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Gilead Drug Shows Promising Results In Treating COVID, Ready For Distribution Says CEO

KEY POINTS

  • Gilead’s coronavirus treatment redemsivir was found to reduce recovery time in patients by several days
  • Redemsivir and other drug treatments could serve as stopgap measures until a proper vaccine is ready and approved
  • The Trump administration and Congress re-entered negotiations about a stimulus package to help a U.S. economy hit hard by the pandemic

Final results from Gilead Sciences’ latest remdesivir trial showed the antiviral drug was effective in treating coronavirus patients and cutting recovery time by at least a week.

Gilead’s CEO said, given the positive results, the company was ready for mass production and distribution of the drug.

As of Friday, Johns Hopkins said the U.S. has over 7.6 million confirmed cases of coronavirus and 212,805 reported deaths from it. The latest trial was conducted for nearly a month and involved over 1,062 patients hospitalized for coronavirus. Half of the patients were given remdesivir while the other half were given placebo as part of the randomized, double-blind trial. Trial sites were located in the U.S., United Kingdom, Denmark, Mexico, Japan, Germany, Greece, Korea, Spain, and Singapore.

Average recovery time for people given remdesivir was found to be shortened by five days. While overall data showed the drug was not significant in reducing mortality, it appeared effective in lowering the mortality rate among patients on oxygen.

“Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with COVID-19 and had evidence of lower respiratory tract infection,” the final report in the New England Journal of Medicine said.

Gilead CEO Daniel O’Day said the company was pleased with the results and ready for distribution, if and when the drug is approved.

“These results are meaningful,” O’Day told CNBC. “They’ll definitely help patients around the world who have the misfortune of entering the hospital to get better, and I’m really pleased to say that we have ample supply.”

Former Food and Drug Administration Commissioner Dr. Scott Gottlieb said while remdesivir, alone, is likely not enough to treat coronavirus, this data is a good sign in battling the pandemic.

“I think combined with the antibody drugs, which should be coming onto the market soon based on the data that we’ve seen, this is a pretty effective treatment regime in advance of a vaccine,” Gottlieb told CNBC.

While a drug like remdesivir, or the antibody treatment developed by Eli Lilly, serve as a stopgap means of addressing coronavirus, a vaccine will still be needed to serve as a long-term answer. The hope is that a vaccine will be approved and ready for distribution by the end of December, with timetables having life get back to some degree of normalcy by summer 2021.

Some of the vaccines furthest along include:

  • Moderna and the National Institute of Health’s mRNA vaccine, currently in Phase 3 trials
  • China’s CanSino Biologics and Russia’s Gamaleya Research Institute have vaccines in limited approval, though experts warned these were likely rushed and could still be harmful
  • AstraZeneca and the

The Daily 202: Trump tries frantically to make up lost ground with seniors, promising free medicine and checks

Other polls released over the last week show Biden leading among voters 65 and older, including in the battlegrounds of Florida, Wisconsin, Michigan and Pennsylvania. Pew’s survey was in the field from Wednesday, the day after the first presidential debate, through Monday, the day Trump checked himself out of Walter Reed after his three-night stay in the hospital. Pew’s unusually large sample size of 10,543 registered voters means smaller margins of error for subgroups, which allows for deeper analysis.

Trump and many of his top advisers see his weakness among seniors as an existential threat to his hopes for a second term, and the president is demanding that his aides use all the levers of the federal government to woo older voters who have drifted away during the final 25 days of the campaign.

The president tweeted a two-and-a-half minute video Thursday afternoon of himself speaking directly to seniors, whom he referred to as “MY FAVORITE PEOPLE IN THE WORLD.”

“I’m a senior,” the 74-year-old said to the camera. “I know you don’t know that. Nobody knows that. Maybe you don’t have to tell them, but I’m a senior.”

Trump said he was “very sick” when he went to the hospital, but the experimental antibody treatment he received helped him feel better immediately. He promised that he’s going to make sure that other seniors can also access the medicine he got by pushing the FDA to immediately authorize its emergency use. 

“They like to say ‘the vulnerable,’ but you’re the least vulnerable, but for this one thing, you are vulnerable. And so am I. But I want you to get the same care that I got,” Trump said. “You’re going to get the same medicine, you’re going to get it free, no charge, and we’re going to get it to you soon. … All free! … I do know what I’m doing. The seniors are going to be taken care of, and then everybody is going to be taken care of.”

Assuming the medication gets approved for wider use, doctors say there will not be enough doses to make it widely available and note that there are potentially significant side effects. Just as importantly, Trump cannot distribute any medicine free of charge unless he agrees to a coronavirus relief deal with Congress, something he has sent mixed messages about all week. Evan Hollander, a spokesman for the Democratic majority on the House Appropriations Committee, said Trump is lying: “Without new legislation, the Trump administration cannot make covid-19 treatment available for free.” 

About 4 in 5 of the 212,000 Americans killed by the coronavirus have been over the age of 65. This group is less antsy about getting workers back into offices or kids back into school. Many seniors have sacrificed a great deal, foregoing time with loved ones to avoid potential exposure to a virus they know is more likely to kill them.

After temporarily halting negative ads against Trump while he was hospitalized, the Biden campaign unveiled several new

Trump politicizes promising coronavirus antibody treatments, erroneously calling them a ‘cure’

Trump also claimed in the videos he had granted the drugs an emergency use authorization (EUA), a designation that would make the medicines more broadly available. But the companies said they have submitted the requests to the Food and Drug Administration — a process that the agency has repeatedly tried to assure the public is based on science and free of political interference.

“We’re going to make them available immediately, we have an emergency use authorization that I want to get signed immediately,” Trump said in the video posted Thursday afternoon.

Experts said that by inserting himself and his own recovery story into an area of ongoing medical research, Trump risks disappointing and confusing the American public with a hopeful anecdote that may not reflect how the drug works for others or how broadly it will become available when it is approved, which he also promised would be free.

“The fundamental problem with monoclonal antibodies is there’s not enough worldwide capacity to produce enough of them to have a real impact on the disease,” said Ezekiel Emanuel, a health policy expert who is advising the campaign of Joe Biden. “Yes, they might be great, but for a small number of patients.”

The president also said in the video that people in hospitals should receive the drugs, but the data so far supports using them in people with mild or moderate illness who are recently diagnosed. Early data from ongoing studies have shown evidence the drugs reduce symptoms over days, knock back the virus by reducing levels in the body and may cut down the need for further medical visits. That data is considered very promising, but not definite evidence of a cure.

Trump’s endorsement of monoclonal antibodies comes as the authorization of a coronavirus vaccine before Election Day appears increasingly unlikely. Such an okay had loomed as a potential “October surprise” that some believed could alter the course of the election with the prospect of a quick return to normalcy. An influential medical journal argued in an editorial Wednesday that the Trump administration’s handling of the pandemic took “a crisis and turned it into a tragedy,” so the antibody drugs could offer a rare victory.

Trump said in one video that the therapies were “more important” than the vaccine, the same day that both companies disclosed that they had filed with regulators for emergency authorization to use the drugs in some patients. On Fox Business on Thursday morning, he called the Regeneron drug “a gift from heaven.”

Both the Regeneron and Eli Lilly drugs are being tested in clinical trials, and no one knows if the former helped Trump recover, whether it did so in addition to all the other treatments he received or whether he would have recovered on his own as part of the natural course of the disease.

Several experts said that Trump touting a drug as a cure will make it even harder to persuade patients to participate in ongoing clinical trials where they will have

Antibody drugs are no cure but seem promising for COVID-19

WASHINGTON (AP) — They’re not cures and it’s not likely that everyone will be able to get them as President Donald Trump has suggested. But experimental antibody drugs like the one Trump was given are among the most promising therapies being tested for treating and preventing coronavirus infections.

Eli Lilly and Regeneron Pharmaceuticals Inc. are asking the U.S. government to allow emergency use of their antibody drugs, which aim to help the immune system clear the virus. The medicines are still in testing; their safety and effectiveness are not yet known.

Trump is among fewer than 10 people who were able to access the Regeneron one under “compassionate use” rules, without enrolling in a study.

Q: How do they work?

A: Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. Vaccines mimic an infection to spur antibody production. But it can take several weeks after a vaccine or natural infection for the most effective antibodies to form. The experimental drugs are concentrated versions of specific antibodies that worked best against the coronavirus in lab and animal tests. In theory, they start helping right away. The one-time treatment is given through an IV — it’s not like a pill that people can take at home.

Q: How do the drugs differ?

A: Regeneron is using two antibodies to enhance chances its therapy will work even if the virus evades one. The company made a successful Ebola combo antibody treatment this way. Lilly is testing two different antibodies — one with the Canadian company AbCellera and another with a Chinese company, Junshi Biosciences — individually and in combination. Others testing similar drugs are GlaxoSmithKline and Vir Biotechnology Inc., which says it has engineered antibodies to last longer than they usually do. Amgen, Adaptive Biotechnologies and the Singapore biotech company Tychan Pte Ltd. also have studies underway.

Q: When might they be available?

A: Eli Lilly and Regeneron have asked the Food and Drug Administration for emergency authorization. During public health emergencies the FDA can speed drugs to market based on a lower standard of evidence than is normally required. Drugmakers need only show that the expected benefits of their therapies outweigh the risks for treating COVID-19. There is no deadline for the FDA to rule on the drugs, but it typically makes decisions on such emergency applications within days or weeks.

Q: Who would get them?

A: Researchers are still trying to determine the best candidates for antibody treatment. Some studies involve newly infected people to see if early treatment can lower the risk of becoming sick. Other studies in hospitalized patients aim to prevent serious illness, complications or death. Researchers also are testing these drugs to try to prevent infection in people at high risk of it, such as health workers, housemates of people with COVID-19, and nursing home workers and residents.

Q: Will there be enough for everyone?

A: It depends on how potent the drugs prove

BIAL Goes Global With New US Research Center and Acquisition of Promising Parkinson’s Disease Programs

  • BIAL Biotech to be based in Cambridge, Massachusetts and will be a Research Center of Excellence dedicated to genetically-defined Parkinson’s disease

  • LTI-291 clinical program and other research programs in Parkinson’s disease acquired from Lysosomal Therapeutics, Inc.

  • R&D team led by Peter Lansbury, professor of neurology at Harvard Medical School

  • Investment may add up to 130 million dollars depending on the accomplishment of downstream development, and several regulatory and commercial milestones

BIAL, a pharmaceutical company based in Portugal with locations across Europe and dedicated to R&D in CNS diseases, announced today that it has established a new affiliate in the United States of America, BIAL Biotech Investments Inc. (BIAL Biotech). This new research center focused on genetically-defined Parkinson’s disease is based in Cambridge, Massachusetts, a prominent biotech hub in the world.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201001005323/en/

Simultaneously, BIAL announced that it has acquired worldwide rights of LTI-291 and all the Parkinson’s disease research programs of Lysosomal Therapeutics Inc. (LTI) and taken on the entire R&D team.

António Portela, executive president of BIAL, reveals: “Our entry into the US with the creation of BIAL Biotech and the acquisition of the promising programs from LTI, is a decisive step towards the fulfilment of our mission to contribute to improving the quality of life of people worldwide. The development of this new research center in the US, is a landmark of enormous relevance for us. We are investing in science and research, through our direct presence in one of the most important research hubs in the world and in one of the most promising areas of medicine.

This acquisition not only provides the company with a pipeline of new product candidates in Parkinson’s disease but also an experienced R&D team, led by Peter Lansbury, professor of neurology at Harvard Medical School and a recognized thought leader in the field of neurodegenerative diseases.

With this acquisition, BIAL is expanding its pipeline, namely with the integration of new compounds in neurodegeneration already in clinical development, specifically for Parkinson’s disease, where the pharmaceutical company already has a significant market position.

The executive president of BIAL also points out: “The compounds we’ve acquired are based on genetics, a new field of research for us. The lead asset, which now has the code name ‘BIA 28-6156/LTI-291’, has an innovative mechanism of action and presents the potential of being a first disease-modifying therapy for a genetic subset of Parkinson’s disease. It has successfully completed a Phase I trial program and should be ready to start Phase II studies in 2021. We´re progressing from symptomatic treatment to an intervention in the mechanisms of the disease, which is very exciting for BIAL.

“We are happy to be part of BIAL and take the lead on the growth story in the US,” says Kees Been, former CEO of LTI and now CEO of BIAL Biotech. “With the commitment and resources of BIAL we will be able to accelerate our novel