[Ip-health] Fierce Pharma: AstraZeneca, Lilly, GSK and more will share COVID antibody secrets to speed manufacturing scale-up

Thiru Balasubramaniam thiru at keionline.org
Sun Jul 26 01:14:31 PDT 2020


https://www.fiercepharma.com/manufacturing/az-lilly-amgen-and-more-score-justice-department-nod-for-monoclonal-antibody-scale-up

Manufacturing

AstraZeneca, Lilly, GSK and more will share COVID antibody secrets to speed
manufacturing scale-up

by Fraiser Kansteiner | Jul 24, 2020 12:13pm


Six drugmakers working on COVID-19 antibody treatments want to swap
information and scale up production before those therapies win approval—and
now they have Justice Department approval to share their need-to-know
secrets.

Eli Lilly, AstraZeneca, Roche's Genentech unit, Amgen, GlaxoSmithKline and
Lilly partner AbCellera can now share manufacturing information that could
help speed up coronavirus antibody production, thanks to a business review
letter from the Justice Department's antitrust division.

The cadre of drugmakers—all in different stages of antibody
development—will share information about their manufacturing facilities,
capacity, raw materials and other supplies needed to pump out successful
monoclonal antibodies. Through the collaborative effort, the six firms aim
to lock down manufacturing capacity so they can deliver their
COVID-fighting treatments right out of the gate after regulatory approval.

Two things those drugmakers can't collaborate on, though? Production costs
and pricing. The DOJ believes sharing that info could lead to
anticompetitive behavior.

The rest of the collaboration could grant Americans access to potentially
life-saving treatments sooner—and without stymying competition from other
developers plotting antibody therapies for COVID-19.

"The demand for monoclonal antibodies targeting COVID-19 is likely to
exceed what any one firm could produce on its own," the DOJ said in its
letter. "Moreover, waiting until regulators approve specific treatments
before scaling up manufacturing might delay access to these potentially
life-saving medicines by many months, which adversely could affect the
nation’s efforts to fight COVID-19."

Monoclonal antibodies, which bind to targeted cells and tee them up for
elimination by the body's immune system, have become a hot ticket item in
the realm of COVID-19 treatment. In addition to their use as a therapy to
curb COVID-19 symptoms, monoclonal antibodies could potentially halt
infection, too, providing a much-needed alternative for those who are
vaccine-sensitive, like the elderly and the immunocompromised.

NIAID Director Anthony Fauci has pointed to antibody treatments several
times as an exciting prospect that could keep patients with milder cases of
COVID-19 from progressing to hospitalization. In a Medscape interview,
Fauci also highlighted the success of two earlier antibodies—monoclonal
antibody 144 and a Regeneron-made product—shown to slash death rates in
Ebola patients last year.

Notably absent from the collaboration project was Regeneron. The Tarrytown,
New York-headquartered biotech first pushed its antibody cocktail, dubbed
REGN-COV2, into clinical trials in June. The treatment was created by
selecting hundreds of neutralizing antibodies against SARS-CoV-2 from a
mouse model and humans who recovered from the virus. The company ultimately
settled on two of the most potent antibodies, pairing them to prevent a
viral mutation from evading treatment.

In July, Regeneron signed a $450 million deal with the Trump administration
to supply 1.6 million doses of its antibody cocktail, possibly by summer's
end, the company said. Because the biopharma is still pinning down dosage,
that order could eventually cover 70,000 to 300,000 treatment courses and
420,000 to 1.3 million preventive courses. The cocktail recently launched
into a phase 3 prevention trial and is plugging along in two phase 2
treatment studies.

Meanwhile, Eli Lilly started dosing COVID-19 patients in a phase 1 trial of
its AbCellera-partnered antibody therapy last month. The companies said
they expected results by the end of June, but that trial data hasn't yet
appeared. A little over a week after the Lilly-AbCellera announcement,
AstraZeneca revealed it had snagged the license for six
coronavirus-neutralizing antibodies from Vanderbilt University, with plans
to advance a pair into testing as a combo treatment for COVID-19.

And earlier this month, GlaxoSmithKline shelled out £234 million ($294
million) to Germany's CureVac to collaborate on mRNA-based vaccine and
monoclonal antibody development. Under the deal, GSK will fund CureVac's
COVID-19 research before stepping in to push those shots and therapies into
clinical testing, with CureVac retaining marketing rights in selected
countries.

-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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