October 12, 2020

AstraZeneca strikes $486M deal for up to 100,000 doses of coronavirus antibody cocktail

Daily Briefing

    HHS is looking to purchase hundreds of thousands of doses of experimental antibody treatments for Covid-19 in an effort to ensure Americans have access to the potential treatments until a vaccine against the novel coronavirus becomes available.

    How Covid-19 is changing the future of the health care industry

    US new coronavirus cases surpass 7.7M, deaths top 214K

    The effort comes as U.S. officials as of Monday morning reported a total of 7,792,400 cases of the novel coronavirus since the country's epidemic began—up from 7,639,600 cases reported as of Friday morning.

    According to the New York Times, the United States' average daily number of newly reported coronavirus cases over the past week was 49,674—which is up by 15% when compared with the average from two weeks ago.

    Data from the Times shows that the rates of newly reported coronavirus cases are "staying high" in Guam and 26 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alabama, Alaska, Arkansas, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Mexico, North Carolina, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Wisconsin, and Wyoming.

    Washington, D.C., and 17 states that have had comparatively low case rates are now seeing those rates "going up," according to the Times. Those states are Arizona, Colorado, Connecticut, Delaware, Louisiana, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Vermont, Virginia, and West Virginia.

    In the nine remaining U.S. states and territories, rates of newly reported coronavirus cases are "staying low," according to the Times' analysis.

    U.S. officials as of Monday morning also reported a total of 214,604 deaths linked to the coronavirus since the country's epidemic began—up from 212,778 deaths reported as of Friday morning.

    HHS looks to purchase hundreds of thousands of doses of experimental Covid-19 treatments

    As the coronavirus continues to spread throughout America and deaths related to the virus continue to rise, scientists have been scrambling to discover treatments for Covid-19, the disease caused by the virus, and to develop a vaccine against the pathogen. But although several pharmaceutical companies have begun late-stage trials on coronavirus vaccine candidates, many top health officials and drugmakers have said a coronavirus vaccine likely will not be ready for widespread distribution until the end of 2020 or later.

    As such, the Trump administration now is hoping to purchase enough doses of experimental antibody treatments for Covid-19 to help protect Americans against the novel coronavirus until a vaccine becomes available, Inside Health Policy reports.

    Specifically, Paul Mango, HHS' deputy chief of staff for policy, on Friday told Inside Health Policy that the Trump administration is looking to purchase doses of potential antibody treatments for Covid-19 to ensure the country has enough supplies of the drugs to distribute until a vaccine against the novel coronavirus is available. He said, "We have engaged in a number of contracts for procurement of these monoclonal antibodies already, so as they are fully manufactured, the federal government will have access to them."

    Further, Mango implied that the federal government would distribute the medications at no cost to the entities that receive them, Inside Health Policy reports. "For any product that we procure that's part of the Strategic National Stockpile, which is the means by which we are acquiring these, we are prohibited from selling it," Mango said.

    Mango's comments comer after President Trump in a video posted Wednesday credited Regeneron Pharmaceutical's experimental antibody treatment with helping him quickly recover from Covid-19 and said his administration would provide Americans with the experimental treatment at no cost. Separately, a top health official in the administration during a call with reporters on Friday said the administration expects to provide more than one million doses of antibody treatments to Covid-19 patients at no cost, Reuters reports.

    Later on Friday, HHS announced that it had reached a $486 million agreement with AstraZeneca to develop and secure supplies of up to 100,000 doses of its experimental antibody cocktail aimed at preventing or treating novel coronavirus infections. Under the agreement, AstraZeneca will evaluate the effectiveness of the possible Covid-19 treatment, which the company currently refers to as AZD7442, in two Phase 3 clinical trials. The deal will help the company cover the cost of development activities related to the antibody cocktail, including a large-scale manufacturing demonstration project for the drug and a supply of the drug. AstraZeneca estimates that 100,000 doses of AZD7442 could be available by the end of this year.

    "If the FDA authorizes use of AZD7442 for prevention of [coronavirus infection], as outlined in agency guidance, the federal government will distribute the doses at no cost," HHS said in a release. However, HHS added, "As is customary with government-purchased medical products, health care professionals could charge for the cost of administering the product."

    According to Politico, Trump has vowed that FDA will quickly authorize experimental antibody treatments for Covid-19.

    During a radio interview with Rush Limbaugh on Friday, Trump said he is working to get FDA to quickly authorize experimental antibody drugs developed by Eli Lilly and Regeneron and to get those potential treatments shipped out to hospitals, Reuters reports.

    There may be problems with the Trump admin's plans, experts say

    However, the Trump administration's push to quickly authorize and supply hospitals with the experimental antibody treatments could face some obstacles.

    For one, as Politico reports, there's only limited evidence so far that supports the effectiveness of these treatments for Covid-19 patients.

    Preliminary data on Regeneron's antibody cocktail from a late-stage clinical trial involving 275 participants showed that the treatment may reduce the viral loads of the novel coronavirus in patients and quicken recovery from infections with the virus. Meanwhile, partial results from a late-stage clinical trial on Eli Lilly's antibody treatments show the therapy may reduce patients' viral loads and possibly minimize Covid-19 symptoms.

    Regeneron and Eli Lilly on Wednesday each filed applications seeking emergency use authorizations from FDA for their drugs. However, it's unclear when FDA will issue decisions on the applications. FDA in a statement to Politico said it's the agency's policy to not issue comments on pending applications.

    In addition, many experts said they expect that antibody treatments will be in short supply if they are authorized for use, because few manufacturing facilities are equipped to produce them—and the cocktails are costly to develop, Politico reports.

    For instance, former FDA Commissioner Scott Gottlieb on Friday told CNBC's "Closing Bell" that the United States  likely would run out of supplies of the potential antibody treatments quickly—particularly if coronavirus infection rates in the country continue to accelerate.

    "You're gonna burn through the supply very quickly even if infection rates stay at the current levels, which I think that they'll probably continue to rise," he said  (Wilkerson [1], Inside Health Policy, 10/9 [subscription required]; Banerjee, Reuters, 10/9; Wilkerson [2], Inside Health Policy, 10/9 [subscription required]; Heavey, Reuters, 10/9; Brennan, Politico, 10/8; CNBC's "Closing Bell" tweet, 10/9; New York Times, 10/12).

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