknowledge that," he added. Read more: Coronavirus researchers are crafting drug cocktails with Gilead's antiviral remdesivir, tapping the HIV playbook to fight the coronavirus Later on the call, O'Day said that as the company measures production for remdesivir in the millions of doses, "we have to have a sustainable economic model that works." As the frontrunner in the sprint to an effective COVID-19 treatment, Gilead will be first to face the task of mapping a commercial strategy for a coronavirus drug. At least for now, the company isn't ready to share a plan.Join the conversation about this story » NOW WATCH: 4 potential coronavirus treatments that researchers are working on right now