Last checked at 
* Could offer an alternative advance protection for COVID-19
* Addressing people with weakened immune system
* Part of monoclonal antibody drug class
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By Ludwig Burger and Sachin Ravikumar
Oct 5 (Reuters) - AstraZeneca has requested
emergency approval from U.S. regulators for its antibody
cocktail, the first protective shot other than vaccines against
COVID-19, another potential major step in the global fight to
combat the virus.
While vaccines rely on an intact immune system to develop
targeted antibodies and infection-fighting cells, Astra's
biotech compound known as AZD7442 contains lab-made antibodies
designed to linger in the body for months to contain the virus
in case of an infection.
COVID-19 therapies based on the same class of monoclonal
antibodies are sold by rivals Regeneron, Eli Lilly
and GlaxoSmithKline and its partner Vir
to stop the disease from worsening during early, milder stages
of the infection.
The AstraZeneca therapy, designed to last several months to
a year, could protect people who do not have a strong enough
immune response to COVID-19 vaccines due to, for instance,
chemotherapy or anti-rejection drugs after organ transplants.
The drug, given in two sequential injections, could also
supplement a vaccination course for those, such as military
personnel, who need to booster their protection further,
AstraZeneca has said.
The U.S. Food and Drug Administration authorized Regeneron's
drug in September for use in preventing COVID-19 after exposure
to infected people. AstraZeneca's application is however for
prevention before any exposure.
Astra's AZD7442 fell through in the post-exposure setting in
a trial in June. Another trial https://clinicaltrials.gov/ct2/show/NCT04723394
is ongoing to test the drug as a treatment of the infected.
In a statement on Tuesday, the Anglo-Swedish drugmaker said
it included data in its filing with the FDA from a late-stage
trial that showed the drug reduced the risk of people developing
any COVID-19 symptoms by 77%. The positive trial data was
published in August.
SUPPLY TALKS
A U.S. authorisation for AZD7442 - based on antibodies
discovered by Vanderbilt University Medical Center in the United
States - could be a major win for AstraZeneca, whose widely used
COVID-19 vaccine has yet to be approved by U.S. authorities.
Talks regarding supply agreements for AZD7442 are ongoing
with the United States and other governments, AstraZeneca said.
The company agreed in March to supply up to half a million
extra doses of the antibody cocktail to the United States. The
$205 million U.S. extension deal built on a U.S. contract a year
ago for initial supplies of 200,000 doses.
In June last year, the U.S. provided $23.7 million in early
funding for the development project.
Britain's government also has an in-principle agreement over
a million doses of AZD7442. The government declined to provide
an update.
Under a plan to set up a global production network, Astra
enlisted contract manufacturer Lonza a year ago to
produce the antibody treatment in Portsmouth, New Hampshire,
starting in the first half of 2021.
The company did not immediately respond to a request for an
update on the supply and production agreements.
Astra's pioneering filing contrasts with delays in its quest
for approval for its COVID-19 vaccine Vaxzevria in the United
States, where the vast majority of those willing to get
immunised have already received shots from the Pfizer-BioNTech
alliance, Moderna or Johnson &
Johnson.
(Reporting by Sachin Ravikumar in Bengaluru and Ludwig Burger
in Frankfurt; Editing by Barbara Lewis and Keith Weir)
